U.S. Department of Health and Human Services

Nutrition and Your Health:
Dietary Guidelines for Americans

U.S. Department of Agriculture
 
Read all comments for the 2005 Dietary Guideline Committee Report:
 
select topic: Alcoholic Beverages    Carbohydrates    Discretionary Calories    Energy Balance/Weight Management     Fats    Fluids and Electrolytes    Food Groups    Food Safety    General/Overarching issues    Nutrient Intake    Physical Activity   

Number of Comments Found:446

Alcoholic Beverages
   General
Summary We think that the information provided to consumers on the alcohol content of various types of alcoholic beverages could be clearer, and suggest additional information to include.
Comments In general, we find that the science base section (D8) on ethanol is clearly written and provides consumers with easily accessible, scientifically valid information on the health effects of ethanol consumption. We suggest some relatively minor changes to the definition of a standard drink in order to provide consumers with the clearest possible information on the size of various alcoholic beverages and the relation to the amount of ethanol they contain. The current information in the proposed Guideline is: “One drink is defined as 12 oz of regular beer, 5 oz. of wine (12 percent alcohol), or 1.5 oz of 80-proof distilled spirits.” In our opinion, this definition would be clearer and more consistent if the percent alcohol were included with each type of beverage, and if the definition also stated that each of these standard drinks contains 0.6 fl oz of alcohol. In addition, the term “fl oz” (or fluid ounce) should be used. and the percent alcohol should be given for each type of beverage so that consumers of each understand that if they drink, for example, 60 proof distilled spirits, they will be consuming less than one standard drink. We suggest the following formulation: A standard drink, which contains 0.6 fluid ounces of alcohol, consists of: • 12 fluid ounces of regular beer (5 percent alcohol) • 5 fluid ounces of wine (12 percent alcohol) • 1.5 fluid ounces of 80-proof distilled spirits (40 percent alcohol). Thank you for the opportunity to comment on the proposed Guidelines. We hope that our suggestions will help improve communication with consumers. Sincerely, Ruth Kava, Ph.D., R.D. Director of Nutrition, ACSH Elizabeth M. Whelan, D.Sc., M.P.H. President, ACSH
Submission Date 9/22/2004 2:33:00 PM
Author American Council on Science and Health

Summary Recommend you revise the definition of "moderate" to the equivalent of 3 or 4 beers per week. This sends a much better signal to people on what is "healthy."
Comments By defining "moderation" as the equivalent of 2 beers per day, you are endorsing this quantity as acceptable. Inclusion of the words "or less" does not change this endorsement. Two beers a day may be what many Americans consume, but it is clear that the effects of this much alcohol for most people is just plain unhealthy.
Submission Date 9/23/2004 10:19:00 PM
Author from Canal Winchester, OH

Summary The Committee report states: One drink is defined as 12 oz of regular beer, 5 oz. of wine (12 percent alcohol), or 1.5 oz of 80-proof distilled spirits. It would be more useful to consumers if it included the information that defined each drink in terms of 0.6 fluid ounces of alcohol.
Comments Clearly written consumer guidance on ethanol, with a comprehendible and consistent definition of a standard drink will assist dietitians and other health professionals in giving guidance about moderate and responsible consumption of alcohol for those adults who choose to drink. Given the importance of the definition of a drink in giving guidance for following the ethanol guideline, I propose two recommendations to make this statement more clear. First, the addition of the percent alcohol for wine that was added in the 2005 draft is extremely helpful, but propose that the percent alcohol should be stated for each type of beverage. Second, an additional important piece of information is that each of these standard drinks contains 0.6 fl oz of alcohol. There is a wide variety of alcohol beverages that have different percents of alcohol. Knowing that a ¡§standard drink¡¨ contains 0.6 fl oz of alcohol would allow the individual who consumes alcohol drinks to easily determine the amount of alcohol they are consuming so that they can follow the moderation guideline.
Submission Date 9/24/2004 4:05:00 PM
Author from boston, ma

Summary Standard drink definition should include amount of alcohol in each drink (0.6 fl ounces). Suggestion: 12 fl ounces of regular beer (5% alcohol); 5 fl ounces of wine (12% alcohol); 1.5 fl ounces of 80-proof distilled spirits (40% alcohol). Each standard drink contains 0.6 fl ounces of alcohol.
Comments September 24, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science STE LL100 1101 Wootton Parkway Rockville, MD 20852 FR Docket No. 04-19563, Department of Health and Human Services, Announcement of the Availability of the Final Report of the Dietary Guidelines Advisory Committee, a Public Comment Period, and a Public Meeting Dear Ms. McMurry: Thank you for providing the opportunity to comment on the Advisory Committee’s draft report of the 2005 Dietary Guidelines for Americans. These Guidelines are an important tool for consumers and the dietitians and other health professionals who advise them. As a professor in the Department of Family Medicine in the Graduate School of Medicine at the University of Tennessee, and past-president of the American Dietetic Association, I would like to thank the Committee for its efforts to provide useful and clear guidance on alcohol consumption. In general, the alcohol guideline provides evidence based information that will be helpful to dietitians and all health professionals in providing guidance to their patients. In counseling with patients, I am often asked, “What does moderation mean?” and “How much is a drink?” To effectively explain moderation, I need to be able to clearly communicate the meaning of a standard drink. The current definition in the proposed guideline is helpful. However, a clearer and more complete definition would better assist the dietitian in communicating the guidance on moderate and responsible consumption as defined in the alcohol guideline to their adult patients who choose to drink. The proposed 2005 guideline defines a standard drink as: One drink is defined as 12 oz of regular beer, 5 oz. of wine (12 percent alcohol), or 1.5 oz of 80-proof distilled spirits. The addition in the current draft of the percent alcohol for a serving of wine is an excellent revision to past Guidelines. However, to make this definition more complete and consistent, information on percent of alcohol by volume for each type of alcohol beverage (beer, wine and distilled spirits) should be included. Additionally, in counseling patients, dietitians address the fact that the alcohol content in different types of alcohol drinks may vary. Thus, the drink definition should also include information on the amount of alcohol in each standard drink (0.6 fl ounces). This information will provide a benchmark for quantification and assist consumers to better determine the number of standard drinks they are consuming. The additional clarifications I have suggested, as illustrated below, will provide consumers with the necessary information to most easily follow the recommendations set forth in the alcohol guideline. A standard drink is defined as: • 12 fluid ounces of regular beer (5 percent alcohol) • 5 fluid ounces of wine (12 percent alcohol) • 1.5 fluid ounces of 80-proof distilled spirits (40 percent alcohol). Each standard drink contains 0.6 fl ounces of alcohol. Once again I appreciate the opportunity to comment on the proposed 2005 Dietary Guideline’s guideline on alcohol. As a dietitian, I am committed to providing accurate and meaningful information to my patients regarding their diet and lifestyle. I think the suggested revisions will provide useful information to all health professionals in communicating their messages to their patients. Sincerely, Jane White, PhD, RD, FADA Professor, Department of Family Medicine Graduate School of Medicine University of Tennessee – Knoxville Knoxville, TN
Submission Date 9/24/2004 6:00:00 PM
Author University of Tennessee – Knoxville

Summary
Comments Alcohol risks listed do not include women with risk factors for breast cancer. The best studies are absolutely conclusive regarding the link, with the curve of risk never reaching zero even with only a very, very small alcohol intake.
Submission Date 9/27/2004 11:25:00 AM
Author American College of Preventive Medicine

Summary Health Professionals wishing to have the Dietary Guidelines provide additional information for patients so that they can more easily calculate the amount of alcohol they are consuming when they drink alcohol. This can be for patient self-education or in the context of working with a physician.
Comments Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science STE LL100 1101 Wootton Parkway Rockville, MD 20852 RE: Federal Register Docket No. 04-19563, Department of Health and Human Services, Announcement of the Availability of the Final Report of the Dietary Guidelines Advisory Committee, a Public Comment Period, and a Public Meeting. Dear Ms. McMurry: Thank you for the opportunity to provide comments on the alcohol guideline in the proposed 2005 Dietary Guidelines for Americans. As physicians we regularly see patients who have various questions regarding drinking alcohol. We find that the alcohol guideline provides very informative, evidenced based information that will be helpful in providing guidance. We do wish to bring attention to one area where we believe the Dietary Guidelines can be improved even further. One scenario that repeatedly arises in patient interactions is, “Can I figure out how much I am drinking when I drink?” We are asking whether it could be possible to make a few changes that could provide even more useful information for physicians to communicate the guidance provided on consumption of alcohol? The current definition of a drink in the 2005 proposed Guideline is: “One drink is defined as 12 oz of regular beer, 5 oz. of wine (12 percent alcohol), or 1.5 oz of 80-proof distilled spirits.” To make this definition most clear, percent of alcohol by volume should be included for each type of alcohol drink. This would assist in helping patients calculate their total alcohol intake. Furthermore, the definition should also include a statement regarding the amount of alcohol in each drink. This additional information would provide the individual all necessary information to determine the amount of alcohol he or she is consuming so that they may follow the recommendations for moderation set forth in the proposed 2005 alcohol guideline. In addition and we believe of even greater importance, the guidelines could then be used to demonstrate to patients who are not drinking in a healthy manner, the amount by wish they might be misjudging their own alcohol intake due to lack of knowledge concerning equivalence of alcohol across types of drinks consumed. Some patients are uncomfortable discussing their drinking patterns with physicians and we believe that with the following changes, the dietary guidelines could be brought home from the physicians visit and used for self-education concerning this and many other topics of nutrition and health. We suggest the following drink definition: A standard drink contains 0.6 fluid ounces of alcohol. A standard drink is defined as: 12 ounces of regular beer (5 percent alcohol) 5 ounces of wine (12 percent alcohol) 1.5 ounces of 80-proof distilled spirits (40 percent alcohol). In discussions with patients we point out that there is a range of alcohol content in drinks and that they must therefore be aware of alcohol content they are consuming when they choose to drink. The Standard Drink is a helpful and easy way to help educate patients concerning total alcohol consumption. This is why we think it is important to include the amount of alcohol per standard serving in the 2005 Dietary Guidelines definition of a standard drink. Providing this information makes it straightforward for the health-conscious consumer to calculate the amount of alcohol they are consuming. This knowledge is key to making responsible decisions about drinking and following the Dietary Guidelines recommendations on moderation. We appreciate the opportunity to comment on the alcohol guideline in the proposed 2005 Dietary Guidelines. As physicians we are committed to providing patients with the most accurate and useful information for making prudent choices in their diet and lifestyle. We feel that our suggested revisions to the alcohol guideline will assist physicians and all health professionals in communicating to patients who choose to drink alcohol, the information most accurate and useful for making responsible decisions about drinking moderately. Please contact Howard Forman at hforman@aecom.yu.edu if you have any questions or would like more information. Sincerely, Stephen M. Kreitzer M.D. Internal Medicine, Pulmonary Medicine, Sleep Medicine Nava Bak M.D. Emergency Medicine Howard Forman Co-Chair, American Medical Association Action Team on Alcohol and Health
Submission Date 9/27/2004 11:33:00 AM
Author from Bronx, NY

Summary Supporting text should include alcohol consumption as a risk factor for breast cancer, as well as for high blood pressure and congestive heart failure if drinking is prolonged.
Comments
Submission Date 9/27/2004 1:18:00 PM
Author ACS, ADA, AHA

Summary Drink definition should include alcohol % for each type & add each drink contains 0.6 oz. The calorie table for alcohol is misleading & has inaccurate information. The recommendation to reduce alcohol consumption as a good weight loss strategy is not supported by the scientific literature.
Comments September 27, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science 1101 Wootton Parkway, Suite LL100 Rockville, Maryland 20852 Regarding: Federal Register Docket No. 04-19563; Department of Health and Human Services, Announcement of the Availability of the Final Report of the Dietary Guidelines Advisory Committee, a Public Comment Period, and a Public Meeting. Dear Ms. McMurry: The Distilled Spirits Council of the United States, Inc. (DISCUS) is a national trade association representing producers and marketers of distilled spirits and importers of wine sold in this country. We appreciate the opportunity to provide comments concerning the 2005 Committee report for the Dietary Guidelines for Americans that will be published by the Departments of Agriculture and Health and Human Services. These Guidelines provide an important public service to Americans and provide the basis for Federal nutrition policy and nutrition education activities. DISCUS and its members stand second to none in our concern about the abuse of beverage alcohol products. Throughout the decades, DISCUS and its members have developed, disseminated and supported numerous programs to reduce drunk driving; illegal underage drinking; and all forms of alcohol abuse. Many of these programs include the Dietary Guidelines alcohol guideline as a key message. DISCUS disseminates several thousand copies of the Dietary Guidelines at various venues throughout the year. Our commitment to combating alcohol abuse is longstanding and steadfast. Alcohol guideline We commend the Dietary Guidelines Advisory Committee’s commitment to provide evidenced based dietary guidance to consumers regarding beverage alcohol consumption. We strongly agree with the beverage alcohol guideline’s primary message concerning beverage alcohol consumption—“If you drink alcoholic beverages, do so in moderation.” This message has been the centerpiece of all editions of the Dietary Guidelines and of many education programs and efforts undertaken and supported by DISCUS and its members over the decades. In that regard, we will continue to incorporate the Dietary Guidelines into our programs and offer any help or assistance to the Department of Agriculture in its mandate to provide these guidelines to health professionals who provide nutrition and lifestyle advice to consumers. Standard drink definition It is essential that the evidence-based guidance on ethanol is supplemented with a complete and consistent definition of a standard drink. A clear understanding of a standard drink will assist the individual in following the alcohol guideline. We propose two recommendations to improve the clarity and completeness of the definition of a standard drink proposed in the 2005 Committee report. First, while the addition of the percent alcohol for wine that was added in the 2005 Committee report is extremely helpful towards a clearer definition, a further improvement would be that the percent alcohol should be stated for each type of beverage alcohol product. Second, an additional important piece of information is that each of these standard drinks contains 0.6 fl oz of alcohol. There is a wide variety of alcohol beverages that have different percents of alcohol. Knowing that a “standard drink” contains 0.6 fl oz of alcohol would provide an individual with necessary information to determine the amount of alcohol he or she is consuming, which is all about making responsible decisions about drinking moderately. The Committee report states: “One drink is defined as 12 ounces of regular beer, 5 ounces of wine (12% alcohol), or 1.5 ounces of 80-proof distilled spirits.” We suggest that the following definition would provide the most accurate and useful information to help consumers make responsible choices about beverage alcohol consumption: A standard drink contains 0.6 fluid ounces of alcohol. A standard drink is defined as: • 12 fluid ounces of regular beer (5 percent alcohol) • 5 fluid ounces of wine (12 percent alcohol); or • 1.5 fluid ounces of 80-proof distilled spirits (40 percent alcohol). The U.S. Department of Education’s Higher Education Center for Alcohol and Other Drug Abuse and Violence uses a similar definition (Please see Appendix 1). There can be a range of alcohol content in drinks. This is precisely why we think it is important to include the amount of alcohol per standard serving in the 2005 Dietary Guidelines definition of a standard drink. Providing this information makes it straightforward for the consumer to calculate the amount of alcohol they are consuming. This knowledge is key to enabling consumers to make responsible decisions about drinking in following the Dietary Guidelines recommendations on moderation. A guideline on moderate drinking Since the overwhelming majority of adult Americans who choose to drink do so responsibly and are at low risk for developing problems (NIH publication, 2000), a balanced discussion regarding moderate beverage alcohol consumption is of critical importance in formulating our nation’s nutrition and dietary policy, which is a stated goal of the Dietary Guidelines. Furthermore, the point has been made by the Committee that the Dietary Guidelines are intended for “healthy” Americans. “Healthy” adult Americans are those who either drink in moderation or choose to abstain. Therefore, the beverage alcohol guideline should start out with a statement that the overwhelming majority of adult Americans drink moderately or abstain. This statement emphasizes normative behavior and the expectations in our society for those adults that choose to drink (NIH publication, 2000). This also incorporates the Committee’s recommendation that language be added to state that abstention is an appropriate personal choice. DISCUS fully supports the right of an adult to abstain. Finally, the Departments of HHS and Agriculture should consider adding to the Dietary Guidelines NIAAA’s conclusion in its submission to the Committee: “Except for those individuals at particular risk (as are described in the current guidelines), consumption of 2 drinks a day for men and 1 for women is unlikely to increase health risks. As risks for some conditions and diseases do increase at higher levels of consumption, men should be cautioned to not exceed 4 drinks on any day and women to not exceed 3 on any day." (NIAAA, 2003, page 30) Calories Table E-3: Estimated Caloric Content of Alcoholic Beverages, is in some instances misleading to the consumer and in other cases incorrect. Although the majority of distilled spirits contain 100 calories, wine 100 calories and regular beer 150 calories per standard drink, there is certainly some variability in calories. Therefore, a general statement that some beers, wines and distilled spirits may have higher or lower calories may be helpful. The Dietary Guidelines, however, is not an appropriate vehicle to attempt to present an exhaustive list of drinks with associated calories. First, recipes for ingredients other than alcohol differ greatly depending on the individual making the drink, for example, regular soda vs. diet soda. Even though the Table states that calorie content may differ by recipe, recipes for many drinks are so varied that calories in a mixed drink could differ by 100 %. For this reason, it is not helpful to provide calorie estimates for mixed drinks, which include ingredients other than beverage alcohol. Second, the drink by drink approach is not only unhelpful, but unnecessary. We are not aware of any literature supporting the proposition that consumers are unaware that adding a mixer (such as juice) to beverage alcohol adds additional calories or, conversely, that adding a mixer (such as a no calorie soda) does not add extra calories. Finally, the Table lists “dark beer” as 165 calories. “Dark" beer is a category that contains many types of beer with different calories. For example, Guinness, which accounts for 95% of the Stout consumed in the United States, is probably among the best known of the “dark" beers. Guinness Stout has only 125 calories per serving. Obesity According to several studies over the past two decades, (For example see, Jequier, 1999; Cordain et al., 1997; Kahn et al., 1997; Mannisto et al., 1997; Istvan et al., 1995; Prentice, 1995; Liu et al., 1994; Colditz et al, 1991; Hellerstedt et al., 1990), the relationship between moderate alcohol consumption and obesity is unclear. For example, Lands (1995), in a review article concluded that the cumulative evidence of 31 separate studies does not support the concept that reduced alcohol consumption would help maintain a lower body weight. This conclusion was echoed in the NIAAA review of the literature submitted to the Committee (NIAAA, 2003), which stated that, “Thus far, the evidence on the relationship between moderate alcohol consumption and obesity remains inconclusive.” The NIAAA report goes on to state that “…there appears to be some protective effect of moderate consumption on two of the major sequelae of obesity, i.e., metabolic syndrome and diabetes.” The draft report states “The healthiest way to reduce calorie intake is to reduce one’s intake of saturated fat, added sugars and alcohol—they all provide calories, but don’t provide essential nutrients.” This may be misleading to those consumers who moderately consume beverage alcohol products and are interested in losing weight. First, much of the data shows that the extra calories from one or two drinks a day does not result in weight gain. Therefore, it is unclear whether calorie reduction by simply not consuming beverage alcohol will actually result in weight loss to the individual who has been moderately consuming. Certainly, given the ambiguities in the existing research literature, a clinical trial should be completed before the government recommends to the moderate consumer of beverage alcohol that they will lose weight by reducing their beverage alcohol consumption. Second, the literature shows that there may be some protective effect of moderate consumption of beverage alcohol on two major sequelae of obesity; metabolic syndrome and Type II Diabetes; particularly in overweight individuals (NIAAA, 2003). Thus, the recommendation to the moderate consumer of beverage alcohol to reduce alcohol consumption to reduce weight may not result in weight loss and may eliminate a potential protective effect for Type II diabetes and metabolic syndrome. Again, we urge that clinical trials be concluded before a recommendation is made that may be at best misleading to the individual attempting to lose weight, and at worst result in a potential increased risk of disease for some individuals. “Question 1: Among persons who consume four or fewer alcoholic beverages per day, what is the dose-response relationship between alcohol intake and health?” Conclusion 4. states, “Relationships of alcohol consumption with major causes of death do not differ for middle-aged and elderly Americans. Among younger people, however, alcohol consumption appears to provide little, if any, health benefit; alcohol use among young adults is associated with a higher risk of traumatic injury or death.” First, while mortality data indicate that there are few coronary deaths under the ages of 45 for men and 55 for women (NIAAA, 2003), there is a lack of scientific data to show whether or not potential benefits may accrue from exposure at an earlier age. In fact, most of the epidemiological data on risk reductions are from populations who have been drinking over several decades, not just at a point in time in their fourth or fifth decade. Thus, there does not appear to be scientific justification for the statement that moderate consumption provides little, if any, potential health benefit for younger adults (NIAAA, 2003, page 8). Second, we are aware of no data that support the statement that alcohol use among “young adults” is associated with a higher risk of traumatic injury or death and, certainly, none is provided in the draft. Furthermore, this statement is vague with respect to both age and alcohol consumption. The term young adult can refer to anyone from age 18-40. In addition, there is no qualification of the amount of beverage alcohol consumed. Taken to an extreme example, the individual can interpret that sentence to mean a 39 year old woman who consumes one drink per week is at increased risk for traumatic injury and death. Again, there is certainly no scientific data to support this statement. Meals versus Food We would like to again comment on the suggestion made by several Committee members over the past few editions of the Dietary Guidelines to consider changing consuming beverage alcohol with “meals” to “food.” Food is often consumed outside of what traditionally is considered a meal. Consumers may find themselves in social situations outside of regularly scheduled meal times where they may wish to consume a beverage alcohol product, such as having a cocktail at a reception or party where food is served, before dinner at home with a snack or hors d’oeuvres, or as an after dinner drink. The language in the 2000 Dietary Guidelines’ beverage alcohol guideline may create confusion among consumers inasmuch as the guideline suggests only consuming beverage alcohol with a meal. Moreover, there is no scientific evidence to suggest that consuming beverage alcohol only with meals is a more healthy choice. For example, in a study by Mukamal et al. (2003), the association of beverage alcohol consumption and cardiovascular disease was examined with consumption during meals as an independent variable. There were no differences in reduced risk of cardiovascular disease risk when beverage alcohol was consumed with meals versus not with meals. Clearly, the intent of the 2005 edition of the Dietary Guidelines is to encourage individuals to consume food when they are consuming a beverage alcohol product in order to slow down absorption. The food consumed with beverage alcohol, however, need not and should not be limited to food consumed only as part of a formal meal. Illegal underage consumption Research recommendation # 23 is: “Investigate the impact of banning alcohol advertising when and where it might increase underage drinking (e.g., during college sports events).” As stated earlier, the Distilled Spirits Council of the United States and its sister organization, The Century Council, have developed and implemented numerous programs over the decades aimed at reducing illegal, underage drinking. We all agree that underage drinking is unacceptable and is a complex societal problem that requires a sustained, collaborative commitment. The National Academy of Sciences (NAS) recently reviewed the scientific literature to develop a strategy to reduce underage drinking. The number one recommendation was a media campaign directed at parents. In reviewing the literature on advertising, NAS concluded that accumulated evidence does not demonstrate that advertising causes underage persons to consume beverage alcohol. The Department of Health and Human Services reached the same conclusion in their 1990 and 2000 Report to Congress (U.S. HHS, and NIAAA, 1990, 2000). It seems prudent to focus research recommendations on evidenced based factors. Finally, the data are clear that the majority of beverage alcohol consumed by underage persons is obtained through parents and other adults (NAS, 2003; FTC, 2003). A statement reminding adults not to provide beverage alcohol to underage consumers would appear to be warranted. Food Guide Pyramid There has been discussion about including beverage alcohol in the revised Food Guide Graphic that has been known as the Food Guide Pyramid for decades. The current preamble states: What's in this booklet for me? This booklet introduces you to The Food Guide Pyramid. The Pyramid illustrates the research-based food guidance system developed by USDA and supported by the Department of Health and Human Services (HHS). It goes beyond the "basic four food groups" to help you put the Dietary Guidelines into action. The Pyramid is based on USDA's research on what foods Americans eat, what nutrients are in these foods, and how to make the best food choices for you. The Pyramid and this booklet will help you choose what and how much to eat from each food group to get the nutrients you need and not too many calories, or too much fat, saturated fat, cholesterol, sugar, sodium, or alcohol. Indeed, the assumption would be that the Food Guide Graphic would offer guidance on all areas mentioned in the Dietary Guidelines. Many individuals only see the Food Guide Graphic and do not read the entire Dietary Guidelines and therefore, at this point in time, are left without the Guidelines’ message on beverage alcohol consumption. Additionally, this is a missed opportunity to reinforce messages on moderate and responsible consumption. Concern was raised by the Committee that the Food Guide Graphic is for all individuals greater than two years of age and that including alcohol in the Graphic may result in mixed messages for the underage. As the Food Guide Graphic will be revised to reflect the 2005 Dietary Guidelines, we think that it will be important to include beverage alcohol consumption so that a greater number of individuals will be exposed to the government’s guideline on beverage alcohol consumption. It has been mentioned repeatedly that one graphic may not be appropriate for all consumers and that there is a need for flexibility. Thus, there can be, as one suggestion, a version of the Food Guide Graphic for adults over the age of 21 so that they can benefit from a visual representation of the Dietary Guideline advice on how to make choices about beverage alcohol consumption in the context of an overall adult healthy diet. Conclusion The beverage alcohol guideline in the 2005 edition of the Dietary Guidelines for Americans will continue to assist adult Americans in making informed decisions for a healthy diet and lifestyle. For this reason, it is important that the statements in the alcohol guideline, as in all other guidelines in the Dietary Guidelines, are based on sound science. Furthermore, we feel that the revisions we have suggested to make the standard drink definition more complete and consistent will assist individuals in following the guidance for moderate beverage alcohol consumption as set forth in the 2005 Committee report. We thank you in advance for consideration of our comments. If you have any questions concerning our comments or if we can be of any assistance, please contact Monica Gourovitch, Ph.D. at Distilled Spirits Council of the U.S. (202.682.8837; mgourovitch@discus.org). Sincerely, Monica L. Gourovitch, Ph.D. Sr. VP, Office of Scientific Affairs Distilled Spirits Council of the United States CC: The Honorable Tommy Thompson The Honorable Ann Veneman Ms. Carole Davis References Colditz, G. A., Giovannucci, E., Rimm, E., Stampfer, M. J., Speizer, F. E., Gordis, E., Willett, W. Alcohol intake in relation to diet and obesity in women and men. (1991). American Journal of Clinical Nutrition, 54, 49-55. Cordain, L., Bryan, E. D., Melby, C. L., Smith, M. J. Influence of moderate daily wine consumption upon body weight regulation and metabolism in healthy free living males. (1997). Journal of the American College of Nutrition, 16(2), 134-139. Federal Trade Commission. (September 2003). Alcohol Marketing and Advertising, A Report to Congress. Hellerstedt, W. L., Jeffery, R. W., Murray, D. M. The association between alcohol intake and adiposity in the general population. (1990). American Journal of Epidemiology, 132(4), 594-611. Institute of Medicine, National Research Council of the National Academies. (September 2003). Reducing Underage Drinking A Collective Responsibility. The National Academies Press Washington, D.C. Istvan, J., Murray, R., Voelker, H. The relationship between patterns of alcohol consumption and body weight. (1995). International Journal of Epidemiology, 24(3), 543-546. Jequier, E. Alcohol intake and body weight: a paradox. (1999). American Journal of Clinical Nutrition, 69, 173-174. Kahn, H. S., Tatham, L. M., Rodriguez, C., Calle, E. E., Thun, M. J., Heath, C. W. Stable behaviors associated with adults' 10-year change in body mass index and the likelihood of gain at the waist. (1997). American Journal of Public Health, 87(5), 747-754. Lands, M. Alcohol and energy intake. (1995). American Journal of Clinical Nutrition, 62(5-suppl), 1101S-1106S. Liu, S., Serdula, M. K., Williamson, D. F., Mokdad, A. H., Byers, T. A prospective study of alcohol intake and change in body weight among US adults. (1994). American Journal of Epidemiology, 140(10), 912-920. Mannisto, S., Uusitalo, K., Roos, E., Fogelholm, M., Pietinen, P. Alcohol beverage drinking, diet and body mass index in a cross-national survey. (1997). European Journal of Clinical Nutrition, 151, 326-332. Mukamal, K. J., Conigrave, K, M., Mittleman, M. A., Camargo, C. A., Stampfer, M. J., Willett, W. C., Rimm, E. B. Roles of drinking pattern and type of alcohol consumed in coronary heart disease in men. (2003). The New England Journal of Medicine, 348, (2), 109-118. National Institutes of Health, National Institute on Alcohol Abuse and Alcoholism and Department of Health & Human Services. (2003). State of the Science Report on the Effects of Moderate Drinking. Prentice, A. M. Alcohol and obesity. (1995). International Journal of Obesity, 19(5), S44-S50. U.S. Department of Health & Human Services, Public Health Service Alcohol, Drug Abuse, and Mental Health Administration, National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism. (1990). Seventh Special Report to the U.S. Congress: Alcohol and Health (DHHS Publication No. (ADM) 90-1656). U.S. Department of Health & Human Services, Public Health Service, National Institute of Health and National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism. (2000). 10th Special Report to the U.S. Congress: Alcohol and Health (DHHS Publication No. (ADM) 90-1656). U.S. Department of Health & Human Services, National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism. (2000). The Physicians guide to helping patients with alcohol problems (NIH Publication No. 95-3769).
Submission Date 9/27/2004 4:58:00 PM
Author Distilled Spirits Council of the U.S.

Summary We recommend the definition of one drink of wine be retained as stated in the 2000 version of the Guidelines in Box 26 – What is Drinking in Moderation? Any changes made to the current definition would lead to inaccurate and misleading representations of the Guidelines’ moderation message.
Comments September 27, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science Suite LL100 1101 Wootton Parkway Rockville, MD 20852 Dear Ms. McMurry: Wine Institute is the public policy association of California wineries representing over 800 California wineries and affiliated businesses. These companies are responsible for 80 percent of the nation’s wine production. On behalf or our members, we are pleased to submit comments in response to the request for public input on the 2005 Dietary Guidelines Advisory Committee Report to the Departments of Health and Human Services and Agriculture. We agree that the 2005 Dietary Guidelines for Americans should represent a balanced approach to recommendations on the full range of nutrition, lifestyle and health issues. In particular, we support the Ethanol Subcommittee’s continued recommended advice to discourage excessive consumption and indicate that, even in moderation, there are individuals who should not drink. We are pleased that the main alcohol message has been maintained from the 2000 Dietary Guidelines: “If you drink alcoholic beverages, do so in moderation” and that the Committee has maintained the recommendation (advice) that, “For those who choose to drink an alcoholic beverage, it is advisable to consume it with meals to slow absorption. Data suggest that the presence of food in the stomach can slow the absorption of alcohol and thereby mitigate the associated rise in blood alcohol concentration.” While we support the majority of the findings in the Committee Report, we would like to provide additional comment in two important areas: • There should be no changes to the Drinking In Moderation Definition, especially with the “Count as a Drink” language regarding expressions of alcohol content for wine, because there will be extensive rulemaking by the Treasury Department’s Tax and Trade Bureau (TTB) in 2005 that will address several significant issues that are based on the language of the Dietary Guidelines. Language in the Dietary Guidelines should not be misused or misconstrued in any future regulatory action or rulemaking. • Messages relating to moderate drinking and weight gain and obesity for the public should clearly state that the scientific findings in this area are inconclusive and that alcohol, as well as other sources of discretionary calories, should be monitored closely for optimal health. I. MODERATE DRINKING DEFINITION In the 2000 version of the Dietary Guidelines for Americans, drinking in moderation is defined in Box 26 on page 36 - What is Drinking in Moderation?: The Advice For Today on page 37 goes one step further and recommends “Limit intake to one drink per day for women and two per day for men, and take with meals to slow alcohol absorption.” The Advisory Committee found this definition of moderate drinking as optimal for adults who choose to drink as a means to provide both beneficial effects on heart disease and all-cause mortality as well as reduce risks caused by heavy drinking. However, the Advisory Committee also states that, “The definition of moderation, including the size of one drink, requires emphasis. (Some investigators and apparently many individuals interpret ‘moderate drinking’ to cover higher levels of intake than shown in Table E-25. Many mixed drinks actually provide several servings of alcohol per drink.” (DG Advisory Committee Report, Part D, Section 8, page 3). In an apparent response to further define a moderate serving of each beverage, the Advisory Committee has added a “12 percent alcohol” qualifier to the definition of a serving of wine. Throughout the text of the Advisory Committee Report, one serving of wine is defined as “a 5-ounce glass of 12 percent alcohol.” (See Table E-25, below). Wine Institute believes that providing the public a frame of reference by including serving size information in ounces will assist wine, beer, and distilled spirits consumers in their awareness of alcohol consumption levels. We believe that direct serving size information in ounces about the product being consumed is relevant and, if truthful, accurate and specific, should be able to be included. However, within each category of drinks (wine, beer and distilled spirits) there is a range of products with different alcohol percent values. Unlike distilled spirits, wine is not a “mixed” drink. Consumers discriminate among the various wine products more by their broad product categories, and producers of wine do not target a particular alcohol level but a sensory style and taste. Even from a regulatory standpoint, the standards of identity for wine differ significantly from distilled spirits product standards. Table wine, for example, is defined as still wine between 7 and 14 percent alcohol by volume. While from a scientific or clinical standpoint it may make sense to qualify wine with a specific alcohol content, we do not believe that assigning an arbitrary value of 12 percent alcohol to wine provides the consumer with any additional useful information from which to make an informed decision. As the alcohol percent value of table wine varies between 7 percent and 14 percent and that for dessert wine is 14 percent and above, such a listing would not necessarily be truthful or accurate and could be misleading. We believe that the addition of a “12% alcohol” qualifier in the “Count as a Drink” language will be misinterpreted by some as the establishment of a “standard drink” size, which will eventually lead to a distortion and/or omission of the important moderation message. The Guidelines represent great efforts to explain moderate consumption to U.S. consumers, but they have also been misunderstood. We are seeing the moderation message giving way to a much broader interpretation that the Guidelines themselves have established the size of a “standard drink,” and there have been several regulatory actions that have been based on this contention. We have seen the “count as a drink” language stripped of its accompanying moderation context, with what remains being repackaged as a definition for a “standard drink.” We do not believe that this is what was intended by the authors of the Guidelines, and we are concerned that this misinterpretation and misuse, all pending the safeguards of future rulemaking, will raise serious social as well as political implications. While adding a “12% alcohol” qualifier to wine may appear to be minor and consistent with the “80 proof distilled spirits” language, we are concerned that such changes will result in an argument that these sizes equate to “standard drink” sizes and will become the basis for untruthful and misleading information on wine, beer, and spirits labels. Changes such as this will tend to bolster an argument that all alcoholic beverages are “equal,” a notion that Wine Institute disagrees with. It is an oversimplification to single out the ethyl alcohol property that all alcoholic beverages have in common, and then to conveniently boot strap this commonality into a graphic equation that all alcoholic beverages are equal but only in specific but differing quantities. There are three separate regulatory actions that are pending administrative rulemaking, all based in large part on the contention that the U.S. Dietary Guidelines have established standard serving sizes. Carbohydrate Labeling of Alcoholic Beverages Awaits Rulemaking On April 7, 2004, without the benefit and safeguards of the rulemaking process, the TTB published an Industry Circular that authorized the voluntary labeling of carbohydrate information for wine, beer, and distilled spirits . Citing the 2000 Dietary Guidelines , TTB in its Industry Circular uses the Dietary Guidelines “Count as a drink” language as a measure of a serving size: Accordingly, this ruling holds that the statement of average analysis must apply to a serving of the product, and that the serving must be 12 fl. oz. for malt beverages, 5 fl. oz. for wine, and 1.5 fl. oz. for distilled spirits. TTB indicates in this ruling that it will conduct a rulemaking on this issue in the future. To date, almost six months since the publication of this interim policy, Wine Institute still awaits the promised publication of a Notice of Proposed Rulemaking by TTB on this matter. The significance of this action, however, should not be lost. This is an instance where an administrative agency has taken information from the Dietary Guidelines, eliminated the notion of moderate consumption, and concludes that the “Count as a drink” volumes for alcoholic beverages are “standard drink” sizes. “Serving Facts Panel” Labeling of Alcoholic Beverages Awaits Rulemaking The issue of whether the Dietary Guidelines established a definition of a “standard drink” came to light again with TTB in early August, 2004. On August 5, 2004, and again without the benefit of rulemaking, TTB released what it referred to as a “Serving Facts White Paper” where the identical drink volume values were being used by TTB to permit not simply additional nutritional information, but a comparative “equivalency” graphic” showing illustrations of a beer, wine and spirits container: The beer and wine sectors of the alcoholic beverage industry, strenuously objected to both the process and the content of the “White Paper.” Wine Institute opposed the “White Paper” for many reasons, but we point out that the term “standard drink” used by TTB and attributed to the Dietary Guidelines does not appear anywhere within the 2000 version of the Dietary Guidelines. It should be noted that TTB did not move ahead on this version of the “Serving Facts Panel” white paper, but revised and reissued a second white paper on September 21, 2004. While this white paper removes the more onerous provisions embodied in the first version and is careful not to use the term “standard drink,” this second white paper maintains, without benefit of rulemaking, serving size information that is identical to the Guidelines’ “Count as a Drink” sizes. TTB states in this version of the white paper that it will be conducting a rulemaking in the future. National Consumer League / Center for Science in the Public Interest Rulemaking Petition Awaits Rulemaking Submitted to TTB in December of 2003, the rulemaking petition of the National Consumer League and the Center for Science in the Public Interest calls for uniform information on several label items: • Alcohol content • Standard serving size • Amount of alcohol in ounces and number of calories per serving • Number of standard drinks per container • Ingredient declaration • U.S. Dietary Guideline recommendations for moderate drinking The petitioners contend that more uniform alcohol information should be conveyed to consumers in a context where consumers can more easily understand how much alcohol they are consuming. They suggest that the serving sizes “prescribed” by the U.S. Dietary Guidelines should be used as the “standard serving size.” Additionally, the petitioners suggest that a consistent graphic, such as a beer mug or a glass of wine, be used to alert consumers to the statement. The sample label proposed in that petition looks like this: We urge the authors of the Dietary Guidelines 2005 version to allow for the completion of rulemaking before considering any changes to that portion of the Guidelines. II. CALORIES AND WEIGHT The issue of caloric content and association of alcohol with added sugar and solid fats in relation to discretionary calories and maintaining a healthy weight/weight gain is addressed both in Part A: Executive Summary and Part E: Translating the Science into Dietary Guidance. In the section “Control Calorie Intake to Manage Body Weight” (Part E page 7), the Advisory Committee states that, “Calories come from fat, carbohydrate, protein, and alcohol. The healthiest way to reduce calorie intake is to reduce one’s intake of added sugars, solid fat, and alcohol – they all provide calories, but they do not provide essential nutrients.” … “Table E-3 gives examples of how calories can be decreased by decreasing alcoholic beverage intake.” As we stated in our May 2003 submission to the Advisory Committee, “Given the current lack of consensus on the issue of moderate wine, beer and spirits consumption and its relationship to weight gain, Wine Institute recommends that the Committee provide more detailed discussion on the issue of moderate consumption of wine, beer and distilled spirits and its relationship to weight gain.” (WI Comment 2003, pages 6-7) The NIAAA review, State of the Science Report on the Effects of Moderate Drinking, concluded that the current scientific literature suggests that, “The data on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive. However, there is some evidence for reduced risk of diabetes and metabolic syndrome, which often co-exist with or develop from obesity.” (NIAAA 2003, page 29) An independent review commissioned by Wine Institute to review wine and alcohol and its effects on calories and body weight control since 1985 stated that, “At least 90 papers were published that have dealt directly or indirectly with alcohol consumption and body weight regulation. This renewed interest in how alcohol influences body weight stems, in part, from concern over dietary elements that may underlie the world-wide obesity epidemic. Although no universal consensus has been reached, a number of lines of evidence increasingly suggest that moderate alcohol consumption does not represent a dietary risk for developing obesity and may in fact promote certain metabolic changes which reduce the risk for overweight and obesity.” (Cordain 2003, page 2) In response to the scientific evidence presented, the Ethanol Subcommittee concluded that the relationship between consuming four or fewer alcoholic beverages daily and obesity was an “Unresolved Issue.” They state that, “The available data on the relationship between alcohol consumption and weight gain/obesity are sparse and inconclusive. There are contradictory findings at the higher end of the spectrum (i.e. 3 to 4 drinks per day) that may relate to fundamental limitations of the cross-sectional study design. At moderate drinking levels (i.e. up to one drink per day for women, up to one (sic?) drink per day for men), there is no apparent association between alcohol intake and obesity.” The Subcommittee concludes, “In summary, although prospective data are limited, there is no apparent association between consuming one or two alcoholic beverages daily and obesity.” Dietary Guidelines Advisory Committee Report, (Part 6, Section 8, page 6) Based on the Ethanol Subcommittee conclusion, we would like to recommend the statement made in Part E: Translating the Science into Dietary Guidelines be revised to read: “Calories come from fat, carbohydrate, protein, and alcohol. The healthiest way to reduce calorie intake is to reduce one’s intake of added sugars and solid fats. The findings on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive, however, it may be prudent to monitor consumption as it relates to the intake of discretionary calories.” CLOSING STATEMENTS We would like to commend the members of the Advisory Committee for their thorough review of the scientific literature and overall balanced recommendations on moderate alcohol consumption by healthy adults. On the issue of the Drinking In Moderation Definition, we strongly support the current definition of moderation (no more than 1 drink per day for women and no more than 2 drinks per day for men). We recommend the definition of one drink of wine be retained as stated in the 2000 version of the Guidelines in Box 26 – What is Drinking in Moderation? We believe that any changes made to the current definition would lead to inaccurate and misleading representations of the Guidelines’ moderation message to the public. Therefore, we recommend the addition of a clear and unambiguous statement in the guidelines that the “Count as a Drink” statements should not be interpreted as the establishment of a “standard drink,” and that the information is being provided to further explain the moderation message. As stated, there will be full and extensive industry and regulatory agency review accompanied by public comment for both serving size and serving facts labeling at the start of 2005. We would ask that any messages relating to moderate drinking and weight gain and obesity for the public clearly state that the scientific findings in this area are inconclusive and that alcohol, as well as other sources of discretionary calories, should be monitored closely for optimal health. We thank you for the opportunity to present additional information and recommendations on the Dietary Guidelines Advisory Committee Report. Sincerely, Robert P. Koch President and CEO cc: Secretary Tommy Thompson, HHS Secretary Ann Veneman, USDA
Submission Date 9/27/2004 5:30:00 PM
Author Wine Institute

Summary AIM appreciates the Committee's continued emphasis on moderation for those adults who choose to drink. However, recent research conclusions reveal that the wording on alcohol and calories needs further clarifications. We also suggest that moderate consumption with food should be emphasized.
Comments This submission is made on behalf of Peter Duff, Chairman of AIM-Alcohol in Moderation. We would like DHHS and USDA to consider our earlier comments when reviewing the Dietary Guidelines Advisory Committee's report. Specifically, AIM would like the agencies to review and further consider AIM's original research submission, especially as it pertains to the question on alcohol and calories. Towards this end, we would like to underscore that the science to date does not support any message that implies that alcohol in moderation would lead to excess weight gain. May 18, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Room 738-G, 200 Independence Ave, SW Washington, DC 20201 Email: dietaryguidelines@osophs.dhhs.gov RE: Year 2005 Draft Edition of Dietary Guidelines for Americans Dear Ms. McMurry: The following comments are submitted on behalf of AIM (Alcohol in Moderation), an international non-profit education group dedicated to science and social responsibility related initiatives. Specifically, AIM is devoted to increase socially responsible behavior with respect to alcohol consumption by bringing scientifically based education messages to the public via websites and other programs. Our efforts are centered on governmental and public health messages from around the world. We work with a Social, Scientific and Medical Council of physicians, scientists, and experts in social policy in preparing and presenting information related to an ongoing debate on alcohol use and abuse. We appreciate the opportunity to make comments on the recommended wording of the 2005 Dietary Guidelines that will be published by the Departments of Agriculture and Health and Human Services. AIM has long acknowledged that these Guidelines represent an important foundation for nutrition education activities. In fact, the Dietary Guidelines for Americans have served as an important consumer education tool as part of AIM’s outreach efforts. These programs advocate moderate consumption as the only responsible option for those who choose to enjoy wine, beer and spirits as a component of a well-balanced diet and lifestyle. Towards this end, we are committed to continuing and expanding our educational outreach efforts with the upcoming 2005 Dietary Guidelines for Americans edition. First and foremost, we applaud the Advisory Committee’s effort and express our strong support for expanded wording intended to discourage abuse while indicating that moderate and responsible use of alcohol is an acceptable lifestyle choice, and encouraging the consumption of alcoholic beverages with food (which markedly decreases the risk of abuse). In our view, however, the Guidelines should more fully take into account the research facts presented by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) in their December, 2003, submission. In particular, we agree that the Guidelines should be based on the “preponderance of scientific and medical knowledge current at the time of publication”. (1, 2) In light of the developing research consensus on moderate consumption, reflected in both published scientific research studies and official nutrition and public policy positions, we would like to respectfully ask you to consider the following additional points when finalizing the alcohol guideline wording: I. Provide a more positive opening of the guideline, underscoring that responsible consumption is the only acceptable choice for those adults who choose to drink In line with the emerging evidence on moderate versus abusive drinking, the Guidelines should give more weight to positive messages about moderation as part of a healthy diet and lifestyle. In fact, we believe that the currently proposed wording disproportionately focuses on reported risks of abusive consumption while not adequately addressing scientific findings with respect to moderation. This is especially warranted as the overwhelming majority of those who choose to drink consume alcohol moderately and responsibly. This is not only reflected on page 20 in the recent NIAAA submission (1) and in the NIH 2000 physician’s guide (3) but also in earlier reports by NIAAA on alcohol and health to the US Congress.( 4) Along those lines the recent NIAAA submission emphasizes that “the consequences of alcohol use must be evaluated in conjunction with its potential benefits.” It is stressed that alcohol’s apparent protective effect against coronary heart disease and other atherosclerotic diseases are significant, as these are the most common cause of death in the US. The submission also cites a 1994 study predicting that abstention among current drinkers would lead to significant increases in coronary heart disease death rates. Another recent review article by Dr. Arthur Klatsky from Kaiser Permanente, who has published dozens of scientific studies over the last two decades, also cautions that while non drinkers should not necessarily be encouraged to drink, current moderate drinkers with no health contraindications should not be discouraged from drinking.(5) These and other statements underscore the importance of a more balanced discussion on moderation and abuse when formulating the US nutrition and dietary policy, which is also a stated goal for the Dietary guidelines 2005 ( Fed. Reg., Vol.68, no 171. Sept 4, 2003). With these and other research and public health facts in mind, we firmly believe that it is important to open the Guidelines with an additional message that underscores the acceptable behavior of moderation while also stressing the consequences of abuse. In sum, we recommend the addition of a sentence before the current lead sentence that would underscore, “The moderate and responsible consumption of wine, beer and spirits as part of a well-balanced diet and lifestyle is the only acceptable option for adults who choose to enjoy consumption of alcoholic beverages. The overwhelming majority of adult Americans drinks moderately or abstains, depending on their lifestyle choice.” This could lead the reader directly to the definition of moderation, underscoring that heavy drinking and binge drinking are irresponsible, which would also be underscored by the next sentence of the guideline reading, “Alcoholic beverages are harmful when consumed in excess.” II Further expand discussions on moderation and stress both the consumption with food and/or meals to foster responsible drinking behavior even outside the traditional mealtime consumption. We fully endorse the emphasis on eating and meals and would suggest including an expanded wording that would underscore that consumption should “preferably occur with food and/or with meals to slow alcohol absorption.” You may also wish to point out that alcohol should be consumed slowly, preferably over several hours. Such messages would encompass a wider range of drinking occasions and would also address NIAAA’s statement that people should be given more detailed advice on what encompasses “moderation.” Along those lines, we would also like to recommend that the following NIAAA statement be included, “Except for those individuals at particular risk ( as described in the current guidelines), consumption of 2 drinks a day for men and 1 drink a day for women is unlikely to increase health risks. As risks for some conditions and diseases do increase at higher levels of consumption, men should be cautioned to not exceed 4 drinks on any day and women to not exceed 3 on any day.” This represents an important caution intended to prevent serious binge drinking behaviors. Furthermore, this more detailed approach is also in line with other governmental guidelines such as those of the UK and Australia that provide more specific guidance for the consumer. (6, 7) In fact, official guidelines such as the UK Sensible Drinking Guidelines and the Australian Alcohol Guideline are taking a more positive approach (as reflected in our recommendations I. and II). In addition, social scientists have underscored that such education messages emphasizing positive cultural norms reinforce and initiate the most responsible drinking behaviors in a given society. In fact, these points are directly and indirectly addressed in a Rutgers University monograph entitled, “Society, Culture, and Drinking Patterns Reexamined,” as well as the International Handbook on Alcohol and Culture published by Brown University Professor Dwight Heath. ( 8,9) III. Address scientific findings with respect to moderation and other aspects of health, including overall mortality and stroke (in line with the recent NIAAA submission). As the NIAAA submission attests, since 2000 scientific support of moderate consumption’s role as part of a healthy lifestyle has gotten stronger. Large-scale studies from the US and around the world have found moderate drinkers not only have a reduced rate of cardiovascular disease, but also have a reduced overall mortality rate. The largest study on alcohol consumption to date by Thun et al(add ref), based on nearly 500,000 Americans, reports that overall death rates were lowest among men and women reporting about one drink daily (approximately 20% lower than abstainers for both men and women). (10) The American Heart Association concluded in 1996, “The lowest mortality occurs in those who consume one or two drinks a day.” (11)These findings were also acknowledged in the NIAAA submission along with many other research findings including a 2003 meta-analysis based on more than 50 studies on the subject. (1) Therefore, we urge the Committee to consider expanding the discussions on the health effects of moderation by including the NIAAA statement:” The lowest total all-cause mortality occurs at the level of 1 - 2 drinks per day.” Along those lines we also suggest including a statement acknowledging the potential positive affects with respect to ischemic stroke and Type II diabetes, in line with the research findings presented by NIAAA in its appendix 2.(1) The suggested mentioning of potential stroke risk reductions is also in line with the National Stroke Association’s official statement, which states:” Current scientific data continue to show that moderate levels of alcohol consumption do not increase risk for heart failure, myocardial infarction or ischemic stroke, and in fact provide protective effects along a J-shaped curve.”(12) A meta-analysis published recently in the Journal of the American Medical Association by Reynolds, et al concluded, “Heavy alcohol consumption increases the risk of stroke while light or moderate alcohol consumption may be protective against total and ischemic stroke.” Another study suggested that alcohol may protect against reoccurring strokes, and others have confirmed these findings. (13,14) The inclusion of discussions on diabetes is also appropriate as recent studies continue to reveal a reduced risk of diabetes among moderate drinkers. These include a study by Davies, et al in 2003 and a recent study by Wannamethee, et al, which reported that light drinking cuts diabetes risk in women. (15-18) IV. Discussions on calories and obesity should not be misleading. While we agree that the guidelines should provide a general benchmark for outlining average calories for wine, beer and spirits, we would like to caution against a more detailed statement on moderate drinking and obesity. Numerous studies, as outlined in the NIAAA submission, suggest no clear association between alcohol and weight gain for men, and some studies indicate a slight reduction in weight gain for women. Specifically, we would like to urge you to fully consider NIAAA’s conclusion on the subject, which is as follows: “The data on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive. However, there is some evidence for reduced risk of diabetes and metabolic syndrome, which often co-exist with or develop from obesity.”(1) Experimental studies have suggested that alcohol calories are not efficiently utilized and therefore generally do not lead to weight gain. For example, a 1997 study published in the European Journal of Clinical Nutrition concluded, “Alcohol consumers were leaner than abstainers,” and this is a common finding in most epidemiologic studies everywhere. Furthermore, a 1998 study published in the American Journal of Clinical Nutrition suggests that alcohol’s consumption with food slows not only the absorption process, keeping alcohol blood levels low, but may also have a favorable effect on lipid profiles during the postprandial period. (19, 20) In line with many studies over the last two decades,, the relationship between moderate alcohol consumption and obesity is unclear. In line with the 2003 NIAAA conclusion, for example, Lands wrote in a 1995 review article, “Thus, alcohol seemed unable to contribute to the overall body mass of either men or women. In fact, the cumulative evidence of 31 separate studies does not support the concept that reduced alcohol consumption would help maintain a lower body weight. Also the National Health and Nutrition Examination Survey (NHANES) showed that moderate drinkers gained less weight, on average, than abstainers over a ten year follow up period (21-27) In light of these and other findings, we believe an overall cautionary and even warning message on alcohol’s calories would be misleading and is therefore unwarranted, especially if it would suggest in any way that individuals should reduce moderate consumption of beverage alcohol to decrease weight; scientific data are not present to support such a statement. V. The “Who should not drink section” should also be evidence-based and supported by science. In all of AIM’s education efforts, we stress the unacceptability of underage drinking and emphasize adherence to the laws regarding the purchase and possession age limitations in the US. Therefore, we support the Dietary Guideline’s Committee’s focus to reduce underage drinking problems. We are concerned, however, that the statement, “Risk of alcohol abuse increases when drinking starts at an early age,” is scientifically and culturally unwarranted. The issue is still a matter of debate, and indeed alcohol abuse rates are actually lower in many countries (such as Italy) where wine consumption begins early in life. It does appear that early abusers of alcohol and drugs may be more likely to be adult abusers, but studies have reported that it was drinking problems, rather than any drinking, that show the ability to predict later-life alcohol problems.(28,29)Other studies have shown that the age of first use of alcohol (as recalled at age 18) did not predict alcohol or drug use at either 20 or 30 years of age.(30) Another study concluded, “These results suggest the association between drinking onset and diagnosis is no causal, and attempts to prevent the development of alcohol dependence by delaying drinking onset are unlikely to be successful.”(31) More recent studies also conclude that much of the association can be accounted for by genetic vulnerability.(32,33) Recent reports by the Federal Trade Commission and the National Academy of Sciences point out that most alcohol beverages are obtained by underage persons through their parents and other adults.(34,35) Therefore, we strongly suggest to the Committee that it include wording that cautions parents to discourage their children from drinking and to discuss the subject of alcohol in detail with them. VI. The Food Guide Pyramid Graphics should include alcohol to help put the Dietary Guidelines into action, reinforcing the importance of moderation as the only choice. As the Food Guide Graphic will be revised to mirror the 2005 Dietary Guidelines, we would like to strongly recommend that alcoholic beverages will be included as an option for adults. We firmly believe that this would provide increased exposure to the government’s moderation message and the overall Guideline cautioning about abuse and the importance of only moderate consumption as part of an overall healthy and well-balanced lifestyle. The pyramid and accompanying booklet will help Americans get the needed guidance to choose a balanced diet and responsible decision-making skills as outlined in the Guidelines. This approach would provide an important venue to reinforce socially responsible behavior with respect to wine, beer, and spirits consumption. This approach is also in line with other dietary models and accompanying graphics. Specifically, we would like you to review and consider approaches presented in the Mediterranean, Latin-American, Asian, and Vegetarian Diet Pyramids. These concepts have been developed by leading experts from Harvard University of Public Health and other leading institutions. (36-40) In conclusion, we would like to reiterate that the developing research consensus on moderate versus abusive consumption should be fully reflected in the upcoming 2005 Dietary Guidelines for Americans. While we support the admonition against abusive behavior, and agree that for certain groups of individuals any consumption is inadvisable, we respectfully recommend through this submission that you re-examine the impressive and credible evidence suggesting that, for most people, moderate drinking is consistent with a healthy and well-balanced lifestyle. We are confident that the upcoming Guidelines will continue to assist Americans and other consumers around the world in making informed healthy diet and lifestyle choices. Towards this end, AIM will be committed to widely disseminating the 2005 Dietary Guidelines as a basis of our ongoing and expanded education initiatives. Thank you for your time and consideration. If you have any questions concerning our sub mission or if we can be of any assistance, please contact Elisabeth Holmgren, at our US office at (925) 934-3226 or at em-h@pacbell.net . Sincerely, Peter Duff Chairman AIM-Alcohol in Moderation Attachment I: References: 1. National Institute on Alcohol Abuse and Alcoholism, State of the Science Report on the Effects of Moderate Drinking, Submission to the Dietary Guidelines Advisory Committee, December 2003. 2. Dietary Guidelines Advisory Committee Meeting Announcement, September 4, 2003, Federal Register, 68 (171). 3. U.S. Department of Health & Human Services, National Institutes of Health and National Institute on Alcohol Abuse and Alcoholism 2000, The Physician’s Guide to Helping patients with Alcohol Problems, NIH Publication No. 95- 3796. 4. National Institute of Alcohol Abuse and Alcoholism, Ninth and Tenth Special Report to US Congress on Alcohol and Health, DHHS, 1997, 2000. 5. Klatsky A., Alcohol and Health: How Much is Good for You? Scientific American, February 2003. 6. United Kingdom Department of Health, Sensible Drinking, Report, 1995 at http://www.dh.gov.uk/AboutUs/fs/en 7. National Health and Medical Research Council, Australian Drinking Guidelines, 2000 at http://www.alcoholguidelines.gov.au/ 8. Pittman D J et al, Society, Culture, and Drinking Patterns Reexamined, Rutgers Center of Alcohol Studies, 1991. 9. Heath D, International Handbook on Alcohol and Culture, Greenwood Press: Westport, 1995. 10. Thun M. et al, Alcohol Consumption and Mortality among Middle-Aged and Elderly Adults, The New England Journal of Medicine, 1997; 337. 11. Pearson T and Nutrition Committee of the American Heart Association, Alcohol and Heart Disease, Circulation, 94 (11), 1996. 12. Gorelick P. et al, Prevention of first Stroke: A Review of Guidelines from the National Stroke Association, Journal of the American Medical Association, 1999; 281. 13. Sacco, R. et al, The Protective Effect of Moderate Alcohol Consumption on Ischemic Stroke, Journal of the American Medical Association, 281, 53-60, 19999. 14. Reynolds K, et al, Alcohol Consumption and Risk of Stroke: A Meta-Analysis, Journal of the American Medical Association, 289, 579- 588, 2003. 15. Davies MJ et al, Effects of Moderate Alcohol Intake on Fasting Insulin and Glucose Concentrations and Insulin Sensitivity in Postmenopausal Women, Journal of the American Medical Association, 287, 2003. 16. Wannamethee SG et al, Alcohol Consumption and the Incidence of Type 2 diabetes, Journal of Epidemiology and Community Health, Vol 56, 2002. 17. Wannamethee SG et al, Alcohol Drinking Patterns and Risk of Type 2 Diabetes Mellitus among Younger Women, Archives of Internal Medicine, 163, 2003. 18. Howard A et al, Effect of Alcohol Consumption on Diabetes Mellitus – A Systematic Review, Annals of Internal Medicine, Vol 140, No 3, 2004. 19. Howard A et al,, Effect of Alcohol Consumption on Diabetes Mellitus – A Systematic Review”, Annals of Internal Medicine, Vol 140, No 3, 2004.18. Mannisto S et al, Alcohol Beverage Drinking, Diet, and Body Mass Index in a Cross-Sectional Survey, European Journal of Clinical Nutrition, Vol 51, 1997. 20. Locher R et al, Ethanol Suppresses Smooth Muscle Cell Profileration in the Postprandial Stage: A New Antiathereosclerotic Mechanism of Ethanol? American Journal of Clinical Nutrition, Vol 67, 1998. 21. Liu S.et al, A Prospective Study of Alcohol Intake and Change in Body Weight among US Adults, American Journal of Clinical Nutrition, Vol 140, 1994. 22. Coldwitz G et al, Alcohol Intake in Relation to Diet and Obesity in Women and Men, American Journal of Clinical Nutrition, Vol 54, 1991. 23. Istvan, The relationship between patterns of alcohol consumption and body weight. International Journal of Epidemiology, 24 (3), 1995. 24. Jequier, E. Alcohol Intake and Body Weight: a Paradox, American Journal of Clinical Nutrition, 59, 1999. 25. Kahn, H.S., Stable behaviors Associated with Adults’ 10-year Change in Body Mass Index and the Likelihood of Gain at the Waist, American Journal of Public Health, 87, 1997. 26. Mannisto S, Alcohol Beverage Drinking, Diet, and Body Mass Index in a Cross- National Survey, European Journal of Clinical Nutrition, 1997 27. Lands, M. Alcohol and energy intake. American Journal of Clinical Nutrition, 26, 1995. 28. Fillmore F, Relationship between Specific Drinking Problems in Early Adulthood and Middle Age, Journal of Studies on Alcohol, 1975; 36:882-907 29. Labouvie, E et al, Age of First Use: Its Reliability and Predictive Utility. Journal of Studies on Alcohol, 58, 1997. 30. Grant, F et al, Age at onset of alcohol use and DSM-IV alcohol abuse and dependence: A 12-year follow-up. Journal of Substance Abuse, 12, 2001. 31. Guo, J et al, Developmental Pathways to Alcohol Abuse and Dependence in Young Adulthood, Journal of Studies on Alcohol, 61, 2000. 32. Mc Gue M et al, Origins and Consequences of first Drink, Alcoholism: Clinical and Experimental Research, 25 (7, 8), 2001. 33. Harford, T. Early Onset of Alcohol Use and Health Problems: Spurious Associations and Prevention. Addiction, Vol 98, 2003. 33. Anderson A et al, tracking Drinking Behavior from Age 15- 19 years, Addiction, 2003. 34. Federal Trade Commission: Alcohol Marketing and Advertising, A Report to Congress, 2003. 35. Institute of Medicine, National Research Council of the National Academies. Reducing Underage Drinking a Collective Responsibility, The National Academies Press 2003. 36. The Eat Wise Pyramid, released at the 2003 International Conference on the Mediterranean Diet, Boston, Oldways Preservation & Exchange Trust, 2003 37. The Healthy Traditional Mediterranean Diet Pyramid, released at the Intern. Conference on the Diets of the Mediterranean, San Francisco, Oldways, 1994. 38. The Healthy Traditional Asian Diet Pyramid, released at the International Conference on the Diets of Asia, San Francisco, Oldways PT, 1995. 39. 39. The Healthy Traditional Latin America Diet Pyramid, released at the Intern. Conference on the Diets of Latin America, El Paso, Texas, Oldways PT, 1996. 39.40. The Vegetarian Diet Pyramid, released at the International Conference on Vegetarian Diets, Austin, Texas, Oldways Preservation & Exchange Trust, 1997. AIMUS, 2004 May 18, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Room 738-G, 200 Independence Ave, SW Washington, DC 20201 Email: dietaryguidelines@osophs.dhhs.gov RE: Year 2005 Draft Edition of Dietary Guidelines for Americans Dear Ms. McMurry: The following comments are submitted on behalf of AIM (Alcohol in Moderation), an international non-profit education group dedicated to science and social responsibility related initiatives. Specifically, AIM is devoted to increase socially responsible behavior with respect to alcohol consumption by bringing scientifically based education messages to the public via websites and other programs. Our efforts are centered on governmental and public health messages from around the world. We work with a Social, Scientific and Medical Council of physicians, scientists, and experts in social policy in preparing and presenting information related to an ongoing debate on alcohol use and abuse. We appreciate the opportunity to make comments on the recommended wording of the 2005 Dietary Guidelines that will be published by the Departments of Agriculture and Health and Human Services. AIM has long acknowledged that these Guidelines represent an important foundation for nutrition education activities. In fact, the Dietary Guidelines for Americans have served as an important consumer education tool as part of AIM’s outreach efforts. These programs advocate moderate consumption as the only responsible option for those who choose to enjoy wine, beer and spirits as a component of a well-balanced diet and lifestyle. Towards this end, we are committed to continuing and expanding our educational outreach efforts with the upcoming 2005 Dietary Guidelines for Americans edition. First and foremost, we applaud the Advisory Committee’s effort and express our strong support for expanded wording intended to discourage abuse while indicating that moderate and responsible use of alcohol is an acceptable lifestyle choice, and encouraging the consumption of alcoholic beverages with food (which markedly decreases the risk of abuse). In our view, however, the Guidelines should more fully take into account the research facts presented by the National Institute of Alcohol Abuse and Alcoholism (NIAAA) in their December, 2003, submission. In particular, we agree that the Guidelines should be based on the “preponderance of scientific and medical knowledge current at the time of publication”. (1, 2) In light of the developing research consensus on moderate consumption, reflected in both published scientific research studies and official nutrition and public policy positions, we would like to respectfully ask you to consider the following additional points when finalizing the alcohol guideline wording: I. Provide a more positive opening of the guideline, underscoring that responsible consumption is the only acceptable choice for those adults who choose to drink In line with the emerging evidence on moderate versus abusive drinking, the Guidelines should give more weight to positive messages about moderation as part of a healthy diet and lifestyle. In fact, we believe that the currently proposed wording disproportionately focuses on reported risks of abusive consumption while not adequately addressing scientific findings with respect to moderation. This is especially warranted as the overwhelming majority of those who choose to drink consume alcohol moderately and responsibly. This is not only reflected on page 20 in the recent NIAAA submission (1) and in the NIH 2000 physician’s guide (3) but also in earlier reports by NIAAA on alcohol and health to the US Congress.( 4) Along those lines the recent NIAAA submission emphasizes that “the consequences of alcohol use must be evaluated in conjunction with its potential benefits.” It is stressed that alcohol’s apparent protective effect against coronary heart disease and other atherosclerotic diseases are significant, as these are the most common cause of death in the US. The submission also cites a 1994 study predicting that abstention among current drinkers would lead to significant increases in coronary heart disease death rates. Another recent review article by Dr. Arthur Klatsky from Kaiser Permanente, who has published dozens of scientific studies over the last two decades, also cautions that while non drinkers should not necessarily be encouraged to drink, current moderate drinkers with no health contraindications should not be discouraged from drinking.(5) These and other statements underscore the importance of a more balanced discussion on moderation and abuse when formulating the US nutrition and dietary policy, which is also a stated goal for the Dietary guidelines 2005 ( Fed. Reg., Vol.68, no 171. Sept 4, 2003). With these and other research and public health facts in mind, we firmly believe that it is important to open the Guidelines with an additional message that underscores the acceptable behavior of moderation while also stressing the consequences of abuse. In sum, we recommend the addition of a sentence before the current lead sentence that would underscore, “The moderate and responsible consumption of wine, beer and spirits as part of a well-balanced diet and lifestyle is the only acceptable option for adults who choose to enjoy consumption of alcoholic beverages. The overwhelming majority of adult Americans drinks moderately or abstains, depending on their lifestyle choice.” This could lead the reader directly to the definition of moderation, underscoring that heavy drinking and binge drinking are irresponsible, which would also be underscored by the next sentence of the guideline reading, “Alcoholic beverages are harmful when consumed in excess.” II Further expand discussions on moderation and stress both the consumption with food and/or meals to foster responsible drinking behavior even outside the traditional mealtime consumption. We fully endorse the emphasis on eating and meals and would suggest including an expanded wording that would underscore that consumption should “preferably occur with food and/or with meals to slow alcohol absorption.” You may also wish to point out that alcohol should be consumed slowly, preferably over several hours. Such messages would encompass a wider range of drinking occasions and would also address NIAAA’s statement that people should be given more detailed advice on what encompasses “moderation.” Along those lines, we would also like to recommend that the following NIAAA statement be included, “Except for those individuals at particular risk ( as described in the current guidelines), consumption of 2 drinks a day for men and 1 drink a day for women is unlikely to increase health risks. As risks for some conditions and diseases do increase at higher levels of consumption, men should be cautioned to not exceed 4 drinks on any day and women to not exceed 3 on any day.” This represents an important caution intended to prevent serious binge drinking behaviors. Furthermore, this more detailed approach is also in line with other governmental guidelines such as those of the UK and Australia that provide more specific guidance for the consumer. (6, 7) In fact, official guidelines such as the UK Sensible Drinking Guidelines and the Australian Alcohol Guideline are taking a more positive approach (as reflected in our recommendations I. and II). In addition, social scientists have underscored that such education messages emphasizing positive cultural norms reinforce and initiate the most responsible drinking behaviors in a given society. In fact, these points are directly and indirectly addressed in a Rutgers University monograph entitled, “Society, Culture, and Drinking Patterns Reexamined,” as well as the International Handbook on Alcohol and Culture published by Brown University Professor Dwight Heath. ( 8,9) III. Address scientific findings with respect to moderation and other aspects of health, including overall mortality and stroke (in line with the recent NIAAA submission). As the NIAAA submission attests, since 2000 scientific support of moderate consumption’s role as part of a healthy lifestyle has gotten stronger. Large-scale studies from the US and around the world have found moderate drinkers not only have a reduced rate of cardiovascular disease, but also have a reduced overall mortality rate. The largest study on alcohol consumption to date by Thun et al(add ref), based on nearly 500,000 Americans, reports that overall death rates were lowest among men and women reporting about one drink daily (approximately 20% lower than abstainers for both men and women). (10) The American Heart Association concluded in 1996, “The lowest mortality occurs in those who consume one or two drinks a day.” (11)These findings were also acknowledged in the NIAAA submission along with many other research findings including a 2003 meta-analysis based on more than 50 studies on the subject. (1) Therefore, we urge the Committee to consider expanding the discussions on the health effects of moderation by including the NIAAA statement:” The lowest total all-cause mortality occurs at the level of 1 - 2 drinks per day.” Along those lines we also suggest including a statement acknowledging the potential positive affects with respect to ischemic stroke and Type II diabetes, in line with the research findings presented by NIAAA in its appendix 2.(1) The suggested mentioning of potential stroke risk reductions is also in line with the National Stroke Association’s official statement, which states:” Current scientific data continue to show that moderate levels of alcohol consumption do not increase risk for heart failure, myocardial infarction or ischemic stroke, and in fact provide protective effects along a J-shaped curve.”(12) A meta-analysis published recently in the Journal of the American Medical Association by Reynolds, et al concluded, “Heavy alcohol consumption increases the risk of stroke while light or moderate alcohol consumption may be protective against total and ischemic stroke.” Another study suggested that alcohol may protect against reoccurring strokes, and others have confirmed these findings. (13,14) The inclusion of discussions on diabetes is also appropriate as recent studies continue to reveal a reduced risk of diabetes among moderate drinkers. These include a study by Davies, et al in 2003 and a recent study by Wannamethee, et al, which reported that light drinking cuts diabetes risk in women. (15-18) IV. Discussions on calories and obesity should not be misleading. While we agree that the guidelines should provide a general benchmark for outlining average calories for wine, beer and spirits, we would like to caution against a more detailed statement on moderate drinking and obesity. Numerous studies, as outlined in the NIAAA submission, suggest no clear association between alcohol and weight gain for men, and some studies indicate a slight reduction in weight gain for women. Specifically, we would like to urge you to fully consider NIAAA’s conclusion on the subject, which is as follows: “The data on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive. However, there is some evidence for reduced risk of diabetes and metabolic syndrome, which often co-exist with or develop from obesity.”(1) Experimental studies have suggested that alcohol calories are not efficiently utilized and therefore generally do not lead to weight gain. For example, a 1997 study published in the European Journal of Clinical Nutrition concluded, “Alcohol consumers were leaner than abstainers,” and this is a common finding in most epidemiologic studies everywhere. Furthermore, a 1998 study published in the American Journal of Clinical Nutrition suggests that alcohol’s consumption with food slows not only the absorption process, keeping alcohol blood levels low, but may also have a favorable effect on lipid profiles during the postprandial period. (19, 20) In line with many studies over the last two decades,, the relationship between moderate alcohol consumption and obesity is unclear. In line with the 2003 NIAAA conclusion, for example, Lands wrote in a 1995 review article, “Thus, alcohol seemed unable to contribute to the overall body mass of either men or women. In fact, the cumulative evidence of 31 separate studies does not support the concept that reduced alcohol consumption would help maintain a lower body weight. Also the National Health and Nutrition Examination Survey (NHANES) showed that moderate drinkers gained less weight, on average, than abstainers over a ten year follow up period (21-27) In light of these and other findings, we believe an overall cautionary and even warning message on alcohol’s calories would be misleading and is therefore unwarranted, especially if it would suggest in any way that individuals should reduce moderate consumption of beverage alcohol to decrease weight; scientific data are not present to support such a statement. V. The “Who should not drink section” should also be evidence-based and supported by science. In all of AIM’s education efforts, we stress the unacceptability of underage drinking and emphasize adherence to the laws regarding the purchase and possession age limitations in the US. Therefore, we support the Dietary Guideline’s Committee’s focus to reduce underage drinking problems. We are concerned, however, that the statement, “Risk of alcohol abuse increases when drinking starts at an early age,” is scientifically and culturally unwarranted. The issue is still a matter of debate, and indeed alcohol abuse rates are actually lower in many countries (such as Italy) where wine consumption begins early in life. It does appear that early abusers of alcohol and drugs may be more likely to be adult abusers, but studies have reported that it was drinking problems, rather than any drinking, that show the ability to predict later-life alcohol problems.(28,29)Other studies have shown that the age of first use of alcohol (as recalled at age 18) did not predict alcohol or drug use at either 20 or 30 years of age.(30) Another study concluded, “These results suggest the association between drinking onset and diagnosis is no causal, and attempts to prevent the development of alcohol dependence by delaying drinking onset are unlikely to be successful.”(31) More recent studies also conclude that much of the association can be accounted for by genetic vulnerability.(32,33) Recent reports by the Federal Trade Commission and the National Academy of Sciences point out that most alcohol beverages are obtained by underage persons through their parents and other adults.(34,35) Therefore, we strongly suggest to the Committee that it include wording that cautions parents to discourage their children from drinking and to discuss the subject of alcohol in detail with them. VI. The Food Guide Pyramid Graphics should include alcohol to help put the Dietary Guidelines into action, reinforcing the importance of moderation as the only choice. As the Food Guide Graphic will be revised to mirror the 2005 Dietary Guidelines, we would like to strongly recommend that alcoholic beverages will be included as an option for adults. We firmly believe that this would provide increased exposure to the government’s moderation message and the overall Guideline cautioning about abuse and the importance of only moderate consumption as part of an overall healthy and well-balanced lifestyle. The pyramid and accompanying booklet will help Americans get the needed guidance to choose a balanced diet and responsible decision-making skills as outlined in the Guidelines. This approach would provide an important venue to reinforce socially responsible behavior with respect to wine, beer, and spirits consumption. This approach is also in line with other dietary models and accompanying graphics. Specifically, we would like you to review and consider approaches presented in the Mediterranean, Latin-American, Asian, and Vegetarian Diet Pyramids. These concepts have been developed by leading experts from Harvard University of Public Health and other leading institutions. (36-40) In conclusion, we would like to reiterate that the developing research consensus on moderate versus abusive consumption should be fully reflected in the upcoming 2005 Dietary Guidelines for Americans. While we support the admonition against abusive behavior, and agree that for certain groups of individuals any consumption is inadvisable, we respectfully recommend through this submission that you re-examine the impressive and credible evidence suggesting that, for most people, moderate drinking is consistent with a healthy and well-balanced lifestyle. We are confident that the upcoming Guidelines will continue to assist Americans and other consumers around the world in making informed healthy diet and lifestyle choices. Towards this end, AIM will be committed to widely disseminating the 2005 Dietary Guidelines as a basis of our ongoing and expanded education initiatives. Thank you for your time and consideration. If you have any questions concerning our sub mission or if we can be of any assistance, please contact Elisabeth Holmgren, at our US office at (925) 934-3226 or at em-h@pacbell.net . Sincerely, Peter Duff Chairman AIM-Alcohol in Moderation
Submission Date 9/27/2004 7:38:00 PM
Author AIM-Alcohol in Moderation

Summary Keep alcoholic drinks to the bar/tavern in draft form, and encourage unpasteurized traditional soft drinks, herbal teas. Help eliminate alcoholism by encouraging complete hot meals first for all first.
Comments Some of the Native American tribes made their own fermented drinks, mostly sour, with any alcohol being counteracted by the high quantity of B-vitamins in these indegenous drinks (example, pulque is undistilled, also unfermented in its traditional state, and not able to be transported very far - by distilling something similar to make Tequila, you develop the problems of severe intoxication). The Cherokees fermented a sour corn drink for visitors, releasing its nutrients to the highest advantage. Alcoholism is a plague killing many, and disabling many others. By returning even to the traditions of unpasteurized beer on the tap, we would have at least maintained the B-vitamins and kept the drunkenness to the taverns, minimizing its presence behind the wheels. Traditional drinks, including traditionally fermented ginger ale and native herbal flavored teas contain nutrients that strengthen constitution and also provide much less sugar than do the soft drinks of the convenience store.
Submission Date 9/27/2004 10:28:00 PM
Author from Poplar, Montana

Summary While we support the majority of the findings in the Committee Report, we would like to provide additional comment in two important areas: • There should be no changes to the Drinking In Moderation Definition, especially with the “Count as a Drink” language regarding expressions of alcohol content f
Comments Wine Institute is the public policy association of California wineries representing over 800 California wineries and affiliated businesses. These companies are responsible for 80 percent of the nation’s wine production. On behalf or our members, we are pleased to submit comments in response to the request for public input on the 2005 Dietary Guidelines Advisory Committee Report to the Departments of Health and Human Services and Agriculture. We agree that the 2005 Dietary Guidelines for Americans should represent a balanced approach to recommendations on the full range of nutrition, lifestyle and health issues. In particular, we support the Ethanol Subcommittee’s continued recommended advice to discourage excessive consumption and indicate that, even in moderation, there are individuals who should not drink. We are pleased that the main alcohol message has been maintained from the 2000 Dietary Guidelines: “If you drink alcoholic beverages, do so in moderation” and that the Committee has maintained the recommendation (advice) that, “For those who choose to drink an alcoholic beverage, it is advisable to consume it with meals to slow absorption. Data suggest that the presence of food in the stomach can slow the absorption of alcohol and thereby mitigate the associated rise in blood alcohol concentration.” While we support the majority of the findings in the Committee Report, we would like to provide additional comment in two important areas: • There should be no changes to the Drinking In Moderation Definition, especially with the “Count as a Drink” language regarding expressions of alcohol content for wine, because there will be extensive rulemaking by the Treasury Department’s Tax and Trade Bureau (TTB) in 2005 that will address several significant issues that are based on the language of the Dietary Guidelines. Language in the Dietary Guidelines should not be misused or misconstrued in any future regulatory action or rulemaking. • Messages relating to moderate drinking and weight gain and obesity for the public should clearly state that the scientific findings in this area are inconclusive and that alcohol, as well as other sources of discretionary calories, should be monitored closely for optimal health. I. MODERATE DRINKING DEFINITION In the 2000 version of the Dietary Guidelines for Americans, drinking in moderation is defined in Box 26 on page 36 - What is Drinking in Moderation?: The Advice For Today on page 37 goes one step further and recommends “Limit intake to one drink per day for women and two per day for men, and take with meals to slow alcohol absorption.” The Advisory Committee found this definition of moderate drinking as optimal for adults who choose to drink as a means to provide both beneficial effects on heart disease and allcause mortality as well as reduce risks caused by heavy drinking. However, the Advisory Committee also states that, “The definition of moderation, including the size of one drink, requires emphasis. (Some investigators and apparently many individuals interpret ‘moderate drinking’ to cover higher levels of intake than shown in Table E-25. Many mixed drinks actually provide several servings of alcohol per drink.” (DG Advisory Committee Report, Part D, Section 8, page 3). In an apparent response to further define a moderate serving of each beverage, the Advisory Committee has added a “12 percent alcohol” qualifier to the definition of a serving of wine. Throughout the text of the Advisory Committee Report, one serving of wine is defined as “a 5-ounce glass of 12 percent alcohol.” (See Table E-25, below). Wine Institute believes that providing the public a frame of reference by including serving size information in ounces will assist wine, beer, and distilled spirits consumers in their awareness of alcohol consumption levels. We believe that direct serving size information in ounces about the product being consumed is relevant and, if truthful, accurate and specific, should be able to be included. However, within each category of drinks (wine, beer and distilled spirits) there is a range of products with different alcohol percent values. Unlike distilled spirits, wine is not a “mixed” drink. Consumers discriminate among the various wine products more by their broad product categories, and producers of wine do not target a particular alcohol level but a sensory style and taste. Even from a regulatory standpoint, the standards of identity for wine differ significantly from distilled spirits product standards. Table wine, for example, is defined as still wine between 7 and 14 percent alcohol by volume.1 While from a scientific or clinical standpoint it may make 1 27 USC 5041 states, in part, as follows: (a) Imposition There is hereby imposed on all wines (including imitation, substandard, or artificial wine, and compounds sold as wine) having not in excess of 24 percent of alcohol by volume, in bond in, produced in, or imported into, the United States, taxes at the rates shown in subsection (b), such taxes to be determined as of the time of removal for consumption or sale. All wines containing more than 24 percent of alcohol by volume shall be classed as distilled spirits and taxed accordingly. Still wines shall include those wines containing not more than 0.392 gram of carbon dioxide per hundred milliliters of wine; except that the Secretary may by regulations prescribe such tolerances to this maximum limitation as may be reasonably necessary in good commercial practice. (b) Rates of tax (1) On still wines containing not more than 14 percent of alcohol by volume, $1.07 per wine gallon; (2) On still wines containing more than 14 percent and not exceeding 21 percent of alcohol by volume, $1.57 per wine gallon; (3) On still wines containing more than 21 percent and not exceeding 24 percent of alcohol by volume, $3.15 per wine gallon; (4) On champagne and other sparkling wines, $3.40 per wine gallon; (5) On artificially carbonated wines, $3.30 per wine gallon; and (6) On hard cider which is a still wine derived primarily from apples or apple concentrate and water, containing no other fruit product, and containing at least one-half of 1 percent and less than 7 percent alcohol by volume, 22.6 cents per wine gallon. sense to qualify wine with a specific alcohol content, we do not believe that assigning an arbitrary value of 12 percent alcohol to wine provides the consumer with any additional useful information from which to make an informed decision. As the alcohol percent value of table wine varies between 7 percent and 14 percent and that for dessert wine is 14 percent and above, such a listing would not necessarily be truthful or accurate and could be misleading. We believe that the addition of a “12% alcohol” qualifier in the “Count as a Drink” language will be misinterpreted by some as the establishment of a “standard drink” size, which will eventually lead to a distortion and/or omission of the important moderation message. The Guidelines represent great efforts to explain moderate consumption to U.S. consumers, but they have also been misunderstood. We are seeing the moderation message giving way to a much broader interpretation that the Guidelines themselves have established the size of a “standard drink,” and there have been several regulatory actions that have been based on this contention. We have seen the “count as a drink” language stripped of its accompanying moderation context, with what remains being repackaged as a definition for a “standard drink.” We do not believe that this is what was intended by the authors of the Guidelines, and we are concerned that this misinterpretation and misuse, all pending the safeguards of future rulemaking, will raise serious social as well as political implications. While adding a “12% alcohol” qualifier to wine may appear to be minor and consistent with the “80 proof distilled spirits” language, we are concerned that such changes will result in an argument that these sizes equate to “standard drink” sizes and will become the basis for untruthful and misleading information on wine, beer, and spirits labels. Changes such as this will tend to bolster an argument that all alcoholic beverages are “equal,” a notion that Wine Institute disagrees with. It is an oversimplification to single out the ethyl alcohol property that all alcoholic beverages have in common, and then to conveniently boot strap this commonality into a graphic equation that all alcoholic beverages are equal but only in specific but differing quantities. There are three separate regulatory actions that are pending administrative rulemaking, all based in large part on the contention that the U.S. Dietary Guidelines have established standard serving sizes. Carbohydrate Labeling of Alcoholic Beverages Awaits Rulemaking On April 7, 2004, without the benefit and safeguards of the rulemaking process, the TTB published an Industry Circular that authorized the voluntary labeling of carbohydrate information for wine, beer, and distilled spirits2. Citing the 2000 Dietary Guidelines3, TTB in its Industry Circular uses the Dietary Guidelines “Count as a drink” language as a measure of a serving size: 2 TTB Ruling Number 2004-1, dated April 7, 2004, entitled “Caloric and Carbohydrate Representations in the Labeling and Advertising of Wine, Distilled Spirits and Malt Beverages, is currently available on the TTB web site at http://www.ttb.gov/alcohol/info/revrule/rules/2004-1.pdf Accordingly, this ruling holds that the statement of average analysis must apply to a serving of the product, and that the serving must be 12 fl. oz. for malt beverages, 5 fl. oz. for wine, and 1.5 fl. oz. for distilled spirits. TTB indicates in this ruling that it will conduct a rulemaking on this issue in the future.4 To date, almost six months since the publication of this interim policy, Wine Institute still awaits the promised publication of a Notice of Proposed Rulemaking by TTB on this matter. The significance of this action, however, should not be lost. This is an instance where an administrative agency has taken information from the Dietary Guidelines, eliminated the notion of moderate consumption, and concludes that the “Count as a drink” volumes for alcoholic beverages are “standard drink” sizes. “Serving Facts Panel” Labeling of Alcoholic Beverages Awaits Rulemaking The issue of whether the Dietary Guidelines established a definition of a “standard drink” came to light again with TTB in early August, 2004. On August 5, 2004, and again without the benefit of rulemaking, TTB released what it referred to as a “Serving Facts White Paper” where the identical drink volume values were being used by TTB to permit not simply additional nutritional information, but a comparative “equivalency” graphic” showing illustrations of a beer, wine and spirits container: 3 In TTB Ruling Number 2004-1, it is stated: It should be noted that we are setting serving sizes for these products in ounces, even though existing regulations require the use of metric terms in labeling the net contents of wine and distilled spirits containers. It is our belief that consumers are used to seeing serving sizes set forth in ounces, in the U.S. "Dietary Guidelines" and elsewhere. 4 In TTB Ruling Number 2004-1, it is stated that “TTB plans to engage in rulemaking, in the near future, on the issue of labeling and advertising statements regarding calorie and carbohydrate content. We believe that public comment on these issues will be useful in developing a more comprehensive policy on the mandatory or voluntary use of nutritional information on alcohol beverage labels.” The beer and wine sectors of the alcoholic beverage industry, strenuously objected to both the process and the content of the “White Paper.” Wine Institute opposed the “White Paper” for many reasons, but we point out that the term “standard drink” used by TTB and attributed to the Dietary Guidelines does not appear anywhere within the 2000 version of the Dietary Guidelines. It should be noted that TTB did not move ahead on this version of the “Serving Facts Panel” white paper, but revised and reissued a second white paper on September 21, 2004. While this white paper removes the more onerous provisions embodied in the first version and is careful not to use the term “standard drink,” this second white paper maintains, without benefit of rulemaking, serving size information that is identical to the Guidelines’ “Count as a Drink” sizes. TTB states in this version of the white paper that it will be conducting a rulemaking in the future.5 National Consumer League / Center for Science in the Public Interest Rulemaking Petition Awaits Rulemaking Submitted to TTB in December of 2003, the rulemaking petition of the National Consumer League and the Center for Science in the Public Interest calls for uniform information on several label items: • Alcohol content • Standard serving size • Amount of alcohol in ounces and number of calories per serving • Number of standard drinks per container • Ingredient declaration • U.S. Dietary Guideline recommendations for moderate drinking 5 TTB states in its document entitled: “Nutrient Claims in the Labeling and Advertising of Wine, Distilled Spirits and Malt Beverages – “Serving Facts” Panel” as follows: “The ruling would provide guidance to industry members on what TTB will allow as optional serving facts information on labels and in advertising until we develop final regulations concerning such panels. It is possible that the results of the rulemaking will differ from the guidance in the ruling.” The petitioners contend that more uniform alcohol information should be conveyed to consumers in a context where consumers can more easily understand how much alcohol they are consuming. They suggest that the serving sizes “prescribed” by the U.S. Dietary Guidelines should be used as the “standard serving size.” Additionally, the petitioners suggest that a consistent graphic, such as a beer mug or a glass of wine, be used to alert consumers to the statement. The sample label proposed in that petition looks like this: We urge the authors of the Dietary Guidelines 2005 version to allow for the completion of rulemaking before considering any changes to that portion of the Guidelines. II. CALORIES AND WEIGHT The issue of caloric content and association of alcohol with added sugar and solid fats in relation to discretionary calories and maintaining a healthy weight/weight gain is addressed both in Part A: Executive Summary and Part E: Translating the Science into Dietary Guidance. In the section “Control Calorie Intake to Manage Body Weight” (Part E page 7), the Advisory Committee states that, “Calories come from fat, carbohydrate, protein, and alcohol. The healthiest way to reduce calorie intake is to reduce one’s intake of added sugars, solid fat, and alcohol – they all provide calories, but they do not provide essential nutrients.” … “Table E-3 gives examples of how calories can be decreased by decreasing alcoholic beverage intake.” As we stated in our May 2003 submission to the Advisory Committee, “Given the current lack of consensus on the issue of moderate wine, beer and spirits consumption and its relationship to weight gain, Wine Institute recommends that the Committee provide more detailed discussion on the issue of moderate consumption of wine, beer and distilled spirits and its relationship to weight gain.” (WI Comment 2003, pages 6-7) The NIAAA review, State of the Science Report on the Effects of Moderate Drinking, concluded that the current scientific literature suggests that, “The data on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive. However, there is some evidence for reduced risk of diabetes and metabolic syndrome, which often co-exist with or develop from obesity.” (NIAAA 2003, page 29) An independent review commissioned by Wine Institute to review wine and alcohol and its effects on calories and body weight control since 1985 stated that, “At least 90 papers were published that have dealt directly or indirectly with alcohol consumption and body weight regulation. This renewed interest in how alcohol influences body weight stems, in part, from concern over dietary elements that may underlie the world-wide obesity epidemic. Although no universal consensus has been reached, a number of lines of evidence increasingly suggest that moderate alcohol consumption does not represent a dietary risk for developing obesity and may in fact promote certain metabolic changes which reduce the risk for overweight and obesity.” (Cordain 2003, page 2) In response to the scientific evidence presented, the Ethanol Subcommittee concluded that the relationship between consuming four or fewer alcoholic beverages daily and obesity was an “Unresolved Issue.” They state that, “The available data on the relationship between alcohol consumption and weight gain/obesity are sparse and inconclusive. There are contradictory findings at the higher end of the spectrum (i.e. 3 to 4 drinks per day) that may relate to fundamental limitations of the cross-sectional study design. At moderate drinking levels (i.e. up to one drink per day for women, up to one (sic?) drink per day for men), there is no apparent association between alcohol intake and obesity.” The Subcommittee concludes, “In summary, although prospective data are limited, there is no apparent association between consuming one or two alcoholic beverages daily and obesity.” Dietary Guidelines Advisory Committee Report, (Part 6, Section 8, page 6) Based on the Ethanol Subcommittee conclusion, we would like to recommend the statement made in Part E: Translating the Science into Dietary Guidelines be revised to read: “Calories come from fat, carbohydrate, protein, and alcohol. The healthiest way to reduce calorie intake is to reduce one’s intake of added sugars and solid fats. The findings on the relationship between moderate alcohol consumption and weight gain/obesity are inconclusive, however, it may be prudent to monitor consumption as it relates to the intake of discretionary calories.” CLOSING STATEMENTS We would like to commend the members of the Advisory Committee for their thorough review of the scientific literature and overall balanced recommendations on moderate alcohol consumption by healthy adults. On the issue of the Drinking In Moderation Definition, we strongly support the current definition of moderation (no more than 1 drink per day for women and no more than 2 drinks per day for men). We recommend the definition of one drink of wine be retained as stated in the 2000 version of the Guidelines in Box 26 – What is Drinking in Moderation? We believe that any changes made to the current definition would lead to inaccurate and misleading representations of the Guidelines’ moderation message to the public. Therefore, we recommend the addition of a clear and unambiguous statement in the guidelines that the “Count as a Drink” statements should not be interpreted as the establishment of a “standard drink,” and that the information is being provided to further explain the moderation message. As stated, there will be full and extensive industry and regulatory agency review accompanied by public comment for both serving size and serving facts labeling at the start of 2005. We would ask that any messages relating to moderate drinking and weight gain and obesity for the public clearly state that the scientific findings in this area are inconclusive and that alcohol, as well as other sources of discretionary calories, should be monitored closely for optimal health. We thank you for the opportunity to present additional information and recommendations on the Dietary Guidelines Advisory Committee Report.
Submission Date 9/27/2004
Author Wine Institute

Summary If you drink alcoholic beverages, do so in moderation. • Supporting text should include alcohol consumption as a risk factor for breast cancer, as well as for high blood pressure and congestive heart failure if drinking is prolonged. Written by: Ralph B. Vance, Karmeen Kulkarni, Alice K. Jacobs
Comments If you drink alcoholic beverages, do so in moderation. • Supporting text should include alcohol consumption as a risk factor for breast cancer, as well as for high blood pressure and congestive heart failure if drinking is prolonged.
Submission Date 9/27/2004
Author American Cancer Society, American Diabetes Association, American Heart Association

Carbohydrates
   Sugars
Summary Include the recommendation: Reduce added sugars.
Comments These guidelines will be considered a travesty unless you address the problem of added sugars that is a main cause of obesity in America.
Submission Date 9/1/2004 7:14:00 AM
Author Anonymous

Summary Sugar is an addictive substance and the public should be told this in a clear fashion. This report does not address this issue strongly enough. Please revise these recommendations to reflect what scientists, health advocates and the public now know about the dangers of sugar.
Comments Sugar is an addictive substance and the public should be told this in a clear fashion. This report does not address this issue strongly enough. For the sake of the health of this country, please revise these recommendations to reflect what scientists, health advocates and the public now know about the dangers of sugar.
Submission Date 9/1/2004 7:16:00 AM
Author Anonymous

Summary Your correct intent to limit added sugars is not reflected clearly in your theme to "Choose CHO wisely." Please don't confuse the average American.
Comments Reading the fine print of your document, I can see your wise emphasis on decreasing added sugars within total calorie intake. I fear that the average American will not get this message clearly with your overarching theme - to choose carbohydrates carefully. Please be clear, and urge Americans to reduce addes refined sugars in the same way that you urge them to resude salt.
Submission Date 9/1/2004 7:17:00 AM
Author from Swarthmore, PA

Summary Be unambiguous about limiting sugar consumption.
Comments It is crucial that unambiguous advice about sugar consumption be in the final guidelines in early 2005. With the growing obesity epidemic this hardly seems to be the time to be any less specific about limiting sugar in the diet of every person. This seems to be clearly indicated by scientific reports.
Submission Date 9/1/2004 7:53:00 AM
Author from Blooming Grove, New York

Summary The Dietary Guidelines Committee should make explicit recommendations about added sugars in its advisory reporet. Recent studies clearly show a link between simple sugars and adverse health, such as obesity and diabetes. The committee must take responsibility to clearly advise our nation.
Comments The Dietary Guidelines Advisory Committee should make explicit recommendations about added sugars in its advisory report on dietary guidelines. Results from recent studies clearly show a link between simple sugars, such as high fructose corn syrup, and adverse health, such as obesity and diabetes. Our nation needs such detailed advice to live healthier lives. This, in turn, should help to reduce the burden of chronic, preventable health problems on our health care system.
Submission Date 9/1/2004 8:21:00 AM
Author from Madison, WI

Summary Your "nine tips for healthy eating" must include a clear, unambiguous statement about the harmful effects of added sugars in the diet. "Reduce added sugars" is what we need to hear. You will be failing your mission if you neglect to include a clear unequivocal warning about sugar.
Comments I am appalled that the new guidelines eliminate a direct mention of the harmful effect of refined sugars in the diet. As a parent, educator, and activist with extensive knowledge of good nutrition, I expect clear and unequivocal advice in the nutritional pyramid. A simple statement such as "reduce added sugars" is essential. Most people do not have the time, as I did, to read the summary report. I am appalled at the appearance your agency has capitulated to the food, drug, and dietary supplement industries' pressure to removed the statment "Avoid too much sugar" from the food pyramid guidelines. The statement "Choose carbohydrates wisely for good health" is blatantly unhelpful for the millions of obese Americans who haven't the time to read the fine print. Your mission is to provide clear unambiguous information for the citizenry regarding the best health choices we can make. As teacher since the late 1970's, I have witnessed first-hand the dramatic rise in childhood obesity, Attention Deficit Disorder, food allergies, and other diet-related illnesses. I have witnessed the rise in marketing highly processed foods to children. I despair to think that your revised guidelines will encourage school lunches to be further degraded and the health of the citizenry to further erode. Do not capitulate to industry pressure. Revise your statement to read "Reduce added sugars." People need to know this. It is no less than your mission to be clear, consise,and, above all, truthful to the American public.
Submission Date 9/1/2004 8:34:00 AM
Author from Topsham, Maine

Summary I URGE you to reconsider and issue REAL advice and guidleines concerning the consumption of artificial/processed sugar. Please do your job.
Comments I am astounded that you would remove any negative or restrictive comments regarding artificial/processed sugars in your new food pyramid guidelines, e.g., "choose carbohydrates wisely"?!? Did the fact that 7 members of that panel are connected to the food processing industry have anything to do with it? Can we say "conflict of interest?" Have you no regard for public health at all? Shame on you!
Submission Date 9/1/2004 10:40:00 AM
Author Anonymous

Summary
Comments This is for the public comment period for the new nutritional guidelines. Please include a caution specific to the need to limit sugar in diet. These guidelines will be used in classrooms everywhere and our children need to know that too much sugar is actually bad for their health.
Submission Date 9/1/2004 11:03:00 AM
Author Organization Name not Specified

Summary Limit sugars in guidelines
Comments This is for the public comment period for the new nutritional guidelines. Please include a caution specific to the need to limit sugar in diet. These guidelines will be used in classrooms everywhere and our children need to know that too much sugar is actually bad for their health.
Submission Date 9/1/2004 11:04:00 AM
Author from Hydesville, CA

Summary As a physician, I am disturbed by the guideline "Choose carbohydrates wisely for good health," apparently a result of sugar industry pressure. This should be replaced with clear, health-based advice: "Avoid sugar and foods with added sugars."
Comments As both a family physician and head of a growing household, I appreciate the importance of sound expert advice on nutrition in face of conflicting messages about health and nutrition in the media. While I generally agree with the recommendations of the advisory committee, I was taken aback by the recommendations on sugars and carbohydrates. I am a bit dumbfounded by the committee's decision to break with past sound advice about added sugar, such as "Avoid too much sugar." The proposed guideline "Choose carbohydrates wisely for good health" is vague and essentially abdicates responsibility for providing sound, easy-to-follow advice about the importance of limiting added sugars. Strong evidence, much of it cited in the committee's report, supports the link between added sugar and obesity. Added sugar, which has no nutritional value, also replaces comsumption of other foods with nutritional value, leading to a general decline in nutritional status. As a parent constantly bombarded with media advertising promoting processed, sweetened food products, I appreciate the importance of strong, unbiased nutritional guidance. The committees vague unhelpful guidance on sugars is disturbing. The only likely explanation is that the committee has yielded to pressure from the sugar and processed food industry. I urge you to rewrite the guideline on sugar, replacing the draft statement with a statement such as "Avoid sugar and foods with added sugars."
Submission Date 9/1/2004 11:13:00 AM
Author from Elizabeth, NJ

Summary
Comments What happened to saying we should limit the amount of sugar we eat? If 1980 guidelines said to avoid too much sugar why shouldn't we still say that rather than the mealy-mouthed "Choose your carbohydrates wisely." What a cop-out. You know what sugar does to our teeth & how fat too much sugar, especially in soft drinks, has made too many people. I'm skinny & am tired of all the costs fat people are adding to our health care. If you don't hit people over the head with plain nutrition advice they won't do the research necessary to make the wisest decisions. I eat a lot of junk, but I eat a LOT of fruit & vegetables too. Bravo for emphasizing fruits & vegetables. Now if we could just shift subisdies from sugar & corn to apples, cherries, asparagus, etc. it would be great.
Submission Date 9/1/2004 12:45:00 PM
Author from Montgomery, AL

Summary Reduce added sugars
Comments Your use of sugars is a bit vague. You should be more specific about limiting added sugars in one's diet. Maybe something along the lines of "reduce added sugars." There is too much research out there that addresses the harms of eating added sugars to ignore it.
Submission Date 9/1/2004 1:34:00 PM
Author from Seattle, WA

Summary Be more specific on dangers of too much sugar.
Comments "Choose carbohydrates wisely for good health" is too general. The growing evidence regarding the bad effects of added sugars(soft drinks)necessitates more specific guidelines. Do not let the sugar industry influence the report.
Submission Date 9/1/2004 1:41:00 PM
Author from Bronx, NY

Summary Recommend "Reduce added sugars"
Comments As someone who attempts to eat healthfully, I feel that issuing a recommendation to the public like "Choose carbohydrates wisely" is useless for the average reader. To provide valuable assistance to the public, we should be told which types of carbohydrates should be chosen and which should be avoided. As the New York Times editorial suggests, "Reduce added sugars" would be far more helpful, unless it is true that the committee is unduly unfluenced by the sugars industry.
Submission Date 9/1/2004 2:14:00 PM
Author from Newark, DE

Summary A more exact definition of healty carbohydrates is essential - people do not look at the ingredients in what they are eating - they think it is sufficient to look at nutritional facts.
Comments Sugar is a highly addictive substance - it should be limited in intake to only natural foods. A strong suggestion should be made to stay away from foods w/ added sugar (in all forms.)
Submission Date 9/1/2004 3:06:00 PM
Author from Brooklyn, New York

Summary Change “dental caries” to “caries” (all caries are dental caries) Use “potentially cariogenic” rather than “cariogenic,” which is an inaccurate term Change “sugar” to “sugars” to more accurately reflect the range of sugars that are potentially cariogenic (more detailed comments being mailed)
Comments September 7, 2004 TO: 2005 USDA Dietary Guidelines Advisory Committee FROM: Stephen J. Moss, DDS, MS Professor Emeritus, New York University College of Dentistry RE: 2005 USDA Dietary Guidelines Advisory Committee Report (Part D, Section 5, Question 1: Carbohydrates and Caries) As a lifelong oral health professional who has focused on caries prevention, particularly in children, I want to commend the Dietary Guidelines Advisory Committee on an enlightened and well-written report. Your sophisticated explanation of the relationship between intake of carbohydrates and caries (Part D, Section 5, Question 1) is of great service to the American public, as it clearly and concisely describes the multifactorial nature of the caries process. The following comments pertain to terminology. 1. Page 4, line 23 Change: “contributes to dental caries” To: “contributes to caries” (There are a variety of caries, e.g. active, buccal, compound, distal, fissure, incipient, etc., but all are dental caries.) _______________________________________________________ 2. Page 4, line 25 Change: “reduce the risk of dental caries” To: “reduce the risk of caries” _______________________________________________________ 3. Page 4, line 26 Change: “A combined approach of reducing the frequency and duration of exposure to fermentable carbohydrate intake” To: “Reducing the frequency of fermentable carbohydrate intake and optimizing…” 4. Page 4, line 27 Change: “most effective way to reduce caries incidence” To: “most effective way to reduce development of caries” 5. Page 4, line 32 Change: “of substrate by cariogenic bacteria in the mouth” To: “of substrate by plaque bacteria in the mouth to produce acid and subsequent demineralization of the enamel surface by the acid.” (Used alone, the terms “cariogenic” and/or “cariogenicity” are meaningless. The concept began as a prediction of how a particular food or group of foods would impact on the caries process. It is, at best, an educated guess and refers to the food rather than the bacteria. More meaningful terms in conveying the concept include “potential cariogenicity,” a prediction of how the author believes the fermentable carbohydrates in particular foods will impact the future development of caries. It takes in the multi-factorial nature of caries development. A second useful term is “relative cariogenicity,” which generally refers to a comparison test among a group of foods. They are tested against criteria such as oral retention, oral clearance, ability to demineralize enamel, ability to stimulate salivary flow, etc. Rat feeding studies are a good example of attempts to determine relative cariogenicity among a group of foods, but they are fraught with problems such as consistency of the food, the preference for certain foods by the animals and the fact that humans are not giant rats. For those reasons, those studies are seldom referenced today. There is actually no one test or group of tests that enable scientists, with any degree of certainty, to predict the potential cariogenicity of a food in humans.) 6. Page 4, line 35 Change: “available to the bacteria, and the susceptibility…” To: “available to the bacteria, salivary flow and the susceptibility…” 7. Page 5, line 1 Change: “much less cariogenic than other carbohydrates…” To: “are not as readily fermentable as other carbohydrates 8. Page 5, line 2 Change: “whether or not substituting sucrose with sugar substitutes…” To: “whether or not substituting sugar with sugar substitutes…” (Sugar substitutes can replace a range of sugars, not just sucrose, which is commonly known as “refined” or “table” sugar. _____________________________________________________ 9. Page 5, line 10 Change: “The longer a cariogenic substance remains in the oral cavity…” To: “The longer a fermentable carbohydrate remains in the oral cavity…” _______________________________________________________ 10. Page 5, line 22 Change: “Dental hygiene may have a greater role in the development of dental caries…” To: “Dental hygiene may have a greater role in the development of caries…” _______________________________________________________ 11. Page 6, line 6 Change: “The impact of sugar intakes on dental caries…” To: “The impact of sugars intake on caries…” (Colloquially, “sugar” typically refers to sucrose; all sugars have an impact on caries formation. 12. Page 6, line 33 Change: “had a higher score for dental caries…” To: “had a higher score for caries…”
Submission Date 9/17/2004 4:52:00 PM
Author Organization Name not Specified

   Fiber
Summary Avocados are a natural source of eight vitamins, two minerals and at least three phytochemicals. Avocados are included in dietary programs from many of the world’s leading nutrition organizations and can make a significant contribution to the health of Americans.
Comments One of the nine key messages is: Choose carbohydrates wisely for good health. Including avocados in the diet helps meet the recommended intake of dietary fiber of 14 grams per 1000 calories. One-fifth of a medium avocado provides 3 grams of dietary fiber.
Submission Date 9/17/2004 5:53:00 PM
Author California Avocado Commission

   Sugars
Summary The guidelines should specifically advise against substantial consumption of refined sugar and urge the food industry to reduce the sugar content of beverages and other foods. For people to take the guidelines seriously, the guidelines are to be based on facts, not commercial interests.
Comments Based on the available data from research, both long term average BMI and specific studies on refined carbohydrates such as sugars, I believe that the guidelines should be much more foreceful in stating that sugars should be reduced from present consumption. The dietary guidelines run the risk of being ignored if they do not address clear current dietary problems or appear to pander to commercial interests. The committee is to be applauded for finally stating what has been obvious for at least a dozen years about the adverse health effects of trans-fats. While I can understand that the Government did not want to adversely affect commercial interests, the slow reaction to such a clear problem food gave the users of the guidelines little confidence that the guidelines were constituted with their best interests in mind. Please, don't make the same mistake with sugars. While it may not be absolutely clear that high carbohydrate consumption is entirely responsible for the BMI bloat, there is no doubt that high sugar consumptions is at least partially, and probably mostly, responsible.
Submission Date 9/20/2004 12:22:00 PM
Author Carleton University (retired)

   Fiber
Summary
Comments Regarding: Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2005 to the Secretaries of Health and Human Services and Agriculture It is with great interest, we read the Dietary Guidelines Advisory Committee report, which was certainly very thoughtful and comprehensive. We thoroughly reviewed the discussion around the importance of carbohydrates in the American diets. As a producer of a carbohydrate rich product, we were generally in agreement with the committee’s report. Our only concern is the ability to communicate to consumers the fact that all carbohydrates are not equal and how to choose carbohydrates wisely. To that end, we would like to offer the following reasons why we believe that “Pasta is a Good Carb” and should be a food promoted to Americans in the 2005 Dietary Guideline. Choose Carbohydrates Wisely Choose Pasta · Pasta is relatively low in calories Calories 1 Cup Spaghetti (cooked) 200 1 Med. Baked Potato (plain) 220 1 Cup Brown Rice 232 3 oz. Bagel 240 1 Cup Mashed Potato 248 2 oz. Snickers Bar 282 1 slice chocolate cake (iced) 320 4 oz. French Fries (McDonald’s) 515 · A pasta meal consisting of 1 cup cooked spaghetti, ½ cup spaghetti sauce, 2 oz. lean ground beef, ¼ cup chopped onion and ½ cup green bell pepper is below 500 calories. For a diet of 2500 calories, this is less than 20% of the daily caloric intake. · Pasta is a good source of thiamin, folic acid, iron, riboflavin and niacin. Pasta is also a low fat; very low sodium and cholesterol-free food. · Pasta is even more valuable nutritiously when accompanied by healthy partners like: vegetables, beans, tomato sauce, olive oil, fish, lean poultry or beef and low-fat cheese. When combined these ingredients can result in a delicious meal that is nutrient rich and low fat. · Pasta, like other complex carbohydrates, is an excellent source of energy. This is very different than other carbohydrates such as: cakes, cookies, candy, donuts, potato chips and corn chips, to name a few, that have relatively little nutritional value and unlike pasta have a high Glycemic Index resulting in a fast blood sugar response. · An article published in the Journal of The American Medical Association supports using the Glycemic Index to help choose healthy foods. “Clinical use of Glycemic index as a qualitative guide to food selection would seem prudent in view of the preponderance of evidence suggesting benefit and absence of adverse effects.” JAMA – May 8, 2002 · The Glycemic Research Institute (GRI), a nonprofit organization based in Washington, DC, gives the following reasons why low Glycemic foods are beneficial to health: - Low Glycemic foods do not stimulate food-cravings or human-food-craving-mechanism - Low Glycemic foods are not based on starvation or deprivation - Low Glycemic foods do not promote fat storage - Low Glycemic food plans have been proven to reduce incidence of Type II diabetes and to help control Type I and Type II diabetes - Low Glycemic foods do not elevate insulin and blood glucose - Low Glycemic foods do not exacerbate hyperactivity - Low Glycemic foods do not reduce sports performance GRI – Copyright 1999-2003 · Based on the facts that Pasta has excellent nutritional value, provides diverse meal options and is low on the Glycemic Index, it should be considered “A Good Carbohydrate” and promoted as part of a healthful diet in the upcoming sixth edition of the Dietary Guidelines for Americans. We hope you will agree that Pasta is indeed a good carb and therefore is worthy of specific mention as a carbohydrate, which consumers should consider favorably when planning a healthful meal. Sincerely, Drew Lericos Director of Marketing American Italian Pasta Company 4100 N. Mulberry Drive Kansas City, MO 64116
Submission Date 9/20/2004 6:48:00 PM
Author American Italian Pasta Company

   Glycemic Response
Summary Utilizing the clinically proven glycemic index of a food and/or raw material is mandatory in identifying "Net Carb" and "Low Carb" foods, as well as any claims for Diabetic-Friendly foods.
Comments RE: Food Labeling and the Glycemic Index. Low Carb labeling and Sugar Alcohols. Dear Sirs; Our research organization has been conducting clinical studies of the Glycemic Index and human biochemistry for over 20 years. We possess the largest database of glycemic research of any organization in the world. We recently completed clinical for Hershey Foods to identify the biochemical pathway utilized by chocolate in the body. Our clinical studies are conducted at the University of Florida, and include glycemic index, glycemic load, and fat-storing mechanisms in humans, such as Leptin, Lipoprotein Lipase, and Neuropeptide Y. We are submitting our comments to provide scientific evidence that: 1) sugar alcohols can elevate blood glucose and insulin levels, and and stimulate fat-storage in humans, and this needs to be reflected in FDA labeling guidelines. 2) Determination of the glycemic response of foods, Nutraceuticals, and all consumables, is mandatory in the determination of labeling information. 3) Identifying "Low Carb" foods and "Net Carb" foods requires knowledge of the biochemical properties of the food. We concur with the FDA position that the term "Low Carb" should not be allowed until a competent definition on "Low Carb" is established. If the glycemic index of a low carb product is not known, how can that product claim not to elevate blood glucose, insulin levels, and stimulate fat-storing mechanisms in humans? Sugar alcohols can elevate blood glucose, insulin levels, and fat-storage in adipose tissue fat cells, despite what manufacturers claim. Food manufacturers should not be allowed to use the terms "Low Carb" or "Net Carb" foods until there is definitive data showing the clinical response of all raw materials used in food manufacturing, such as sugar alcohols. Only specific laboratory and definitve clinical studies can quantify these terms. If manufacturers are allowed to state "Net Carbs" without clinical evidence of the biochemical properties of foods and raw materials, there will be mis-labeling, misuse, and outright fraud against the public. All carbs and sugars and sugar alcohols present caloric value, as well as blood glucose, insulin, and fat-storage properties. It is our position that all carbohydrates and sugars should be claimed under Carbohydrates, and not allowed to be placed under the guise of "Low Carb" or "Net Carb." Sincerely, Dr. Ann de Wees Allen Chief of Biomedical Research Glycemic Research Institute Washington, D.C. www.glycemic.com
Submission Date 9/21/2004 6:10:00 PM
Author Glycemic Research Institute

   Fiber
Summary The guideline should be modified to increased specificity. Suggested guideline; Choose foods made with whole grains and little added sugar.
Comments If the intent of the proposed general carboydrate guideline is to reinforce the guideline “Increase daily intake of fruits and vegetables, whole grains, and nonfat or low-fat milk and milk products” and address the issue of increasing whole grains and reducing sugar intakes a more actionable guideline would read; “Choose foods made with whole grains and little added sugar”.
Submission Date 9/22/2004 2:23:00 PM
Author from Boston, MA

   Sugars
Summary The guideline should be modified to increase specificity. Suggested guideline; Choose foods made with whole grains and little added sugar.
Comments If the intent is to reinforce the guideline “Increase daily intake of fruits and vegetables, whole grains, and nonfat or low-fat milk and milk products” and address the issue of increasing whole grain and reducing sugar intakes a more actionable guideline would read; “Choose foods made with whole grains and little added sugar”.
Submission Date 9/22/2004 2:28:00 PM
Author from Boston, MA

Summary It is urgent that you distinguish between simple and complex carbs in the new dietary guidelines for the nation. Urge that people eat complex carbs, and leave simple carbs for on occasional, RARE, treat. We need to lower the rate of obesity in this country or we will be a nation of sick people.
Comments In the new Dietary Guidelines you are working on, it is essential that you explain the difference between COMPLEX carbohydrates and SIMPLE carbohydrates, and the way that difference relates to good health vs. poor health, AND to weight loss opportunities. All carbs are NOT created equal. Other than honey, only complex carbohydrates occur in nature. They contain a great deal of fiber. When the fiber is removed from these naturally-occuring complex carbohydrates--by food processing--the complex carbs become simple carbs (read "sugars")and are then ready to be rapidly digested by the body. Keeping the fiber in the naturally-occurring carbohydrates by using only minimal processing that does not remove fiber results in slow digestion, whereby the calories are released SLOWLY into the bloodstream, which does not result in a rapid rise in blood sugar level. Eating carbohydrates that have had all the fiber removed by food processing releases a cascade of simple sugars (read "calories") into the bloodstream rapidly, causing a rise in insulin, which is called the "insulin response." That is NOT a good thing, as it causes quick calorie storage in the fat cells, followed by a quick blood sugar drop, making us even fatter than we already are, and wanting more of what we just ate. Repeating this cycle frequently can significantly raise the risk of diabetes. Furthermore, I have personally observed over the years (I'm now 62)that simple sugars DULL my tastebuds, and my desire for complex carbohydrates and other health-promoting foods, and give me instead a craving for simple carbs(cakes, candy, cookies, chips, etc, ad infinitum), resulting in the "One is not enough" syndrome. It's really, really easy to want to binge on simple-carb foods. This doesn't happen with complex-carb foods. Simple-sugar foods cause cravings, a result of the rapid rise and fall in blood sugar levels. With complex carb intake, cravings go away and blood sugar stabilizes. I have repeated this unfortunate "learning cycle" more times than I care to admit over my 62 years. It is always the same. At the end of the cycle, I need to lose the weight I gained during the "learning" part! All my acquaintances say the same is true for them. When you are eating simple carbs, you simply don't want good, health-promoting food. You will choose "junk" food, instead, and the more the better! It is imperative that the important difference between types of carbohydrate (unrefined vs refined) be spelled out for our citizens. Many don't know how important the difference is to their overall health, or to their waistines. Please, please do the right thing and tell the truth. We depend heavily on your work, so you need to do it right. You are charged with EDUCATION FOR GOOD HEALTH for all Americans. Fulfill your charge. Please.
Submission Date 9/23/2004 9:52:00 AM
Author from Cary, NC

Summary Omit the word “carbohydrate” from the guidelines. Suggest changing to "Choose sugar containing foods and drinks wisely for good health."
Comments Omit the word “carbohydrate” from the guidelines. Suggest changing to "Choose sugar containing foods and drinks wisely for good health." Many people don’t realize that sugar falls under the carbohydrate group- they only relate carbohydrate to breads/grains.
Submission Date 9/23/2004 12:16:00 PM
Author OSU Extension Program- Cleveland, OH

Summary Suggest removing the term "carbohydrate."
Comments Suggest removing the term "carbohydrate." Carbohydrate is such a “popular” term these days that many people don’t know what to think when they hear the term. They are bombarded with "high carb, low carb, no carb, net carb"…how are they to know what is truly a wise carbohydrate choice? Carbohydrates are not the enemy- over consumption is the issue. Over-consumption of carbohydrates, fats & protein- not just carbs!
Submission Date 9/23/2004 12:20:00 PM
Author OSU Extension Program- Cleveland, OH

Summary The DGA could reword its message to distinguish between healthy and not-so-healthy carbohydrate choices. For example "Choose carbohydrates from unrefined grains and sugars" makes a distinction between whole and processed sources.
Comments Given the current "low-carb" climate, "Choose Carbohydrates Wisely" taken without its supporting message may lead to more confusion over which sources of carbohydrates are the healthiest choices.
Submission Date 9/24/2004 1:04:00 PM
Author from Salem, MA

Summary Stress lower daily carbohydrate intake. Stress importance of WHOLE grains, not refiled grains of any kind.
Comments
Submission Date 9/24/2004 2:15:00 PM
Author from Holland, MI

   Glycemic Response
Summary glycemic responses depend on food not considered in isolation...
Comments Please emphasize that the glycemic response of a food is not fixed. A potato eaten with nourishing sour cream has a much lower glycemic index than a plain potato. Foods are not isolated chemicals. They are parts of a meal.
Submission Date 9/24/2004 4:47:00 PM
Author from Beaverton, OR

   Fiber
Summary Leading health organizations promote the benefits of citrus, including the American Heart Association, American Cancer Society, the National Cancer Institute and the Produce for Better Health Foundation.
Comments One of the key messages is: Choose carbohydrates wisely for good health. Including citrus fruits in the diet helps meet the recommended intake of dietary fiber of 14 grams per 1,000 calories. Oranges and grapefruit rank #1 and #2 in fiber out of the top 20 most consumed fruits and vegetables . One medium-sized orange is an excellent source of fiber, providing 7 grams, or 28 percent of the Recommended Daily Value. Half a grapefruit is also an excellent source of fiber providing 6 grams and 24 percent of the Recommended Daily Value.
Submission Date 9/24/2004 5:21:00 PM
Author Sunkist Nutrition Bureau

   Sugars
Summary Thank you again for the opportunity to express my opinion on this topic. Thank you for taking the time to sort through all of the comments that people will no doubt contribute.
Comments Thank you for the opportunity to be able to provide my own individual input on such important matters as the Dietary Guidelines. It is so wonderful to know that you care about individual’s nutrition and health. It is comforting to felt that there is hope in making this country healthy once again. I wanted to comment on the carbohydrate sugars that can increase dental caries. I am in agreement that sugars, over time, can contribute to children having dental caries. This has been a concern of mine for a long time. I work in a hospital and see so many very young children coming in to get multiple crowns and pulpotimies. I think that the most contributing factor to this is negligent hygiene of the parents. Young children can not be responsible for their dental care at such a young age. I think it should be a recommendation that parents help their children brush up until at least age five. This would hopefully instill that habit in to the children for life. Also, I fully believe that parents should carefully watch how much carbohydrates and sugar their child consumes. When parents let the child eat candy this can also contribute to dental caries because of the length of time the sugars remain in the mouth. I completely agree with the studies that were found on this topic in the report. Again, I think it should be recommended that parents keep track of or prevent their very young children from consuming certain sugars and the amounts of the sugars eaten.
Submission Date 9/26/2004 9:28:00 PM
Author Anonymous

   Fiber
Summary I thank you for the opportunity to provide my input on the revised dietary guidelines. I applaud you for caring about the individual’s nutrition and raising the awareness of these issues.
Comments I read over the carbohydrates section of the dietary guidelines and I was very encouraged by all of the research that had been conducted about the role of carbohydrates in our bodies. Because of low-carb diets, carbohydrates have received such bad publicity that people don’t care to hear about or look at a food that contains any sort of carbohydrate in it. The fact is, carbohydrates are essential in our daily diets because they give us the energy we need. My concern is that this information is necessary for the public to hear. How are you going to reach the public? Another concern I have regarding this information is about how to make people understand that this information is truthful and not just dietary propaganda. It has been my experience that people want a quick and easy way to lose weight. The low-carb diets do offer extreme weight loss in a very short amount of time. People want a quick fix and these low-carb diets are offering that. So how are you going to distinguish between the truth and fallacy?
Submission Date 9/27/2004 12:09:00 AM
Author Anonymous

Summary In summary I am glad that carbohydrates such as fiber and its importance were addressed. I think this may help more people in the United States turn away from the Fad Diets that restrict carbohydrates.
Comments Dear Secretaries Veneman and Thompson: Thank you for giving me the opportunity to provide some input in the dietary guidelines. I would also like to thank you for caring about individual's nutrition in the United States. I strongly agree with Choose Carbohydrates Wisely for Good Heatlth. In a world that is consumed with Fad Diets, such as the Atkins Diet or South Beach Diet, where little or no carbohydrates are allowed this lets people know how important it is to consume carbohydrates for energy and overall nutrition. It also allows people to to know that there are bad carbohydrates like sugars and starches that can cause dental caries and unwanted weight gain, so chose good carbohydrates like fruits, vegetables, and grains to help maintain a healthy weight.
Submission Date 9/27/2004 8:53:00 AM
Author Anonymous

   Sugars
Summary In discussions and observation of seniors on a regular basis, many of them that are diabetic assume they cannot eat carbohydrates because of the sugar breakdown.
Comments Specific guidance should be provided on food types that "contain sugar" or breaks down to sugars and the effect this may produce for diabetic individuals.
Submission Date 9/27/2004 10:51:00 AM
Author Northwest Indiana Community Action Corp.

Summary The recommendation to limit calories through reductions in sugars, saturated fats, and alcohol should be retained, even if there are political pressures against such a recommendation.
Comments
Submission Date 9/27/2004 12:05:00 PM
Author from Lincoln, Nebraska

   Glycemic Response
Summary Consumers today (including my 900 college students per year) are so inundated with the low-carb message they think all are bad. The "choose carbohydrates wisely" message must become a major message in the USA.
Comments
Submission Date 9/27/2004 12:40:00 PM
Author University of Nebraska-Lincoln

   Sugars
Summary Page 4 of the Backgrounder notes the recommendation of 45% to 65% CHO, but notes the IOM allowance of 130 g in the same paragraph. These should be separated and 130 g explained perhaps.
Comments
Submission Date 9/27/2004 12:43:00 PM
Author University of Nebraska-Lincoln

   Fiber
Summary
Comments Emphasize healthy carbohydrates, such as whole grains, fruits, and vegetables. Emphasize whole grains instead of refined carbohydrates
Submission Date 9/27/2004 1:21:00 PM
Author Volunteers of America

Summary It is essential that consumers understand the concept of choosing carbohydrates with the most “bang for the carb.” Everyone who communicates these guidelines to consumers should note the distinction about fruits and vegetables as an important dietary choice for maximum health and nutrition.
Comments Given the current attention to low-carbohydrate diets, it is important for consumers to understand the issues surrounding carbohydrates in their diets. The committee writes: “Since the RDA for carbohydrate is relatively easy to meet, and carbohydrates (sugars and starches) supply calories, it is important to choose food sources of carbohydrates carefully to maximize nutrient value per calorie. Also, since fiber has known health benefits (e.g., promoting a healthy laxation and decreasing the risk of CHD and diabetes) it is advisable to select high-fiber foods where possible. For example, fruits provide sugars, usually at a relatively low calorie cost, and they are important sources of fiber and at least eight additional nutrients. Some vegetables are high in starch and some are very low in both starch and sugar, but they all are important sources of fiber. They also are important sources of 19 or more nutrients, including vitamins A, E, and folate and potassium, and, in general, do not supply many calories.” It is essential that consumers understand the concept of choosing carbohydrates with the most “bang for the carb” when choosing the components of their daily diets. Everyone who communicates these guidelines to consumers should note the distinction the committee made about fruits and vegetables as an important dietary choice for maximum health and nutrition.
Submission Date 9/27/2004 4:28:00 PM
Author Produce Marketing Association

   Sugars
Summary -
Comments - The latter part of the first message “while staying within energy needs” is more closely related to the second message “Control Calorie Intake To Manage Body Weight”. The second message is an important one and needs to emphasize the importance of energy balance. According to NHANES data, almost 65% of adults are overweight or obese and over 15% of youth are overweight. As indicated in this message, obesity is caused by over consumption of calories relative to energy expenditure, and therefore the general public needs to have a clearer understanding of this issue. Including this discussion with other key messages, and not as a separate message, does not give the importance to this issue that is needed.
Submission Date 9/27/2004 4:46:00 PM
Author Missouri Department of Health and Senior Services

Summary
Comments - There is an overlap between the fourth message, Increase Daily Intake of Fruits and Vegetables, Whole Grains and Non-fat or Low-fat Milk and Milk Products and the sixth message, Choose Carbohydrates Wisely for Good Health. The information in these two messages is similar and neither message puts strong emphasis on the importance of reducing added sugar and foods high in sugar content. Though the Executive Summary of the Report states that the Committee provides strong rationale for limiting one’s intake of added sugars, the key message does not carry the weight of this recommendation. It is recommended that the message Choose Carbohydrates Wisely for Good Health, be changed to Decrease/Reduce Foods High in Sugar. Carbohydrates are not food components that are necessarily added to foods, as are fat, salt and sugar. The word carbohydrate is too broad, and the general public does not fully understand this term.
Submission Date 9/27/2004 4:48:00 PM
Author Missouri Department of Health and Senior Services

   Fiber
Summary
Comments First, we congratulate the 13-member panel of scientists who devised the above recommendations. We support the majority of recommendations, especially the emphasis on fruits, vegetables, unrefined carbohydrates, and seafood – all of which mirror the Pritikin Eating Plan. We also applaud the conclusion that total calories – and the calorie density of foods – are more important than food components when trying to maintain or lose weight. Finally, we agree that the glycemic index is not a viable weight loss tool. Below is our first (of three) key corrections to the panel’s recommendations: 1. In real-world settings, low-fat, high-carbohydrate diets do not lead to increased levels of triglycerides. In their proposed guidelines, the panel states that a negative consequence of a low-fat diet is that “it is usually a high-carbohydrate diet, which can lead to increased levels of triglycerides.” The data supporting this statement, however, come from controlled laboratory settings; researchers directed subjects to eat the same number of calories on high-carbohydrate diets as they had eaten on high-fat diets. Never did the subjects have the opportunity to evaluate how full they were – and how much of the foods on the differing diets they preferred to eat. In studies that mimicked real-life setting – those in which the subjects themselves were allowed to determine their daily total intake from food – low-fat diets rich in unrefined carbohydrates led to reductions in body weight and improved blood lipids, including triglycerides. Results from two long-term trials in subjects with impaired glucose tolerance found that a diet higher in carbohydrates combined with exercise led to weight loss and about a 60% reduced risk of developing diabetes. Two studies in normal subjects showed that the adverse changes seen in blood lipids do not occur if the subjects – rather than the researchers – determined how much they ate of the high-carbohydrate diets. Finally, recent research demonstrated that type 2 diabetics who were allowed to eat as much as they wanted from either a high-carbohydrate or high-monounsaturated-fat diet did not suffer adverse impacts on blood lipids from the high-carbohydrate diet. The authors concluded: “Contrary to expectations, the ad libitum, low-fat, high-fiber diet promoted weight loss in patients with type 2 diabetes without causing unfavorable alterations in plasma lipids or glycemic control.” Certainly, as the 2005 guidelines elaborate, the type of carbohydrate Americans eat is critical. Refined carbohydrates are not the answer. Because they are rapidly absorbed and are often low in satiety, people may eat nearly as many calories as if they were on a high-fat diet. But a diet with plenty of unrefined carbohydrates like fruits, vegetables, and whole grains is rich in fiber and volume yet low in calories, and is therefore more likely to promote satiety, weight loss, and improved blood lipids.
Submission Date 9/27/2004 5:40:00 PM
Author Pritikin Longevity Center

Summary
Comments Earlier today I submitted comments under the heading "In real-world settings, low-fat, high-carbohydrate diets do not lead to increased levels of triglycerides." I do not believe, however, that the footnotes "traveled" into this comment field. So below are the footnotes for this topic. 1) N Engl J Med, 2002; 346: 393. 2) N Engl J Med, 2001, 334: 1343. 3) JAMA, 1995; 274: 1450. 4) Arterioscler Thromb, 1994; 14: 1751. 5) Am J Clin Nutr, 2004; 80: 668.
Submission Date 9/27/2004 5:57:00 PM
Author Pritikin Longevity Center

   Glycemic Response
Summary Encourage traditional, local processing, minimizing preservatives. Use the whole wild or pasture raised animal (organs, bones, AND fat), and gathered or locally raised fruits, vegetables, and grains. Improve family dinner-time by preparing God-given foods together and eating to satisfaction.
Comments Corrected version - original version I stated that fermenting decreases nutrients such as iron, which was a typographical error, please note, iron availability increases with slow fermentation of grains! Thank you for allowing input. I would like to see a return to a circle of foods, as done in the Native American symbols with the 4 directions with buffalo (or animals) from the north, gathered ones (fruits, berries, vegetables, herbs) from the east, traded ones (squashes, corn, beans, starchy vegetables) from the south, and water from the west,if I remember right! Here on the reservation those who eat more traditional foods, with hunting and fishing do much better with their health. Our children need whole foods, including all parts of the animal, using the fat for its strength and the bones for their soup. We need the fruits and berries, plants and roots for their healthful properties. We do not need the sugar drinks and alcohol from the supermarket. Even the lard from pigs and tallow from beef has high nutrients when raised as nature meant, without hormones, without additives, out in the sun, and on the range - much better than vegetable oils and margarines and crisco that are little better than plastic to our bodies. Please encourage the use of traditional foods from whatever culture they may come from, as additive free as possible, without the dyes and preservatives that harm our sensitive members. Encourage artisan breads and cheeses, without the current requisite pasteurization. We want clean food from clean facilities, not sterilized food from unknown sources. If it comes from overseas, let it be from quality sources. Above all, healthy wild food being the best, and healthy homegrown or locally grown without the many flavorings and other additives needed to cover the sterile taste of sterile food. Were commodities to change the crisco to the original lard, tallow, butter of the healthy animal or even the organic coconut and palm oil of early shortenings, and deliver the cow on the hoof again, we would have made a profound start in alleviating the burden of diabetes. God delivered the bounty for our use in carefulness, and not in waste. Even the mediterraneans ate boiled eggs, cheese, olives, tomatoes and cucumbers as a breakfast - traditional foods wherever we are should be remembered. We can only do that by emphasizing the whole animal and allowing small craftmanship to be retailed, as in tiny three-cow dairies, ten-pig farms, and makers of traditional foods using real kidney fat for the pemmican, lard for native tortillas, unpasteurized milk for cheeses, and real intestine and bones for the native soups. Please emphasize the use of traditional, home, and small-crafted foods. Even some of the Native American tribes made their own fermented drinks, mostly sour, with any alcohol being counteracted by the high quantity of B-vitamins in these indegenous drinks (example, pulque is undistilled, also unfermented in its traditional state, and not able to be transported very far - by distilling something similar to make Tequila, you develop the problems of severe intoxication). The Cherokees fermented a sour corn drink for visitors, releasing its nutrients to the highest advantage. Alcoholism is a plague killing many, and disabling many others. By returning even to the traditions of unpasteurized beer on the tap, we would have at least maintained the B-vitamins and kept the drunkenness to the taverns, minimizing its presence behind the wheels. Traditional drinks, including traditionally fermented ginger ale and native herbal flavored teas contain nutrients that strengthen constitution and also provide much less sugar than do the soft drinks of the convenience store. One last item that may be of interest - our main diabetes did not start until after the second world war. Part can be attributed to the employment in factories to build armament reducing physical activity, but remember also that dried yeast was transmitted to us after Germany was defeated. Before that, bread in all countries was made by a slow-rise, equivalent to what we call sour-doughs today, even though many slow-rise breads are not sour. The grandmas here call them Gabubu bread. You start by mixing flour and water and over a few days it starts to rise, and that is used as a start for whatever bread you may make. 24-hour plus fermentations allow the bacteria to eat starch and make the goo that allows even rye breads to rise. The bacteria also decrease the glycemic index, increasing many nutrients such as iron that originally had been bound by phytic acid, and make it a healthy food for diabetics. In international aid, private foundations have started to send prefermented grains, knowing that to save children on limited protein and fats, they must have the maximum available nutrition from the limited food they do receive, which necesitates fermentations of grains. Native americans consuming the flour delivered in bags in the first commodities didn't get diabetes partly because they had to ferment the flour in order to make some breads taught to them by the whites, except for times when soda ash and baking soda were used, and even then they were often used with soured milk/buttermilk from the cows delivered to them. When frying started, they used real beef tallow, which is absorbed less into the fried substance than vegetable oils do. The Mennonite colonies here in NE Montana also cook sourdough breads for themselves, although they bake quick yeast leavened breads for the outside farmers markets. They have broad straight jaws and teeth, and healthy trim but strong figures. The homemade, homegrown diet includes garden items, chicken eggs, milk products, and meat all from their own colony. The health of the traditional foods, although quite different from the Native American tribal foods, is still very evident. Although a colony existence is not the mainstream, we can encourage local neighborhood artisanship. In the larger community nationwide, we can start by encouraging traditional, lesser processed foods with natural preservation techniques such as salting, natural pickling, drying, and sour fermenting. We can also require the use of strong labeling for any chemical preservatives. Bright labeling of hydrogenated and partially hydrogenated fats would be helpful. An encouragement of organic, animal or tropical natural fats in place of vegetable oils, especially in frying, would also be appreciated. Again, an emphasis on the traditional foods, homegrown or healthily grown and prepared would be appreciated. When we tell people that fats are bad, especially the ones with the vitamins A and D, and the CLA that is so beneficial to the body, we set them up to eat carbohydrates using quick leavens and vegetable oils that leaves them unsatisfied, thus driving them towards sodas and alcohol. Kibbe Conti, a dietician from the Rosebud reservation, taught the 4 winds concept, a circle of nutrition. Other than the fact she thought that the traditional diet is low fat, she was right on. She forgot that 'taneega' (intestines soup saved for the elders of tribe first)and 'was-na'(8 parts pounded dried meat and berries to one part melted fat from above the kidneys)are just prime examples of how traditional native american foods valued the whole animal. I am a newcomer, having only been on the reservation for two years, but in that time have been priveleged to learn how valuable the Native American traditional foods are, as well as the traditional foods from the American, Mexican, and middle-eastern traditions I grew up with. Sincerely, Julene McCurry
Submission Date 9/27/2004 10:20:00 PM
Author from Poplar, Montana

   Sugars
Summary Simply and directly state to clearly limit consumption of processed sugars, which includes things like high fructose corn syrup, white sugar, etc... Don't make people guess at what you mean.
Comments the new guidelines do not directly comment on the criticality of reducing/significantly minimizing consumption of PROCESSED SUGAR. The more DIRECTLY you state this the more likely your AUDIENCE will get the message. Consider your audience and using plain, simple language that is easily understood at 1st glance.
Submission Date 9/28/2004 11:45:00 AM
Author

Summary
Comments I am very dismayed at the new guidelines for the new food pyramid. It is absolutely unconscionalble that you would remove all references to excess sugar as a negative quality in a normal diet. This is the worst kind of pandering to industry I have seen for a while. Please reconsider the diservice to the American Public you are considering and do your duty to the PUBLIC.
Submission Date 9/29/2004 10:52:00 AM
Author Anonymous

Summary as requested by sandy saunders, DGAC, i am submitting my mailed comments via email. thank you.
Comments September 7, 2004 TO: 2005 USDA Dietary Guidelines Advisory Committee FROM: Stephen J. Moss, DDS, MS Professor Emeritus, New York University College of Dentistry RE: 2005 USDA Dietary Guidelines Advisory Committee Report (Part D, Section 5, Question 1: Carbohydrates and Caries) As a lifelong oral health professional who has focused on caries prevention, particularly in children, I want to commend the Dietary Guidelines Advisory Committee on an enlightened and well-written report. Your sophisticated explanation of the relationship between intake of carbohydrates and caries (Part D, Section 5, Question 1) is of great service to the American public, as it clearly and concisely describes the multifactorial nature of the caries process. The following comments pertain to terminology. 1. Page 4, line 23 Change: “contributes to dental caries” To: “contributes to caries” (There are a variety of caries, e.g. active, buccal, compound, distal, fissure, incipient, etc., but all are dental caries.) _______________________________________________________ 2. Page 4, line 25 Change: “reduce the risk of dental caries” To: “reduce the risk of caries” _______________________________________________________ 3. Page 4, line 26 Change: “A combined approach of reducing the frequency and duration of exposure to fermentable carbohydrate intake” To: “Reducing the frequency of fermentable carbohydrate intake and optimizing…” 4. Page 4, line 27 Change: “most effective way to reduce caries incidence” To: “most effective way to reduce development of caries” 5. Page 4, line 32 Change: “of substrate by cariogenic bacteria in the mouth” To: “of substrate by plaque bacteria in the mouth to produce acid and subsequent demineralization of the enamel surface by the acid.” (Used alone, the terms “cariogenic” and/or “cariogenicity” are meaningless. The concept began as a prediction of how a particular food or group of foods would impact on the caries process. It is, at best, an educated guess and refers to the food rather than the bacteria. More meaningful terms in conveying the concept include “potential cariogenicity,” a prediction of how the author believes the fermentable carbohydrates in particular foods will impact the future development of caries. It takes in the multi-factorial nature of caries development. A second useful term is “relative cariogenicity,” which generally refers to a comparison test among a group of foods. They are tested against criteria such as oral retention, oral clearance, ability to demineralize enamel, ability to stimulate salivary flow, etc. Rat feeding studies are a good example of attempts to determine relative cariogenicity among a group of foods, but they are fraught with problems such as consistency of the food, the preference for certain foods by the animals and the fact that humans are not giant rats. For those reasons, those studies are seldom referenced today. There is actually no one test or group of tests that enable scientists, with any degree of certainty, to predict the potential cariogenicity of a food in humans.) 6. Page 4, line 35 Change: “available to the bacteria, and the susceptibility…” To: “available to the bacteria, salivary flow and the susceptibility…” 7. Page 5, line 1 Change: “much less cariogenic than other carbohydrates…” To: “are not as readily fermentable as other carbohydrates 8. Page 5, line 2 Change: “whether or not substituting sucrose with sugar substitutes…” To: “whether or not substituting sugar with sugar substitutes…” (Sugar substitutes can replace a range of sugars, not just sucrose, which is commonly known as “refined” or “table” sugar. _____________________________________________________ 9. Page 5, line 10 Change: “The longer a cariogenic substance remains in the oral cavity…” To: “The longer a fermentable carbohydrate remains in the oral cavity…” _______________________________________________________ 10. Page 5, line 22 Change: “Dental hygiene may have a greater role in the development of dental caries…” To: “Dental hygiene may have a greater role in the development of caries…” _______________________________________________________ 11. Page 6, line 6 Change: “The impact of sugar intakes on dental caries…” To: “The impact of sugars intake on caries…” (Colloquially, “sugar” typically refers to sucrose; all sugars have an impact on caries formation. 12. Page 6, line 33 Change: “had a higher score for dental caries…” To: “had a higher score for caries…”
Submission Date 9/29/2004 11:04:00 AM
Author Organization Name not Specified

   Glycemic Response
Summary The section on low carbohydrate diets is out-of-date.
Comments September 22, 2004 To the Guideline Panel: I have reviewed the Guideline sections below regarding low carbohydrate diets, solicited input from other low carbohydrate diet researchers, and urge you to make changes to this section to reflect the science that has been recently performed. This response is organized into A) Comments to Sections B) Sections Reviewed. A) COMMENTS TO SECTIONS 1) Reference #14 (Westman, 2002) was NOT a randomized trial as mentioned in the text. The randomized controlled trial from that group was: Yancy, W.S., Jr., Olsen, M.K., Guyton, J.R., et al., A Low-Carbohydrate, Ketogenic Diet Versus a Low-Fat Diet to Treat Obesity and Hyperlipidemia: A Randomized, Controlled Trial. Annals of Internal Medicine 2004;140(10):769-777. 2) In the sentence: “…diet compared with 3.2 percent below baseline for those on the control diet. At 18 months, however, there was no statistically significant difference in weight loss. Some of the early weight...” 18 should be changed to 12 months.1) It is not customary to promote a particular lay press popular diet book, so the reference to a diet book should be deleted. 3) Many studies involving very low carbohydrate diets have been published since the reviews by Freedman and Bravata, which makes these reviews out-of-date. Either delete these references, or mention that many studies have been published since these reviews were performed. 4) There is no mention of the low carbohydrate randomized trials (in which half the subjects were eating fewer than 50 grams CHO/day) in the section that states that "the Recommended Dietary Allowance for carbohydrate...is 130 grams/daily." How are the positive findings from the low carbohydrate randomized trials consistent with these statements? 5) The reference to Fleming, 2002 should be deleted because the science was terribly flawed. (e.g. The authors state that subjects were randomly assigned, but the text reads "Patients...were randomly assigned to one of the four dietary regimens based upon dietary preferences." There was no objective documentation that patients instructed in a diet were actually following it. Moreover, there was no reduction in serum triglycerides in the low carbohydrate group, a finding seen in every other clinical trial involving this diet.) 6) The reference to Larosa, 1980 should be deleted because the clinical trials published since 2003 have given much more detail, use contemporary laboratory measures, and the Larosa study was not a randomized controlled trial. 7) There is no definition of "healthy" -- is it weight loss, blood levels of cholesterol, mental health, etc. 8) For an example of how to word recent data in a non-judgmental way, please see the following excerpt from: Klein S, Sheard NF, Pi-Sunyer X, Daly A, Wylie-Rosett J, Kulkarni K, Clark NG. Weight management through lifestyle modification for the prevention and management of type 2 diabetes: rationale and strategies. A statement of the American Diabetes Association, the North American Association for the Study of Obesity, and the American Society for Clinical Nutrition1–3. Am J Clin Nutr 2004;80:257– 63. “Recently, there has been increased interest in the use of low carbohydrate diets as potential therapy for obesity. The results of 5 randomized controlled trials in adults (65–69) found that subjects randomly assigned to a low-carbohydrate, high-protein, high-fat diet (25–40%of calories from carbohydrate) achieved greater short-term (6 mo) (65–67), but not long-term (12 mo) (65, 68), weight loss than did those randomly assigned to a low-fat diet (25–30% of calories from fat and 55–60% of calories from carbohydrate). The data from these studies also found greater improvements in serum triglycerides and HDL cholesterol concentrations but not in serum LDL-cholesterol concentrations in the low-carbohydrate group than in the low-fat group. In addition, glycemic control was better with low carbohydrate than with low-fat diet therapy in subjects with type 2 diabetes (66, 68). Data from a study conducted in overweight adolescents found that altering the dietary glycemic load by reducing the total carbohydrate content (45–50% of energy intake) and consuming foods with a low glycemic index resulted in greater weight loss than did a conventional low-fat diet (25–30%) (70). Additional research is needed to clarify the long-term efficacy and safety of low-carbohydrate diets, particularly in patients with diabetes. It is unlikely that one diet is optimal for all overweight and obese persons.” References found in the Klein excerpt: 65. Foster GD, Wyatt HR, Hill JO, et al. A randomized trial of a lowcarbohydrate diet for obesity. N Engl J Med 2003;348:2082–90. 66. Samaha FF, Iqbal N, Seshadri P,et al.Alow-carbohydrate as compared with a low-fat diet in severe obesity.NEngl J Med 2003;348:2074–81. 67. Brehm BJ, Seeley RJ, Daniels SR, D’Alessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie-restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrinol Metab 2003;88:1617–23. 68. Stern L, Iqbal N, Seshadri P, et al. The effects of low-carbohydrate versus conventional weight loss diets in severely obese adults: one-year follow-up of a randomized trial. Ann Intern Med 2004;140:778–85. 69. Yancy WS Jr, Olsen MK, Guyton JR, Bakst RP, Westman EC. A low-carbohydrate, ketogenic diet versus a low-fat diet to treat obesity and hyperlipidemia: a randomized, controlled trial. Ann Intern Med 2004;140:769–77. 70. Ebbeling CB, Leidig MM, Sinclair KB, Hangen JP, Ludwig DS. A reduced-glycemic load diet in the treatment of adolescent obesity. Arch Pediatr Adolesc Med 2003;157:773–9. PERTINENT REFERENCES NOT MENTIONED IN THE GUIDELINE: 1. Full bibliographic reference details of research Bailes, J.R.J., Strow, M.T., Werthammer, J., et al., "Effect of Low-Carbohydrate, Unlimited Calorie Diet on the Treatment of Childhood Obesity: A Prospective Controlled Study. Metabolic Syndrome and Related Disorders, 1(3), 2003, pages 221-225. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Use of low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<30 grams/day) to low calorie diet for obesity in clinical practice 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects Obese children from a Pediatrics Endocrinology (n=37) 11. Outcome Measures Weight change at 2 months 12. Results/Main Findings Children instructed in the low carbohydrate diet lost more weight than the children on the low calorie diet. Compliance was also better with the low carbohydrate approach 13. Further comments 1. Full bibliographic reference details of research Brehm, B.J., Seeley, R.J., Daniels, S.R., et al., "A Randomized Trial Comparing a Very Low Carbohydrate Diet and a Calorie-Restricted Low Fat Diet on Body Weight and Cardiovascular Risk Factors in Healthy Women. Journal of Clinical Endocrinology and Metabolism, 88(4), 2003, pages 1617-1623. 2. Funding body American Heart AssociationNational Institutes of Health 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<50 grams/day) to 30% fat low calorie diet for obesity 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 53 healthy, obese female volunteers 11. Outcome Measures Anthropometric and metabolic measures at baseline, 3 and 6 mos 12. Results/Main Findings The very low carbohydrate group lost more weight and more body fat than the low fat diet group. Blood pressure, lipids, fasting glucose, and insulin improved in both groups. 13. Further comments 1. Full bibliographic reference details of research Foster, G.D., Wyatt, H.R., Hill, J.O., et al., "A Randomized Trial of a Low-Carbohydrate Diet for Obesity. New England Journal of Medicine 348(21), 2003, pages 2082-2090. 2. Funding body National Institutes of Health 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<20 grams/day) to 30% fat low calorie diet for obesity 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 63 healthy, obese volunteers 11. Outcome Measures Weight change, serum lipids, glucose tolerance at 3 and 6 mos 12. Results/Main Findings Subjects on the low carbohydrate diet had lost more weight than subjects on the conventional diet at 3 months and 6 months, but the difference at 12 months was not significant. Blood pressure, lipids, and the glucose response to an oral glucose load were improved in both groups. 13. Further comments 1. Full bibliographic reference details of research Gannon, M.C., Nuttall, F.Q., "Effect of a High-Protein, Low-Carbohydrate Diet on Blood Glucose Control in People with Type 2 Diabetes. Diabetes 53(9), 2004, pages 2375-2382. 2. Funding body American Diabetes AssociationMinnesota Beef CouncilColorado and Nebraska Beef Councils 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity-related Type 2 diabetes 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on Type 2 Diabetes 8. Principal question that research is designed to answer Comparison of 20% carbohydrate to a 55% carbohydrate diet for Type 2 Diabetes 9. Type of research (please tick) Cross-over trial 10. Population/subjects 8 male volunteers 11. Outcome Measures Serum glucose, insulin at 5 weeks 12. Results/Main Findings Subjects on the 20% carbohydrate diet had a greater reduction in serum glucose, insulin, and glycohemoglobin. 13. Further comments 1. Full bibliographic reference details of research Hays, J.H., DiSabatino, A., Gorman, R.T., et al., "Effect of a High Saturated Fat and No-Starch Diet on Serum Lipid Subfractions in Patients with Documented Atherosclerotic Cardiovascular Disease Mayo Clinic Proceedings 1 , 78(11), 2003, pages 1331-1336. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To determine whether a diet of high saturated fat and avoidance of starch results in weight loss without adverse effects on serum lipids in obese nondiabetic patients 8. Principal question that research is designed to answer Noncomparative description of effect of diet in a clinical practice 9. Type of research (please tick) Observational study in clinical practice 10. Population/subjects 23 patients with atherosclerotic cardiovascular disease 11. Outcome Measures Weight change, body fat, lipoprotein profiles by NMR analysis 12. Results/Main Findings Patients instructed on the high saturated fat, no starch diet lost weight. 13. Further comments 1. Full bibliographic reference details of research Hays, J.H., Gorman, R.T., Shakir, K.M., "Results of Use of Metformin and Replacement of Starch with Saturated Fat in Diets of Patients with Type 2 Diabetes. Endocrine Practice 8(3), 2002, pages 177-183. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity, and obesity-related type 2 diabetes 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity and type 2 diabetes 8. Principal question that research is designed to answer Comparison of high saturated fat, low starch diet to historical controls 9. Type of research (please tick) Retrospective chart review with historical controls 10. Population/subjects 283 patients from a clinical endocrinological practice 11. Outcome Measures Weight change, hemoglobin A1C, serum lipids over 1 year 12. Results/Main Findings Patients on the high saturated fat, low starch diet had improved glycemic control without adverse effects on serum lipids. 13. Further comments 1. Full bibliographic reference details of research Hickey, J.T., Hickey, L., Yancy, W.S.J., et al., "Clinical Use of a Carbohydrate-Restricted Diet to Treat the Dyslipidemia of the Metabolic Syndrome. Metabolic Syndrome and Related Disorders 1(3), 2003, pages 227-232. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity and hyperlipidemia 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet (<20 grams/day) on weight and serum lipids 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Retrospective chart review with two clinical groups using a low carbohydrate diet 10. Population/subjects 80 patients 11. Outcome Measures Weight change, serum lipids using NMR lipoprotein analysis over 240 days 12. Results/Main Findings Patients instructed in a low carbohydrate diet with or without pre-existing statin therapy had improvements in total cholesterol, triglycerides, HDL cholesterol and LDL cholesterol. The LDL particle concentration was reduced similarly in both groups compared to baseline. 13. Further comments 1. Full bibliographic reference details of research Husain, A.M., Yancy, W.S., Jr., Carwile, S.T., et al., "Diet Therapy for Narcolepsy. Neurology, 62(12), 2004, pages 2300-2302. 2. Funding body Narcolepsy Network. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity and obesity-related narcolepsy 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To monitor the effects of a low carbohydrate diet (<20 grams/day) in obese patients with narcolepsy 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Observational study 10. Population/subjects 9 patients with narcolepsy 11. Outcome Measures Weight, narcolepsy questionnaire 12. Results/Main Findings Patients with narcolepsy experienced modest improvements in daytime sleepiness on a low carbohydrate diet. 13. Further comments 1. Full bibliographic reference details of research Kossoff, E.H., Krauss, G.L., McGrogan, J.R., et al., "Efficacy of the Atkins Diet as Therapy for Intractable Epilepsy. Neurology, 61(12), 2003, pages 1789-1791. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity with a low carbohydrate diet-safety and use in children with epilepsy 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To monitor the effects of a low carbohydrate diet (<20 grams/day) in patients with refractory epilepsy 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Observational study 10. Population/subjects 6 patients with seizure disorder 11. Outcome Measures Seizure frequency 12. Results/Main Findings 5 patients maintained moderate to large ketosis for periods of 6 weeks to 24 months; three patients had seizure reduction and were able to reduce antiepileptic medications. 13. Further comments 1. Full bibliographic reference details of research Meckling, K.A., O'Sullivan, C., Saari, D., "Comparison of a Low-Fat Diet to a Low-Carbohydrate Diet on Weight Loss, Body Composition, and Risk Factors for Diabetes and Cardiovascular Disease in Free-Living, Overweight Men and Women. Journal of Clinical Endocrinology and Metabolism, 89(6), 2004, pages 2717-2723. 2. Funding body Natural Sciences Engineering Research Council of Canada 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of a 15% carbohydrate diet to a low fat, 50% carbohydrate diet for obesity 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 40 healthy, obese volunteers 11. Outcome Measures Weight, body composition, serum insulin, blood pressure, serum ketones over 10 weeks 12. Results/Main Findings There was similar weight loss and blood pressure reduction in both groups. Only the 15% carbohydrate diet group had a reduction in fasting serum insulin. The 15% carbohydrate diet group had an increase in HDL cholesterol. 13. Further comments 1. Full bibliographic reference details of research Samaha, F.F., Iqbal, N., Seshadri, P., et al., "A Low-Carbohydrate as Compared with a Low-Fat Diet in Severe Obesity. New England Journal of Medicine 1, 348(21), 2003, pages 2074-2081. 2. Funding body Veterans Affairs Healthcare Network Competitive Pilot Project Grant 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<30 grams/day) to 30% fat low calorie diet for obesity 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 132 healthy, obese volunteers 11. Outcome Measures Weight change, serum lipids, glucose tolerance at 3 and 6 mos 12. Results/Main Findings Severely obese subjects with a high prevalence of diabetes or the metabolic syndrome lost more weight during six months on a carbohydrate-restricted diet than on a calorie and fat-restricted die, with a relative improvement in insulin sensitivity and triglyceride levels. 13. Further comments 1. Full bibliographic reference details of research Sharman, M.J., Gomez, A.L., Kraemer, W.J., et al., "Very Low-Carbohydrate and Low-Fat Diets Affect Fasting Lipids and Postprandial Lipemia Differently in Overweight Men. Journal of Nutrition 1 , 134(4), 2004, pages 880-885. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on cardiovascular risk factors 8. Principal question that research is designed to answer Comparison of 8% carbohydrate to a 47% fat diet 9. Type of research (please tick) Controlled trial 10. Population/subjects 20 normal weight, male volunteers 11. Outcome Measures Serum lipids, serum insulin, LDL particle size 12. Results/Main Findings The 8% carbohydrate diet was associated with a greater reduction in serum triglycerides, postprandial lipemia, and fasting serum insulin. In subjects with a predominance of small LDL particles pattern B, there were significant increases in mean and peak LDL particle diameter and the percentage of LDL-1 after the 8% carbohydrate diet.. 13. Further comments 1. Full bibliographic reference details of research Sharman, M.J., Kraemer, W.J., Love, D.M., et al., "A Ketogenic Diet Favorably Affects Serum Biomarkers for Cardiovascular Disease in Normal-Weight Men. Journal of Nutrition 1, 132(7), 2002, pages 1879-1885. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on cardiovascular risk factors 8. Principal question that research is designed to answer Comparison of 10% carbohydrate to a 30% fat diet 9. Type of research (please tick) Balanced, randomised, cross-over trial 10. Population/subjects 15 overweight, male volunteers 11. Outcome Measures Serum lipids, serum insulin, LDL particle size 12. Results/Main Findings The hypoenergetic low-fat diet was more effective at lowering serum LDL-C, but the very low-carbohydrate diet was more effective at improving characteristics of the metabolic syndrome: a reduction in fasting serum triglycerides, TG/HDL ratio, postprandial lipemia, serum glucose, an increase in LDL particle size and also greater weight loss. 13. Further comments 1. Full bibliographic reference details of research Sondike, S.B., Copperman, N., Jacobson, M.S., "Effects of a Low-Carbohydrate Diet on Weight Loss and Cardiovascular Risk Factors in Overweight Adolescents. Journal of Pediatrics 1, 142(3), 2003, pages 253-258. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity in adolescents 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of very low carbohydrate (<20grams/day) to a 30% fat diet calorie restricted diet 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 30 obese adolescents 11. Outcome Measures Weight, serum lipids 12. Results/Main Findings The very low carbohydrate group lost more weight and had improvements in non-HDL cholesterol levels. There was improvement in LDL cholesterol in the 30% fat diet group, but not the very low carbohydrate diet group. 13. Further comments 1. Full bibliographic reference details of research Stern, L., Iqbal, N., Seshadri, P., et al., "The Effects of Low-Carbohydrate Versus Conventional Weight Loss Diets in Severely Obese Adults: One-Year Follow-up of a Randomized Trial. Annals of Internal Medicine, 140(10), 2004, pages 778-785. 2. Funding body Veterans Affairs Healthcare Network Competitive Pilot Project Grant 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<30 grams/day) to 30% fat low calorie diet for obesity 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 132 healthy, obese volunteers 11. Outcome Measures Weight change, serum lipids, glucose tolerance at 12 months. (extension of previous study by Samaha NEJM 2003) 12. Results/Main Findings Participants in both groups had significant weight loss over a one year period, but there were no between-group differences. Persons following the low-carbohydrate diet had greater reductions in serum triglyceride, and hemoglobin A1c. 13. Further comments 1. Full bibliographic reference details of research Vernon, M.C., Mavropoulos, J., Transue, M., et al., "Clinical Experience of a Carbohydrate-Restricted Diet: Effect on Diabetes Mellitus. Metabolic Syndrome and Related Disorders 1(3), 2003, pages 233-237. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity and type 2 diabetes 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet (<20 grams/day) on weight and diabetes mellitus 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Retrospective chart review 10. Population/subjects 14 patients with diabetes with a median follow-up of 8 months 11. Outcome Measures Weight change, hemoglobin A1c, fasting serum lipids 12. Results/Main Findings Patients instructed in a low carbohydrate diet had an average weight loss of 9.7% and a reduction in hemoglobin A1c from 10.0% to 5.9%. 13. Further comments 1. Full bibliographic reference details of research Volek, J.S., Gomez, A.L., Kraemer, W.J., "Fasting Lipoprotein and Postprandial Triacylglycerol Responses to a Low-Carbohydrate Diet Supplemented with N-3 Fatty Acids. Journal of the American College of Nutrition, 19(3), 2000, pages 383-391. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet on serum lipoproteins and postprandial triacylglycerol response 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on cardiovascular risk factors 8. Principal question that research is designed to answer What are the effects of a low carbohydrate diet 9. Type of research (please tick) Observational study 10. Population/subjects 10 normal weight, male volunteers 11. Outcome Measures Serum lipids, postprandial lipemia over an 8 week period 12. Results/Main Findings Compared to baseline, the low carbohydrate diet led to a reduction in body weight, fasting serum triglycerides, and peak postprandial triglyceride. 13. Further comments 1. Full bibliographic reference details of research Volek, J.S., Sharman, M.J., Gomez, A.L., et al., "Comparison of a Very Low-Carbohydrate and Low-Fat Diet on Fasting Lipids, LDL Subclasses, Insulin Resistance, and Postprandial Lipemic Responses in Overweight Women. Journal of the American College of Nutrition, 23(2), 2004, pages 177-184. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet on cardiovascular risk factors 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on cardiovascular risk factors 8. Principal question that research is designed to answer A comparison of a very low carbohydrate (<10%) diet to a low-fat (<30%) diet 9. Type of research (please tick) Randomised, cross-over study 10. Population/subjects 13 overweight, female volunteers 11. Outcome Measures Weight, serum lipids, fasting glucose and insulin, oxidized LDL and LDL subclass distribution over a 4 week period 12. Results/Main Findings Both diets led to a reduction in postprandial lipemia, fasting triglycerides, oxidized LDL, and LDL subclass distribution. The <10% carbohydrate diet led to improved insulin sensitivity. 13. Further comments 1. Full bibliographic reference details of research Volek, J.S., Sharman, M.J., Gomez, A.L., et al., "An Isoenergetic Very Low Carbohydrate Diet Improves Serum HDL Cholesterol and Triacylglycerol Concentrations, the Total Cholesterol to HDL Cholesterol Ratio and Postprandial Lipemic Responses Compared with a Low Fat Diet in Normal Weight, Normolipidemic Women. Journal of Nutrition, 133(9), 2003, pages 2756-2761. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet on cardiovascular risk factors 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on cardiovascular risk factors in women 8. Principal question that research is designed to answer A comparison of a very low carbohydrate (<10%) diet to a low-fat (<30%) diet 9. Type of research (please tick) Randomised, cross-over study 10. Population/subjects 10 overweight, female volunteers 11. Outcome Measures Weight, serum lipids, oral fat tolerance test, C-reactive protein, interleukin-6, tumor necrosis factor, over a 4 week period 12. Results/Main Findings The <10% carbohydrate diet led to a increase in fasting serum total cholesterol, LDL cholesterol, HDL cholesterol, decreased serum triacylglycerols, and decreased postprandial triacylglycerols. There were no significant changes in LDL size or markers of inflammation. 13. Further comments 1. Full bibliographic reference details of research Volek, J.S., Sharman, M.J., Love, D.M., et al., "Body Composition and Hormonal Responses to a Carbohydrate-Restricted Diet. Metabolism, 51(7), 2002, pages 864-870. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet for obesity on body composition and selected hormones 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet on body composition 8. Principal question that research is designed to answer A comparison of a very low carbohydrate (8%) diet to controls eating their normal diet 9. Type of research (please tick) Controlled study 10. Population/subjects 12 normal weight, male volunteers 11. Outcome Measures Weight, body composition, serum insulin, thyroid hormones over a 6 week period 12. Results/Main Findings The 8% carbohydrate diet led to a decrease in fat mass, and an increase in lean body mass. There was a decrease in serum insulin and ain increase in thyroid hormone levels. There were no significant changes in glucagons, total or free testosterone, sex hormone-binding globulin, insulin-like growth factor, cortisol, or T3 uptake. 13. Further comments 1. Full bibliographic reference details of research Westman, E.C., Mavropoulos, J., Yancy, W.S., et al., "A Review of Low-Carbohydrate Ketogenic Diets. Current Atherosclerosis Reports, 5(6), 2003, pages 476-483. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To review the randomized controlled trials of a low carbohydrate ketogenic (<20 grams/day) diet for obesity 8. Principal question that research is designed to answer What is the evidence supporting the use of these diets? 9. Type of research (please tick) Systematic Review 10. Population/subjects N/A 11. Outcome Measures Weight, serum lipids 12. Results/Main Findings Several recent randomised, controlled efficacy and effectiveness trials have shown that a low carbohydrate ketogenic diet is superior to a reduced calorie 30% fat diet for weight loss over a 6 month period. 13. Further comments 1. Full bibliographic reference details of research Westman, E.C., Yancy, W.S., Edman, J.S., et al., "Effect of 6-Month Adherence to a Very Low Carbohydrate Diet Program. American Journal of Medicine 113(1), 2002, pages 30-36. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer What are the effects of a very low carbohydrate (<20grams/day) diet over a 6 month period? 9. Type of research (please tick) Observational study 10. Population/subjects 51 overweight and obese healthy volunteers 11. Outcome Measures Weight, serum lipids, electrolytes, urinary function 12. Results/Main Findings Subjects lost weight and had improvements in serum lipid profiles over a 6 month period. 13. Further comments 1. Full bibliographic reference details of research Yancy, W.S., Jr., Olsen, M.K., Guyton, J.R., et al., "A Low-Carbohydrate, Ketogenic Diet Versus a Low-Fat Diet to Treat Obesity and Hyperlipidemia: A Randomized, Controlled Trial. Annals of Internal Medicine 140(10), 2004, pages 769-777. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<20 grams/day) to 30% fat low calorie diet for obesity and hyperlipidemia 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 119 healthy, obese volunteers 11. Outcome Measures Weight change, body composition, fasting serum lipids, and tolerability after 6 months 12. Results/Main Findings The low carbohydrate diet had better participant retention and greater weight loss. During active weight loss, serum triglyceride levels decreased more and high-density lipoprotein cholesterol level increased more with the low-carbohydrate diet than with the low-fat diet. 13. Further comments 1. Full bibliographic reference details of research Yancy, W.S., Jr., Provenzale, D., Westman, E.C., "Improvement of Gastroesophageal Reflux Disease after Initiation of a Low-Carbohydrate Diet: Five Brief Case Reports. Alternative Therapies in Health and Medicine, 7(6), 2001, pages 120, 116-129. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity using a low carbohydrate diet 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To describe cases of reflux symptoms improving on a low carbohydrate diet 8. Principal question that research is designed to answer Description of effects of the diet 9. Type of research (please tick) Case series 10. Population/subjects 5 subjects with reflux symptoms 11. Outcome Measures Weight, narcolepsy questionnaire 12. Results/Main Findings These patients with reflux symptoms noted prompt relief of symptoms after starting a very low carbohydrate diet. 13. Further comments 1. Full bibliographic reference details of research Yancy, W.S., Vernon, M.C., Westman, E.C., "A Pilot Trial of a Low-Carbohydrate, Ketogenic Diet in Patients with Type 2 Diabetes. Metabolic Syndrome and Related Disorders, 1(3), 2003, pages 239-243. 2. Funding body The Robert C. Atkins Foundation 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity and type 2 diabetes 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet (<20 grams/day) on weight and diabetes mellitus over a 16 week period 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Prospective pilot study 10. Population/subjects 7 patients with Type 2 diabetes 11. Outcome Measures Weight change, hemoglobin A1c, fasting serum lipids 12. Results/Main Findings Patients instructed in a low carbohydrate diet had an average weight loss of 10% and a reduction in hemoglobin A1c from 7.4% to 5.9%. 13. Further comments 1. Full bibliographic reference details of research Larosa JC, Fry AG, Muesing R, Rosing DR. Effects of high-protein, low-carbohydrate dieting on plasma lipoproteins and body weight. J Am Dietetic Assoc 77, 1980, pages 264-270. 2. Funding body Washington Heart Association 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer What are the effects of a very low carbohydrate (<20grams/day) diet over an 8 week period? 9. Type of research (please tick) Observational study 10. Population/subjects 24 obese, normolipidemic, healthy volunteers 11. Outcome Measures Weight, serum lipids, electrolytes 12. Results/Main Findings Subjects lost weight and had a reduction in fasting triglycerides by the end the study period. Women had a significant rise in LDL cholesterol. 13. Further comments 1. Full bibliographic reference details of research Goldberg JM, O’Mara K. Metabolic and anthropomorphic changes in obese subjects form an unrestricted calorie, high monounsaturated fat, very low carbohydrate diet. Journal of Clinical Ligand Assay, 23(2), 2000; pages 97-103. 2. Funding body Not noted. 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used in the management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a high monounsaturated fat, very low carbohydrate diet for obesity 8. Principal question that research is designed to answer What are the effects of a very low carbohydrate (10%) diet over an 12 week period? 9. Type of research (please tick) Observational study 10. Population/subjects 30 obese, normolipidemic, healthy volunteers 11. Outcome Measures Weight, serum lipids, electrolytes 12. Results/Main Findings The average weight loss was 9.1 kg. There was a reduction in total cholesterol and triglycerides. HDL was not affected. 13. Further comments 1. Full bibliographic reference details of research Landers P, Wolfe MM, Glore S, Build R, Phillips L. Effect of Weight Loss Plans on Body Composition and Diet Duration. J Okla State Med Assoc, 95(5), 2002. 2. Funding body Not noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of several diets for obesity 8. Principal question that research is designed to answer Comparison of low carbohydrate (<20 grams/day), the Zone diet and a conventional diet. 9. Type of research (please tick) Randomised controlled trial (RCT) 10. Population/subjects 91 healthy, obese volunteers 11. Outcome Measures Weight change, body composition, fasting serum lipids, and tolerability after 12 weeks 12. Results/Main Findings The mean weight loss was 5.1 kg, and the weight loss was similar among the treatment groups. There were no differences among the groups for total weight, fat or lean body mass loss. 13. Further comments 1. Full bibliographic reference details of research Bishop HL, Morse WI. Influence of percentage of fat prescribed in reduction diets on rate of weight loss. Journal De L’Association Canadienne des Dietetistes 1965. 2. Funding body Not noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research Assess the effects of several diets for obesity 8. Principal question that research is designed to answer Comparison of two diets with a carbohydrate / fat gram ratio of ½ and 2/1. 9. Type of research (please tick) Controlled trial 10. Population/subjects 19 healthy community volunteers 11. Outcome Measures Weight change after 12 weeks 12. Results/Main Findings Weight loss was similar between the treatment groups. 13. Further comments 1. Full bibliographic reference details of research Meckling KA, Gauthier M, Grubb R, Sanford J. Effects of a hypocaloric, low-carbohydrate diet on weight loss, blood lipids, blood pressure, glucose tolerance, and body composition in free-living overweight women. Can J Physiol Pharmacol, 80, 2002, pages 1095-1105. 2. Funding body Canadian Institutes of Health Research 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer What are the effects of a very low carbohydrate (70 grams/day) diet over an 8 week period? 9. Type of research (please tick) Observational study 10. Population/subjects 20 overweight female volunteers 11. Outcome Measures Weight, serum lipids, electrolytes, blood pressure, body composition 12. Results/Main Findings Subjects lost an average of 5.0 kg over 8 weeks. There were reductions in total cholesterol, triacylglycerol, LDL cholesterol. 13. Further comments 1. Full bibliographic reference details of research Miyashita Y, Koide N, Ohtsuka M et al. Beneficial effect of low carbohydrate in low calorie diets on visceral fat reduction in type 2 diabetic patients with obesity. Diabetes Research and Clinical Practice, 65, 2004, pages 235-241. 2. Funding body Meeting of Obesity and Nutritional Disturbance 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of low calorie diets of different carbohydrate content for obesity 8. Principal question that research is designed to answer Comparison of 1000 kcal 40% carbohydrate to 1000 kcal 65% carbohydrate diet 9. Type of research (please tick) Randomised, controlled trial 10. Population/subjects 22 obese type 2 diabetic patients 11. Outcome Measures Weight, serum glucose and insulin, lipids, visceral fat measured by computed tomography 12. Results/Main Findings Similar decreases in body weight and serum glucose levels were seen. Fasting serum insulin levels were reduced, and HDL levels increased on the 40% carbohydrate diet. There was a larger reduction in visceral fat area for the 40% carbohydrate group. 13. Further comments 1. Full bibliographic reference details of research Alnasir FA, Fateha BE. Low carbohydrate diet. Its effects on selected body parameters of obese patients. Saudi Med J, 24(9), 2003, pages 949-952. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a very low carbohydrate diet for obesity 8. Principal question that research is designed to answer To describe the effects of the diet over a 6 week period 9. Type of research (please tick) Observational study 10. Population/subjects 13 obese type 2 diabetic patients 11. Outcome Measures Weight, serum lipids 12. Results/Main Findings The mean weight loss was 6.6 kg over the 6 week period. Total cholesterol and serum glucose were reduced, but there were no other significant changes from baseline. 13. Further comments 1. Full bibliographic reference details of research Westman, E.C.. A Review of Very Low Carbohydrate Diets for Weight Loss. Journal of Clinical Outcomes Management 6(7), 1999, pages 36-40. 2. Funding body Atkins Center for Complementary Medicine 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To summarize the published literature regarding very low carbohydrate (<40 grams/day) diets 8. Principal question that research is designed to answer What is the evidence supporting the use of these diets? 9. Type of research (please tick) Systematic Review 10. Population/subjects N/A 11. Outcome Measures Weight, serum lipids, serum insulin and glucose levels 12. Results/Main Findings The literature search yielded 329 citations; 32 contained primary data. Based on several small, short-term observational studies, very low carbohydrate diets can lead to ketosis, weight loss, and changes in carbohydrate and lipid metabolism. Most of these studies also included caloric restriction. The long-term risks are not documented. 13. Further comments 1. Full bibliographic reference details of research O’Neill DF, Westman EC, Bernstein RK. The effects of a low-carbohydrate regimen on glycemic control and serum lipids in diabetes mellitus. Metabolic Syndrome and Related Disorders, 1(4), 2003, pages 291-298. 2. Funding body None noted. 3. Relevance to the guideline (refer to the scope where relevant) Management of obesity and diabetes mellitus. Documents use of very low carbohydrate diet. 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a regimen using a low carbohydrate diet (~30 grams/day) on weight and diabetes mellitus 8. Principal question that research is designed to answer Description of effects of the diet in a clinical practice 9. Type of research (please tick) Retrospective chart review 10. Population/subjects 30 patients diabetes 11. Outcome Measures Weight change, hemoglobin A1c, fasting serum lipids over an average of 13.8 years 12. Results/Main Findings Patients instructed in a low carbohydrate diet had an average weight loss of 5.5 kg and a reduction in hemoglobin A1c from 7.9% to 5.7%. There were favorable effects on the fasting lipid profiles. 13. Further comments 1. Full bibliographic reference details of research Miller III, BV, Bertino Jr, JS, Reed RG et al. An evaluation of the Atkins Diet. Metabolic Syndrome and Related Disorders, 1(4), 2003, pages 299-309. 2. Funding body The E. Donnall Thomas Resident Research ProgramStephen C. Clark Research Fund 3. Relevance to the guideline (refer to the scope where relevant) Effect of a very low-carbohydrate diet when used for obesity 4. This article primarily relates to the prevention of overweight and obesity NO 5. This article primarily relates to the identification, assessment and management of overweight and obesity? YES 6. Status (please tick) Complete 7. Objectives/aims of research To assess the effects of a low carbohydrate diet for obesity 8. Principal question that research is designed to answer What are the effects of a very low carbohydrate (<20grams/day) diet over a 4 week period? 9. Type of research (please tick) Observational study 10. Population/subjects 18 overweight and obese healthy volunteers 11. Outcome Measures Weight, serum glucose, insulin, lipids, electrolytes, NPY, leptin 12. Results/Main Findings Subjects lost weight and had significant reductions in serum total cholesterol, triglycerides, and fasting insulin. Weight loss could be explained by the self-selected lower caloric intake. 13. Further comments B) SECTIONS REVIEWED Low-Carbohydrate, High-Fat Diets. The propounded theory behind low carbohydrate, high-fat diets is that a drastically reduced carbohydrate intake will lower insulin levels, allow uninhibited lipolysis, increase fat oxidation, initiate ketone production, and decrease appetite (Atkins, 1999). Another expectation of diets with an extremely low ratio of carbohydrate to fat is that they will facilitate compliance and increase water losses. Five randomized controlled trials (Brehm et al., 2003; Fleming, 2002; Foster et al., 2003; Samaha et al., 2003; Westman et al., 2002) recently have compared weight loss after 6 months to a year on diets that have low carbohydrate-to-fat ratios with weight loss on more balanced diets. The low-carbohydrate diets initially provided less than 20 to 30 g of carbohydrate per day (followed by 40 to 60 g of carbohydrate per day after the first 2 weeks in both Brehm et al. (2003) and Foster et al. (2003)). Control diets provided 60 percent of calories from carbohydrate, 25 to 30 percent of calories from fat, and 15 percent of calories from protein (Brehm et al., 2003; Fleming, 2002; Foster et al., 2003; Samaha et al., 2003; Westman et al., 2002). All studies found that the low-carbohydrate diets produced greater initial weight loss, but the difference was modest. For example, Foster and colleagues (2003) reported that mean weight loss at 6 months was 7.0 percent below baseline for those on the low-carbohydrate diet compared with 3.2 percent below baseline for those on the control diet. At 18 months, however, there was no statistically significant difference in weight loss. Some of the early weight loss on a low-carbohydrate diet is due to water loss (Yang and Van Itallie, 1976; Bortz et al., 1967). Whether the remaining difference in initial weight loss is due to a lower energy intake, a larger energy expenditure, or a combination of the two is not known. In any case, differences in weight loss tend to diminish, and by 12 to 18 months no real difference remains. The long-term safety of any diet needs to be considered. Unfortunately, only short-term data (6 to 12 months) are available for these diets. Within this period of follow up, no evidence of serious adverse effects has been published. However, the diets require that 10 dietary supplements be taken regularly because the diets are low in vitamins E, A, thiamin, B6, and folate; calcium; magnesium; iron; potassium; and dietary fiber (Freedman et al., 2001). Very-low-carbohydrate diets often include a high percentage of protein along with the high percentage of fat. Usually, this includes large amounts of animal protein, which adds substantially to the saturated fat and cholesterol intake. A recent study has cautioned that such diets also can lead to a high urinary calcium loss and kidney stones (Reddy et al., 2002). Uric acid production is increased and may lead to elevated blood uric acid concentrations. There are very few long-term trials of high protein weight loss diets. Skov et al. (1999) showed a greater weight loss with a higher protein diet (25 percent of total energy) than with a lower protein diet (12 percent of total energy) (loss of 8.9 kg and 5.1 kg, respectively) over 6 months. Another study, 10 weeks long, showed no difference in the body composition, cholesterol, triglycerides, uric acid, percent body fat, or nutrient intake in sedentary, overweight women following 1,200 calorie diets with varying macronutrient distributions (Alford et al., 1990). Interestingly, blood lipid values in the various studies of high-fat diets were found to have improved at least as much as in the lower-fat control diets (Foster et al., 2003; Samaha et al., 2003). LaRosa et al. (1980), however, reported an increase in serum low-density lipoprotein (LDL) cholesterol on a high-protein/high-fat diet. The concern regarding the long-term safety of high-fat, low-carbohydrate diets is warranted given that (1) they have a high saturated fat, high cholesterol, and low fiber content; (2) they result in a very low intake of fruits, vegetables, and grains (which could lead to deficiencies in essential vitamins, minerals, and fibers over the long-term); and (3) they originally were designed for short-term use during a weight loss period and have not been evaluated long-term. High-Carbohydrate, Low-Fat Diets. A diet with a high-carbohydrate/fat ratio (that is, a very low-fat diet) has been popularized by Ornish (1990) and Pritikin (1988). This diet suggests decreasing fat intake to about 10 percent of calories, keeping protein at 15 percent of calories, and eating about 75 percent of calories as carbohydrates. The high carbohydrate content is compatible with achieving more than the recommended intake of fruits, vegetables, and fiber. However, the very-low fat content may increase the risk of essential fatty acid deficiency (IOM, 2002) and may reduce the bioavailability of some fat-soluble vitamins (IOM, 2002; Roodenburg et al., 2000). In a weight-loss study Mueller-Cunningham et al. (2003) prescribed a diet with less than 15 percent of total calories from fat and reported a decrease in the intakes of vitamin E (as á-tocopherol) and of n-3 fatty acids. Freedman et al. (2001) described these high-carbohydrate/low-fat diets as being low not only in vitamin E, but also in vitamin B12 and zinc. The other negative consequence of a low-fat diet is that it usually is a high-carbohydrate diet, which can lead to increased levels of triglycerides (see Part D, Section 4, “Fats”). Weight Maintenance For weight maintenance, the desirable diet is one that prevents weight gain, meets nutrient needs, and can be consumed for a long time without adverse effects. One of the questions is how much fat should be in such a diet. The majority of observational studies and surveys support an association between dietary fat intake and BMI. Bray and Popkin (1998) summarized data from a variety of populations in more than 20 countries and reported an association between greater fat intake and higher BMI. However, Willett (1998) points out that this relationship is not consistent across countries and that the effect of fat intake on BMI is rather minor. For adults, the Acceptable Macronutrient Distribution Ranges (AMDRs) for fat, protein, and carbohydrate are estimated to be 20 to 35 percent, 10 to 35 percent, and 45 to 65 percent of energy, respectively (IOM, 2002). The upper range for fat, 35 percent of total calories, is based on the increased risk of overconsuming calories and of obesity with fat intakes above that range (Astrup et al., 2000; Saris et al., 2000; Shepard et al., 2001; Tremblay et al., 1991). Thus, diets with very-low carbohydrate to fat ratios (i.e., diets high in fat) may not be desirable for weight maintenance. The lower limit of fat recommended 20 percent of calories and aims at avoiding (1) fatty acid deficiency when fat intake is too low (Mueller-Cunningham et al., 2003), and (2) excess carbohydrate intake, which may have adverse effects on the blood lipid profile (see Part D, Section 4, “Fats”). Both the low-carbohydrate diet and the low-fat diet limit the variety of foods that can be eaten and, therefore, may be difficult to follow long-term (Foster et al., 2003). This probably explains the extremely high dropout rates in studies of these diets. There is insufficient evidence to make recommendations for or against the use of these diets for weight loss, but there is great concern about their long-term use for weight maintenance (Bravata et al., 2003). Although both low-fat diets and low-carbohydrate diets have been shown to result in weight reduction if followed, the maintenance of a reduced weight ultimately will depend on a change in lifestyle from the one that resulted in the need for weight reduction to one that meets nutrient needs while maintaining a balance between energy consumption and energy expenditure (Freedman et al., 2001). REFERENCES 1. Atkins C. Dr. Atkins’ New Diet Revolution. New York, NY: Avon Books, 1999. 2. Bravata DM, Sanders L, Huang J, Krumholz HM, Olkin I, Gardner CD, Bravata DM. Efficacy and safety of low-carbohydrate diets. JAMA 289:1837-1850, 2003. 3. Bray GA, Popkin BM. Dietary fat intake does affect obesity! Am J Clin Nutr 68(6):1157-1173, 1998. 4. Brehm BJ, Seeley RJ, Daniels SR, D’Allessio DA. A randomized trial comparing a very low carbohydrate diet and a calorie restricted low fat diet on body weight and cardiovascular risk factors in healthy women. J Clin Endocrin Metab 88:1617-1623, 2003. 5. Fleming, RM. The effect of high-, moderate-, and low-fat diets on weight loss and cardiovascular disease risk factors. Prev Cardiol 5:110-118, 2002. 6. Foster GD, Wyatt HR, Hill JO, McGucken BG, Brill C, Mohammed BS, Szapary PO, Rader DJ, Edman I, Klein S. A randomized trial of a low-carbohydrate diet for obesity. N Engl J Med 348:2082-2090, 2003. 7. Freedman MR, King J, Kennedy, E. Popular diets: a scientific review. Obes Res 9 suppl 1:1S-40S, 2001. 8. Institute of Medicine (IOM). Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids. Washington DC: National Academies Press, 2002. 9. Larosa JC, Gordon A, Muesing R, Rosing DR. Effects of high-protein, low-carbohydrate dieting on plasma lipoproteins and body weight. J Am Diet Assoc 77: 264-270, 1980. 10. Samaha F, Iqbal N, Seshadri P, et al. A low-carbohydrate as compared with a low-fat diet in severe obesity. N Engl J Med 348:2074-2081, 2003. 11. Skov AR, Toubro S, Ronn B, Holm L, Astrup A. Randomized trial on protein vs carbohydrate in ad libitum fat reduced diet for the treatment of obesity. Int J Obes Relat Metab Disord 23:528-536, 1999. 12. St. Jeor ST, Howard BV, Prewitt TE, Bovee V, Bazzarre T, Eckel RH. Dietary protein and weight reduction: a statement for healthcare professionals from the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Circulation. 2001; 104: 1869-1874. 13. Westman EC, Yancy WS, Edman JS, et al. Effect of 6-month adherence to a very low carbohydrate diet program. Am J Med 113:30-36, 2002. 14. Willett WC. Is dietary fat a major determinant of body fat? Am J Clin Nutr 67:556S-62S, 1998. 15. Yang MU, Van Itallie TB. Composition of weight lost during short-term weight reduction. Metabolic responses of obese subjects to starvation and low-calorie ketogenic and nonketogenic diets. J Clin Invest 58(3):722-730, 1976. RECOMMENDATIONS FOR THE INTAKE OF SUGARS AND STARCHES The Institute of Medicine report Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (IOM, 2002) established a Recommended Dietary Allowance (RDA) for carbohydrate of 130 g per day for adults and children. This value is based upon the amount of carbohydrate (sugars and starches) required to provide the brain with an adequate supply of glucose. Glucose is the only energy source for red blood cells and the preferred energy source for the brain, central nervous system, placenta, and fetus. When muscle cells operate anaerobically (without oxygen), they rely 100 percent on glucose. If glucose is not provided in the diet and the body’s storage form of glucose (glycogen) is depleted, the body will break down protein in muscles to maintain glucose blood levels and supply glucose to the brain (IOM, 2002). The Institute of Medicine (IOM) also set an Acceptable Macronutrient Distribution Range (AMDR) for carbohydrate of 45 to 65 percent of total calories. At the low end of this range it is very difficult to meet the recommendations for fiber intake, and at the high end of the range overconsumption of carbohydrates may result in high blood triglyceride values. A comparison of the RDA to the AMDR shows that the recommended range of carbohydrate intake is higher than the RDA. For example, if an individual with a caloric intake of 2,000 kcal per day were to consume 55 percent of calories as carbohydrate (the mid-range of the AMDR) that would mean that 1,100 kcal would be from carbohydrate. This equates to 275 g carbohydrate (1 g carbohydrate = 4 kcal), well above the RDA of 130 g per day. In summary, the primary beneficial physiological effect of sugars and starches, and the basis for setting an RDA for carbohydrate, is the contribution of glucose as an energy source for the brain. However, the amount of glucose needed by the brain is lower than the AMDR for carbohydrate (45 to 65 percent of total calories). REFERENCES 1. FAO/WHO (Food and Agriculture Organization/World Health Organization). Carbohydrates in Human Nutrition. Rome: FAO, 1998. 2. Institute of Medicine (IOM). Dietary carbohydrates: sugars and starches. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, DC: National Academies Press, 2002.
Submission Date 9/29/2004 4:49:00 PM
Author from Durham, NC

   Sugars
Summary
Comments AARP urges HHS and USDA to reexamine the guideline “Choose carbohydrates wisely for good health.” The Committee decided to address a number of points under the umbrella of “carbohydrates.” We are concerned that this approach, and the elimination of a specific guideline on sugar, significantly dilutes the important message that people should limit their intake of added sugars.
Submission Date 10/1/2004 4:37:00 PM
Author AARP

   Glycemic Response
Summary We concur with the Committee's statement “The glycemic index and/or glycemic load are of little utility for providing dietary guidance for Americans.”
Comments We concur with the Committee's statement “The glycemic index and/or glycemic load are of little utility for providing dietary guidance for Americans.”
Submission Date 9/21/2004
Author North American Miller's Association

   Sugars
Summary In whole form, carbohydrates support life, but refined carbohydrates are inimical to life because they are devoid of bodybuilding elements.
Comments Only during the last century has man’s diet included a high percentage of refined carbohydrates. Our ancestors ate fruits, vegetables and grains in their whole, unrefined state. In nature, sugars and carbohydrates—the energy providers—are linked together with vitamins, minerals, enzymes, protein, fat and fiber—the bodybuilding and digestion-regulating components of the diet. In whole form, carbohydrates support life, but refined carbohydrates are inimical to life because they are devoid of bodybuilding elements.
Submission Date 9/21/2004
Author Weston A Price Foundation

Summary NFPA recommends that the Dietary Guidelines for Americans acknowledge that there are numerous food products that deliver essential nutrients and contain added sugars, and that these foods can be part of a healthful diet, balanced with physical activity.
Comments NFPA notes that the Dietary Guidelines Advisory Committee focused on added sugars that deliver calories but no essential nutrients. NFPA recommends that the Dietary Guidelines for Americans acknowledge that there are numerous food products that deliver essential nutrients and contain added sugars, and that these foods can be part of a healthful diet, balanced with physical activity.
Submission Date 9/21/2004
Author National Food Processors Association

Summary I would add to this that including meat, dairy, and refined sugars in one’s diet is in fact detrimental to one’s health.
Comments I would add to this that including meat, dairy, and refined sugars in one’s diet is in fact detrimental to one’s health.
Submission Date 9/21/2004
Author Anonymous

Summary The advice to choose carbohydrates wisely doesn’t provide clear enough advice.
Comments The advice to choose carbohydrates wisely doesn’t provide clear enough advice. The two main messages in that section are about increasing whole grains and reducing the consumption of refined sugars. And since the whole grain recommendation is in this section of increasing daily intake of fruits and vegetables, whole grains, and low-fat and nonfat milk products, this section should avoid redundancy and convey the important dietary advice about refined sugars in a way that is easier for the public to understand and more available, and read, drink fewer soft drinks and limit cakes, cookies, and other foods rich in refined sugars
Submission Date 9/21/2004
Author Center for Science in the Public Interest

Summary We support the science-based conclusions on dental caries, diabetes, glycemic index and load and dietary fiber. There are, however, two areas related to the Added Sugars conclusive statements that require further consideration of the evidence. We are concerned that the Report suggests that a high
Comments The Committee’s conclusions concerning carbohydrates closely align with the DRI Macronutrient Report (Institute of Medicine, 2003). We support the science-based conclusions on dental caries, diabetes, glycemic index and load and dietary fiber. There are, however, two areas related to the Added Sugars conclusive statements that require further consideration of the evidence. • Added Sugars We are pleased that the Committee recognized the important nutrient contributions made by sweetened, flavored milks and presweetened cereals. We are concerned that the Report suggests that a high intake of added sugars is associated with reduced nutrient intakes. The DRI Macronutrient Report, however, indicates that association is not significant until added sugars intake reaches 25% or more of caloric intake. It is not clear why the Dietary Guidelines Report fails to use this number to more specifically describe the level at which this shift occurs. In fact, the Dietary Guidelines Report indicates that individuals with moderate intakes of added sugars (5-10% of calories) have better nutrient status than those at higher or lower intake levels. The Advisory Report lists that 10% of added sugars intake comes from breakfast cereals and other grains such as breakfast bars. We recommend that this category be split due to the different usage and consumption patterns of cereals (predominantly breakfast occasions) versus the bar category (snacks and sometimes breakfast occasions). We would also like to clarify that ready to eat cereals contribute approximately 4% of added sugars intake.
Submission Date 9/27/2004
Author General Mills

   Glycemic Response
Summary We concur with the committee’s finding that the glycemic index and/or glycemic load are of little utility for providing dietary guidance for Americans.
Comments We concur with the committee’s finding that the glycemic index and/or glycemic load are of little utility for providing dietary guidance for Americans.
Submission Date 9/27/2004
Author U.S. Rice Federal

   Sugars
Summary Overview of the Sugar Association position on sugars • People eat foods, not individual nutrients. • Sugar is valued as a food ingredient not only for its flavor enhancement but also for its uniqueness to meet the myriad of fundamental and essential functional requirements, particularly safety. •
Comments The Sugar Association, Inc. (Association) is pleased to provide comments to the Department of Health and Human Services and the United States Department of Agriculture (Agencies) relating to sugars intake advice in the final report of the Dietary Guidelines Advisory Committee (Committee.) The Association acknowledges the dedication of those in the Federal Government working hard to provide the best possible advice to assist the American public in making choices that will improve overall health and well being. The Association believes today’s public health challenges require innovative strategies and contemporary initiatives when educating the American public about healthful eating and active lifestyles. The Association was founded in 1943 by the US sugar industry to monitor nutrition science and educate consumers about sugar’s role in a healthy diet. We ask the Agencies to consider the Association’s scientific expertise and years of experience in consumer education when evaluating these comments as part of the process of establishing federal nutrition advice about sugar. While the Association submitted written comments to the Dietary Guidelines Advisory Committee throughout its deliberative process, the Association would like to provide the Agencies with the following bulleted overview of specific issues provided to the Committee regarding sugars and a detailed response on the issues: discretionary calories, added sugars and nutrient displacement, and terminology. Overview of the Sugar Association position on sugars • People eat foods, not individual nutrients. • Sugar is valued as a food ingredient not only for its flavor enhancement but also for its uniqueness to meet the myriad of fundamental and essential functional requirements, particularly safety. • There is no scientifically verifiable body of evidence persistently documenting negative health impacts ascribable to sugar intake, including obesity and nutrient displacement, at current consumption levels. • Every major scientific review completely exonerates the direct involvement of sugars in the etiology of lifestyle diseases. , , , • The National Academy of Sciences, Institute of Medicine Macronutrient Report (IOM Report) concludes that current scientific data are insufficient to support evidence of any major health impact from sugars intake, including obesity. • The IOM Report did not establish a UL (Upper Level) for total or added sugars intake, only a suggested threshold for added sugars. • In the matter of added sugars and nutrient displacement, the IOM Report stated unequivocally that the suggested intake threshold applied to only some micronutrients within some subpopulation groups. The suggested intake threshold is well above the current average consumption level of sugars in the US population. • The US Food and Drug Administration has ruled that “added” and “naturally occurring” sugars are indistinguishable, and therefore concludes that consumers could be misled into believing that food containing no refined sugar is superior to food containing refined sugar. • Inordinate emphasis on added sugars could create a public health outcome similar to the one resulting from the simplistic focus on low-fat. The importance of energy balance is obscured by such one-dimensional approaches. • We ask the Agencies to consider the potential long-term repercussions the current trend of increasing use of sugar replacers may exert on satiety, metabolism and taste preference, especially among children.Recommended daily nutrient intake values are established to meet the dietary needs of healthy individuals. Micronutrient intake recommendations are established such that 98% of a normally distributed population receives adequate micronutrients. Consequently, micronutrient intake values provide a tool to evaluate the dietary adequacy of the general population. Although a single study might show that the intake of one or more selected vitamins or minerals is less than 100% of its established intake recommendation, this observation has little to do with a single food or a particular food ingredient. In any given short-term dietary sampling, it is highly unusual if the recorded intake of every micronutrient equals its recommended intake value.xi In fact, dietary intake expert committees “tend to err on the side of generosity.”xi There are always sectors that lie beyond the lower and upper boundaries of a normal distribution. It is no different with micronutrient intakes. Accordingly, small fractions of a population exhibiting dietary habits and eating patterns outside the norm are to be expected. Unless micronutrient intakes consistently fall below two-thirds of the recommended intake level, there is no long-term harm to health.xi Dietary guidance must be focused on the foods and beverages not consumed by a minority of individuals, not on a dietary component like added sugars. It is indefensible to construct dietary guidance systems, intended for 98% of the population, on the micronutrient intakes of the select few individuals requiring highly specialized dietary advice. There is no validated body of irrefutable evidence that corroborates the popular theory that added sugars reduce the nutrient adequacy of the American diet. Thorough examination of the data in the stable of articles cited repeatedly as substantiating this theory points out the fallacy of this hypothesis. For example, the data in the article emphasized by the Committee as supporting the added sugars and nutrient displacement hypothesis say the opposite. As listed in Table 3 of the cited article, micronutrient intakes range between 78% (zinc) and 237% (vitamin B12) of dietary recommendations for those Americans consuming more than 18% of their daily energy as added sugars. These intake levels are not nutritionally inadequate. While it is true that added sugars can be mathematically associated with the intake of a micronutrient like calcium, , critical analysis points out the ineffectiveness of using the nutrient displacement theory to explain low calcium intakes.xiv, However, the Committee continued to perpetuate the flawed nutrient displacement hypothesis by its treatment of the recently published IOM Report data of the comparative added sugars and calcium intake levels. As seen in Figure 1, the ‘inverted U-shaped’ response between the comparative calcium and added sugars intakes argue against the nutrient displacement hypothesis. Legitimate nutrient displacement requires that highest calcium intakes occur at the lowest level of added sugars intake. The fact that genuine nutrient displacement is obviously absent is underscored by the Figure-1 arrow labeled “This level represents the best with respect to micronutrient intake.”xix Not only has this statement been so generalized as to imply that it is true for all micronutrients, it disregards the fact that Figure 1 pertains only to calcium intakes for children ages 4 to 8. The arrowed statement of Figure 1 further ignores the fact that the second added sugars category (5 – 10%) is not always reflective of highest calcium intakes reported in the IoM added sugars dataset.xviii For example, males ages 19 to 50 have higher calcium intakes in the third added sugars category (10 – 15%) than in the second added sugars category. Second, inclusion of age-specific recommended intake values further weakens the relevance of unilaterally applying the nutrient displacement theory to added sugars and calcium intake comparisons. The dashed line in Figure 2 readily demonstrates that children’s calcium intakes uniformly exceed the recommended 800-mg/day level at added sugars levels as high as 25% of daily calories (fifth category). In fact when the reported statistical errorsxv are included (data not shown), some children within the 25 – 30% added sugars group (sixth category) achieve their daily 800-mg/day intake level established for calcium.Finally, Figure D5–1 should have been labeled with the terminology “added sugars,” not “added sugar.”xix Terminology - Sugar-sweetened drinks The Food and Drug Administration has defined sugar to mean sucrose for the purpose of ingredient labeling, 21 C.F.R. 101.4(b)(20). For the purposes of ingredient labeling, the term sugar shall refer to sucrose, which is obtained from sugar cane and sugar beets in accordance with the provisions of 184.1854. The terms sugars (plural) is used to designate all mono- and disaccharides. Therefore, The Association takes strong issue with the use of the term “sugar-sweetened drinks” to denote caloric beverages throughout the Committee’s final recommendations and asks that the Agencies not allow this terminology in the messages developed to communicate dietary guidance to the American public. Very few beverages, and all major soft drinks, have not contained sugar since the mid 1980s. High fructose corn syrup (HFCS) is the major sweetener in nearly all caloric beverages and to use the term “sugar-sweetened drinks” is not only inaccurate but misleads the consuming public. Today’s foods and food ingredients are not the same as those of our grandmothers. No longer is a jelly or jam, for example, simply made with fruit, sugar (sucrose) and pectin. While consumers can read a detailed list of ingredients on many food products, many of today’s foods contain ingredients that consumers cannot pronounce, let alone have any idea of what the ingredient is and its function in the food. This is particularly true regarding sweetening ingredients used in today’s foods. As verified in Figure 3, the sucrose share of the US caloric sweetener market has fallen from nearly 86% in 1970 to 43% in 2003. While Figure 3 was updated specifically for these comments, an earlier edition was published recently in the peer-reviewed literature.xx The Association recently conducted eight focus groups across the country. In an exercise where participants were asked to list ingredients now used to sweeten foods, not one participant identified high fructose corn syrup as a sweetening ingredient even though HFCS is a major sweetener used in today’s food supply. Nor did these consumers have any knowledge of sugar alcohols or fillers, such as maltodextrins, used today to replace fats and sugar in foods. However, consumers do understand the term “sugar” to mean pure, white granulated sugar that their mothers and grandmothers used and trusted. Although there are conflicting points of view as to whether or not individual caloric sweeteners are equivalent, the Association firmly believes the public interest is not served when consumers continue to be misled by the improper use of the term “sugar” to describe the myriad of sweeteners used in today’s food and beverage products. In closing, the Association would like to restate a part of its oral comments presented on September 21, 2004 to representatives of the Agencies. Sugar is an important food ingredient that has provided safety and important functional properties to our food supply for thousands of years, and is an essential component in many nutrient-rich foods. We are encouraged that the Committee has emphasized the central importance for individuals to balance their energy intake with their activity level for weight control. If one eats more food and thus calories – no matter the source - than one burns, weight gain is inevitable. We agree emphasis should be placed on helping Americans understand the importance of having nutrient-rich diets, and are confident the Agencies will develop science-based, credible messages to help Americans achieve their individual energy balance goals for improved health.
Submission Date 9/27/2004
Author Sugar Association

Summary Executive Summary Should Reflect the Order of Priority of the Guidelines Written by: Maureen Storey & Richard Forshee
Comments The Center for Food and Nutrition Policy (“Center” or CFNP) at Virginia Tech—National Capital Region located in Alexandria is an independent, non-profit research and education organization that is dedicated to advancing rational, science-based food and nutrition policy. It is recognized as a Center of Excellence on such matters by the Food and Agriculture Organization of the United Nations (FAO). The Center uniquely operates like an independent “think-tank,” while maintaining its academic affiliation with Virginia Tech, a major land-grant university. The research, education, outreach, and communications activities of the faculty are conducted in a relevant, time-sensitive manner that helps inform the public policy process on food and nutrition issues. Encompassed in the Center’s activities on nutrition policy are its interests in policy and regulatory issues involving dietary guidance. The Center respectfully submits the following comments in response to the solicitation for written comments regarding the proposed 2005 Dietary Guidelines for Americans as published in the Federal Register.1 The comments contained herein urge the final guidelines to 1) reflect the priorities or order of importance in producing desirable health outcomes; 2) delete the section on the role of the environment as speculative rather than substantive; and 3) re-draft certain segments of the carbohydrates chapter to accurately reflect the results of publications used to justify the recommendations of the DGAC. Choose Carbohydrates Wisely for Good Health The following comments pertain to Part D Science Base, Section 5 Carbohydrates. The Center agrees that the message to “choose carbohydrates wisely for good health” is scientifically sound advice. Yet the language of the Conclusion and the Rationale of the guideline suggesting that added sugars may uniquely contribute to certain undesirable health outcomes such as poorer nutrient intake, unhealthy body weight, and increased risk of dental caries, is overstated. What is the relationship between intake of carbohydrates and dental health? The DGAC draft report suggests a possible relationship between added sugars and dental health. Question 1 asked: “What is the relationship between intake of carbohydrates and dental health?” Enclosed is a recent paper published by Forshee and Storey examining the association between dental caries and soft drink consumption.4 The study showed that for most age groups, soft drink consumption was not linked to an increase in dental caries. Our examination generally agrees with the findings of Heller and coworkers, but our interpretation of the policy implications of the results differs from theirs.5 The Center agrees that good dental hygiene, drinking fluoridated water, and using fluoridated dentifrices are the most effective ways to reduce dental caries. A secondary consideration is intake of fermentable carbohydrates that stick to the teeth and are not removed by brushing or rinsing the mouth. The Center therefore urges the draft report to reflect the priority of behaviors that will lead to better oral health by re-stating the final sentence in the conclusion to read: “A combined approach of optimizing oral hygiene practices and reducing the frequency and duration of exposure to fermentable carbohydrate intake is the most effective way to reduce caries incidence.” 4 Forshee RA, Storey ML. Evaluation of the association of demographics and beverage consumption with dental caries. Food Chem Toxicol. 2004; 42:1805-1816. 5 Heller KE, Burt BA, Eklund SA. Sugared soda consumption and dental caries in the United States. Journal of Dental Research 2001; 80: 1949-1953. 4 Does intake of added sugars have a negative impact on achieving recommended nutrient intake? The sentence in the Conclusion—“A reduced intake of added sugars (especially sugarsweetened beverages) may be helpful in achieving recommended intakes of nutrients and in weight control”—overstates the evidence presented. The evidence in fact shows that focusing on added sugars intake as a way to control or lose weight or improve micronutrient intake is unlikely to have any effect on these outcomes. The Center is pleased that the DGAC considered our research during its deliberations, however, we object to the manner in which our research is characterized in the draft report. For example, the draft report notes that most cross-sectional studies have found that “an increased intake of added sugars is associated with increased total energy intake” and the study by Storey et al, 20036 is cited as support for this statement. Our study in fact showed that less than 10% of children’s BMI and less than 15% of adolescents’ BMI could be explained by the parameters of our models. Of the variance that was explained by the models we developed, the largest predictors of BMI among children and adolescents were factors that can not be modified, such as age, gender, and race-ethnicity. Of the lifestyle factors that can be modified, sedentary behavior was far more predictive of BMI than was dietary intake; and within dietary intake, added sugars did not predict BMI. The conclusions we reached therefore do not support the statement made in the draft DGAC report. The Center also objects to how another one of our studies is represented in the draft report. The DGAC asked the sub-question: “Does intake of added sugars have a negative impact on achieving recommended nutrient intake?” The sentence in the draft report—“each of these papers shows a decreased intake of at least one micronutrient with higher levels of added sugar intake”—is true on its face, but it misrepresents the intent and overall conclusion of at least the study conducted by the Center. While again the Center is pleased that the DGAC cited our study (Forshee and Storey, 2001),7 we in fact showed that added sugars intake had an inconsistent association with micronutrient intake and that the association was always small. In addition, whether the association was positive or negative, it was probably small enough to be biologically insignificant. The DGAC also relied heavily on the Institute of Medicine of the National Academies draft report—specifically Appendix J—that examined the relationship between added sugars intake and micronutrient intake. Unfortunately, the NAS report used a ratio variable (percent energy from added sugars [%EAS]) that introduced a statistical and mathematical complexity that certainly affected the results of the study. In a study to be published by Forshee and Storey and that was provided to the DGAC carbohydrate subcommittee, we found that the relationship between total energy intake and 6 Storey ML, Forshee RA, Weaver AR, Sansalone WR. Demographic and lifestyle factors associated with BMI among children and adolescents. International Journal of Food Science and Nutrition 2003; 54: 491- 503. 7 Forshee RA, Storey ML. The role of added sugars in the diet quality of children and adolescents. Journal of the American College of Nutrition 2001; 20: 32-43. 5 micronutrient intake is far stronger than the one between energy from added sugars and micronutrients.8 Does intake of added sugars contribute to excess intake of energy? This question is irrelevant because one could just as easily ask if intake of any macronutrient contributes to excess intake of energy. Of course, the answer is yes; intake of any macronutrient, including added sugars, can contribute to excess intake of energy. In addition, the first two sentences in this section should be deleted because the statements address a different scientific question of underreporting food intake.9 The language in the draft report alludes to “prospective studies” that suggest a positive association between consumption of sugar-sweetened beverages and weight gain. At least one DGAC member argued that prospective studies are more important than cross-sectional studies in providing evidence regarding relationships between health behaviors and health outcomes. The Center agrees that prospective studies allow the testing of certain hypotheses that cannot be tested in cross-sectional studies. We therefore encourage the principal investigators of existing prospective studies to make the data widely available so that the scientific and policy communities can benefit from the work of many independent research teams. In order to better understand the importance of these studies, we critically reviewed five of the prospective studies cited by the DGAC 10, 11, 12, 13, 14 and one prospective study published since the release of the draft report.15 8 Forshee RA, Storey ML. Controversy and statistical issues in the use of nutrient density in assessing diet quality. Journal of Nutrition 2004; in press. 9 “The analysis of dietary data on added sugars may underestimate intake because of the underreporting of food intake, which is more pervasive among obese adolescents and adults than among their lean counterparts (Johnson, 2000). It appears that foods high in added sugars are selectively underreported (Krebs-Smith et al., 2000).” 10 Ludwig DS, Peterson KE, Gortmaker SL. Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. The Lancet 2001; 357: 505-508. 11 Berkey CS, Rockett HR, Field AE, Gillman MW, Colditz GA. Sugar-added beverages and adolescent weight change. Obesity Research 2004; 12: 778-788. 12 Newby PK, Peterson KE, Berkey CS, Leppert J, Willett WC, Colditz GA. Beverage consumption is not associated with changes in weight and body mass index among low-income preschool children in North Dakota. J Am Diet Assoc. 2004; 104: 1086-94. 13 James J, Thomas P, Cavan D, Kerr D. Preventing childhood obesity by reducing the consumption of carbonated soft drinks: cluster randomised controlled trial. British Medical Journal 2004; 328:1237-1242. 14 Schulze MB, Manson JE, Ludwig DS, Colditz GA, Stampfer MJ, Willett WC, Hu FB. Sugarsweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. Journal of the American Medical Association 2004; 292: 927-934. 15 Field AE, Austin SB, Gillman MW, Rosner B, Rockett HR, Colditz GA. Snack food intake does not predict weight change among children and adolescents. Int J Obes Relat Metab Disord. 2004; 28:1210- 1216. 6 Each of these studies was conducted with the primary purpose of linking sweetened beverages with weight gain in children, adolescents, or adults. We believe the studies, as a body of evidence, show inconsistent results. The relationship between sugarsweetened beverages and BMI ranges from not statistically significant to a weak relationship affecting a small percentage of the population. A critique of each study is shown below. Ludwig et al., Relation between consumption of sugar-sweetened drinks and childhood obesity: a prospective, observational analysis. The Lancet 2001; 357: 505-508. This 19-month prospective observational study examined dietary habits and weight gain among 548 11-12 year old school children living in Massachusetts. Separate multivariate regression analyses were performed to estimate BMI and the probability of a child becoming overweight as a result of consuming calorie-containing carbonated soft drinks. At the end of the study, the authors found that only 6.8% of the study population of growing children, or 37 previously normal-weight, growing children, moved to the overweight category. At the same time, 35 (6.4% of the study population) previously overweight, growing children moved to the normal-weight category. Therefore, a net of two more children out of 548 (or 0.36% of the population) were classified as overweight at the end of the study. The regression analysis in Table 2 reports a relation of 0.24 kg/m2 increase in BMI for a one serving per day increase in sugar-sweetened drink consumption (controlling for other covariates). According to Table 1, baseline sugar-sweetened drink consumption was 1.22 servings per day and increased by 0.22 to 1.44 servings per day at followup. Therefore, the model predicts that for the average participant sugar-sweetened drink consumption contributed to a 0.05 kg/m2 increase in BMI over 19 months. While statistically significant, it does not appear that sugar-sweetened drinks made a large contribution to BMI for the average child in this study. Moreover, the authors did not report the coefficients of the other independent variables in the regression analyses. This prevents readers from determining the relative strength of the evidence upon which the authors made their conclusions regarding any possible unique contribution of soft drink consumption and weight gain among growing children. Berkey et al., Sugar-added beverages and adolescent weight gain. Obes Res 2004; 12: 778-788. This prospective, observational study (U.S. Growing Up Today Study) uses a powerful dataset, and the statistical modeling is generally good. However, the interpretation of the results does not appear to reflect the findings. Many of the reported p-values for the sweetened beverage variables were greater than (not statistically significant) or barely below 0.05. This is particularly surprising for such a large sample (>10,000 after exclusion criteria). 7 For example, in this sample of more than 10,000 boys and girls ages 9-14 years (y), the largest increase in BMI was 0.14 kg/m2 for boys who increased their consumption of caloric beverages by more than two servings per day. This small increase in BMI was attributed to a very large increase in calorically sweetened beverages. On average, there was an increase of 0.03 kg/m2 per serving/day for males, which was significant at p = 0.04. For females, there was a non-significant increase of 0.02 kg/m2 per serving/day (p = 0.096). Sugar-added beverages were defined as soda pop, sweetened iced tea, and non-carbonated fruit drinks. For boys, the average soda pop consumption in this study ranged form 0.34 (for 9 y) to 0.77 (for 14 y); iced tea ranged from 0.69 (for 9 y) to 0.20 (for 14 y), and non-carbonated fruit drinks ranged from 0.69 (for 9 y) to 0.78 (for 14 y). An increase of two servings per day is very large relative to the average consumer; indeed it is larger than the mean servings for the highest consuming age group. Even if we reduced consumption by more than the mean of the highest consumers, we would reduce average BMI by 0.14 kg/m2 at most. The coefficients and p-values for milk, sweetened beverages, and fruit juices are all very similar. Furthermore, the coefficients are much smaller and not statistically significant once total energy is introduced as a control variable. This suggests, as the authors report, that energy explains the relationships observed rather than any special property of sweetened beverages. Given the small magnitude of the reported relationships and the borderline p-values, the impact of sweetened beverages on BMI appears to be small. The authors also collected data on physical activity and sedentary behavior. Although these variables were included in the analysis, the authors did not report the results. Other research has shown that these variables have a stronger relationship with BMI than does added sugars. Since the results for physical activity and sedentary behavior were not reported, there is no context or basis for comparison in the interpretation of the reported relationship between sugar-added beverages and BMI. Despite these weak relationships and the lack of context, the authors still call for limiting the consumption of soft drinks and claim that this approach may prevent excessive weight gain. However, their results do not support the claim that limiting consumption of soft drinks may play a meaningful role in preventing weight gain. Based on these results, it is difficult to see how discouraging sweetened drink consumption could have a meaningful impact on average adolescent BMI. 8 James et al., Preventing childhood obesity by reducing the consumption of carbonated soft drinks: cluster randomised controlled trial. BMJ 2004; 328:1237-1242. This cluster, randomized controlled trial was designed to discourage consumption of “fizzy” drinks among 7-11 year old British school children. The so-called “Ditch the Fizz” campaign told the children that reducing calorie-containing soft drink consumption would improve well-being and dental health. The original published version of the paper noted that consumption of carbonated drinks decreased by 0.6 glasses per day. It was amended to show that consumption decreased by 0.6 servings over three days, or 0.2 servings per day. These results indicated that few children changed their dietary habits as a result of the campaign. The results also showed that consumption of carbonated drinks with sugar was unchanged in the control group and decreased by 0.3 of a (250ml) serving over a 3-day period in the intervention group. Neither change was statistically significant, and there was no statistically significant difference between the control and intervention groups. Furthermore, the mean change in BMI was 0.8 kg/m2 for the control group and 0.7 kg/m2 for the intervention group. This difference was not statistically significant. Newby et al. Beverage consumption is not associated with changes in weight and body mass index among low-income preschool children in North Dakota. J Am Diet Assoc. 2004; 104:1086-94. Newby et al. analyzed data from a prospective cohort study of 1,345 children 2-5y who were participating in the North Dakota Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). Their models found no statistically significant association between beverage consumption and change in either weight or BMI. Specifically with regard to soda consumption, the estimated coefficient in the multivariate adjusted model for weight was -0.00 ± 0.04 (p=.95) and for BMI was -0.01 ± 0.02 (p=.58). Moreover, zero was in the middle of the confidence interval and the estimate was negative, not positive, which was the hypothesis being tested. As the authors note, average consumption of soda in this study is only a little over one ounce per day, but this is very close to the national average of 1.75 oz/day for children under 5y as reported by the CSFII 1994-96, 1998 Table Set 17, Table 15A.16 This prospective study of a group of young, low-income children consuming nearly the national average of 16 U.S. Department of Agriculture, Agricultural Research Service. 1999. Food and Nutrient Intakes by Children 1994-96, 1998. Online. ARS Food Surveys Research Group, available on the "Products" page at [accessed September 23, 2004]. 9 soda showed no association between soda consumption and either weight or BMI. Schulze et al., Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-aged women. JAMA 2004; 292: 927- 934. This article addresses important nutrition, public health, and public policy issues using an extraordinarily rich and important dataset. Unfortunately, some of the commentary in the study does not accurately reflect the data presented. This prospective cohort analysis used data from the Nurses’ Health Study II. This non-representative sample of women had a full sample of 116,671 women, but the authors excluded nearly half of the respondents (n=51,603). It is important to note that the average weight increased in all sugar-sweetened beverage consumption categories during the four-year periods 1991-1995 and 1995-1999. Even the category that sharply reduced consumption of sugar-sweetened beverages had an average weight gain of 1.34 kg from 1991-1995. Percent of Population Affected by Sugar-sweetened Beverage Consumption 1991-1995 Consumption Category Percentage of the Population ?kg/4years ?lb/year Consistent =1/wk 75 3.21 1.8 Consistent =1/day 5 3.12 1.7 =1/wk to =1/day 2 4.69 2.6 =1/day to =1/wk 2 1.34 0.7 Other 16 3.04 1.7 Source: Adapted from data presented in Schulze et al. As shown in the table above, 75% of the participants were already in the lowest category of sweetened beverage consumption, consistently drinking one or fewer soft drinks per week (Consistent =1/wk). Only 2% of the participants increased sweetened beverage consumption from =1/wk to =1/day, and these participants gained about 1.5 kg more than those in the lowest consumption category. Similarly, only 2% of the participants reduced their sweetened beverage from =1/day to =1/wk, and those 10 participants gained 1.9 kg less than participants in the lowest consumption category. Percent of Population Affected by Sugar-sweetened Beverage Consumption 1995-1999 Consumption Category Percentage of the Population1 ?kg/4years ?lb/year Consistent =1/wk 76 2.04 1.1 Consistent =1/day 5 2.21 1.2 =1/wk to =1/day 1.5 4.20 2.3 =1/day to =1/wk 2 0.15 0.1 Other 16 2.10 1.2 Source: Adapted from data presented in Schulze et al. 1 Does not sum to 100 due to rounding. Slightly more than 96% of the women in this study had the same average weight gain between 1995 and 1999. Three out of four women in this study already consumed soft drinks once a week or less and can not be expected to reduce their consumption much further. Of the four percent of women who went from one extreme category to another (i.e., dramatically decreased or increased consumption), their weight gain changed by about one pound per year compared with the 96% of the rest of the population. This association was somewhat smaller after controlling for total energy. If less than a two kilogram change over a four-year period for less than four percent of the population is the best single opportunity we have to curb the obesity epidemic, then we have a serious challenge ahead for all of us, including the 96 percent of the population who are low or very modest consumers of sweetened beverages. Field et al. Snack food intake does not predict weight change among children and adolescents. Int J Obes Relat Metab Disord. 2004;28:1210- 1216. Using the same prospective, observational study as Berkey et al. (U.S. Growing Up Today Study), Field et al. report no association between consumption of snack foods and annual change in BMI z-score among the nearly 15,000 girls and boys who were 9-14y in 1996. The estimated coefficients were negative, small, and not significant for both boys and 11 girls. Adding sugar-sweetened beverages to the snack food category “did not meaningfully change the results” (p. 1214). Body of Evidence Does Not Support a Public Health Strategy Targeting Sweetened Beverages Overall risk from any substance depends on the level of exposure and the degree to which the substance is considered a hazard. The table below illustrates that seven studies using a variety of designs show a very slight difference in BMI that is often not significant. “Hazard” estimates in this set of data range from not significant to about 0.20 (kg/m2)/year per serving/day. It is therefore difficult to justify public health strategies that would focus on reducing sweetened beverages as a unique risk for obesity and Type 2 diabetes. Summary of Findings from Selected Major Papers Study Magnitude ?BMI/year/(serving/day) Significance Forshee & Storey17 (cross-sectional) 0.11 (males) 0.26 (females) Not Significant Not Significant Ludwig et al. (prospective) 0.15 (0.24 over 19 months) p=0.03 Berkey et al. (prospective) 0.03 (boys) 0.02 (girls) p=0.04 p=0.096 Not Significant James et al. (intervention) 0.1 difference between treatment and control Not Significant Newby et al. (prospective) -0.01 (children) Not Significant Schulze et al. (prospective) 0.20 (women) (applies to 4% of participants) p<0.05 Field et al. (prospective) ~0 (not directly reported) Not Significant Source: Compiled by CFNP from data presented in published studies. Several approaches have been developed to evaluate the overall strength of a body of scientific evidence. One recent example is the U.S. Food and Drug Administration’s Interim Evidence-based Ranking System for Scientific Data18 that is part of the Interim 17 Forshee RA, Anderson PA, Storey ML. The role of beverage consumption, physical activity, sedentary behavior, and demographics on body mass index of adolescents. Int J Food Sci Nutr. In press. 18 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition. Interim Evidence-based Ranking System for Scientific Data. July 2003. last accessed September 21, 2004. 12 Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements.19 The guidance describes an approach to evaluate how strongly the totality of scientific evidence supports a claim in the form of “consuming more X reduces the risk of Y,” with its counterpart claim being, “consuming less X reduces the risk of Y.” Based on the type and quality of the evidence, a proposed claim will be placed in one of four categories (First-level is the existing standard of Significant Scientific Agreement): Scientific Ranking FDA Category Appropriate Qualifying Language Second Level B ... "although there is scientific evidence supporting the claim, the evidence is not conclusive." Third Level C "Some scientific evidence suggests ... however, FDA has determined that this evidence is limited and not conclusive." Fourth Level D "Very limited and preliminary scientific research suggests... FDA concludes that there is little scientific evidence supporting this claim." Source: FDA Interim Procedures for Qualified Health Claims Using this approach, we believe that the claim “Consuming less sugar-sweetened beverages may reduce body mass index” would be a Third-level or Fourth-Level claim. There are no large clinical trials testing this claim. One small randomized control trial (James et al.) showed no difference in the change in BMI between treatment and control groups. The evidence from prospective observational studies is inconsistent. The Newby et al. and Field et al. studies found no relationship between sugarsweetened beverages and BMI. The Berkey et al. study found only a weak relationship between sugar-sweetened beverages and BMI, and that relationship disappeared after controlling for total energy. Ludwig et al. found a statistically significant relationship (p=0.03) that predicted an increase of 0.05 kg/m2 over 19 months for the average respondent in their study. Schulze et al. found statistically significant differences of about one pound/year that affected the approximately four percent of the participants who went from one extreme consumption category to the opposite extreme category. The other ninety-six percent of the participants had indistinguishable weight gains regardless of their sugar-sweetened beverage consumption. The prospective studies therefore have not confirmed a relationship between calorically sweetened beverages and BMI and cross-sectional studies generally have not found a relationship between sugar-sweetened beverage consumption and BMI either. 19 U.S. Department of Health and Human Services, Food and Drug Administration, Center for Food Safety and Applied Nutrition. Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements. July 2003. last accessed September 21, 2004. 13 Broad policies promoting the reduction of caloric-sweetened beverage consumption in order to decrease overweight/obesity in the U.S. population are not supported by the existing evidence. Summary of Comments In summary, the Center for Food and Nutrition Policy urges the following: 1) Prioritize the executive summary of the report to reflect the order of priority of the guidelines; 2) Delete the section on the role of the environment in implementing the guidelines as speculative and not supported by a science base; 3) Re-write the sentence on dental health as shown in these comments, which reflect the priority and relative importance of the factors that contribute the most to dental caries. 4) Re-write the section on added sugars and micronutrient intake to reflect the inconsistency and size of the relationship; 5) Re-write the section on added sugars and weight gain to reflect the actual findings in the scientific literature; that is, the relationship is small, weak, or not statistically significant. Furthermore, only a small percentage of the population appears to be affected by excessive intake of added sugars and/or sweetened beverages. Respectfully submitted, Maureen Storey, PhD Richard A. Forshee, PhD Director, CFNP Associate Director, CFNP Director, Research
Submission Date 9/27/2004
Author Center for Food and Nutrition Policy

Summary Choose carbohydrates wisely for good health. • Suggest changing key message to “Choose carbohydrates wisely for good health, including to help manage body weight”. • Supporting text should provide explicit recommendations on those carbohydrate-rich food and beverage sources that should be limited an
Comments Choose carbohydrates wisely for good health. • Suggest changing key message to “Choose carbohydrates wisely for good health, including to help manage body weight”. • Supporting text should provide explicit recommendations on those carbohydrate-rich food and beverage sources that should be limited and which should be consumed more frequently as part of a healthy diet.
Submission Date 9/27/2004
Author American Cancer Society, American Diabetes Association, American Heart Association

Summary
Comments
Submission Date 12/1/2004 12:20:00 PM
Author Anonymous

   Fiber
Summary Why is it Americans fall for the low carb advertising. We need carbs, chldren to thrive. Over carbs over weight Exercise America. You do youve funds to launch a massive advertising campaign.
Comments We learned in 4th grade, in 1958 that calories turn into fat if we don't burn the calories through exercise. I remember my teacher to this day.
Submission Date 1/12/2005 10:04:00 AM
Author from Springfield,`, MA

Discretionary Calories
   General
Summary 2005 Dietary Guidelines for Americans looks great! I am extremely excited for this report to impact the individuals of America. Good luck sorting through all the comments!
Comments Dear Secretaries Veneman and Thompson: First of all, I just want to thank you for the opportunity to provide input for the 2005 Dietary Guidelines for Americans. I am currently a senior at Ball State University majoring in elementary education. As a future educator I feel individuals nutrition is imperative for classroom success! Thank you for caring for the people of America. I have always been a huge advocate of fat grams and proportion sizes in food. As I was reading this report, the section on Control Calorie Intake to Mange Body Weight grabbed my attention. This section comments on how calories control weight. Then it goes on to state how the proportion sizes of carbohydrate, fat, and protein in diets don’t matter. I agree with the statement on how calories control weight. But I disagree with how proportion sizes don’t matter. So is this saying an individual’s diet can consist of fatty foods, as long as they keep within there recommended calorie intake? The same goes for carbohydrate and protein. This would not be healthy for an individual. I feel a healthy diet consists of all areas of the food guide pyramid. My concern with this statement is that people will start focusing in on how many calories they consume, and not variety in their diet. This could be a problem. The right variety in a diet is crucial. Our society can become vulnerable to different trends that are diet related. I have seen it happen, for example the Atkins diet. My advice to you would be to take out the statement on how the proportions of carbohydrate, fat, and protein in diets don’t matter. Instead, I would include a statement on how people should control calorie intake by making smart choices within the food guide pyramid. The overall report looks great, and I am really excited! Again, I just want to thank you for the opportunity to here out my comment. Good luck! Sincerely,
Submission Date 9/21/2004 8:18:00 AM
Author from Anderson, Indiana

Summary recommendations to be in real food specifications sugar must be addressed with specifics as to decreased quantity
Comments I concur with letter sent to Ms McMurry Sept 21 signed by numerous professionals beginning with Garry Auld of Colorado State University. Information to the public must be in usable, specific information - not generalities. Sugar must be addressed as well as corn syrup, high fructose syrup, etc as the amount is being consumed in exageraged quantities
Submission Date 9/23/2004 4:31:00 PM
Author from Durango, Colorado

Summary Discretionary calories is a correct concept scientifically, but difficult educationally. This concept will undoubtedly be preferentially used against the obese while giving thin people the license to eat whatever they want, whether or not the nutritional value of their selected foods is adequate.
Comments Discretionary calories were implicit in all dietary advice before the Food Guide Pyramid. The assumption was that one would eat at least the recommend amounts of each food group. If more calories were needed the person would include some sugar or fat or simply eat more foods from the recommended groups. However, in the pasts 30 years the consumption of added sugars has increased, particularly sweetened beverage consumption [Haines, 2000, Putnam, et al., 2002]. The studies cited by the Committee indicate that practically everyone is eating more fat and sugar than recommended, not just those who are overweight or obese. Although it is a scientific fact that very few discretionary calories are available if one is sedentary, educationally it is a concept that is very difficult to handle. Sedentary and active people are found among those that have a normal BMI, as well as those who are considered overweight or obese [Farrell, et al., 2002, Lee, et al., 1999]. Therefore, there is no good way to tell if a person is sedentary based on whether they are thin or fat. Because of the ignorance of the public as to the true nature of obesity and the difficulty of permanently reducing weight [Stern et al., 1995], this concept will undoubtedly be preferentially used against the obese while giving thin people the license to eat whatever they want, whether or not the nutritional value of their selected foods is adequate. I can best sum up the problem with an incident that occurred about 40 years ago. Dr. Charlotte Young was my major professor for my Master’s studies and a very large woman. She did not own a car, and walked everywhere. One day there was a departmental birthday party. As people were leaving the room she was eating a ½” wedge of birthday cake, the only piece of cake she had eaten during the celebration. One very thin person remarked in a loud voice as she walked out: “Imagine someone that fat eating cake”. Dr. Young was obviously hurt by the remark. She said to me: “You know, I am 5’ 10” tall and weigh 250 lbs. However, all my brothers and sisters weigh over 300 lbs.” Dr. Young’s area of expertise was obesity and she did everything we have always taught to control her weight. She was successful compared with other members of her family. Please do not turn in a report that foments the kind of ignorance and cruelty to which she was subjected. Farrell SW, Braun L, Barlow CE, Cheng YJ, Blair SN. 2002. The relation for body mass index, cardiorespiratory fitness, and all-cause mortality in women. Obes. Res. 10(6): 417-423. Haines PS. 2000. Consumer trends in fats and sweets: Policy options for dietary change. J. Food Distribution Res. 31(1): 32-38. Lee CD, Blair SN, Jackson AS. 1999. Cardiorespiratory fitness, body composition, and all-cause and cardiovascular disease mortality in men. Am. J. Clin. Nutr. 69(3):373-80 Putnam J, Allshouse J, Kanter LS. 2002. U.S. Per Capita Food Supply Trends: More Calories, Refined Carbohydrates and Fats. Food Review 25(3): 2-15. (Economic Research Service). Stern JS, Hirsch J, Blair SN, Foreyt JP, Frank A, Kumanika SK, Madans JH, Marlatt GA, St.Jeor ST, Stunkard AJ. Weighing the options: criteria for evaluating weight-management programs. The Committee to Develop Criteria for Evaluatin the Outcomes of Approaches to Prevent and Treat Obesity. Obes. Res. 3(6): 591-604.
Submission Date 9/26/2004 7:02:00 PM
Author from Mayagüez, ¨PR

Summary This letter on Discretionary Calories will include how low caloric intake will not only give you a good body image, but it will help you feel better about yourself and have a good mental state. It also agrees with what you already have in the dietary guidelines.
Comments Dear Secretaries Veneman and Thompson, Thank you for providing the opportunity for me to provide my suggestions about the Revised Dietary Guidelines for Americans. I find it very inspiring that you are revising these guidelines to better individual's personal nutrition. The next topic I believe goes hand in hand with physical activity and body maintiance; it is Control Calorie Intake To Manage Body Weight. I find this section very important, especially with our overweight epidemic. I believe portion sizes and caloric intake cannot be talked about enough. In this section, I would consider informing Americans that a low caloric intake diet will help you feel better about yourself, while maintaining a good body image. Other than this comment, I feel you inform individual's exactly what they need to do to manage body weight. Thank you very much for taking suggestion and giving careful consideration on how you might improve the Revised Dietary Guidlines for Americans. It is a very good idea to take suggestion from individuals who actually will read and have to follow these guidelines, the public. Good luck with your journey and sorting through the many suggestion. Sincerely, Kendra Chestnut 1012 Ashland Ave. Muncie, In 47303
Submission Date 9/27/2004 12:47:00 AM
Author from Muncie, Indiana

Summary This entire section should be deleted because it is both unnecessary and a wasteful distraction from the important basics of nutrient intake.
Comments This section is unnecessary according to the 2005 guideline itself, “…most Americans have used up discretionary calories even before meeting recommendations for nutrient intakes.” The American people, approximately half of whom are overweight, do not need information on discretionary calories. They need help (desperately) on moderation, wise choices, and nutrients. This section distracts from the primary aim of this important document. If this section is released, it will unleash a torrent of wasteful discussion and debate, energy that would be better spent helping people understand portion control and nutrient intake. People already reference the overwhelming explosion of “new information, new fads” as excuses for not using common sense (and clear basics) in dietary choices. Please do not contribute to the “confusion.” Please, please, please, delete this entire section, and focus on the basics. This entire section should be deleted because it is both unnecessary and a wasteful distraction from the important basics of nutrient intake.
Submission Date 9/27/2004 10:40:00 AM
Author from Okemos, MI

Summary I agree with the comments and suggestions posted in the guidlines for this section on discretionary calories.
Comments September 27, 2004 HHS Office of Disease Prevention and Health Promotion %Kathryn McMurry Office of Public Health and Science Suite LL 100 1101 Wootton Parkway Rockville, MD 20852 Dear Secretaries Veneman and Thompson: Thank you for this opportunity to provide my own opinion about the Revised Guidelines for Americans. I appreciate your concern and desire to gain feedback from the people whom the guidelines will apply to. I hope others will take the time to read through and comment on the guidelines as well. Most of the information provided in the document seemed to be an affirmation of what many people who visit a doctor already know or at least have heard about before. There was one section in particular that caught my attention, the section titled "Control Calorie Intake to Manage Body Weight." In it, you state "When it comes to weight control, calories do count- not the proportions of carbohydrate, fat, and protein in the diet. Calories expended must equal energy consumed to stay at the same weight. A deficit could be achieve by eating less, being more active physically, or combing the two." I completely agree with this statement. This, however, is a fact that many people who are dieting tend to overlook. People see "Low Fat" or "Low Carb" on a lable and automatically think that it is good for them and they may eat large portions because it is light or low fat. Calories definitely do count! A person must take in fewer calories than they expend in order to lose weight. Portion control is a big problem in the lives of many people, which partly comes for the thinking that low fat or low carb gives them free reign to eat however much they want, regardless of calories, which simply is not the case. In order to successfully lose and maintain weight loss, a person must carefully watch calories and exercise daily, both of which are stated in this document. I would like to thank you again for asking for feedback. I appreciate the opportunity to share my thoughts. I wish you luck with your project and hope that everything goes well. Thank you again. Sincerely, Amy VanDeWielle 224 N. Meeks Ave. Muncie, IN 47303
Submission Date 9/27/2004 11:47:00 AM
Author

Summary NFPA recommends that the Departments approach the concept of “discretionary calories” cautiously.
Comments NFPA recommends that the Departments approach the concept of “discretionary calories” cautiously. We note that the report reflects some contradictory recommendations on this subject – the physical activity recommendations encourage increased activity, yet the “discretionary calorie” recommendations reflect only needs of sedentary individuals. This concept must be evaluated carefully with consumers to avoid interpretation as calorie permissiveness. “Discretionary calories” must be communicated with great care, if at all.
Submission Date 9/21/2004
Author National Food Processors Association

Summary The issue of discretionary calories and how to effectively communicate it to consumers will be a difficult problem to deal with when composing the Dietary Guidelines, and in the future, the food Guide Pyramid.
Comments The issue of discretionary calories and how to effectively communicate it to consumers will be a difficult problem to deal with when composing the Dietary Guidelines, and in the future, the food Guide Pyramid. We are concerned that the concept will be confusing to consumers, especially when it seems to restrict foods that provide many nutrients, such as whole milk. If this seen as a punishment for an individual’s weight or inactivity, consumers could tune out this detail, along with the entire positive message of the Dietary Guidelines.
Submission Date 9/21/2004
Author International Dairy Foods Association

Summary The upcoming edition of the Dietary Guidelines should emphasize the Committee’s conclusion that calorie intake, not macronutrient composition, is the critical factor for managing weight. We believe the concepts of discretionary and essential calories will be difficult to communicate to consumers. T
Comments General Mills appreciates the Committee’s focus on weight management throughout the report and commends the committee for promoting science-based approaches such as increasing intake of whole grains, fruits and vegetables. The scientific evidence supporting these strategies will continue to grow as more emphasis is placed on the health benefits of these foods. The upcoming edition of the Dietary Guidelines should also emphasize the Advisory Committee’s conclusion that calorie intake, not macronutrient composition, is the critical factor for weight maintenance/weight loss. This message enables consumers to select foods from all food groups, thus contributing to a more balanced intake of nutrients. We believe that consumer testing will be critical to determine how best to communicate and motivate consumers about the importance of calories. General Mills is concerned about the consumer appropriateness of the concepts of discretionary and essential calories. We believe that it will be difficult to communicate these concepts to consumers without stigmatizing foods that have been part of the American diet for many years. The strong emphasis on limiting foods with fat and added sugar reduces flexibility in diet planning and may not lead to improved nutrient intakes. As mentioned in the report, research shows that individuals who consume a moderate amount of added sugar (5-10% of calories) have higher intakes of certain micronutrients than those who consume fewer calories from added sugar. This may be because added sugar (and fat) can improve the palatability of many nutrient-rich foods. The Dietary Guidelines should aim to communicate that all foods can fit into a diet rather than reinforcing “good food/bad food” messages. This is an ideal opportunity to educate consumers about the importance of portion size and calorie content when making food choices. General Mills commends the Advisory Committee for reviewing relevant scientific literature and developing physical activity recommendations for adults and children. We strongly believe that a guideline for physical activity should be included in the upcoming Dietary Guidelines. Scientific studies show that physical activity and appropriate food choices form the foundation of a healthy lifestyle. Balancing energy intake and energy expenditure is increasingly important given the high prevalence of overweight/obesity and other associated health conditions and chronic diseases in the US. Developing consumer messages related to energy balance, however, will likely be a significant challenge. Nevertheless, we encourage the Communications Committee to commit to this endeavor since meaningful, motivational messages about the relationship between “calories in” and “calories out” have great potential to improve the health of Americans.
Submission Date 9/27/2004
Author General Mills

Summary The Association acknowledges that advising the American public on the importance of achieving nutrient adequate diets is a very central consideration for Federal nutrition policy recommendations. We agree wholeheartedly that individuals should strive to meet their nutritional requirements within the
Comments The Association acknowledges that advising the American public on the importance of achieving nutrient adequate diets is a very central consideration for Federal nutrition policy recommendations. We agree wholeheartedly that individuals should strive to meet their nutritional requirements within their particular energy needs. We disagree, however, that nutrient adequacy can be achieved by following extremely restrictive and complicated meal patterns that fundamentally require individuals to exclude calories from individual macronutrients. The concept of discretionary calories is impractical because people don’t eat individual nutrients or calories, they eat foods. While certain foods could be considered “discretionary foods” whose intakes depend on an individual’s energy needs, the premise that all sugars are simply discretionary calories is flawed. For example, a candy bar may have fewer grams of sugars than a nutrient-rich yogurt. To eat within the discretionary calorie intake limits for sugars proposed by the Committee appears to be based totally on the supposition that sugars are an expendable ingredient in all foods. In order to meet this stringent advice for sugars intake, one would have to almost exclusively consume many nutrient-rich foods, such as cereals, yogurt and even peanut butter, that are sweetened only with artificial sweeteners. This could have unforeseen consequences, especially for children. Suggestions to designate added sugars as discretionary calories does not help average consumers make informed food choices, and may direct them to foods that may have fewer sugars but not fewer calories. The meal patterns developed by the USDA Center for Nutrition Policy and Promotion for revising the Food Guide Pyramid (Pyramid) are the mathematical calculations the Committee used for its suggested intake levels of discretionary calories for sugars. It is critical to reiterate that these meal patterns are based on mathematical formulas, not on scientific consensus of negative health impact from sugars intake. The mathematical model used to develop these meal patterns is established on attaining only the highest recommended micronutrient intakes (detailed explanation in section on added sugars and micronutrient displacement) without the benefits of our fortified and enriched food supply. Therefore, in order to consume the required upper levels of micronutrients, caloric intake is unnecessarily inflated. One consequence is sugars calories are artificially restricted. Furthermore, the Association would like to suggest that the current undue emphasis on upper intake amounts as the standard for defining micronutrient adequacy is inadequate for nutrition advice, and such food guidance policy may not achieve the primary goal of better overall health for the US public. In a recent review article, Dr. Cutberto Garza wrote about the importance of considering micronutrient toxicity in the development of revised dietary reference intakes. “It was clear that scientific, healthcare practitioners and consumer communities had moved beyond focused interest in the prevention of classical nutrient deficiencies.” “Related to this consideration was an appreciation of the unprecedented ability to manipulate nutrient intakes over wide ranges by increasingly common voluntary fortification of foods, increasing and expanding uses of nutrient supplements and nutrient-related botanicals, and the growing likelihood of expanded capabilities to alter the nutritional characteristics of food crops and animals by genetic modification. These on-going and anticipated changes in food supply raised concerns regarding the evidence base justifying the putative benefits of intake levels higher than necessary to prevent classical deficiency diseases and to possibilities of more easily reaching toxic levels of nutrients in diets easily accessible to the public.” (Emphasis Added) The Association would like to emphasize its strongly held position. The Pyramid’s mathematical model lacks the scientific underpinning to be used as the basis to make official or unofficial quantitative recommendations for levels of added sugars intake. This is also the conclusion of the American Dietetic Association (ADA) in its revised position paper on nutritive and non-nutritive sweeteners. After providing a detailed description of the paradigm of the Pyramid, ADA concluded, “Thus, the suggestion of 6% to 10% of energy from added sugars was not based on any scientific evidence regarding health impacts but was calculated using the Food Guide Pyramid.” Therefore, we ask the Agencies to re-evaluate the practical implications, as well as the scientific basis, for promoting the concept of discretionary calories based solely on the Pyramid’s proposed meal patterns in issuing guidelines for sugars intake.
Submission Date 9/27/2004
Author Sugar Association

Energy Balance/Weight Management
   Weight loss
Summary How does one determine an accurate daily calorie need based on their height, weight, age, activity and metabolic rate?
Comments How does one determine an accurate daily calorie need based on height, weight, age, activity and metabolic rate? If one knows exactly what their need is then they can decrease calories and increase activity according to the guidelines.
Submission Date 8/27/2004 1:18:00 PM
Author Anonymous

   Weight maintenance
Summary The USDA and the Dietary Guidelines Advisory Committee only need to confirm the Mayo Clinic food pyramid.
Comments The Mayo Clinic's Weight Pyramid is already the best food pyramid design.
Submission Date 8/29/2004 1:54:00 PM
Author from Albuquerque, NM

Summary Based on about five years' of personal experience, I recommend that your panel consider the blood type diet developed by Dr. Peter D'Adamo and described in his book, "Eat Right 4 Your Type."
Comments Based on about five years' of personal experience, I recommend that your panel consider the blood type diet developed by Dr. Peter D'Adamo and described in his book, "Eat Right 4 Your Type." I have found his system, which keys dietary recommendations to one's blood type, to be instrumental in strengthening my immune system and maintaining a healthy weight and cholesterol levels. Since going on the diet, my productivity at work is much higher, I recover from minor illnesses more rapidly, and sick days are almost nonexistent. Dr D'Adamo has summarized extensive clinical and research experience that conclusively demonstrates the efficacy of this system.
Submission Date 9/1/2004 9:32:00 AM
Author Anonymous

   Energy density
Summary In closing, we would like to point out that avocados are included in dietary programs from many of the world’s leading nutrition organizations including.
Comments Control calorie intake to manage body weight. As a nutrient-rich food, substituting avocados for nutrient-poor foods helps achieve recommended nutrient intake without excess calories.
Submission Date 9/17/2004 5:25:00 PM
Author California Avocado Commission

Summary Avocados are a natural source of eight vitamins, two minerals and at least three phytochemicals. Avocados are included in dietary programs from many of the world’s leading nutrition organizations and can make a significant contribution to the health of Americans.
Comments One of the 9 key messages is: Consume a variety of foods within and among the basic food groups while staying within energy needs. Avocados are a naturally nutrient-dense fruit that can help Americans increase their intake of carotenoids, vitamins E and C, magnesium, potassium, and fiber. As the top-ranking fruit source for folate, avocados can help adolescent females and women of childbearing age meet their needs for folic acid.
Submission Date 9/17/2004 5:48:00 PM
Author California Avocado Commission

Summary In closing, we would like to point out that avocados are included in dietary programs from many of the world’s leading nutrition organizations including.
Comments Control calorie intake to manage body weight. As a nutrient-rich food, substituting avocados for nutrient-poor foods helps achieve recommended nutrient intake without excess calories.
Submission Date 9/17/2004 6:07:00 PM
Author California Avocado Commission

   Portion Sizes
Summary Simpler portion measurement.
Comments Portion size should be described in a simpler format, other than use of measuring tools. Example: A serving size of protein is equal to the size of your palm.
Submission Date 9/19/2004 12:01:00 PM
Author Seton Hill University

Summary Simpler portion measurement.
Comments Portion size should be described in a simpler format, other than use of measuring tools. Example: A serving size of protein is equal to the size of your palm.
Submission Date 9/19/2004 12:03:00 PM
Author from Greensburg, PA

   Weight maintenance
Summary Please consider revising the Nutrition Facts label to reflect any decreases in recommended total calories for the day. 1800 might be a better level for the daily values to reflect. Thank you.
Comments Recommended calories and other nutrients are listed in table format by age and gender. Just wondering if the Nutrition Facts Label will reflect different total calories. (Currently labels lists 2000 and 2500 calories; and % daily value is based on 2000 calories a day)
Submission Date 9/21/2004 3:58:00 PM
Author Anonymous

Summary
Comments I submit the following 2005 Dietary Guidelines concerns for consideration by the expert committee. It has been my experience when working with patients as well as their care providers that little is understood about the recommended energy requirements. Physicians refer patient to Weight Watchers simply because of availability and it seems any prgram is preferred to no program. I realize you are well aware of the pit falls of weight cycling. Please consider stressing the importance of adequate calories to address those who cut below recommendations in the hope for a rapid weight loss. All the guidelines about adequate carbs but not too many, and the restrictions on fat etc. are great but we skip over education and recommendation on adequate caloreis. I believe the studies by Ancel Keyes from the U of Minnesota should alert us to the probelm with undernutirion and starvation effects. We see so much that addressed overeating and I beleive we can create a positive psychological effect by stressing the importance of getting enough calories. I still see recommendations for 500- 1200 calories orderd by physician. Thank you for your consideration and all the work you do on behalf of the guidelines.
Submission Date 9/22/2004 10:43:00 AM
Author from Fargo , ND

Summary Suggest retuning to "aim for a healthy weight" and omit the use of the word "control." It carries too many negative connotations if the "control intake" guidleline is not met.
Comments Suggest not using the word “control.” The word “control” tends to set people up for failure- uncontrolled. Suggest changing back to “aim for a healthy weight” & not use “control intake-” when people loose weight, but are unable to reach/maintain a specific weight- adding in the term control will set them up for continued failure. It denotes that they are unable to “gain control” of their lives (out of control) and thus, they must deal with the consequences.
Submission Date 9/23/2004 11:59:00 AM
Author OSU Extension Program- Cleveland, OH

Summary PBH supports the emphasis on nutrient density and the unique role of fruits and vegetables in weight management. We hope that this important concept will be better communicated to consumers.
Comments PBH supports the emphasis on nutrient density and the unique role of fruits and vegetables in weight management. We hope that this important concept will be better communicated to consumers and that more specific examples of substituting fruits and vegetable for energy dense-nutrient poor food choices are provided. PBH would welcome the opportunity to help expand Table E-9: Ways to Increase Consumption of Fruits and Vegetables, by providing actionable ways that consumers can increase the variety of fruits and vegetables especially dark green and orange ones, such as through the successful PBH Color Way Campaign and hope it can be included in the consumer document. Simple, positive and specific examples of how to incorporate more fruits and vegetables into the diet will be welcome by consumers who are constantly reminded of what they should NOT eat. Emphasizing a more positive message including the need for consumers to “SWITCH” to more nutrient-rich, and low calorie fruits and vegetables, will also help consumers meet the higher fruit and vegetable recommendations.
Submission Date 9/24/2004 1:23:00 PM
Author Produce for Better Health Foundation

Summary The Council urges HHS to include statements in the 2005 Dietary Guidelines acknowledging that intense sweeteners are low in calories and the usefulness of reduced calorie products containing them, as well as fat-free and low-fat products that are also reduced in calories.
Comments September 24, 2004 Kathryn McMurray HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science Suite LL100 1101 Wootton Parkway Rockville, MD 20852 RE: 2005 Dietary Guidelines for Americans Dear Ms. McMurray: The Calorie Control Council (the “Council”) is an international association of manufacturers of low-calorie, light, and special dietary foods and beverages, including the manufacturers of a variety of sweeteners, fat replacers and other low-calorie ingredients used in these foods. The Council commends the 2005 Dietary Guidelines Advisory Committee for its diligence and comprehensive report. The Council, is concerned, however, that the report made no mention of the safe and appropriate use of sugar substitutes and fat replacers. The Council urges HHS to include statements in the 2005 Dietary Guidelines acknowledging that intense sweeteners are low in calories and the usefulness of reduced calorie products containing them, as well as fat-free and low-fat products that are also reduced in calories. For example, the 2000 Dietary Guidelines did acknowledge the role of sugar substitutes stating: “Sugar substitutes, such as saccharin, aspartame, acesulfame potassium, and sucralose are extremely low in calories. Some people find them useful if they want a sweet taste without the calories. Some foods that contain sugar substitutes, however, still have calories. Unless you reduce the total calories you eat or increase your physical activity, using sugar substitutes will not cause you to lose weight.” The consumer, as well as the food and beverage industry, is fortunate to now have five low-calorie sweeteners (the four mentioned above plus neotame) and several reduced calorie sweeteners and fat replacers from which to choose. This variety of low-calorie ingredients allows the calorie control industry to use the ingredient, or combination of ingredients, best suited for a given product. According to the Council’s 2004 Light Products Survey, 198 million adult Americans use light products, i.e., low-calorie, sugar free and/or reduced fat products. More than eight out of ten of these consumers say they want additional light products from which to choose. Low-calorie sweeteners, fat replacers and the reduced-calorie products containing them provide good taste without the calories of their full calorie counterparts. Studies demonstrate, for example, that when sucrose is covertly replaced with low-calorie sweeteners non-dieting obese and normal weight individuals incompletely compensate for the calorie reduction. In other words, they eat fewer calories. Importantly, it has been demonstrated that multidisciplinary weight control programs that include the use of reduced-calorie foods and beverages may facilitate weight loss and weight maintenance. The Advisory Committee cites one (Raben et al., 2002) of the number of studies, which demonstrate that reduced calorie products may be useful in weight control and weight maintenance. In its 2004 updated position paper, “Use of Nutritive and Nonnutritive Sweeteners,” the American Dietetic Association concludes that “High-intensity sweeteners can offer consumers a way to enjoy the taste of sweetness with little or no energy and or glycemic response. Nonnutritive sweeteners may assist in weight management, control of blood glucose, and prevention of dental caries.” The Calorie Control Council urges HHS to reconfirm the safe and appropriate use of FDA approved low-calorie sweeteners and fat replacers and state that the use of reduced-calorie foods in place of their full calorie counterparts can assist in weight management efforts. The Council would be pleased to provide additional information upon request. Respectfully submitted, Lyn O’Brien Nabors Lyn O’Brien Nabors Executive Vice President
Submission Date 9/24/2004 4:27:00 PM
Author Calorie Control Council

   Weight loss
Summary Leading health organizations promote the benefits of citrus, including the American Heart Association, American Cancer Society, the National Cancer Institute and the Produce for Better Health Foundation.
Comments One of the key messages is: Control calorie intake to manage body weight. As a nutrient-rich food, substituting citrus fruits for nutrient-poor foods helps achieve recommended nutrient intake without excess calories. One medium-size orange contains just 80 calories and has been shown to suppress hunger levels for up to four hours after eating . New research from the Nutrition and Metabolic Research Center at Scripps Clinic shows that consuming half of a fresh grapefruit before meals can result in significant weight loss.
Submission Date 9/24/2004 5:18:00 PM
Author Sunkist Nutrition Bureau

   Energy density
Summary In summray, I think the term "low fat soups" should be omitted. Soups provide the consumer with a higher sodium content and a low satiety value. I would replace that area and sugges the consumer choose, whole raw fruits and vegetables, dairy products, or whole grains.
Comments I would like to comment, however, on the area in the executive summary titled: Control Calorie Intake to Manage Body Weight. In the summary it states, “consuming large portions of raw vegetables or low fat soups may help limit one’s intake of other foods that are more energy dense.” I feel that this is strongly misleading, contradictory to other sections of the document, and most notably, false. Indeed, the part about consuming raw vegetables is true and important. However, I do not agree with the “low fat soup” comment. For an average American, the word soup immediately causes the consumer to think of a can of soup. Canned goods are generally higher in sodium content, and a simple can of condensed chicken noodle soup contains 175 calories, 4.5 g of fat and 890mg of sodium. While the soup is low-fat, it is not low sodium. Throughout the summary, there is consistent talk of reducing sodium in the diet, and this is surely not the best advice on limiting sodium or controlling caloric intake. The soup is a made up mostly of liquid content. This is not effective in providing a high satiety value. The consumer will most likely eat the soup and be hungry within an hour due to the lack of satiety. I recommend altering this section of the document and offer consumption of raw fruits and vegetables or a serving of a dairy product or whole grain product. By stating these choices instead, the consumer will ingest more essential vitamins and minerals and they will be eating foods that certainly provide a higher satiety value than a can of condensed soup. In turn, the consumer’s caloric intake will be lowered due to consuming foods that keep one fuller for a longer period of time and avoid excessive snacking or excessive portions at meal time.
Submission Date 9/26/2004 11:49:00 PM
Author from Muncie , IN

   Weight maintenance
Summary We feel that people need to adjust to be at the appropriate body weight.
Comments We recommend that you change "Control Calorie Intake to Manage Body Weight" to "Adjust Calorie Intake to Manage Appropriate Body Weight."
Submission Date 9/27/2004 1:19:00 PM
Author Volunteers of America

Summary Please try to provide in the final draft specific exercise guidelines in 1. minutes/session 2. times/week 3. intensity for both children and adults.
Comments Please try to provide in the final draft specific exercise guidelines in 1. minutes/session 2. times/week 3. intensity for both children and adults. There is conflicting information available to the public. I understand it is hard to provide a global recommendation for various needs such as weight maintenance, weight loss, and fitness. In CA we have an employees fitness program for WIC employees. I work with employees to keep the program going. I have found, the more specific the message the easier it is for folks to use. If anything, I find many people under exercise, both in time and intensity, and assume they are doing enough. There are many reasons for this, but time constraints and a culture of inactivity seem to influence many people's perception of adequate activity. I know this is not scientific, but it is what I see 'on the streets' out here working with people. Thank you.
Submission Date 9/27/2004 1:56:00 PM
Author CA WIC Assn

   Energy density
Summary Although peanut butter and peanuts are energy-dense, research does not show that they contribute to weight gain. Data shows that peanut users tend to have an overall better diet quality and a lower body mass index than non peanut users.
Comments Although peanut butter and peanuts are energy-dense, research does not show that they contribute to weight gain. Further, consuming peanuts and peanut butter may improve the overall nutrient profile of the diet. CSFII data shows that the overall nutrient profile of peanut eaters was significantly better than that of non-users and that the average body mass index (BMI) of peanut users tended to be lower than that of nonusers (1). Further, a Harvard weight-loss study compared a moderate-fat diet with small amounts of healthy fats, to a low-fat diet and found that three times as many people stuck to the moderate-fat diet, which resulted in long-term weight loss and weight maintenance. The additional benefit of the moderate-fat diet with peanuts and peanut butter is that participants increased their vegetable consumption by one serving per day and their peanut butter consumption by almost a serving (32 grams or 2 tablespoons) each day compared to baseline. As a result, people on the moderate-fat diet consumed greater amounts of fiber, protein, and "good" unsaturated fat compared people on the lower-fat diet. Therefore, the moderate-fat diet with peanuts and peanut butter proved to be a better quality diet overall (2). References: 1. "Dietary Patterns for Families," Scientific Presentation by Penny Kris-Etherton, PhD, RD. American Dietetic Association Meeting, October 19, 2002. 2. McManus, K., et al. A randomized controlled trial of a moderate-fat, low-energy diet compared with a low-fat, low-energy diet for weight loss in overweight adults. International Journal of Obesity. 2001;25:1503-1511.
Submission Date 9/27/2004 4:44:00 PM
Author The Peanut Institute

   Weight loss
Summary The PCRM urges you to give specific advice regarding safe effective ways to achieve and maintain a healthy weight while reducing chronic disease risk and to warn consumers against the use of carbohydrate-restricted diets, such as the Atkins Diet, for weight loss.
Comments The Physicians Committee for Responsible Medicine (PCRM) urges you to give specific advice regarding safe effective ways to achieve and maintain a healthy weight while reducing chronic disease risk and to warn consumers against the use of high-protein, high-fat, carbohydrate-restricted diets, such as the Atkins Diet, for weight loss in the 2005 Dietary Guideline for Americans. We recommend guiding individuals to low-fat diets built from plant foods to help them achieve and maintain a healthy weight. According to the USDA commissioned paper “Popular Diets: A Scientific Review,” low-fat and very low-fat diets are effective for weight loss because they lead to a reduction in calorie intake and an increase in fiber, which can help people feel fuller longer.1 In addition, low-fat, high-fiber, near-vegetarian, vegetarian, and vegan diets have been used effectively for long-term weight control2 and to treat and to reduce the risk of heart disease,3-5 diabetes,6-8 some cancers, 9,10 and other chronic conditions. In addition, the physicians and nutritionists at PCRM ask that you warn individuals about the potentially harmful effects of high-protein, high-fat, carbohydrate-restricted diets in the Dietary Guidelines for Americans. These popular diets are potentially dangerous because they skew nutritional intake toward higher-than-recommended amounts of dietary cholesterol, fat, saturated fat, and protein and very low levels of fiber and other protective dietary constituents and put individuals at risk of compromised vitamin and mineral intake.11 And, when followed over the long term, these dietary patterns are associated with increased risk of colorectal cancer,9 cardiovascular disease,12, 13 impaired renal function,14 osteoporosis,15 and complications of diabetes.16 Since the Fall of 2002, PCRM has been collecting reports of adverse events from individuals following high-protein, high-fat, carbohydrate-restricted diets through an online registry (www.atkinsdietalert.org/registry.html). In summary, among the reports of 429 individuals who experienced health problems while on a high-protein, high-fat, carbohydrate-restricted diet, 19 percent reported renal problems (stones, severe infections, or reduced kidney function), 33 percent reported cardiac disorders (including coronary artery occlusion requiring stent placement, heart attack, atrial fibrillation, tachycardia, and elevated serum cholesterol concentrations), 9 percent reported gallbladder problems, 5 percent have reported the onset of gout, and 4 percent reported cancer diagnoses. Less serious problems, such as constipation (44 percent), bad breath (40 percent), difficulty concentrating (29 percent), and loss of energy (40 percent) were recorded with higher frequency. Because of these risks and the scientific evidence showing that these diets are not more effective than other, safer, weight loss methods, we recommend that a warning statement be added to the 2005 version of the Dietary Guidelines for Americans against the use of low-carbohydrate, high-protein diets.17,18 Nutrition policy statements would best serve Americans by recommending a low-saturated fat, high-fiber, high–complex-carbohydrate diet based on plant foods. Literature cited: 1. Freedman MR, King J, Kennedy E. Popular diets: a scientific review. Obes Res. 2001 Mar;9 Suppl 1:1S-40S. 2. Ornish D, Scherwitz LW, Billings JH, et al. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998;280:2001-7. 3. Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA. Can lifestyle changes reverse coronary heart disease? Lancet 1990;336:129–33. 4. Esselstyn CB Jr, Ellis SG, Medendorp SV, Crowe TD. A strategy to arrest and reverse coronary artery disease: a 5-year longitudinal study of a single physician's practice. J Fam Pract. 1995;41:560-8. 5. Barnard RJ, Inkeles SB. Effects of an intensive diet and exercise program on lipids in postmenopausal women. Women’s Health Issues 1999;9:155-61. 6. Barnard RJ, Jung T, Inkeles SB. Diet and exercise in the treatment of NIDDM: the need for early emphasis. Diabetes Care 1994;17:1469-72. 7. Crane MG, Sample C. Regression of diabetic neuropathy with total vegetarian (vegan) diet. J Nutr Med 1994;4:431-9. 8. Nicholson AS, Sklar M, Barnard ND, Gore S, Sullivan R, Browning S. Toward improved management of NIDDM: a randomized, controlled, pilot intervention using a lowfat, vegetarian diet. Prev Med 1999;29:87-91. 9. World Cancer Research Fund/American Institute for Cancer Research. Food, Nutrition, and the Prevention of Cancer: a global perspective. World Cancer Research Fund/American Institute for Cancer Research, Washington, DC, 1997, pp. 216-51. 10. Ornish DM, Lee KL, Fair WR, Pettengill EB, Carroll PR. Dietary trial in prostate cancer: Early experience and implications for clinical trial design. Urology. 2001;57:200-1. 11. St Jeor ST, Howard BV, Prewitt TE, Bovee V, Bazzarre T, Eckel RH. Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Dietary protein and weight reduction: a statement for healthcare professionals from the Nutrition Committee of the Council on Nutrition, Physical Activity, and Metabolism of the American Heart Association. Circulation 2001;104:1869–74. 12. Nestel PJ, Shige H, Pomeroy S, Cehun M, Chin-Dusting J. Post-prandial remnant lipids impair arterial compliance. J Am Coll Cardiol 2001;37:1929-35. 13. Fleming RM. The effect of high-protein diets on coronary blood flow. Angiology 2000 Oct;51(10):817–26. 14. Knight EL, Stampfer MJ, Hankinson SE, Spiegelman D, Curhan GC. The Impact of Protein Intake on Renal Function Decline in Women with Normal Renal Function or Mild Renal Insufficiency Ann Int Med 2003;138:460-7. 15. Feskanich D, Willett WC, Stampfer MJ, Colditz GA. Protein consumption and bone fractures in women. Am J Epidemiol 1996;143:472-9. 16. Gin H, Rigalleau V, Aparicio M. Lipids, protein intake, and diabetic nephropathy. Diabetes Metab 2000 Jul;26 Suppl 4:45-53. 17. Foster GD, et al. A randomized trial of a low-carb diet for obesity. N Engl J Med 2003;348:2082-90. 18. Bravata DM, Sanders L, Huang J, et al. Efficacy and safety of low-carbohydrate diets: a systematic review. JAMA. 2003;289:1837-50.
Submission Date 9/27/2004 5:00:00 PM
Author Physicians Committee for Responsible Medicine

   Weight maintenance
Summary The focus of the foods to eat plenty of and the foods to stay away from allow the public to see just how healthy their eating habits are. The special nutrient recommendations are also a great way to get the message out about how important it is to eat healthy.
Comments
Submission Date 9/27/2004 5:03:00 PM
Author Anonymous

Summary BMI should not be the only method for determining a persons health status. Many athletes and physically fit people with muscle mass may fall into the category of "overweight" or "obese" according to the BMI.
Comments the wording here seems a little vague: "A BMI above the healthy range is less healthy for most people; but it may be fine if you have lots of muscle and little fat." What exactly does "less healthy" mean? also, perhaps an example should be given to describe what type of person may have "lots of muscle and little fat", i.e. bodybuilder or professional athlete. BMI for these types of people will most likely be higher, sometimes way beyond what is considered healthy. therefore these people should also be considered and mentioned as a sidenote.
Submission Date 9/28/2004 11:55:00 PM
Author Anonymous

Summary BMI should not be the only method for determining a persons health status. Many athletes and physically fit people with muscle mass may fall into the category of "overweight" or "obese" according to the BMI.
Comments The wording here seems a little vague: "A BMI above the healthy range is less healthy for most people; but it may be fine if you have lots of muscle and little fat." What exactly does "less healthy" mean? also, perhaps an example should be given to describe what type of person may have "lots of muscle and little fat", i.e. bodybuilder or professional athlete. BMI for these types of people will most likely be higher, sometimes way beyond what is considered healthy. therefore these people should also be considered and mentioned as a sidenote
Submission Date 9/29/2004 12:03:00 AM
Author Anonymous

Summary Introduction The American Beverage Association (ABA) welcomes the opportunity to submit comments on the final Report of the Dietary Guidelines Advisory Committee.
Comments Comments on the Final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans 2005 from The American Beverage Association Washington, D.C. September 24, 2004 Introduction The American Beverage Association (ABA) welcomes the opportunity to submit comments on the final Report of the Dietary Guidelines Advisory Committee. The ABA is the national trade organization representing the broad spectrum of companies that manufacture and distribute non-alcoholic beverages in the United States. The ABA changed its name from the National Soft Drink Association (NSDA) effective July 30, 2004. The new name reflects the great variety of non-alcoholic beverages produced and sold by members in today’s marketplace. These include bottled waters, teas, sports drinks, fruit juices, fruit drinks, milk based beverages, regular soft drinks, mid-calorie soft drinks, and diet drinks. It is on behalf of our members that we submit these comments. ABA (NSDA) submitted comments on March 19, 2004 and May 12, 2004 to the 2005 Dietary Guidelines Committee; we reaffirm those comments. We are submitting additional comments because we agree with the admonition from Secretaries Thompson and Veneman that the committee’s comments should be a scientific evidence-based review of diet and health. Our comments will focus on specific areas where we believe recent scientific articles should not change the evidence-based comments of the committee as well as specific areas we believe the scientific evidence is too conflicting or the evidence does not support the committee’s comments. ABA firmly believes that the scientific literature supports our general view that to have and maintain a healthy lifestyle it is important to consume a variety of foods and beverages in moderation and to get daily exercise for 30-60 minutes. Comments on Part D: Science Base-Section 1: Aiming to Meet Recommended Intakes of Nutrients ABA is cognizant of the fact that the committee is concerned about several nutrients for adults including, but not limited to, vitamin C, calcium and potassium and for children, calcium and potassium. It is worth noting that many of our members produce beverages that are calcium fortified including juices and juice beverages which also are a good source of vitamin C and potassium. A study published in 2004 in the Journal of the American College of Nutrition (1) on calcium intake and diet and beverage consumption made several important conclusions. This study examined the U.S. Department of Agriculture’s Continuing Survey of Food Intake by Individuals 1994-96, 98 (CSFII). The authors found that carbonated soft drink consumption, among adolescent girls was modest and did not appear to be linked to decreased calcium intake. The authors stated that making low-fat milk products, flavored milks, calcium fortified beverages and foods more attractive and available would encourage girls to consume more of this important nutrient. The authors also stated “when adequate calcium intake is not achieved through foods, health professionals should consider recommending calcium supplements.” (1). Comments on Part D: Science Base-Section 2: Energy The peer-reviewed science demonstrates that the causes of overweight and obesity are multifactorial involving genetics, too much energy intake and too little energy expenditure (2). No single food or beverage causes obesity. The total diet and physical activity must be considered. ABA agrees with the committee’s conclusion: Weight maintenance depends on a balance of energy intake and energy expenditure, regardless of the proportions of fat, carbohydrate, and protein in the diet. Weight loss occurs when energy intake is less than energy expenditure, also regardless of the proportions of fat, carbohydrate, and protein in the diet. For adults, well-planned weight loss diets that are consistent with the Accepted Macronutrient Distribution Ranges (IOM, 2002) for fat, carbohydrate, and protein can be safe and efficacious over the long term. The ABA also believes that the guidelines should include an increased emphasis on the importance of physical activity for children, adolescents and adults. Parents also need to be involved in encouraging physical activity in their children, as well as engaging in physical activity as role models. ABA agrees with the committee’s evaluation that “the evidence is conflicting that liquid and solid foods differ in their effects on calorie compensation.” Comments on Part D: Science Base-Section 5: Carbohydrates The ABA agrees, “there is no difference in the molecular structure of sugar molecules, whether they are naturally occurring in food or added to the food.” There also is no known difference in the way the body metabolizes naturally occurring sugar or sugars added to food or their effect on the body. Although any fermentable carbohydrate, including sugars, can contribute to dental caries, the ABA agrees with the Institute of Medicine (IOM) report that concludes, “because of the various factors that can contribute to dental caries it is not possible to determine an intake level of sugar at which increased risk of dental caries can occur.” (3). Furthermore, a recent study found that age and ethnicity are the strongest predictors of dental caries and that carbonated soft drinks were not associated with poor dental health (4). The authors also stated that “useful strategies to reduce dental caries involve good personal dental hygiene, regular use of fluoridated toothpastes and mouthwashes, and regular care by dental professional”(4). The ABA agrees with the committee’s statement that “current evidence suggests that there is no relationship between total carbohydrate intake (minus fiber) and the incidence of either type 1 or type 2 diabetes” and also that “there is no evidence that total sugar intake is associated with the development of type 2 diabetes.” The recent paper by Schulze et. al. (5) does not change this conclusion. Although the study reports an association between sweetened soft drinks and type 2 diabetes in adult women, the authors acknowledge the limitations of their data, stating that because of the observational nature of their work, the study cannot prove that increased soft drink consumption causes type 2 diabetes. The authors also acknowledge that their study is the first to report such an association. In addition, the reported data have several findings inconsistent with the paper’s conclusion. For example, the observed association was not seen in those women who consistently consumed more sweetened soft drinks but only in the smaller group of women whose consumption changed over the course of the study. Also, when the authors adjusted for body mass index, and total caloric intake, the association between soft drinks and type 2 diabetes decreased by over one-half. The small association that remained after the adjustment for body mass index and total caloric intake (R.R. 1.32, CI 1.01-1.73) was negligibly different than the adjusted relative risk estimate for high consumption of diet soft drinks (R.R. 1.21, CI 0.97-1.50). The authors indicate that the reported association could theoretically be the result of residual confounding and not the result of an association between sugar sweetened beverage consumption and type 2 diabetes. The ABA disagrees with the committee’s statement that “although more research is needed, available prospective studies suggest a positive association between the consumption of sugar-sweetened beverages and weight gain. A reduced intake of added sugars (especially sugar-sweetened beverages) may be helpful in achieving recommended intakes of nutrients and in weight control.” This statement and the summary in this section should be eliminated or modified because it is not supported by the admittedly inconsistent data reviewed by the committee and it is inconsistent with the committee’s conclusion in section 2 of the Guidelines. The committee reviewed three types of studies in this section, cross-sectional, prospective and intervention. Within each group, the committee noted conflicting results, in addition to noting that the overall evidence is “not large” and has “methodologic problems.” Thus, the committee’s review of the existing research does not support its statement regarding sugar-sweetened beverages. In addition, the committee’s focus on sugar-sweetened beverages, particularly in the face of conflicting evidence, is inconsistent with the committee’s conclusion in section 2 that “[w]eight maintenance depends on a balance of energy intake and energy expenditure, regardless of the proportions of fat, carbohydrate, and protein in the diet. Weight loss occurs when energy intake is less than energy expenditure, also regardless of the proportions of fat, carbohydrate, and protein in the diet.” Furthermore, the committee’s statement is not supported by the recent large longitudinal study on snack food intake in children and adolescents and weight gain (6) which also was published online on August 17, 2004. The study consisted of 8203 girls and 6774 boys of age 9-14 years in 1996 who completed at least two questionnaires on snack food intake between 1996 and 1999. This study found that snack foods were not an independent determinant of weight gain among the children and adolescents even when sugar-sweetened beverages were included as snack foods (6). The committee’s statement is also inconsistent with the IOM report (3) which reviewed 279 published studies and stated “published reports disagree about whether a direct link exists between the trend toward increased intakes of sugars and increased rates of obesity.” The IOM report further states, “there is no clear and consistent association between increased intake of added sugars and BMI. Therefore, the above data cannot be used to set a UL for either added or total sugars” (3). The committee should eliminate or modify its statement to better reflect the inconsistency of the existing research and to be consistent with the conclusion reached in section 2 that reducing any source of calories and increasing energy expenditure are the best means of weight control. For consumers who want to drink a sweetened beverage without calories a number of beverage options and sweeteners, approved by the FDA, are available. The sweeteners include aspartame, acesulfame K, neotame, saccharin and sucralose. The Dietary Guidelines should include information on these nonnutritive sweeteners. Comments on Part D: Science Base-Section 7: Fluid and Electrolytes As the Dietary Guidelines are encouraging Americans to increase their physical activity, Americans need to be reminded to ensure adequate hydration. Physical activity and environmental exposure increase the body’s need for fluid. Therefore, messages on fluid needs should be incorporated into the Dietary Guidelines since hydration is essential to health and wellness. The ABA is cognizant of the IOM report as referenced in this section (7). The intake of water is important for a number of vital body functions and this can be supplied by drinking water, various other beverages as well as water contained in food. In the U.S. about 20-25 percent of the water consumed is from food and 75-80 percent from beverages. There is evidence that both children and adults will consume more water if it is flavored versus unflavored during periods of exercise. Dehydration occurs when water or electrolyte intake does not equal output and it is important to determine the specific type of dehydration for the appropriate treatment. Sports drinks may be the appropriate beverage in some situations. All beverages, including caffeinated beverages, can contribute to hydration (7) and members of ABA produce a variety of beverages as enumerated in the introduction. Conclusion ABA recognizes and is concerned about the increase of overweight and obesity in the U.S. population. ABA supports educational efforts and comments from the 2005 Dietary Guidelines that encourage enjoyment and pleasure of moderate amounts of food and beverages daily as well as physical activity of 30-60 minutes. Respectfully submitted. Richard H. Adamson, Ph.D. Vice President Scientific and Technical Affairs American Beverage Association References 1. Storey, M.L., Forshee, R.A., and Anderson, P.A.: Associations of adequate intake of calcium with diet, beverage consumption, and demographic characteristics among children and adolescents. J. American College of Nutrition, 23: 18-33, 2004. 2. Hill, J.O, and Peters, J.C.: Environmental contributions to the obesity epidemic. Science, 280: 1371-1374, 1998. 3. Institute of Medicine (IOM). Dietary carbohydrates: sugars and starches. Dietary Reference Intakes for Energy, Carbohydrates, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino acids. Washington, D.C.: National Academies Press, 2002. 4. Forshee, R.A., and Storey, M.L.: Evaluation of the association of demographics and beverage consumption with dental caries. Food Chemical Toxicology, 42: 1805-1816, 2004. 5. Schulze, M.B., Manson, J.E., and Ludwig, D.S., Colditz, G.A., Stampfer, M.J., Willett, W.C., and Hu, F.B. Sugar-sweetened beverages, weight gain, and incidence of type 2 diabetes in young and middle-age women. JAMA: 292: 927-934, 2004. 6. Field, A.E., Austin, S.B., Gillman, M.W., Rosner, B., Rockett, H.R., and Colditz, G.A.: Snack food intake does not predict weight gain among children and adolescents. Int. J. of Obesity, 28: 1210-1216, 2004. 7. IOM. Dietary Reference Intakes: Water, Potassium, Sodium, Chloride and Sulfate. Washington, D.C.: National Academies Press, 2004.
Submission Date 10/1/2004 12:40:00 PM
Author American Beverage Association

   Macronutrient ratios
Summary We concur with the committee's statement that “Weight maintenance depends on a balance of energy intake and energy expenditure, regardless of the proportions of carbohydrate, fat and protein in the diet. Popular weight-loss diets encompassing a very wide range of carbohydrate/fat ratios have not bee
Comments We concur with the committee's statement that “Weight maintenance depends on a balance of energy intake and energy expenditure, regardless of the proportions of carbohydrate, fat and protein in the diet. Popular weight-loss diets encompassing a very wide range of carbohydrate/fat ratios have not been tested adequately over the long term and are best followed only for short periods of time
Submission Date 9/21/2004
Author North American Miller's Association

   Weight maintenance
Summary We urge the Committee to be explicit in its recommendations regarding food choices and dietary patterns that help support weight management and that focus on choosing nutrient-dense foods. The simple, over-riding message, and one understandable to the public, would be to choose foods of high nutri
Comments To help reduce consumer confusion and frustration regarding food choices - especially in light of the latest diet trends - we urge the Committee to be explicit in its recommendations regarding food choices and dietary patterns that help support weight management and that focus on choosing nutrient-dense foods. This will offer the public a much more coherent and practical means by which to achieve a healthy diet and to maintain a healthy weight. We suggest that each message that addresses intake of calories, carbohydrates, fats, and choice of foods be presented first in the context of controlling weight – specifically, that these main messages each include parallel language that states “to help manage body weight”. For each of these messages, details should then be provided regarding specific practical recommendations to choose appropriate amounts of nutrient dense, lower calorie choices, rather than choosing less healthy, more calorically-dense foods within each food group.
Submission Date 9/21/2004
Author American Diabetes Association

   Macronutrient ratios
Summary There is no conclusive evidence from epidemiologic studies that dietary fat intake promotes the development of obesity independently of total energy intake.
Comments There is no conclusive evidence from epidemiologic studies that dietary fat intake promotes the development of obesity independently of total energy intake. Many researchers now recognize that one of the most important factors in preventing weight gain involves the total amount of calories consumed; when a significant portion of these calories come from healthy fats, the body experiences satiety and overall caloric intake is reduced.
Submission Date 9/21/2004
Author Weston A Price Foundation

   Weight maintenance
Summary We suggest that the main message regarding calories reflect the fact that most Americans are overweight and over consuming calories relative to their physical activity levels. The message about calorie intake could be edited to something like, limit calorie intake to manage body weight.
Comments We suggest that the main message regarding calories reflect the fact that most Americans are overweight and over consuming calories relative to their physical activity levels. The message about calorie intake could be edited to something like, limit calorie intake to manage body weight.
Submission Date 9/21/2004
Author Center for Science in the Public Interest

Summary We agree with the committee’s conclusion that “When it comes to weight control, calories do count – not the proportion of carbohydrate, fat and protein in the diet. The healthiest way to reduce calorie intake is to reduce one’s intake of saturated fat, added sugars, and alcohol…” This should be th
Comments We agree with the committee’s conclusion that “When it comes to weight control, calories do count – not the proportion of carbohydrate, fat and protein in the diet. The healthiest way to reduce calorie intake is to reduce one’s intake of saturated fat, added sugars, and alcohol…” This should be the overarching message regarding weight management.
Submission Date 9/27/2004
Author U.S. Rice Federal

Summary Control caloric intake to manage body weight. • Supporting text should emphasize striving to achieve and maintain a BMI of = 25. • Recommendations to decrease caloric intake should be explicit with regards to foods high in added sugar, fat (as opposed to solid fats, which is currently stated) and a
Comments Control caloric intake to manage body weight. • Supporting text should emphasize striving to achieve and maintain a BMI of = 25. • Recommendations to decrease caloric intake should be explicit with regards to foods high in added sugar, fat (as opposed to solid fats, which is currently stated) and alcohol. • Given the increase in portion sizes, especially while eating out, emphasize should be placed on portion control.
Submission Date
Author American Cancer Society, American Diabetes Association, American Heart Association

Summary Control calorie intake to manage body fat
Comments Heading: “Control Calorie Intake to Manage Body Fat.” Please don’t say “weight.” The overemphasis on weight has led to umpteen problems from fad diet ripoffs to anorexia nervosa, and discourages physical strength building. Text, 2nd paragraph: “To stem the obesity epidemic, most Americans need to consume fewer calories. Energy expended must equal energy consumed to maintain body shape. Reducing body fat could be achieved by eating less, being more active physically or combining the two. Since many gain fat slowly over time, even a small calorie deficit can correct the problem. A calorie deficit of 50 to 100 calories per day would enable many adults to maintain a good shape rather than continuing to put on fat each year. For children who are gaining excess fat, a similar small decrease in energy intake can reduce the rate at which they put on fat so as they age they will grow into a healthy physique. Small changes maintained over time can make a big difference.” Text, 3rd paragraph: “Measuring their waist or checking how their clothes fit helps people to know if they need …” Please avoid any allusion to scales or weight.
Submission Date 10/7/2004 4:08:00 PM
Author from Hartford, CT

Fats
   Alpha-Linolenic Acid
Summary The evidence for CHD benefit for ALA is weak, and that for increased prostate cancer risk is growing and cannot be ignored. Further research is needed. A UL for ALA at current intakes should be considered. ALA should not be conflated with EPA+DHA. Recommending two oily fishmeals a week is applauded.
Comments Comments on n-3 fatty acids section of the Draft Dietary Guidelines Question 6 (p. 22) Three papers are quoted supporting a beneficial CHD effect of ALA – Djousse1, Hu2, and Dolecek3. Other supportive studies by Pietinen4 and Ascherio5 are not mentioned. These were all epidemiological studies in which ALA intakes were estimated from diet surveys. Oomen et al.6 did essentially the same in the Netherlands and found no effect of ALA intake on 10-year CHD risk. This study is not mentioned. In the latter, there may have been some confounding by trans FA intakes, but there was still no association with reduced risk for CHD for foods containing ALA but no trans FA. An objective review cannot ignore negative studies and embrace only the positive ones. Two secondary prevention RCTs are mentioned: Singh7 and de Lorgeril8. They both are problematic. The former is a highly questionable study and uninterpretable for several reasons: 1. Based on the reported relative risk reductions given in Table 3, the ONLY significant effect was observed for fish oil and total cardiac events. There was no significant effect of the ALA rich oil on any endpoint. Unfortunately, also in Table 3, there are p-values associated with each intervention for each cardiac endpoint (sudden cardiac death, total cardiac deaths, non-fatal MI, and total cardiac events). In contradiction to the above, for all but the first endpoint, the authors indicate that both fish oil and ALA had statistically significant effects relative to placebo! Yet in the next columns in the same table, they report no significant effect. So it is unclear whether either fish oil or ALA had any statistically significant impact on cardiac events in this study. 2. The 1-year total cardiac event rates in the fish oil and mustardseed oil groups were given as the sum of the total cardiac deaths and non-fatal reinfarctions. For the placebo group, there were 26 cardiac deaths (22% of the group) and 30 non-fatal reinfarctions (25%) for a total of 56 events (47% of the group). But Table 3 lists 41 total cardiac events (37%). Something is wrong, not only with the math but also with the death rates. 3. The authors report phenomenal event rates in this study, especially considering that these patients were only ‘suspected’ of having had a heart attack at admission. In the GISSI Prevenzione study, total cardiac event rates were 1.4% per year and all patients in that study had documented MI’s. In the Lyon Heart Study (below), the rate was 4%. Here the total cardiac event rates were 25% and 47%. There is either something incredibly toxic about either living (or being admitted to the hospital) in Moradabad, or the data are suspect. In any event, this study cannot be used to support the claim that ALA (or fish oil) is cardioprotective. It should have no place in this document. Although a much better study, the Mediterranean diet heart (Lyon) study8 can likewise not be used to conclude that ALA is cardioprotective. There are multiple dietary alterations in the intervention group, and to attribute the benefits to ALA is wishful thinking, not objective science. It is interesting to contrast how the writers dealt with the the Natvig study9 and the Lyon study. The former did not find a beneficial effect of 5 g of ALA per day in a very large (13,578, 50-59 year old men were randomized) but short (1-year) primary prevention study. The writers state on p. 23, “Notably, the two diets [in Natvig] differed in other ways related to [than?] the unique fatty acid profiles of linseed oil and sunflower oil.” First, there is no evidence in the Natvig paper that the diets were different in “other ways.” The subjects were simply randomized to sunflower seed oil or linseed oil and no recommendation for any other dietary change was made. Secondly, why is this (unfounded) criticism considered a weakness of the Natvig study, but in the Lyon study, where diets were very different by protocol, it is not criticized? In Lyon, at least 8 types of foods (breads, fruits, vegetables, legumes, deli and regular meats, butter, cream and margarine) were intentionally altered so as to reduce risk in the intervention group. Yet this is not considered a weakness? The bias toward favorable studies is rather blatant here. Similarly, significant ink is expended by the DGAC authors to explain why the well-controlled, 2-yr, RCT by Bemelmans et al.10 did not show a reduction in CHD risk factors. Maybe no effect was found because no effect was elicited by the intervention. Why was such a critical eye cast upon the studies that failed to show a protective effect of ALA and flawed but favorable studies receive a blind eye? Significantly, the DGAC authors failed to include several case-control studies that reported the relationship between tissue or plasma ALA content and risk for a variety of CHD outcomes. In 10 studies11-21 no association was found, whereas in one22, serum ALA levels were lower in cases than controls. Why were these studies not included? The same trend continues with the potential association between ALA and prostate cancer risk, only here the tendancy to dismiss, not neutral trials, but those suggesting increased cancer risk. This is especially disconcerting. In the meta-analysis of both CHD and prostate cancer with ALA by Brouwer et al.23, the combined relative risk was not significantly different from 1 for CHD but it was significantly increased in for prostate cancer. There were 5 CHD studies included and 9 cancer studies. The unbiased conclusion would be that ALA has no effect on CHD risk but may increase risk for prostate cancer. But the DGAC committee reversed it. They concluded that ALA is cardioprotective, and that the cancer connection “requires further research.” It’s one thing to mistakenly (implicitly) recommend higher intakes of a nutrient in the hopes that CHD risk will be reduced when there is little risk associated with this recommendation. It is quite another to dismiss a larger body of evidence of increased risk for cancer with increased ALA intakes and still paint ALA with a golden glow. The Dietary Guidelines committee have a grave obligation to “first do no harm”, that is, to be especially conservative when recommending increased intakes of a nutrient (or at least painting the nutrient as being “healthy” which will certainly encourage increased intake) for which there is suggestive evidence of harm. The situation with ALA, CHD and prostate cancer may be summarized as follows: Evidence for Reduced Risk for CAD: Cohort/Case-Control Studies (diet record based studies, 5 positive and 1 negative; biomarker based studies, 1 positive and 10 negative). RCT primary prevention trials, 2 negative; RCT secondary prevention trials, 2 inconclusive. DGAC Conclusions: “ALA is cardioprotective”. Evidence for Increased Risk for Prostate cancer: Cohort/Case-Control Studies (diet record based studies, 4 positive and 2 negative; biomarker based studies, 3 positive and 2 negative). RCT primary or secondary prevention trials, none reported. DGAC Conclusions: “More research is needed.” Harris recommended language: ALA may have cardioprotective properties but further research is needed. Higher ALA intakes may be associated with increased risk for prostate cancer, but further research is needed. At present there is no basis for recommending any change in the current ALA intake, and an UL set at current intake levels should be considered. There appears to be a strong bias favoring ALA in these Guidelines. The supporting evidence is accepted uncritically while the non-supportive studies are picked apart and dismissed. In some cases, negative studies are criticized for design elements that are more greviously found in the supportive studies (Natvig vs. de Lorgeril). The epidemiological studies which suggested an increase in cancer risk were just a rigorously conducted, and in one case used essentially the same diet questionnaire (Hu for CHD and Giovannucci24 for cancer) as the studies reporting CHD benefit. Prudence would demand that increased consumption of ALA not be promoted in any way until the cancer question is settled. There is, in fact, reason to consider capping ALA intake at current levels (see UL discussion below). ALA=EPA+DHA? The evidence for ALA and CHD risk reduction is at best suggestive but far less compelling than that for the longer chain n-3 FA. There is no justification for conflating these two types of n-3 FA or implying anywhere in the document that they have equivalent effects. (see P22 para 5; P24, para 3; P25 para 2; P28 para 7). P24 EPA, DHA and Fish Overview The final sentence should be scratched. Next para, line 2: scratch “to” No UL for ALA. There is no mention here of the potential cancer risk. A conservative approach would be to suggest a tentative UL at what is the current upper level of typical American intakes. There is certainly no basis for recommending increased intakes since the CHD data is incomplete, and there is a definite concern about higher intakes potentially being linked to prostate cancer. Until we know more about the latter, a UL could reasonably be set for ALA. P25 Review of the Evidence Near the end, ALA is again interjected in company with n-3 HUFA. Scratch Para 3: line 1: “two servings of high n-3 fish per week” Line 3: “two servings of tuna/other non-fried fish per week…” P26 Line 2. … the relative risks for total stroke were very slightly higher than those for CHD mortality at each level of fish intake.” This is confusing. Simply say, “…the relative risks for total stroke were reduced at each level of fish intake.” Para 2: Under discussion of Singh, the weaknesses of the study should be included (or referred to from the ALA section), and the implication that mustard oil reduced cardiac events etc needs to be removed Para 3: only two nonconforming studies?? There are several others including Pietinen4, Morris25, Osler26, Ascherio27, and Salonen28. The latter showed that one of the confounders, besides those listed here, is mercury. P27 Para3: 500 mg is a 2-fold increase?? On p 28, mean intakes are about 110 mg/d. Adverse effects are not routinely seen at 3 g as implied here. Better to say, “According to the FDA, an intake of up to 3 g of EPA+DHA per day is considered safe for all adults.” P 28 Summary. Line 4. Better to simply say, “Fish is recommended because it is a good source of n-3 fatty acids and other nutients.” There is no reason to mention supplements here, or to imply that supplements have not been shown to reduce risk for CHD events - supplements were used in the GISSI study and shown to be effective. If the DGAC authors want to continue to include the 1997 Singh study as well, then supplements were also reported to be effective there. n-3 FA intake Para 3. Median intakes of EPA are 4-7 mg/d and of DHA, 52-93 mg/d. In Para 4, mean intakes are 40 and 70 mg/d, respectively. If these numbers are true, then the statement on p. 27 para 3, that 500 mg of EPA+DHA/d would be a two-fold increase over current intake would be false; it would be about a 5x increase over current intake. Para 5. In the 2nd to last line, n-fatty acids needs a “3”. Para 6. Line 1. Presumably the authors meant to say “Some foods are fortified…” Also, in line 2, it is not true that foods are fortified with algae, but with DHA (not EPA) purified from algal sources. In addition, what does “EPA+DHA supplements may provide variable amounts of these FA” mean? True, some capsules contain 300 mg and some 600 mg (by intent and as described on the label) but the Consumer’s Report article concluded that label claims were generally correct. Better to simply say, “EPA+DHA are available in supplements in various concentrations and in variable EPA:DHA ratios.” Again, the evidence for ALA is not objectively presented. The authors have ignored the work of Pawlosky et al.29,30 from the NIH who have performed the most sophisticated analysis of ALA conversion to EPA and DHA. They (alone) have used multicompartmental modeling (instead of area under the curve analysis for the accumulation of n-3 FA metabolites in plasma) to determine the rates of conversion of ALA to the long-chain n-3 FA. They reported conversion rates to EPA of 0.2% and to DHA of 0.047%. The Report says “approximately 10%.” Summary ALA should not be endorsed as CHD protective given the thin evidence for benefit and the growing concerns with prostate cancer. Further research is needed, not glowing recommendations. An upper limit of ALA at current intakes should be considered. ALA should never be conflated with EPA+DHA. The recommendation for two oily fish meals a week is applauded. Reference List (1) Djousse L, Pankow JS, Eckfeldt JH, Folsom AR, Hopkins PN, Province MA et al. Relation between dietary linolenic acid and coronary artery disease in the National Heart, Lung, and Blood Institute Family Heart Study. Am J Clin Nutr 2001; 74:612-619. (2) Hu FB, Stampfer MJ, Manson JE, Rimm EB, Wolk A, Colditz GA et al. Dietary intake of a-linolenic acid and risk of fatal ischemic heart disease among women. Am J Clin Nutr 1999; 69:890-897. (3) Dolecek TA. Epidemiological Evidence of Relationships between Dietary Polyunsaturated Fatty Acids and Mortality in the Multiple Risk Factor Intervention Trial. Proc Soc Exper Bio Med 1992; 200:177-182. (4) Pietinen P, Ascherio A, Korhonen P, Hartman AM, Willett WC, Albanes D et al. Intake of Fatty Acids and Risk of Coronary Heart Disease in a Cohort of Finnish Men. The Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Epidemiol 1997; 145:876-887. (5) Ascherio A, Rimm EB, Giovannucci EL, Spiegelman D, Stampfer MWWC. Dietary fat and risk of coronary heart disease in men: cohort follow up study in the United States. BMJ 1996; 313:84-90. (6) Oomen CM, Ocke MC, Feskens EJ, Kok FJ, Kromhout D. alpha-Linolenic acid intake is not beneficially associated with 10-y risk of coronary artery disease incidence: the Zutphen Elderly Study. Am J Clin Nutr 2001; 74:457-463. (7) Singh RB, Niaz MA, Sharma JP, Kumar R, Rastogi V, Moshiri M. Randomized, Double-Blind, Placebo-Controlled Trial of Fish Oil and Mustard Oil in Patients with Suspected Acute Myocardial Infarction: The Indian Experiment of Infarct Survival--4. Cardiovasc Drugs Ther 1997; 11:485-491. (8) de Lorgeril M, Salen P, Martin JL, Renaud S, Monjaud I, Mamelle N et al. Mediterranean diet, traditional risk factors, and the rate of cardiovascular complications after myocardial infarction: Final report of the Lyon Diet Heart Study. Circulation 1999; 99:779-785. (9) Natvig H, Borchgrevink CF, Dedichen J, Owren PA, Schiotz EH, Westlund K. A controlled trial of the effect of linolenic acid on incidence of coronary heart disease. The Norwegian vegetable oil experiment of 1965-66. Scand J Clin Lab Invest 1968; 105 (Suppl):1-20. (10) Bemelmans WJ, Broer J, Feskens EJ, Smit AJ, Muskiet FA, Lefrandt JD et al. Effect of an increased intake of alpha-linolenic acid and group nutritional education on cardiovascular risk factors: the Mediterranean Alpha-linolenic Enriched Groningen Dietary Intervention (MARGARIN) study. Am J Clin Nutr 2002; 75:221-227. (11) Albert CM, Campos H, Stampfer MJ, Ridker PM, Manson JE, Willett WC et al. Blood levels of long-chain n-3 fatty acids and the risk of sudden death. N Engl J Med 2002; 346:1113-1118. (12) Lemaitre RN, King IB, Mozaffarian D, Kuller LH, Tracy RP, Siscovick DS. N-3 polyunsaturated fatty acids, fatal ischemic heart disease and non-fatal myocardial infarction in older adults. The Cardiovascular Health Study. Am J Clin Nutr 2002; 76:319-325. (13) Lea EJ, Jones SP, Hamilton DV. The fatty acids of erythrocytes of myocardial infarction patients. Atherosclerosis 1982; 41:363-369. (14) Lemaitre RN, King IB, Raghunathan TE, Pearce RM, Weinmann S, Knopp RH et al. Cell membrane trans-fatty acids and the risk of primary cardiac arrest. Circulation 2002; 105:697-701. (15) Yli-Jama P, Meyer HE, Ringstad J, Pedersen JI. Serum free fatty acid pattern and risk of myocardial infarction: a case-control study. J Intern Med 2002; 251:19-28. (16) Leng GC, Horrobin DF, Fowkes FG, Smith FB, Lowe GD, Donnan PT et al. Plasma essential fatty acids, cigarette smoking, and dietary antioxidants in peripheral arterial disease. A population-based case-control study. Arterioscler Thromb 1994; 14:471-478. (17) Reavis SC, Chetty N. The fatty acids of platelets and red blood cells in urban black South Africans with myocardial infarction. Artery 1990; 17:325-343. (18) Paganelli F, Maixent JM, Duran MJ, Parhizgar R, Pieroni G, Sennoune S. Altered erythrocyte n-3 fatty acids in Mediterranean patients with coronary artery disease. Int J Cardiol 2001; 78:27-32. (19) Siguel EN, Lerman RH. Altered fatty acid metabolism in patients with angiographically documented coronary artery disease. Metabolism 1994; 43:982-993. (20) Leng GC, Taylor GS, Lee AJ, Fowkes FG, Horrobin D. Essential fatty acids and cardiovascular disease: the Edinburgh Artery Study. Vasc Med 1999; 4:219-226. (21) Simon JA, Hodgkins ML, Browner WS, Neuhaus JM, Bernert JT, Jr., Hulley SB. Serum fatty acids and the risk of coronary heart disease. Am J Epidemiol 1995; 142:469-476. (22) Miettinen TA, Naukkarinen V, Huttunen JK, Mattila S, Kumlin T. Fatty-acid composition of serum lipids predicts myocardial infarction. Br Med J 1982; 285:993-996. (23) Brouwer IA, Katan MB, Zock PL. Dietary alpha-linolenic acid is associated with reduced risk of fatal coronary heart disease, but increased prostate cancer risk: a meta-analysis. J Nutr 2004; 134:919-922. (24) Giovannucci E, Rimm EB, Colditz GA, Stampfer MJ, Ascherio A, ChuteCC et al. A prospective study of dietary fat and risk of prostate cancer [see comments]. Journal of the National Cancer Institute 1993; 85:1571-1579. (25) Morris MC, Manson JE, Rosner B, Buring JE, Willett WC, Hennekens CH. Fish consumption and cardiovascular disease in the Physicians' Health Study: A prospective study. Am J Epidemiol 1995; 142:166-175. (26) Osler M, Andreasen AH, Hoidrup S. No inverse association between fish consumption and risk of death from all-causes, and incidence of coronary heart disease in middle-aged, Danish adults. J Clin Epidemiol 2003; 56:274-279. (27) Ascherio A, Rimm EB, Stampfer MJ, Giovannucci EL, Willett WC. Dietary intake of marine n-3 fatty acids, fish intake, and the risk of coronary disease among men. N Engl J Med 1995; 332:977-982. (28) Salonen JT, Seppanen K, Nyyssonen K, Korpela H, Kauhanen J, Kantola M et al. Intake of mercury from fish, lipid peroxidation, and the risk of myocardial infarction and coronary, cardiovascular, and any death in eastern Finnish men. Circulation 1995; 91:645-655. (29) Pawlosky RJ, Hibbeln JR, Novotny JA, Salem NJ. Physiological compartmental analysis of alpha-linolenic acid metabolism in adult humans. J Lipid Res 2001; 42:1257-1265. (30) Pawlosky RJ, Hibbeln JR, Lin Y, Goodson S, Riggs P, Sebring N et al. Effects of beef- and fish-based diets on the kinetics of n-3 fatty acid metabolism in human subjects. Am J Clin Nutr 2003; 77:565-572.
Submission Date 9/17/2004 2:26:00 PM
Author from Kansas City, MO

   Monounsaturated Fat
Summary Avocados are a natural source of eight vitamins, two minerals and at least three phytochemicals. Avocados are included in dietary programs from many of the world’s leading nutrition organizations and can make a significant contribution to the health of Americans.
Comments One of the 9 key messages is: Choose fats wisely for good health. Avocados are one of the few fruits that provide “good” fats. Unsaturated fat like monounsaturated fat (MUFA) found in avocados has been linked to a reduced risk of heart disease, cancer and diabetes. If equal amounts of MUFAs are substituted for saturated fatty acids, low-density lipoprotein (LDL) or “bad” cholesterol decreases.
Submission Date 9/17/2004 5:45:00 PM
Author California Avocado Commission

Summary Avocados are a natural source of eight vitamins, two minerals and at least three phytochemicals. Avocados are included in dietary programs from many of the world’s leading nutrition organizations and can make a significant contribution to the health of Americans.
Comments One of the 9 key messages is: Choose fats wisely for good health. Avocados are one of the few fruits that provide “good” fats. Unsaturated fat like monounsaturated fat (MUFA) found in avocados has been linked to a reduced risk of heart disease, cancer and diabetes. If equal amounts of MUFAs are substituted for saturated fatty acids, low-density lipoprotein (LDL) or “bad” cholesterol decreases.
Submission Date 9/17/2004 6:07:00 PM
Author California Avocado Commission

   Trans Fat
Summary Now that companies have included trans fat in their nutrition labels, I feel that it is important that the general public is informed on what ingredients are responsible for its presence in food and have a brief scientific background of understanding on the formation of trans fat.
Comments Upon reviewing the dietary guidelines I was pleased to see that trans fatty acids were mentioned. However, I feel that there should be a more detailed section describing trans fat. Now that companies are including trans fat on their nutrition labels, the general public may be curious about it. It would be helpful to have a section explaining what trans fat is and how its configuration is obtained. Informing consumers that trans fat comes from partially hydrogenated oils can help them make better food choices by looking for this ingredient in the ingredients list of products who have not yet provided the total trans fat in the nutrition label.
Submission Date 9/21/2004 1:53:00 PM
Author from , Pennsylvania

   Saturated Fat
Summary The guideline should be modified to increase specificity. Suggested guideline; Choose lean meat, low- and nonfat dairy products and eat fish regularly.
Comments If the intent is to advocate restrictions in saturated and to include fish in the diet on a regular basis it would be appropriate to translate these messages into wording of the guideline itself. Because the majority of fat in the American diet does not come from added fat but from foods containing fat the message should be in terms of food, not fatty acids. A potential guideline would read, “Choose lean meat, low- and nonfat dairy products and eat fish regularly”. Additionally, such a guideline would allow for a more focused message in the guideline that currently reads “Increase daily intake of fruits and vegetables, whole grains, and nonfat or low-fat milk and milk products”. The concept of limiting intake of hydrogenated fat is a little more difficult to include in the guideline, however, the phrase "foods made with oils” could be added.
Submission Date 9/22/2004 2:26:00 PM
Author from Boston, MA

   Total Fat
Summary The distinction between raw and cooked foods must be included to make the nutrition guidelines meaningful.
Comments Until the concept of cooked versus raw foods is included in the study, the public cannot utilize the food recommendations adequately because the body processes cooked food differently than raw food. Cooked (and to some extent processed foods) food is absorbed into our systems much faster than raw foods and turns to sugar which is stored as fat in our bodies. Raw food passes through our bodies and acts as roughage and does not turn to fat. The major negative of cooked food is when it is NOT burned off by exercise it goes right into our storage of body fat and leads to diabetes and arthritis.
Submission Date 9/22/2004 5:48:00 PM
Author

   EPA/DHA (Fish)
Summary Alternatives need to be offered to obtain essential fatty acids and other nutritional needs besides animal products for those who choose or can't consume them.
Comments I want to compliment your committee on the new guidelines which I think have promise toward guiding people toward healthier eating. I particularly liked the encouragement of conscious calorie consumption and exercise. As a vegan, I would encourage you to offer people alternatives to dairy which can give them more accessible calcium, such as soy, rice, almond, hazelnut, oat, or multi-grain beverages. Many people are lacto-intolerant and need to find alternative sources. Your guidelines recommend eating fish twice a week, yet most fish are contaminated with chemicals and are filled with saturated fat. Again, there are alternatives to getting your essential fatty acids, particularly Omega 3, through plant-based sources, such as ground flax seeds and sea vegetables (Wakame). I would hope the committee would put the healthy of the citizens of the United States above pressure and interests of food producers. Thank you for your attention and hard work. Carol Merrick Secretary, Northwest VEG Tigard, OR 97223
Submission Date 9/23/2004 10:33:00 AM
Author Northwest VEG

   Total Fat
Summary
Comments testing
Submission Date 9/23/2004 11:54:00 AM
Author

Summary Benefits include improvement and elimination of skin problems, lowered cholesterol, weight loss, and overall well-being.
Comments Advocate of grassfed animal protein for 12 years
Submission Date 9/23/2004 12:54:00 PM
Author from salisbury, nc

   Saturated Fat
Summary The data do not support a positive correlation between cardiac disease and saturated fat consumption. My health history is a case in point, as I was raised eating very few sweets, but much milk, cream and butter, and my arteries are free of plaque, in spite of a "high" cholesterol count.
Comments To the Dietary Guidelines Advisory Committee ~ I hope you will take a moment to read through my comments. I was born on a farm, married a farmer, drank whole milk (unpasteurized), butter and ate a lot of meat. My cholesterol has always been around 225, give or take 10 points. In today's world, that is considered high and my last three doctors have all tried to get me to take statins. My triglycerides are very low (below 75). Well, I am lucky (or unlucky, depending on how you look at it), in that I have a genetic disease, fibromuscular dysplasia. The muscles in the wall of the artery wrap around the artery like a rubber band, causing a stenosis. In my case, I have three stenoses, with small aneurysms behind them. It is in my right renal artery, and it was discovered several months after my normally low (100/60) blood pressure jumped to 230/130 in a one week period and resisted all treatment with hypertension medication. Angioplasty seems to have taken care of it. Here is why I am lucky. During the second angioplasty (they cautiously did one stenosis at a time in 1988), the doctor who was performing the angioplasty took a look at my arteries all the way to my heart. He was amazed at them, saying they were totally free of plaque. So my high fat diet - AND a cholesterol reading that is considered too high - has caused absolutely no injuries to my arteries. The reason I say I am lucky is that I have an iron-clad argument about why I should not be on statins. (By the way, 50% of people who have heart attacks have normal cholesterol levels. That does not mean we need to lower cholesterol even further - what it may indicate is that cholesterol level is a poor indicator of heart health.) Having this disease has caused me to do a great deal of research. I am amazed at how we have latched on to a low fat diet when all the data say that we need to limit sugar and simple carbohydrates, not fat. Granted, we must be fussy about our fats, but the very fats I was loading up on as a child were the right ones. What happened? Why were they denigrated? I am totally NOT convinced by any recent trials that are conducted and paid for by the very pharmaceutical companies that will benefit from the sale of statin drugs. If we look at the "old" data, they just simply do not support a low fat diet. In fact, to the contrary, they indicate a high fat diet is better for us. I was a vegetarian for 15 years. On average, I probably ate about 700 g of carbohydrates a day, and did try to watch my fats. During that time, my teeth fell apart (two bridges, lots of crowns, root canals), I developed hypoglycemia and diverticulosis, and I begin struggling with my weight. I also developed some pretty nasty mood swings. Then I read a book, Life Without Bread and decided to go back to eating meat and fat. Since giving up my vegetarian ways in late 2000, my hypoglycemia is virtually symptomless, my bowels are working right again and I have had no additional problems with my teeth. My weight has stabilized. My mood swings are still with me, but I guess four out of five ain't bad! Please go back to the data provided in the 1950 Seven Country Study. Nothing in that study supported a low fat diet. There was no correlation strong enough between fat consumption and heart health to raise a concern. What SHOULD have raised concern was the fact that in some of the countries, increased fat intake actually LOWERED the incidence of death rates due to heart disease. That should have spurred the researchers to find out why it varied so greatly from country to country. The clue is in one paragraph in the middle of this 200-page report. It states that sugar intake is correlated with heart disease. No difference country to country, over all this correlation held true. So why didn't the researches look at those countries with high fat intake AND high incidence of heart disease and look at their sugar consumption? I don't know. I am hoping that your committee will take a look at this now. Certainly the proof is in the pudding. Since 1950, when we were told fats were bad and margarine was good, since we began replacing the good-tasting fat in food with sugar to mask its bland taste, diabetes has risen to epidemic proportions, as has obesity. The answer is not to do what we have been doing since 1950 only more so (even less fat), but to look back at how we were eating prior to 1950. I implore you to examine historical data regarding the correlation between overall health and fat consumption, and to look with great suspicion at recent data compiled by drug companies that have a vested interest in the outcome of these studies. The health of our nation is at stake, and it should be examined without the taint of politics and corporate interests. Respectfully, Susan Siemers Walkerton, IN 46574
Submission Date 9/23/2004 10:37:00 PM
Author Anonymous

   Trans Fat
Summary Omega 3 fatty acids from grass-fed livestock and poultry need to replace trans fat. Grow cotton and peanuts organically because chemicals applied to cotton pollute milk and too many children are allergic to peanuts.
Comments Trans fat needs to be replaced by fat from grass-fed livestock and poultry because fish are affected by mercury pollution. Grass-fed livestock are reportedly high in omega 3 fatty acids that supposedly prevent cancer and heart disease. Zero tolerance of trans fat is recommended because you can never eat just one! Due to many children being allergic to peanuts, the recommendations should require that peanuts be grown organically. It could be encouraged that cotton be grown organically by 2009 so that non-organic milk would not be polluted by chemically grown cottonseed meal. Organic cotton is being produced in New Mexico.
Submission Date 9/23/2004 10:50:00 PM
Author from Jarrettsville, MD

   EPA/DHA (Fish)
Summary If you check, I believe you will find that tuna is **not** a 'high fat fish'.
Comments If you check, I believe you will find that tuna is **not** a 'high fat fish', contrary to what you state. Please correct me if you find some species of tuna that you do consider to have a high fat content.
Submission Date 9/24/2004 12:12:00 PM
Author from Richmond Hill, ON

Summary Source: USDA Handbook No. 8 ...............
Comments To add to my comment on tuna about ten minutes ago. My data suggest the percentage of calories from fat in tuna are between 20% and 26%, compared with 50% to 65% for fish like mackerel, salmon and some species of trout. My source attributes this data to "USDA Handbook No. 8 Composiion of Foods, Table 1, "Composition of foods, 100 grams, edible portion" "
Submission Date 9/24/2004 12:26:00 PM
Author from Richmond Hill, ON

   Total Fat
Summary No limits on saturated fats and cholesterol, a low fat diet has been crammed down peoples throats for years, yet heart disease is on the rise. Fat is NOT the problem. Refined grains and added sugar are the culprits.
Comments
Submission Date 9/24/2004 2:17:00 PM
Author from Holland, MI

   Saturated Fat
Summary Please stop villifying natural saturated fats and instead urge US to eliminate trans fats. Check the science!
Comments Please review the actual scientific evidence against naturally occuring saturated fats. They are actually a good form of nutrient dense calories and kept humans healthy for millenia. Transfats are the bad guys, not saturated fat. Check the science!
Submission Date 9/24/2004 4:39:00 PM
Author from Beaverton, OR

Summary USDA should address fast food.
Comments This is the first time I have ever looked at the dietary giudlines and I can see why so many Americans do not bother with them. The informtion is good but it is alot of information. Even with being interested in health and fitness I struggled through the whole thing; imgaine how the everyday person may feel just glancing at the document. We live in a sound bite society. All the specific information is essential but the information needs to be presented in an alternate way- quick, newsflash style like on Entertainement Tonight, jumping from one riveting fact to another. Example: The USDA has discovered 3 ways to get energy up and weight down! 1. Skip McDonalds 2. Walk up stairs 3. Eat a fruit Getting to the FAT. Another component I would add to the fat section is FAST FOOD. We live in a fast food society and i think that topic needs to be addresed. How to Choose Sensibly at McDonalds would be relevent and more specific to the lives of American people. Granted, it is important to know what saturated fat is but alot of people just want the QUICK FIX, so give it to them. Fast Food restaraunts offer very fattening choices; many of which are the most appealing and the ones many Americans go with. The present guidlines does not mention fast food or how it should be eaten in moderation along with cookies, cakes and other refined foods. In the end it comes down to the consumer and if a person really wants that double quater pounder with cheese super sized with fries and a Coke, then they are going to have it. But maybe If people knew that the government is acknowledging that one of the contributing factors(highly refined, sugary, fatty foods) to this nations obesity epidemic is our constant attraction to Jack in the Box, Taco Bell, Arby's, Carl's Jr.,KFC and so on. And that consumers should avoid going to fast food restraunts more then once a month, or at least knowing how to choose sensibly when going into one. Most people understand that the quarter pounder with cheese is not the best thing for their bodily health, but if the government took a stance against the quarter pounder and advocated the chicken cobb salad maybe more Americans would opt for the latter.
Submission Date 9/25/2004 3:08:00 PM
Author from Honolulu, HI

   Monounsaturated Fat
Summary Put the guidelines on hold. Follow my proposed Siguel’s Natural Food Pyramid. Eat natural foods with cells; Emphasize vegetables and reduce intake of grains; Minimize processed carbohydrates and fat; Be slim or cut your caloric intake (substantially) and exercise more.
Comments TO: HHS/USDA 2005 Dietary Guidelines From: Edward Siguel, MD, PhD Ref: The USDA Food Pyramid Date: September 23, 2004 Introduction My presentation is oversimplified due to time restrictions. These are my opinions and may contain errors. Please read my papers at my web site, essentialfats.com, and at Medline. The disclaimers at essentialfats.com apply to these notes. Definitions: Essential fats = EFs = PUFAs of the omega-3 and omega-6 families. About myself I study the effects of different types of fats on health and disease. I invented a method to measure different types of fatty acids and trans fats in blood. I created a data base of fatty acid profiles with over 1,000 blood samples from patients, people, and Framingham Heart study subjects. Based on my presentations at scientific meetings, published articles, and personal conversations with over 100 fat researchers, I believe I have the best data on the relationship between fats in blood vs. health and disease. I will summarize a few findings. Excessive caloric intake from foods low in essential fats creates a biochemical deficiency of essential fats. Most overweight people have biochemical deficiencies of essential fats. Overweight people who are not biochemically deficient usually became overweight from eating too many healthy foods rich in essential fats, a rare condition in America. These matters are discussed in several of my publications and patent. More than 25% of the US population is biochemically deficient in w6s; more than 50% of the US population is biochemically deficient in w3s (based on blood tests of different population groups). Whole grains and processed grains are not much different from each other. Distinctions are too subtle and too complex for consumers to understand and to use to make wise food choices. It is easy to distort these differences and provide nutrient-poor calories with cookies/ energy bars made with whole grains but few essential fats. A diet that follows the USDA Food Pyramid, as it is interpreted or implemented by most people, is deficient in EFs, particularly w3s, and has too many calories. Americans need to eat few calories or else gain weight. Each calorie must be nutrient dense. Some grains contain relatively few essential fats and nutrients (particularly w3s). When many calories come from grains, it is difficult for people to eat enough essential fats from the remaining daily calories (restricted to maintain optimal weight). Low fat foods, even if made with whole grains, may not provide enough essential fats to meet daily needs. It is also important that the requirements for essential fats should be listed as grams/kg body weight/day instead of as a percent of calories (see my book at amazon.com). The reason being that people on low calorie diets need essential fats in proportion to their body cells, not their caloric intake. There are several other issues relevant to the Food Pyramid. For example, it is misleading to recommend that people eat foods, such as breakfast cereals, with 100% RDA. During the rest of the day, people continue to eat more vitamins and minerals. The body has to work to eliminate them. This may cause kidney overwork and the expelling of key nutrients, such as K, in the urine. The proposed Dietary Guidelines are misleading with regard to fat • MUFAs are not necessarily “healthy” fats and should not be emphasized. Dietary guidelines should follow biochemical principles and distinguish essential from non-essential fats. Essential fats are needed by humans; non-essential fats (including MUFAs) are not needed. My research proves that levels of MUFAs in the body are primarily regulated by levels of essential fats, not by dietary intake of MUFAs. In my opinion, the proposed dietary guidelines will mislead people into eating too many MUFAs. • Recommendations for intake of essential fats should be expressed in grams per kg of ideal body weight (or in a range of grams/day), not as a percent of calories. The body’s need for essential fats depends on the number of cells and processes that use essential fats (repair and maintenance, etc.). The need for EFs is far more related to ideal body weight than to caloric intake. A person needs roughly the same amount of essential fats per day whether he eats 1,200 calories or 2,000 calories. Most Americans are overweight. Many Americans lead sedentary lives. Thus, most Americans need to eat far fewer than 2000 calories/day. A requirement based on calories is misleading. In my opinion, the proposed dietary guidelines are likely to continue the effect of past dietary guidelines. In my opinion, current (and proposed) dietary guidelines are a significant factor in the epidemic of overweight and obesity, and they contribute to cardiovascular disease and cancer. Better guidelines would recommend that people eat more foods in their natural states and minimize intake of foods with highly processed carbohydrates or fats. Essential Fats are more important for optimal health than trans and other fats TC/HDLC (one of the best risk factors for cardiovascular disease) is inversely proportional to Essential Fats, directly proportional to trans fats (based on measurements in human blood). Essential fats account for ~50% of variability, trans for ~ 10%. Levels of essential fats appear to be, by far, the most significant factor in cardiovascular diseases, abnormal lipids, diabetes, and hypertension. Other factors are minor in comparison. Read my papers on these matters. What this means is that essential fats are by far the best and most significant variable (in terms of the percent of variability predicted by correlation R or R2). Other variables such as age, sex, and weight, have less effect on TC/HDLC. It follows that any study that fails to account for blood levels of essential fats fails to consider a major variable and is therefore likely to produce misleading results. Also notice that it is very difficult to predict blood or tissue levels of essential fats from dietary intake (due to a variety of reasons beyond the scope of this document). Trans FA in blood are burned (used) quickly. Although trans fats are likely to be undesirable in foods, it is more harmful to have a diet lacking in essential fats. A diet low in EFs and trans fats is likely to be more harmful than a diet high in trans fats and EFs (this is a complex issue, depending on body levels of trans and EFs, weight, etc.). The implication is that replacing trans fats in foods with non- trans fats may be counterproductive when the fats replaced contain fewer essential fats than the original fats (some foods with trans also contain EFs). For this reason, some margarines rich in essential fats may be healthier than others poor in essential fats, particularly for people who exercise and burn the extra fats. The current trend to replace trans fats in food with fats low in essential fats (accompanied with the trend to eat too many calories) will likely increase morbidity and mortality. This is not necessarily bad news if the intent is to balance the budget by cutting the life span of social security recipients. The replacement of trans fats, in my opinion, offers great opportunities to consultants, lawyers and companies marketing new products. Together with HIPAA, they represent one of the greatest employment acts of the current century. Moreover, while HIPAA applies mainly to the US (thereby reducing its profit-making appeal), reducing trans fats in foods and convincing people to eat other foods has global appeal. Eating too many calories low in essential fats is far more harmful than eating trans fats. This means that being overweight or gaining weight from eating too many calories is likely to be more harmful than eating a few trans fats. A person’s risk for cardiovascular disease may increase when he stops eating 100 calories per day of cookies or French fries with trans and essential fats, and starts eating 150 calories per day of cookies or French fries made with a fat low in essential and trans fats. This situation may occur when people eat a lot of foods rich in saturated or monounsaturated (MONO) fats but low in trans because they read the label low in trans and cholesterol and think the food is healthy (or think MONOs are healthy). Beware of MONOs (= MUFAs). They are mostly unnecessary. Emphasize eating more essential fats, not eating more unsaturated fats (that includes MONOs). It is known that MONOs are not essential fats in humans. Humans can make them from saturated fat. There is a very strong inverse relationship between plasma PUFA and MUFA levels in human blood. The relationship exists in people from different study groups, different health conditions, different weight, sex, etc. My implication is that eating more or less MUFA is likely to have a long term effect similar to sat fat. I consider the reports from the US Dietary Guidelines made in May, 2004, as well as those posted in the HHS web site by August, 2004, to be flawed. They misunderstood my data. I consider their comments on MONOs flawed because apparently they indicate that there is a positive relationship between MONOs and PUFAs, or there is some health advantage to eating more MONOs. Instead, people should eat more calories from natural foods naturally low in fat, such as vegetables or lean meats, and eat fewer calories. Because monos are fat, eating more foods high in monos requires eating foods high in fat. These foods may contain a smaller percent of calories as essential fats in their biologically active form. People do not need to eat artificially produced fats in forms that may not have the same biological activity as natural fats in cells. Beware that olive oil contains little w3s. Eating olive oil requires a sophisticated diet low in calories and rich in w3s and nutrients + lots of exercise. KISS people with KISS principle = Keep It Simple S. There is too much info on labels and nutrition recommendations. I cannot carry a computer and scale to stores, restaurants, kitchen to calculate nutrient intake each day. I submit food labels are misleading for most consumers. Food labels concentrate on a few items and miss many others. The government should get out of the business of requiring people to keep daily track of each vitamin and mineral and major nutrient, and instead offer a simpler message based on practical foods. Alternatively, they could encourage companies to market more PCs with built-in food scales. My simple message is to emphasize total calories, eating natural foods high in cells. These foods are naturally rich in protein, essential fats, vitamins, minerals, and other nutrients. My suggestions are: • Eat foods with cells. Foods without cells ~ = nutrient-poor calories. People can learn to recognize foods with cells. They “grow” in nature. They move or grow before we eat them. That is what animals eat. That is what humans used to eat before the advent of food-processing machinery. • Avoid highly processed foods. They are often nutrient poor and calorie rich. • Eat foods rich in w3 and w6 essential fats, such as membranes, some vegetable oils. This is important for people who are deficient in essential fats or those on low calorie diets who do not get enough essential fats from their foods. • Supplement with a multivitamin a few times per week unless one eats lots of healthy food and little junk food. This is particularly important for people who have a relatively sedentary life and cannot get enough nutrients from their food (because they do not eat nutrient-dense foods or eat few calories to remain slim). Speaking of sedentary life, remember that our ancestors spent time chasing and being chased by food (or hungry colleagues). The way we chase food today at supermarkets and restaurants is not enough exercise. The food pyramid and how to improve it I propose a food pyramid that relies on natural foods rich in cells. These foods contain thousands of nutrients; processed foods contain very few. My food pyramid is available in my web site and publications. Controlling obesity and overweight: a simple message The government should have a very simple message: people gain weight from eating too many calories. There is a simple, practical and meaningful way to lose unnecessary weight: EAT FEWER CALORIES and eat food in accordance with Dr. Siguel’s pyramid (eat more vegetables, avoid processed carbs). Medicare, Medicaid, and health insurance companies are going broke trying to pay for expensive diagnosis and treatment associated with overweight. I propose a radical solution. High tech, simple, inexpensive. People should use their belts (or a rope) to measure their waists. In consultation with a health professional or tables by height, sex, they should select an ideal waist. If they are over it, they should use my TREATMENT. Treatment consists of duct tape applied during meals (on the mouth). This treatment is likely to lead to weight loss regardless of people’s genes, metabolism, environment, state of mind (psychotic or otherwise), or political preference (as I indicated in my book, exceptions apply to people with plant-like genes who gain weight from excessive breathing. These people convert air into carbon like plants do. However, despite contrary opinions, this is probably a very small portion of the US population). I propose that Medicare and Medicaid offer consumers a choice of coverage: they will pay for either (a) conventional treatments, or (b) the use of the belt and duct tape + an all expenses paid trip to the city of the consumer’s choice. Dangers of the proposed dietary guidelines: they should be kept secret I believe the choices and decisions made by HHS/USDA to write the dietary guidelines will shorten the lives of thousands of Americans. Thererfore, I propose that the guidelines be put on hold and be evaluated by the top 20 largest government agencies, including NIH, Department of Homeland Security, National Science Foundation, Dept of Transportation (people who become overweight cause a transportation problem + airlines need to comment on the impact on their food services), Dept of Interior (should employees follow the guidelines?), CIA, FBI, Border patrol (can illegal immigrants be forced to eat in accordance with the guidelines?), and labor (how many people are making a living from dietary guidelines and food pyramids?). Among non-government agencies, I suggest the American Enterprise Institute, CATO, Brookings Institute, The Urban Institute, Hudson Foundation, Gates Foundation, and the dog associations (will dogs be forced to eat leftovers from people who follow the dietary guidelines, and, if so, is that healthy for them or is it animal cruelty?). All the entities that testified on these matters should submit a 30 page paper with references. Thousands of other foundations and medical centers ought to give their comments. Trial lawyers associations should definitely be involved (can the government be sued under RICO if the guidelines are intentionally faulty, like cigarettes?). In my opinion, the proposed dietary guidelines will cause thousands of people to die prematurely. Implementation of better dietary guidelines would prolong the lives of thousand of people and reduce the costs of health care (reduce morbidity and mortality). In my opinion, implementation of the proposed dietary guidelines is unethical, immoral, a violation of our constitutional rights. The nutrition policies being considered are unhealthy. People may have a right to be fat or dumb, but the government has no right to use its influence and power and taxes to promote unhealthy policies. We are better off without any guidelines than with the proposed guidelines. In my opinion, sending the guidelines back to the drawing board and eliminating previous guidelines will save American children from harmful government intrusion that may encourage people to be fat or dumb. Children cannot resist the social pressures of school meals, educators, magazines, peers, and commercials. A child is under tremendous school pressure to eat foods that conform with the guidelines but that will harm them. As a parent, I would be better off without the dietary guidelines. I do not believe that schools should encourage children to eat bad so they are unlikely to live long enough to collect social security. During the past 5 years, the current dietary guidelines were implemented by schools and people across the country. Are you better off today, with less overweight, healthier eating, smarter kids and fewer children with special problems? Or were you healthier 5 years ago? Unfortunately, we know the answer. Bad eating, a major factor in overweight, is responsible for thousands of deaths. Will we be better off with the proposed dietary guidelines? Do they make such a drastic departure from the past that we can predict opposite outcomes, weight reduction, slim and smarter kids, drastic drops in mortality and morbidity? I do not think so. The committee states that MONOs are proportional to PUFAs. My data shows that MONOs are INVERSELY proportional to PUFAs. My studies are easy to replicate. Measure fatty acids in plasma and plot MONOs vs PUFAs. The proposed recommendations lead consumers to believe that eating monos are healthy and should eat more. My research has shown more MONOs to be associated with cardiovascular disease. I spoke with HHS/USDA committee members, I reviewed their sources. I read the IOM documents and papers written about MONOs. I personally did the fatty acid analysis that showed that MONOs are inversely proportional to PUFAs. I wrote about my findings in peer-reviewed journals. I explained my findings to HHS committee member. How can it be that HHS/USDA reach opposite conclusions about MONOs than I do? What secret knowledge they have that I have not found? Perhaps HHS/USDA have sought to incorporate too many views. I once did a mathematical experiment to solve a linear equation with an unknown. I asked the opinion of a variety of consultants and government employees. Resolving mathematical equations by committee lead to absurd results. Trying to incorporate different views and reach a consensus can also lead to absurd results. Cardiovascular disease and cancer caused by suboptimal eating contributes to the premature deaths of thousands of Americans. Getting Americans to eat more processed fat and carbohydrates is a great way to kill brain cells (make people dumb) and cause cardiovascular disease or cancer. Within 30 years, more deaths could be caused by bad eating than by other weapons. The recommendations are also misleading for essential fats. What assurances do we have they are not wrong on other nutrients? I consider the dietary recommendations to be dangerous and harmful. They are an insult to science and the taxpayer. I am afraid this waste of money encourages our foreign enemies, misrepresents the need for fair taxes, and provides support for those who want a smaller government. The Republicans do not want to kill Americans. And the Democrats don’t either. Who is behind these flawed guidelines? Who benefits? The answer may be obvious to everyone with experience providing testimony on the dietary guidelines and understanding the different viewpoints. We really need to know who and why is behind these guidelines. FOLLOW THE MONEY. YOU KNOW [PAUSE --- those who testify ought to know]. I have a new theory. Who are the slim men who exercise a lot and do not follow the US dietary guidelines and want Americans to die prematurely? Who stands to win from fat and dumb Americans eating junk foods rich in processed fats and carbohydrates while our enemies are slim, trim, fast and eat healthy? I recommend that the guidelines be reviewed ASAP by the Dept of Homeland Security. The dietary guidelines should be supervised by the Department of Homeland Security, not HHS. Homeland Security has the talent to keep dangerous documents under wraps. Homeland security should investigate and put the guidelines in a safe 100 ft underground, to be opened AFTER they are reviewed by everyone else (after my kids are grown and safe from misguided nutritional guidelines by government agents). In the meantime, put the guidelines on hold and tell Americans to cut calories. They need to eat more natural foods with cells, low in saturated, monos and trans, and high in essential fats, the kinds of foods humans evolved to eat for the past 50,000 years. Use of ambiguous words and lack of common sense People who know how to eat reasonably and in moderation do not need these guidelines. The guidelines need to be specific and clearly state what types of foods are healthy and which ones are not. The guidelines should not require people to study them for days, carry dictionaries of definitions, and use computers to keep daily track of intake of each food to determine whether or not they are eating too much or too little of the daily allowances for 20+ nutrients. My concerns about the proposed Food Pyramid/Dietary Guidelines I repeat my concerns about the Food Pyramid published in Am. J. Clinical Nutrition, an exchange of letters with the USDA. My position is that current and proposed recommendations encourage eating too many calories low in nutrients and essential fats. The nutrition guidelines encourage the marketing of junk food made with highly processed ingredients low in essential fats and nutrients. One fallacy is that an interpretation of the food pyramid is an energy bar made with highly processed ingredients. Consider a food or energy bar made with vegetable carbs, protein, vegetable cocoa, added vitamins, minerals, and genetically modified oils rich in monos. This type of food bar may be eaten by millions thinking that it provides energy (it does, but people confuse caloric energy with energy as a sense of well-being) and complies with the USDA food pyramid because it has a balance of nutrients. Some food bars may have fiber, choline, antioxidants, and many other nutrients, perhaps in very small quantities, but no one can keep track of so many ingredients. It may even have some soybean or flax seeds to incorporate essential fats (although these fats may not be absorbed). This energy bar may appear to represent an almost perfect food pyramid except that it has no cells. But if we spit on it before we eat it, we add cells, enzymes, and immunoglobulins. We should not need to spit on food that complies with the food pyramid to make it healthier. Conclusion For 20+ years, I hoped science could teach the follies of current nutrition recommendations. Instead, I saw people get overweight and die following the government guidelines. I think the food pyramid is one of the major contributors to premature death. I have tried for many years to convince the government and researchers that nutrition recommendations must be drastically changed, or else people will eat suboptimally and develop health conditions associated with nutrient imbalances. A CME (continuing medical education) course I took discussed the case of an overweight diabetic Type II person. The 1st, 2nd, and 3rd priority treatments proposed were statins, statins, statins. I suggested that the treatment of choice was eating to lose weight, but that was considered too difficult and unnecessarily drastic. Perhaps satire will do better. We must avoid the trail of those who recommended bleeding to cure disease, or assured us the earth was flat. I took me more than 20 years before people recognized the follies of eating low fat diets deprived of essential fats or filled with margarines rich in trans fats. I wish it would not take 20 years to recognize the follies of current nutrition recommendations. Be wary of silly recommendations. Recommending that people eat food in moderation, eat a healthy or balanced diet, do not get overweight, eat sensibly, drink a lot of water but not too much, and so on are like telling people to buy low and sell high - obvious and not useful. To conclude, keep nutrition recommendations and the food pyramid very simple. Follow my proposed Siguel’s Natural Food Pyramid. Eat natural foods with cells. Emphasize vegetables and reduce intake of grains. Minimize processed carbohydrates and fat. Be slim or cut your caloric intake (substantially) and exercise more. Exercising is rarely enough for most people because we can eat in a few minutes what takes an hour to lose by exercise. We should start teaching 3 year old children to eat well. Prohibit schools from dispensing foods with highly processed fat or carbohydrates (i.e., eliminate sweets, pizza, etc.). If we start children early enough, they learn to like vegetables, fruits, and lean protein. Respectfully yours. References Siguel E, Lerman RH. The role of EFAs: Dangers in the USDA dietary recommendations ("pyramid") and in low fat diets. Am. J. Clin. Nutrition, 1994; 60:973-9. Essential fatty Acids in Health and Disease (book). By Dr. Siguel. Available from amazon.com. Siguel, E. Deficiencies and Abnormalities of Essential Fats in Gastrointestinal and Coronary Artery Disease. Journal of Clinical Ligand Assay 2000; 23:104–111. Siguel E. Re: Anticipation in Crohn's disease may be influenced by gender and ethnicity of the transmitting parent. Am J Gastroenterol. 1999 Jul;94(7):1996. Siguel, E. "Low-fat, high carbohydrate diets also reduce high-density lipoprotein (HDL) cholesterol levels and raise fasting levels of triglycerides." BioMedicina, January 1998; 1(1): 9. Siguel, E. Dietary Fat: How Low Can or Should You Go? Abstracts, Am. Oil. Chemistry Society Annual Meeting 1997; INFORM, 1997:8, No7:714-717. Siguel, E. Issues and Problems in the Design of Foods Rich in Essential Fatty Acids. Lipid Technology, 8(4):81-86, 1996 (July). Siguel E, Lerman RH. The effects of Low-Fat Diet on Lipid Levels. JAMA, 1996; 275:759. Siguel, E. A new relationship between PUFAs and TC/HDLC. Lipids, 1996; 31, S51-S56. Siguel E, Lerman RH, MacBeath, B. Very Low-Fat Diets for Coronary Heart Disease: Perhaps, But Which One? JAMA, 1996:275: 1402-1403 Web site. Essentialfats.com. Click on research. Also search on search engine for healthnewsreview, Obesity, poor nutrition may lower test scores. Wash Post, Sept 24, 2004, p. A9. Obese children were found to have lower test scores, have difficulty concentrating and other mental problems. According to Dr. Siguel’s research, obese children are highly likely to be deficient in essential fats and have imbalances of fatty acid metabolism. These abnormalities impair brain function, making people less smart than they could be based on their genetic abilities.
Submission Date 9/26/2004 11:26:00 PM
Author from Gaithersburg, MD

Summary Oral Testimony
Comments ORAL TESTIMONY September 21, 2004 I am Edward Siguel. I patented a method to measure fatty acids. I will present my opinions to help American children. People may have a right to be fat or dumb, but the government has no right to use its influence, power and taxes to promote unhealthy policies. Children cannot resist the social pressures of school meals, educators, magazines, peers, and commercials. Children face school pressure to eat foods that conform with the guidelines but that will harm them. As a parent, I would be better off without the dietary guidelines. In my opinion, sending the guidelines back to the drawing board and eliminating previous guidelines will save American children from harmful government intrusion that may encourage people to be fat or dumb. During the past 5 years, the current dietary guidelines were implemented by schools and people across the country. Are we better off today than 5 years ago, with less overweight, healthier eating, smarter kids and fewer children with special problems? Unfortunately, we know the answer. School children are worse. Bad eating, a major factor in overweight, contributes to thousands of deaths. Will we be better off with the proposed dietary guidelines? Do they make such a drastic departure from the past that we can predict weight reduction, slim and smarter kids, major drops in mortality and morbidity? I do not think so. The committee states that MONOs (MUFAs, monounsaturates) are proportional to PUFAs. My data shows that MONOs are INVERSELY proportional to PUFAs. My studies are easy to replicate. Measure fatty acids in plasma and plot MONOs vs PUFAs. The proposed recommendations lead consumers to believe that eating MONOs are healthy and should eat more. My research has shown MONOs to be associated with cardiovascular disease. The recommendations are also misleading for essential fats. What assurances we have they are not wrong on other nutrients? Getting Americans to eat more highly processed fat and carbohydrates is a great way to kill brain cells (make people dumb) and cause cardiovascular disease or cancer. Within 30 years, more deaths could be caused by bad eating than by other weapons. Who is behind these flawed guidelines? Who benefits? The answer should be obvious. YOU KNOW [PAUSE ---] Who are the slim men who exercise a lot and do not follow the US dietary guidelines and want Americans to die prematurely? I recommend that the guidelines be reviewed by the Dept of Homeland Security. They have the talent to keep dangerous documents under wraps and can help with my cost/effective and foolproof method to lose weight: When hungry, cover your mouth with duct tape. In the meantime, put the guidelines on hold and tell Americans to cut calories. They need to eat more natural foods with cells, low in processed fats, and high in essential fats and nutrients, the kinds of foods humans evolved to eat for the past 50,000 years. Please read my published papers + written comments. Thank you.
Submission Date 9/26/2004 11:28:00 PM
Author from Gaithersburg, MD

   Trans Fat
Summary I have listed two comments about the section on fiber and the section on fats.
Comments September 26, 2004 HHS Office of Disease Prevention and Health Promotion C/O Kathryn McMurry Office of Public Health and Science Suite LL 100 1101 Wootton Parkway Rockville, MD 20852 Dear Secretaries Veneman and Thompson: Thank you for providing the opportunity for me to give my input about the new Dietary Guidelines. I am impressed that you care not only for the general population’s nutrition, but also for the individual. Your tireless work has helped to bring about positive change in the health of American Citizens. I felt that the section on Fats in your report was very clear in explaining what the fats were, but insufficient in explaining why it is harmful to consume too many of certain fats. For example, in your paragraph on trans fatty acids, you explained all of the sources of trans, and their chemical make-up very clearly and efficiently. However I was disappointed that there was no explanation on what can happen if a person consumes too much of them. The fact that trans fatty acids are one of the most controversial issues in the nutrition scene, makes me think that their effects should be explained as well. The section on carbohydrates, specifically fiber, I found to be quite thorough and interesting. It conveyed a relatively hard-to-understand topic in more simple terms than I have seen before. It also was complete with a general list of foods that contain fiber. I think that thing which could have been mentioned is that eating foods closer to their natural forms can help increase the consumption of fiber. Fiber is one of the few things that Americans consume too little of; most of the other nutrients they consume in excess and perhaps for that reason, it needs to be emphasized more. Once again, I am very grateful to you for allowing me this opportunity to express my comments to you. I hope that you can successfully sort through all of the many comments I am sure are coming your way. Sincerely, Jodi Treese 3313 W. Devon Rd. Muncie, IN 47304
Submission Date 9/27/2004 12:22:00 AM
Author from Muncie, Indiana

Summary Our studies in humans suggest that naturally occurring trans fatty acids, VA and CLA, do not have adverse effects on plasma lipids in humans observed for trans fatty acids produced by partial hydrogenation. These results are in accordance with results from large epidemiological studies.
Comments Kathryn McMurry MS, RD HHS Office of Disease of Public and Health Promotion Office of Public Health and Science 1101 Wootton Parkway Suite LL100 Rockville, MD 20852 FR Docket No. 04-19563, Department of Healthy and Human Services, Announcement of the Availability of the Final Report of the Dietary Guidelines Advisory Committee, a Public Comment Period, and a Public Meeting Dear Ms. McMurry, I understand that the United States Department of Health and Human Services and Department of Agriculture is revising the Dietary Guidelines of Americans and that these guidelines address the dietary fat. I have studied the metabolism and health effects of naturally occurring trans fatty acids, vaccenic acid (VA) and conjugated linoleic acid (CLA) in humans for several years at Cornell University (Ithaca, NY) and University of Helsinki, Finland. Therefore, I would like to take the opportunity to share with you some results from our studies. In a strictly controlled dietary intervention investigating bioconversion of VA to CLA, we fed 30 healthy subjects diets containing 1.5g, 3g and 4.5g VA/day (Turpeinen et al. Am J Clin Nutr 2002;76:504-510). Diet was controlled throughout the 3-week study. VA in serum fatty acids increased 94%, 307% and 620% and bioconversion of VA to CLA was significant (19%), whereas no changes in serum total cholesterol or triglycerides in any of the groups were seen at these intake levels representing 1.5-fold, 3-fold and 4-fold the average intake of VA. In another controlled intervention, the effects of CLA on the metabolism of linoleic acid and á-linolenic acid were studied. Fifteen healthy subjects were supplemented with 1,25 g of pure cis-9, trans-11 CLA or trans-10, cis-12 CLA daily during a 2-week study. In addition to observing no effects on metabolism of essential fatty acids, also plasma lipids (total cholesterol, triglycerids, HDL, LDL) were not affected in either group. Thus, our results suggest that naturally occurring trans fatty acids, VA and CLA, do not have adverse effects on plasma lipids in humans observed for trans fatty acids produced by partial hydrogenation. These results are in accordance with results from large epidemiological studies suggesting differences in the health effects of man-made trans fatty acids and those naturally present in ruminant fats (Willett et al. Lancet 1993;341:581-5, Ascherio et al. Circulation 1994;89:94-101). Sincerely, Anu Turpeinen, PhD University of Helsinki Department of Applied Chemistry and Microbiology (Nutrition) P.O. Box 66 00014 University of Helsinki, Finland Email: anu.turpeinen@helsinki.fi
Submission Date 9/27/2004 1:33:00 AM
Author Anonymous

   Cholesterol
Summary
Comments Eggs are moderately strongly vilified; numerous studies find either no evidence or very marginal evidence for avoiding eggs except in the small number of the devastating hereditary hyperlipidemias (less than 3 percent). While there is ample evidence that dietary saturated and trans-fats raise serum cholesterol, dietary cholesterol itself bears little if any relationship to serum cholesterol. For this reason eggs have not deserved their bad reputation.
Submission Date 9/27/2004 11:18:00 AM
Author American College of Preventive Medicine

   Monounsaturated Fat
Summary
Comments Oxidation of vegetable oils makes them less than optimal sources of fat; the resistance to oxidation of monosaturated fats deserves more emphasis.
Submission Date 9/27/2004 11:26:00 AM
Author American College of Preventive Medicine

   Saturated Fat
Summary Saturated fats are beneficial in many ways. Polyunsaturates are known to be a factor in heart disease. Children need saturated fats for thyroid and adrenal growth and function. The food groups should include whole milk, butter and eggs, and not include refined foods devoid of nutrients humans need.
Comments Your report was very interesting, particularly in that it emphasized the need for fooods with better nutrient content, and recognizes the now well-known dangerous effects of trans fats. However, the excellent scientific research now available shows clearly that saturated fats are not the cause of heart disease, which can be shown to have increased due to the much higher consumption of polyunsaturated fats and refined carbohydrates that form such a large part of so many Americans' diets. Saturated fats have been eaten by man since the beginning, and play many important roles in the body chemistry; they are natural substances that exist in the normal food supply for a reason. Biochemistry honestly looked at shows that saturated fat necessary for aiding the immune system, bone health, cell integrity and strength, the liver, and helping the body use the essential fatty acids. Children kept on lowfat diets suffer from several serious problems as their growing thyroid and adrenal glands are deprived of nutrients they need. There is money to be made by the processed food and snack foods industries, which rely heavily on polyunsaturated fats, and of course the refined white flour and white sugar that even rats and roaches won't eat if they can find something with some nutrition in it. Did you ever see mold growing on white sugar? The pressures and lobbying from these industries must not be allowed to sway you from urging us towards the foods that really contribute to health. For centuries man lived on whole foods not denatured by manufacturing processes, and he was remarkably free from the diseases that plague modern industrialized societies. We need our government to preserve our right to good food in its natural state witihout refined and artificial additives, not to be urged to subsist on foods lacking the very enzynmes and fatty acids that our bodies need to be healthy. I suggest the food groups should be: Animal foods, including whole milk and eggs; whole grains and legumes; vegetables and fruits; and good fats, such as butter, lard, beef fat, coconut oil. Thank you for your time. Marlyn Blessum
Submission Date 9/27/2004 12:06:00 PM
Author Anonymous

   Trans Fat
Summary 1. Including NuSun™ sunflower oil can increase vitamin E consumption. 2. Trans-free, low saturated fat oils, like NuSun™ sunflower oil, can replace partially hydrogenated oils that contain trans fat. 3. Using NuSun™ daily in place of saturated fat can significantly improve blood cholesterol levels.
Comments September 27, 2004 2005 Dietary Guidelines Advisory Committee Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science Room 738-G 200 Independence Avenue, SW Washington, DC 20201 Re: Proposed Dietary Guidelines Dear Dietary Guidelines Advisory Committee: We support the Dietary Guidelines Advisory Committee’s recommendations to significantly reduce consumption of both saturated and trans fats. Including sunflower oil in the diet in place of less healthful oils is one way to help consumers achieve this goal. NuSun™ sunflower oil contains mostly unsaturated fat, no trans fat by FDA definition, and is an excellent source of vitamin E, providing 45% of the Recommended Dietary Allowance (1, 2). A new variety of sunflower oil, NuSun™, can be used in commercial applications without contributing trans fat, as most other unsaturated oils do. It does not require hydrogenation and is naturally trans fat free. NuSun™ sunflower oil was developed by standard breeding techniques and is therefore, a natural, non-transgenic cooking oil. NuSun™ sunflower oil works extremely well in commercial cooking and frying with a smoke point of 450? and a clean light taste. In addition, the natural stability of NuSun™ sunflower oil enhances product fry-life and shelf-life. In addition, researchers at The Pennsylvania State University recently compared healthful diets with either NuSun™ sunflower oil or olive oil to the average American diet. Preliminary results from this clinical study show that substituting small amounts of NuSun™ sunflower oil daily in place of saturated fat had a significantly better cholesterol lowering effect than substituting a similar amount of olive oil (3). NuSun™ sunflower oil contains not only monounsaturated fat, similar to olive oil, but also contains adequate amounts of polyunsaturated fat. In addition, it is lower in saturated fat than olive oil (9.6% versus 14.3%). In summary, we request that you consider the following points: 1. Including NuSun™ sunflower oil may be an easy way to significantly increase vitamin E consumption. 2. Trans-free, low saturated fat oils, like NuSun™ sunflower oil, can replace partially hydrogenated oils that contain trans fat that are currently used in manufacturing and food service applications. 3. Research supports that using NuSun™ sunflower oil daily in place of saturated fat can significantly improve blood cholesterol levels. Thank you for your consideration. Best Regards, Larry Kleingartner Executive Director References: 1. USDA Nutrient Database for Standard Reference, Release 17 (2004). Nutrient Data Laboratory Home Page, http://www.nal.usda.gov/fnic/foodcomp 2. US Food and Drug Administration. A Food Labeling Guide—Appendix B. Relative (or comparative) Claims. September 1994, Revised June 1999. Accessed February 9, 2004. http://vm.cfsan.fda.gov/~dms/flg-6b.html 3. Abstract 7930 (revised). Experimental Biology 2003, San Diego, CA.
Submission Date 9/27/2004 12:09:00 PM
Author National Sunflower Association

Summary Please review the human subjects research on trans fats. We doubt enough evidence exists to recommend <1% of calories as a public policy statement.
Comments
Submission Date 9/27/2004 12:46:00 PM
Author University of Nebraska-Lincoln

   Total Fat
Summary Fat from meats. Buffalo/bison meat is an extremely low fat product. Please add references regarding low fat in meats, such as buffalo meat and grassfed meats. Grassfed buffalo meat provides a better balance of good fats to bad fats (3 to 1 grassfed buffalo, 99 to 1 grainfed buffalo.)
Comments Fat comes from many sources - even meats. Buffalo meat (bison meat) is an extremely low fat product. I urge you to consider some references regarding fat to include low fat meats, such as buffalo meat and grassfed meats. Additionally, grassfed buffalo meat provides a better balance of good fats to bad fats (research shows 3 to 1 for grassfed buffalo, and 99 to 1 for grainfed buffalo.) For additional information about the nutritional benefits of grassfed buffalo meat, visit www.buffalogroves.com.
Submission Date 9/27/2004 2:55:00 PM
Author Buffalo Groves, Inc.

   Alpha-Linolenic Acid
Summary The Dietary Guidelines should specify a minimum intake of healthy cis-unsaturated fat in addition to a range for total fat intake. Total daily fat consumption should come primarily from unsaturated fats, so consumers should be given a specific dietary goal for these fats as macronutrients.
Comments The U.S. Canola Growers Association (USCA) appreciates the opportunity to comment on the 2005 Report of the U.S. Dietary Guidelines Advisory Committee (DGAC) as requested in the Aug. 27, 2004 Federal Register. The USCA applauds the DGAC’s efforts and supports its recommended revisions to the guidelines, especially as they pertain to fats. The USCA well recognizes the need to differentiate among the types of fats, namely between healthy cis-unsaturated fats and unhealthy saturated and trans fats, and is pleased to see “choose fats wisely for good health” as one of the nine major messages in the DGAC’s report. The type of fat consumed is as important as the amount due to the affect of certain fats on blood lipid values and heart health. The USCA concurs with the DGAC in its recommendation of a food pattern that is low in saturated and trans fats, cholesterol and sodium. Canola oil – which has the lowest saturated fat content of any standard vegetable oil and zero trans fat, cholesterol and sodium – can allow Americans to increase their intake of healthy unsaturated fat, including the essential fatty acids alpha-linolenic acid (ALA) and linoleic acid (LA), and vitamin E. Healthy oils in general may also displace consumption of unhealthy fats. As noted by the DGAC, “the lower the combined intake of saturated and trans fat and the lower the dietary cholesterol intake, the greater the cardiovascular benefit will be.” The USCA supports the DGAC’s recommended minimum total fat intake for adults of 20 percent for a 2,000-calorie diet with an upper limit of 35 percent. However, specifying a minimum intake of healthy cis-unsaturated fat could strengthen this recommendation. The latter concept is inferred by the DGAC in its call for low intake of saturated fat and cholesterol and minimal intake of trans fat, but it should be clearly stated for consumer benefit. Healthy fats, particularly the essential fatty acids ALA and LA, are essential nutrients and should be recognized as such in the daily goals for macronutrients. The DGAC’s report acknowledges that fat intakes lower than 20 percent of energy put individuals at risk for inadequate intakes of ALA, LA, and vitamin E. This underscores the need for a minimum intake of healthy fats that are good sources of the latter nutrients. As the DGAC notes, “a diet that provides 20 percent of calories from fat could be designed to meet recommended intakes for vitamin E, LA, and ALA by choosing the foods that are better sources of these nutrients, e.g., certain liquid vegetable oils.” Canola oil is a good source of all three nutrients. The ALA content of canola oil is particularly noteworthy as ALA is more difficult to obtain in the diet than LA, which is found in many plant-based oils. The vitamin E content of canola oil is also important as vitamin E is listed in the DGAC’s report as a nutrient that American adults and children do not get enough of in their diets. The USCA supports the DGAC’s conclusions relating to polyunsaturated fatty acids (PUFAs) and monounsaturated fatty acids (MUFAs) as well as its adoption of Dietary Reference Intake recommendations from the Institute of Medicine (IOM) pertaining to healthy fats. The USCA concurs with the DGAC’s conclusion based on the IOM’s 2002 report that an “ALA intake between 0.6 to 1.2 percent of calories will meet requirements for this fatty acid and may afford some protection against CVD outcomes.” While the DGAC’s report states that “collectively, the evidence supports the hypothesis that the consumption of ALA reduces all-cause mortality and various cardiovascular disease events,” the USCA supports the DGAC’s conclusion that “further research is warranted” on sources of longer chain omega-3s (EPA and DHA) other than fatty fish. The potential benefits of ALA, which is converted by the body into EPA and DHA at a rate of approximately 10 percent, should be further studied, especially as food sources of ALA may be more appealing to consumers than fatty fish. Moreover, food sources of ALA, such as canola oil, do not contain mercury like certain species of fatty fish. The USCA also agrees with the DGAC’s conclusion regarding ALA and prostate cancer that “at this time, there are insufficient data to reach a conclusion about an association between ALA intake and risk of prostate cancer. Thus, further research is warranted to resolve this question.” Regarding MUFAs, the DGAC notes they are not required in the diet, but that “evidence is clear that replacing saturated fatty acid calories with MUFAs lowers total LDL and cholesterol levels.” The DGAC suggests that MUFAs are one form of unsaturated fat that can replace saturated fat and should be primarily derived from vegetable sources. The USCA concurs with this conclusion, but believes that vegetable oils high in MUFAs and PUFAs and low in unhealthy saturated fat should be specifically cited. Similarly, food sources of ALA, LA, and vitamin E recommended to consumers should be low in unhealthy saturated and trans fats. For example, rather than listing oils and soft margarines as general sources of these nutrients, vegetable oils and soft margarines low in unhealthy fats should be specifically noted. The DGAC’s report acknowledges the influence of environmental factors on individual diets and lifestyles, including the trans fatty acid content of many ready-to-eat foods. The USCA strongly supports the DGAC’s push to minimize trans fats in the food supply and agrees with its statement that “decreased consumption of foods made with industrial sources of trans fats provides the most effective means of reducing trans fat intake.” Healthy vegetable oils like canola oil are viable trans-free alternatives for food manufacturers to make healthier products. Oils high in saturated fat, such as palm and coconut oils, are not viable alternatives to the trans fat problem; substituting saturated fat for trans fat in food products would fly in the face of the DGAC’s report, which emphasizes keeping saturated fat intake below 10 percent of calories as it is “the predominant fat that adversely affects blood lipid values.” The DGAC notes that “although intakes of saturated fat, trans fat, and cholesterol all should be decreased, because saturated fat consumption is proportionately much greater than that of these other fats, saturated fat should be the primary focus of dietary modification.” Thank you for consideration of these comments. Please also see the USCA’s previously submitted white paper entitled, “The Need for a Minimum Healthy Fat Intake,” which supports our comments on the DGAC’s report.
Submission Date 9/27/2004 2:55:00 PM
Author U.S. Canola Association

   EPA/DHA (Fish)
Summary It is not prudent to recommend the consumption of 8 to 9 ounces of fish per week given that it is a highly polluted food. The warning offered in the report regarding the consumption of highly contaminated fish by pregnant women and developing children is far too weak to protect consumers.
Comments Fish and Shellfish: Contamination Problems Preclude Inclusion in the Dietary Guidelines for Americans The Issue The Fats Subcommittee of the Dietary Guidelines Advisory Committee, led by Dr. Penny Kris-Etherton, has recommended to the full committee that the 2005 Dietary Guidelines for Americans include a guideline that Americans include 8 to 9 ounces of fatty fish per week in their diets, presumably to achieve adequate intake of omega-3 fatty acids and reduce the risk of heart disease. Although diets rich in fatty fish, as compared to red meat, have been shown to be associated with less cardiovascular risk, fish and shellfish often contain unsafe levels of contaminants. It is also high in animal protein, and often, in saturated fat and cholesterol. Omega-3 fatty acids are readily available in plant foods that do not have these attendant disadvantages. The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) recently issued a joint statement warning pregnant women, women who may become pregnant, breastfeeding women, and children to limit the consumption of fatty fish because of the potential effects of mercury and organochlorine toxicity. Given the high levels of mercury, organochlorines, and other environmental toxins that accumulate in fish, and in view of our nation’s already animal-protein-heavy diets, a recommendation to consume two to three portions of fish weekly is likely to do far more harm than good. Understanding Mercury Mercury is a global pollutant that comes from both natural and human-generated sources. Naturally occurring mercury is present in rock and soils. Combustion of fossil fuels is the main way mercury is released into the environment. Medical and municipal waste incinerators and coal-fired utility plants contribute much of the mercury released into the atmosphere. Once released, mercury can travel long distances and pollute the air, water, and food supply.1 In the environment, mercury exists in its elemental form and in a variety of organic forms. One of these organic forms, methylmercury, accumulates up the food chain in aquatic systems, concentrating especially in large predatory fish. The potential sources of mercury contamination for the general population are consumption of water or food stuffs contaminated with mercury, inhalation of mercury-containing vapors, and exposure to dental amalgams or medical treatments that contain mercury. Of these, the consumption of fish and shellfish contributes most to the methylmercury concentration in humans.1 Nearly all fish contain traces of methylmercury. Some fish and shellfish tend to contain higher levels either because they live in more contaminated waters or because they are larger carnivores consuming many contaminated smaller fish. Because mercury is eliminated slowly from the body, it may build to very high levels in the systems of animals—including humans—that consume it. Shark, swordfish, king mackerel, and tile fish are known to have especially high concentrations of methylmercury (mean of samples tested: 0.73, 0.99, 0.97, and 1.45 parts per million (ppm), respectively). Other commonly eaten fish also contain high levels of methylmercury (between 0.25 and 0.55 ppm): bass, bluefish, grouper, halibut, lobster, marlin, orange roughy, canned albacore tuna, and fresh tuna. Some fish have more modest amounts on average (less than 0.1 ppm); these include anchovies, catfish, clams, cod, crab, haddock, perch, pollock, salmon, scallops, shrimp, and trout.2 Levels of contamination vary widely. Among tuna, for example, there is a three-fold difference in mean levels of contamination between canned light tuna (0.12 ppm) and canned albacore tuna (0.35 ppm) or tuna that is sold fresh or frozen (0.38 ppm).2 Contamination also varies greatly between individual fish. Therefore, even well-informed consumers have no way of knowing whether the fish they have purchased to feed has a high or low level of mercury contamination. In 2000, the National Research Council convened a group of scientists to make recommendations on “acceptable” levels of mercury consumption. This level, known as the exposure reference dose (RfD), is the level of daily exposure to mercury thought likely to be without risk of adverse effects for humans (including sensitive subgroups), even if exposure occurred regularly over a lifetime. This committee set the RfD at 0.1 micrograms (µg) of mercury per kilogram of body weight per day.1 This means that the weekly RfD would be about 7 µg per week for a toddler, about 14 µg per week for a five-year-old child, and about 42 µg per week for a 135-pound woman.3 Specific examples put these numbers in perspective. Two ounces of canned tuna with .36 ppm would provide 20 µg mercury—nearly three times the RfD for a toddler. Six ounces, the amount in two tuna salad sandwiches, would provide 61µg of mercury, which would exceed the weekly RfD for a five-year-old by four times; it would also be about 50 percent over the weekly RfD for an adult. Clearly, even modest consumption of moderately contaminated and commonly eaten fish can put consumers at risk very quickly.3 It is not surprising that the most recent surveys of methylmercury contamination (based on data from 1999—2000) found that 7.8 percent of women of childbearing age have blood mercury levels above the EPA’s “safe” limit of 5.8 µg of mercury per liter. Moreover, 15.7 percent of women of childbearing age have levels above 3.5 µg/L, which is high enough to put a fetus or breastfeeding infant at risk.4,5 The EPA estimates that about 7 million women and children are eating mercury-contaminated fish at or above levels it considers safe.4 The bottom line: Significant numbers of Americans are already over-consuming mercury-laden fish and seafood. It is inadvisable from a public health perspective to encourage further consumption of this contaminated product. Effects of Mercury Contamination Mercury exposure has been linked to a wide variety of ills, including acute and chronic effects on the cardiovascular and central nervous systems. Moreover, the EPA and the International Agency for Research on Cancer (IARC) have designated mercury as a possible human carcinogen.1 Human occupational studies suggest that methylmercury exposure alters immune function.1 Methylmercury exposure has also been shown to affect reproduction.1 In one study, the rate of spontaneous abortions for wives of mercury-exposed men (with urinary mercury greater than 50 µg per liter) was double that for controls.6 Some exposure studies also suggest that fertility may be lower in mercury-exposed individuals.1 Mercury and the heart Mercury accumulates in the heart, as well as other tissues, and has been associated with increased blood pressure, irregular and increased heart rate, and increased rates of death from cardiovascular disease in at least 12 scientific studies.1 Consumption of fish and omega-3 fatty acids, including docosahexaneonic acid (DHA) and eicosapentanoic acid, has been associated with decreased risk of heart attack in individuals consuming a western-style diet.7,8 However, two recent studies have shown that mercury exposure may have the opposite effect. In a case-control study conducted in eight European countries and Israel, the relative risk of first myocardial infarction (heart attack) for men in the highest quartile of mercury exposure was 2.16 that of those in the lowest quartile, after adjustment for DHA levels and cardiovascular disease risk factors. When comparing patients to controls, the toenail mercury levels were 15 percent higher among those who had suffered a first heart attack.9 A second study showed increased risk of cardiovascular mortality with increasing methylmercury exposure.10 A recent study of 14-year-old children who had been pre- and postnatally exposed to relatively high levels of methylmercury found the children were less capable of maintaining the normal variability of the heart rate necessary to secure adequate oxygen supply to the tissues (a risk factor for cardiovascular disease and sudden death) as level of exposure increased.11 This study provides a possible mechanism for explaining the increased risk of cardiovascular disease in methylmercury-exposed individuals. Mercury and the Central Nervous System Acute methylmercury exposure has been shown to cause severe neurological dysfunction and developmental abnormalities, including mental retardation, abnormal reflexes, disturbances in physical growth, blindness, paralysis, cerebral palsy, and limb deformities in children whose mothers were exposed to high levels of mercury while they were in utero.1 Lower-dose chronic exposures also have very serious effects on the developing central nervous system in children and on the adult central nervous system. In general, children exposed to mercury show changes in neurological status and achieve lower scores on developmental scales, language development tests, IQ tests, visual-spatial skills scales, and other tests.1 A recent paper showed that some of these neurodevelopmental effects of prenatal exposure to methylmercury persist through 14 years of age and thus are likely to be irreversible.12 The study also found correlations between neurodevelopmental impairments and post-natal mercury exposure (i.e., the children’s levels of fish consumption). The most striking finding in this study was that some of the adverse effects on brain function occurred in children who had exposure levels well below the RfD.12 Other Bioaccumulative Pollutants in Fish There are four primary groups of pollutants in addition to the heavy metal mercury in waterways that accumulate in aquatic animals in concentrations many times higher than those in the water. Taken together, polychorinated biphenyls (PCBs), dioxin, chlordane, DDT, and mercury account for 96 percent of all fish advisories issued in 2002. Many other toxins find their way into water and aquatic life as well, including other heavy metals and other organochlorine pesticides.13 These pollutants are toxic to humans, fish, and other animals that consume and bioaccumulate them. Many of these chemicals are especially problematic, because they are not readily cleared from the body and accumulate over a lifetime. Thus, even if exposure is limited to a discreet period of time, the potential risks persist. According to the EPA, PCBs are known carcinogens in some species and a probable carcinogen in humans. PCBs also have been shown to disrupt immune function, cause learning disabilities, and disrupt neurological development; they may have endocrine effects as well. Furthermore, children born to women in fishing villages or exposed through occupational contact with PCBs have lower birth weight and lower weights for gestational age as PCB exposure level increases.14 Dioxins, too, are known carcinogens and have also been shown to cause liver damage, weight loss, and reductions in immune function, and to have a negative effect on early development and hormone levels.15 At high doses, human exposure to dioxins can result in a serious skin disease called chloracne.16 The main route of human exposure to dioxins is consumption of contaminated foods, especially fish and other products containing animal fats.17 Chlordane and DDT, an organochlorine, are pesticides that have been banned from use in the United States. Nonetheless, appreciable levels of these highly toxic chemicals remain in our waterways and bioaccumulate in fish. Recent sources show that contamination with these pollutants is widespread both globally18 and domestically, especially in the Great Lakes region and the Eastern seaboard.13,19 In a survey of skipjack tuna from offshore waters around the world, Japanese researchers made an astonishing discovery. Organochlorines had contaminated every liver of every tested tuna, even though the fish came from a wide variety of locations, including Japan, Taiwan, the Philippines, Indonesia, Seychelles, and Brazil, as well as the Japan Sea, the East China Sea, the South China Sea, the Bay of Bengal, and the North Pacific Ocean. That researchers did not find even one uncontaminated liver illustrates how pervasive such pollution has become.18 Lessons Learned from Farmed Salmon A consumer might think that farmed salmon would contain fewer toxins than sea or lake fish, since farmed fish live in a more controlled environment. But, at least in the case of salmon, the opposite is true. Researchers analyzed 2 metric tons of farmed salmon from major salmon-farming sites around the world for organochlorine contaminants and found that the levels of these toxic compounds are significantly higher in farmed than wild salmon.20 Scientists suspect that this concentration of toxins is caused by the practice of feeding these fish large volumes of contaminated fish remains. High-Risk Populations Women who may become pregnant, pregnant and breastfeeding women, and children are especially vulnerable to the effects of environmental toxins that accumulate in fish. Exposure to even low levels of methylmercury in utero can cause developmental problems and impairments in motor and visual integration. Other environmental toxins—such as dioxins, some of which are known carcinogens—are especially dangerous during fetal development and early childhood.16 According to a new study in the April issue of Environmental Health Perspectives, women are already eating too much fish; as a result, as many as one in six newborns has a mercury level above that considered safe by the EPA. The authors reviewed diet records and tested the mercury levels in blood of more than 1,700 women (from 1999-2000 NHANES data) and found that those who consumed fish or shellfish two or more times per week had blood mercury concentrations seven times higher than those who ate no fish in the previous month.21 Based on the distribution of blood mercury concentrations noted for various populations from this study and the number of U.S. births in 2000, the authors estimates that at least 300,000—and possibly as many as 630,000—newborns each year in the United States may have been exposed in utero to methylmercury concentrations sufficiently high to potentially cause neurodevelopmental problems.21 Toxins Passed from Mother to Child Scientists and doctors have long known that chemicals consumed by mothers-to-be are readily passed to the fetus. Such chemicals are also passed to infants via breast milk. In fact, pollutants such as mercury show up in higher concentrations in fetal blood than in maternal blood. A recent report showed that blood mercury levels in a fetus may be as much as 70 percent higher than in the mother’s levels.3 Infants and small children are often especially sensitive to the effects of toxins, because of their developing body systems and their small size; thus, it is essential for mothers to limit their exposure to toxins as much as possible. Avoiding foods and medicines known to contain toxins is one important way to do this. More than 20 years ago, when waterways were somewhat less polluted, the breast milk of vegetarian mothers had only 1 to 2 percent of the national average levels of certain pesticides and industrial chemicals compared to levels in the breast milk of omnivorous Americans.22 A second contemporary study found that the organochlorine contaminants (such as DDT and PCBs) were highest in the breast milk of fish-eating omnivores, intermediate in omnivores, and lowest in vegetarians.23 Government Warnings Recently, the Joint Federal Advisory Panel of the EPA and the FDA issued its “2004 Consumer Advisory: What You Need to Know About Mercury in Fish and Shellfish,”24 which gives the following advice for women who might become pregnant, women who are pregnant, nursing mothers, and young children: 1. Do not eat Shark, Swordfish, King Mackerel, or Tilefish because they contain high levels of mercury. 2. Eat up to 12 ounces (2 average meals) a week of a variety of fish and shellfish that are lower in mercury. • Five of the most commonly eaten fish that are low in mercury are shrimp, canned light tuna, salmon, pollock, and catfish. • Another commonly eaten fish, albacore ("white") tuna has more mercury than canned light tuna. So, when choosing your two meals of fish and shellfish, you may eat up to 6 ounces (one average meal) of albacore tuna per week. 3. Check local advisories about the safety of fish caught by family and friends in your local lakes, rivers, and coastal areas. If no advice is available, eat up to 6 ounces (one average meal) per week of fish you catch from local waters, but don’t consume any other fish during that week. Follow these same recommendations when feeding fish and shellfish to your young child, but serve smaller portions. While these warnings may seem sufficiently strict and detailed at first glance, many scientists and organizations have argued that they are not strict or clear enough to truly protect the consumer from harm. Organizations as varied as the Consumers Union, Physicians for Social Responsibility, Natural Resources Defense Council, and the National Wildlife Federation joined Michael Bender of the Mercury Policy Project in signing a letter to the FDA urging better protections for women and children from exposure to mercury. These organizations argue that current guidelines do not effectively protect sensitive populations from excess exposure to methylmercury from fish; they also say that efforts to monitor mercury levels in the food supply need great improvement.3 For example, the mercury levels in some types of fish are derived from data collected in 1978. Even the figures from a 1990–92 FDA survey are likely to be outdated, since mercury pollution is largely due to industrial combustion of coal and other human-generated wastes, which may have significantly increased in scope and volume over the past decade.2 Vas Aposhian, a toxicologist and professor of molecular and cell biology and pharmacology at the University of Arizona who served as a key advisor on mercury issues to the FDA and EPA, reported that mercury levels in albacore tuna are so high consumers should avoid the fish completely. Dr. Aposhian also criticized the food industry for exerting influence to weaken mercury warnings.25 Contamination is widespread. The EPA’s fact sheet “Update: National Listing of Fish and Wildlife Advisories” covering PCBs, dioxins, mercury, and chlordane notes that as of 2002, 28 states had statewide advisories. Overall, the 2,800 advisories in the national listing account for about one-third of the nation’s lakes and about 15 percent of its total river miles; this includes each of the Great Lakes and their connecting water ways.13 Mercury advisories are especially common, but New York, Washington, the District of Columbia, and most New England states also have advisories for PCBs, cadmium, and dioxins.13 Nutrient Composition of Fish Like other meats, fish are especially dense in animal protein (15 to 20 grams in a 3-ounce cooked portion). People in the United States already consume well above the daily value for protein (50 to 65 grams). Protein intake averages about 15 percent of total calories, for a mean intake of approximately 100 grams per day for men and 70 grams per day for women.26 Much of this protein comes from animal sources. Diets containing excessive protein are associated with increased risk of impaired renal function,27 osteoporosis,28 and complications of diabetes.29 Promotion of fish products may increase protein intake and aggravate these risks. Furthermore, increasing fish intake would likely increase total fat and saturated fat intake. Although a small amount of the fat in fish is omega-3s, much of the remaining fat is saturated. Chinook salmon, for example, derives 55 percent of its calories from fat, and swordfish derives 30 percent. About one-quarter of the fat in both types of fish is saturated. Fish and shellfish are alos significant sources of cholesterol. Three ounces of shrimp have 130 milligrams of cholesterol, while the same amount of bass has 68 milligrams; in comparison, a 3-ounce steak has about 80 milligrams.30 Safer Sources of Omega-3 Fatty Acids High levels of toxins, fat, and cholesterol and a lack of fiber make fish a poor dietary choice. Fish oils have been popularized as a panacea against everything from heart problems to arthritis. The bad news about fish oils, though, is that omega-3s in fish oils are highly unstable molecules that tend to decompose and, in the process, release free radicals. Research has shown that omega-3s are found in a more stable form in vegetables, fruits, and beans.31,32 Individuals need to include foods rich in omega-3 fatty acids in their diets on a daily basis. Alpha-linolenic acid, a common omega-3 fatty acid, is found in many vegetables, beans, nuts, seeds, and fruits. It is concentrated in flaxseeds and flaxseed oil and also found in oils such as canola, soybean, walnut, and wheat germ. Omega-3 fatty acids can be found in smaller quantities in nuts, seeds, and soy products, as well as beans, vegetables, and whole grains.33,34 Corn, safflower, sunflower, and cottonseed oils are generally low in omega-3s. Fish consumption is by no means the only way to ensure adquate intake of essential fatty acids. Conclusion Given the clear evidence that fish are commonly contaminated with toxins that have well-known and irreversible damaging effects on children and adults, public health policy should not encourage the consumption of fish. The risks are known, and especially for infants and women of childbearing age, significant. Even if a fish reccomendation were to carry a carefully-worded warning about how much and what types of fish might minimize potential risk from mercury toxicity, it would still be inadvisable. The other risks associated with fish consumption are also considerable--contamination with other bioaccumulated pollutants and diets that are already too high in saturated fat and animal protein to protect consumers from chronic disease. Further, due to the variability in levels of pollutants among and between species and individual fish, and to the fact that these toxins accumulate in the tissue of the fish so food safety practices at home will not reduce risk of contamination, consumers should not be encouraged to navigate these dangers which they cannot truly minimize or control. Therefore, the Physicians Committee for Responsible Medicine urges the members of the 2005 Dietary Guidelines Advisory Committee to reconsider the proposed recommendation that Americans consume 8 to 9 ounces of fatty fish per week. Instead, PCRM’s doctors and dietitians recommend that the Committee discourage the consumption of fish and shellfish. Other, more healthful, foods from plant sources offer the full range of essential nutrients without the toxins and other health risks in fish. References 1. Committee on the Toxicological Effects of Methylmercury; National Research Council. Toxicological effects of methylmercury. National Academy Press, Washington DC, 2000. 2. U.S. Department of Health and Human Services and U.S. Enviromental Protection Agency. Mercury levels in commercial fish and shellfish. Accessed April 2004 at: www.cfsan.fda.gov/~frf/sea-mehg.html. 3. Bender, M. Letter to FDA about better protecting women and children from exposure to mercury. February 24, 2004. Accessed April 2004 at: www.mercurypolicy.org/new/fdaletter022404.html 4. Mahaffey KR, Clickner RP, Bodurow CC. Blood organic mercury and dietary mercury intake: National Health and Nutrition Examination Survey, 1999 and 2000. Environ Health Perspect 2004;112:562-70. 5. Schober SE, Sinks TH, Jones RL, Bolger PM, McDowell M, Osterloh J., et al. Blood mercury levels in US Children and women of childbearing age, 1999-2000. JAMA 2003;289:1667-74. 6. Cordier S, Deplan F, Mandereau L, Hemon D. Paternal exposure to mercury and spontaneous abortions. Brit J Ind Med 1991;48:375-81. 7. Hu FGB, Bronner L, Willett WC, Stampfer MK, Rexrode KM, Albert CM, Hunter D, Manson JE. Fish and omega-3a fatty acid intake and risk of coronary heart disease in women. JAMA 2002;287:1815-21. 8. Siscovick DS, Raghunathan TE, King I, Weinmann S, Bovbjerg VE, Kushi L, Cobb LA, Copass MK, Psaty BM, Lelmaitre R, Retzlaff B, Knopp RH. Dietary intake of long-chain n-3 polyunsaturated fatty acids and the risk of primary cardiac arrest. Am J Clin Nutr 2000;71:208S-12S. 9. Guallar E, Sanz-Gallardo MI, van't Veer P, Bode P, Aro A, Gomez-Aracena J, Kark JD, Riemersma RA, Martin-Moreno JM, Kok FJ. Heavy Metals and Myocardial Infarction Study Group. Mercury, fish oils, and the risk of myocardial infarction. N Engl J Med. 2002;347:1747-54. 10. Salonen JT, Seppanen K, Nyyssonen K, Korpela H, Kauhanen J, Kantola M, Tuomilehto J, Esterbauer H, Tatzber F, Salonen R. Intake of mercury from fish, lipid peroxidation, and the risk of myocardial infarction and coronary, cardiovascular and any death in eastern Finnish men. Circulation 1995;91:645-55. 11. Grandjean P, Murata K, Budtz-Jørgensen E, Weihe P. Cardiac autonomic activity in methylmercury neurotoxicity: 14-year follow-up of a Faroese birth cohort. Pediatrics 2004;144:169-76. 12. Murata K, Weihe P, Budtz-Jørgensen E, Jørgensen PJ, Grandjean P. Delayed brainstem auditory evoked potential latencies in 14-year-old children exposed to methylmercury. Pediatrics 2004;144:177-83. 13. United States Environmental Protection Agency. Update: National listing of fish and wildlife advisories. Fact Sheet EPA-823-F-03-003, May 2003. Accessed April 2004 at: www.epa.gov.waterscience/fish/. 14. United States Environmental Protection Agency. Health effects of PCBs. June 2002. Accessed April 2004 at: www.epa.gov/opptintr/pcb/effects.html. 15. United States Environmental Protection Agency. Dioxins. April 2004. Accessed April 2004 at: www.epa.gov/ebtpages/pollchemicdioxins.html. 16. United States Environmental Protection Agency. Persistent Bioaccumulative and Toxic (PBT) Chemical Program: Dioxins and furans. April 2003. Accessed April 2004 at: www.epa.gov/pbt/dioxins.htm. 17. United States Environmental Protection Agency. Consumer factsheet on: Polychlorinated biphenyls. April 2004. Accessed April 2004 at: www.epa.gov/safewater/dwh/c-soc/pcbs/html. 18. Ueno D, Takahashi S, Tanaka H, Subramanian AN, Fillmann G, Nakata H, Lam PK, Zheng J, Muchtar M, Prudente M, Chung KH, Tanabe S. Global pollution monitoring of PCBs and organochlorine pesticides using skipjack tuna as a bioindicator. Arch Environ Contam Toxicol. 2003;45:378-89. 19. Hicks HE, De Rosa CT. Sentinel human health indicators: to evaluate the health status of vulnerable communities. Can J Public Health. 2002;93:S57-61. 20. Hites RA, Foran JA, Carpenter DO, Hamilton MC, Knuth BA, Schwager SJ. Global assessment of organic contaminants in farmed salmon. Science 2004;303:226-9. 21. Mahaffey KR. Methylmercury: Epidemiology Update. Presentation at the National Forum on Contaminants in Fish, San Diego, January 28, 2004. Accessed April 2004 at: http://www.ewg.org/issues_content/mercury/ppt/3. 22. Hergenrather J, Hlady G, Wallace B, Savage E. Pollutants in breast milk of vegetarians. N Engl J Med 1981;304:792. 23. Noren K. Levels of organochlorine contaminants in human milk in relation to the dietary habits of the mothers. Acta Paediatr Scand. 1983;72:811-6. 24. U.S. Department of Health and Human Services and U.S. Environmental Protection Agency. What you need to know about mercury in fish and shellfish. EPA-823-R-04-005, March 2004. Accessed April 2004 at: www.cfsan.fda.gov/~dms/admehg3.html. 25. Kaufman M. Women, children warned about tuna consumption:government offers more specific guidelines on mercury in fish. Washington Post, March 19, 2004. Accessed April 2004 at: http://www.washingtonpost.com/wp-dyn/articles/A8179-2004Mar19.html. 26. Wright JD, Kennedy-Stephenson J, Wang CY, McDowell MA, Johnson DC. Trends in Intake of Energy and Macronutrients --- United States, 1971—2000. MMWR 2004;53:80-2. Accessed April 2004 at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5304a3.htm. 27. Knight EL, Stampfer MJ, Hankinson SE, Spiegelman D, Curhan GC. The Impact of Protein Intake on Renal Function Decline in Women with Normal Renal Function or Mild Renal Insufficiency. Ann Int Med 2003;138:460-7. 28. Feskanich D, Willett WC, Stampfer MJ, Colditz GA. Protein consumption and bone fractures in women. Am J Epidemiol 1996;143:472-9. 29. Gin H, Rigalleau V, Aparicio M. Lipids, protein intake, and diabetic nephropathy. Diabetes Metab 2000;26:45-53. 30. Pennington JAT. Bowes and Church’s food values of portions commonly used. 15th Edition, Harper Perennial, 1989. 31. Odeleye OE, Watson RR. Health implications of the n-3 fatty acids. Am J Clin Nutr 1991;53:177-8. 32. Kinsella JE. Reply to O Odeleye and R Watson. Am J Clin Nutr 1991;53:178. 33. Hunter JE. n-3 Fatty acids from vegetable oils. Am J Clin Nutr 1990;51:809-14. 34. Mantzioris E, James MJ, Gibson RA, Cleland LG. Dietary substitution with an alpha-linolenic acid-rich vegetable oil increases eicosapentaenoic acid concentrations in tissues. Am J Clin Nutr 1994;59:1304-9.
Submission Date 9/27/2004 3:49:00 PM
Author Physicians Committee for Responsible Medicine

   Trans Fat
Summary It is important to lower trans fat and saturated fat simultaneously in the diet. NatreonTM canola oil, from Dow AgroSciences, is a cost competitive, healthy, and highly functional oil that is now readily available to cut trans and saturated fat in the food supply.
Comments Nutrition and Your Health: Dietary Guidelines for Americans Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science 1101 Wootton Parkway, Suite LL100 Rockville, MD 20852 Re: Proposed Dietary Guidelines Dear Dietary Guidelines Advisory Committee: We strongly support the recommendation of the 2005 Dietary Guidelines Committee to reduce saturated and trans fats in the diet. Further, we urge the simultaneous reduction of saturated and trans fats as both are scientifically linked to an increased risk of coronary heart disease. Cost competitive, healthy, and highly functional oils are now readily available to the food service industry, restaurants, and processors, which can help meet these nutritional requirements. For example, Dow AgroSciences has developed NatreonTM canola oil, which is available today and is a natural, highly stable, virtually trans fat free, low saturate solution to partially hydrogenated oils. It is estimated that over fifty percent of partially hydrogenated oils currently in use can be replaced with naturally stable, no trans, low saturated fat oils like Natreon within the next two years. Sixty-four percent of trans fat in the American diet comes from fast food and restaurant items. In one serving of French fries, the amount of saturated plus trans fat could be reduced by approximately 83 percent by switching from partially hydrogenated soybean oil to Natreon. While trans fats have been recently highlighted in new labeling guidelines issued by the U.S. government, it is important to recognize the need to also lower saturated fat, as Americans eat twice as much saturated fat as trans fat. Like traditional canola oil, Natreon contains about seven percent saturated fat, the lowest of any vegetable oil. Natreon has over 70 percent monounsaturated fat for stability and has a higher polyunsaturated omega-3 fatty acid content than most of the partially hydrogenated oils it can replace. The finished product contains less than one percent trans fat, the minimum content acquired by any vegetable oil during refining. Natreon is a readily available, natural, highly stable and healthful alternative to other vegetable oils that must be hydrogenated for commercial applications. Its use could substantially reduce the amount of trans fat and saturated fat in the American diet. Thank you for your consideration. Sincerely, Bradley A. Shurdut Global Director, Public & Government Affairs, Biotechnology Dow AgroSciences LLC
Submission Date 9/27/2004 3:57:00 PM
Author Dow AgroSciences LLC

   Alpha-Linolenic Acid
Summary BENEFITS OF GRASSFED FOODS: (Meats & Dairy) „X Grassfed foods are lower in fat, calories & cholesterol („X Grassfed foods are higher in beta carotene, vitamin e, conjucated linoleic acid (cla) and omega 3 fatty acids
Comments FATS/OMEGA3/EPA: „X Grassfed foods need to be added in any and all references (like references to fish) as good sources of good fats (omega 3¡¦s, EPA, etc.) „X Grassfed foods are lower in fat, calories & cholesterol (supporting better overall health & nutrition) „X Grassfed foods are higher in beta carotene, vitamin e, conjucated linoleic acid (cla) and omega 3 fatty acids (research shows all these items are important to reducing cancer, cholesterol, diabetes, high blood pressure and heart diseases).
Submission Date 9/27/2004 4:09:00 PM
Author American Grassfed Association

   Monounsaturated Fat
Summary A distinction should be made not only between solid and liquid fats, but also between solid animal fats, which are higher in saturated fats, and all plant-based fats, like peanut butter and peanuts, which contain healthful mono- and polyunsaturated fats.
Comments We strongly support your recommendation to distinguish between types of fat in the diet. Further, when educating consumers, a distinction should be made not only between solid and liquid fats, but also between solid animal fats, which are higher in saturated fats, and all plant-based fats, like peanut butter and peanuts, which contain healthful mono- and polyunsaturated fats.
Submission Date 9/27/2004 4:35:00 PM
Author The Peanut Institute

   Saturated Fat
Summary Our bodies need saturated fats. They’re important in body chemistry. Scientific evidence doesn’t support the assertion that saturated fats cause heart disease. Children, particularly, need the nutrients found in butterfat and whole milk. We need whole milk, raw if possible, from pastured ruminants.
Comments Saturated fats and cholesterol are necessary components of the diet: given the misrepresentation of saturated fats and cholesterol by major sectors of the medical establishment, based on no or bad or misreported science, special notice should be made of the importance of saturated fats and cholesterol in the diet. Saturated fatty acids play many important roles in body chemistry. They are important in the immune system, in living bone, in cell structure, energy production, liver protection and in the use of other nutrients; they are carriers of important vitamins. The scientific evidence does not support the assertion that "artery-clogging" saturated fats cause heart disease. Only about 26%of the fat in artery clogs is saturated – the rest is unsaturated, of which more than half is polyunsaturated. Furthermore, as the consumption of saturated fat in this country has gone down, the rates of cancer, heart disease and other degenerative diseases have gone up. For these reason, we urge you to reconsider your recommendation that Americans increase their daily consumption of nonfat or low-fat milk and milk products. Children, in particular, need the nutrients found in butterfat and whole milk.
Submission Date 9/27/2004 4:39:00 PM
Author Lehigh Valley Chapter of the Weston A. Price Foundation

   Trans Fat
Summary
Comments September 27, 2004 Kathryn McMurry, M.S., R.D. HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science 1101 Wootton Parkway, Suite LL100 Rockville, MD 20852 FR Docket No. 04-19563, Department of Healthy and Human Services, Announcement of the Availability of the Final Report of the Dietary Guidelines Advisory Committee, a Public Comment Period, and a Public Meeting Dear Ms. McMurry: The NATIONAL DAIRY COUNCIL (NDC) submits the following comments on the docket referenced above. The NDC is a not-for-profit organization funded by America’s dairy farmers and recognized throughout the nation as a leader in nutrition research and education. For more than 85 years the NDC has worked to advance the state of scientific knowledge on the role and value of dairy foods in promoting and enhancing human nutrition and health, and we look forward to seeing the final results to the guidelines that promote health, prevent disease, and help Americans maintain ideal body weight. We commend the Dietary Guidelines Advisory Committee (DGAC), United Stated Department of Agriculture (USDA) and the Department of Health and Human Services (HHS) for the evidence-based review of current nutrition science to help Americans build better diets. As the Food and Nutrition Science Alliance (FANSA) emphasized, the continued practice of evidence-based reviews of the science will help to ensure that the Dietary Guidelines for Americans will be further improved in coming years. NDC appreciates the opportunity to provide comments on the final report of the DGAC. The topics we address below include:  Lack of scientific evidence to support a quantitative recommendation for limiting trans fatty acid intake to 1 percent of energy or less  Start this the “no effect level” of trans fatty acid intake on LDL/cholesterol does not justify a quantitative recommendation to limit TFA intake to 1 percent of energy or less  Health organizations have not recommended quantitative goals to reduce TFA intake to 1 percent of energy or less  Adoption of a 1 percent of energy intake for trans fatty acid will effect consumer food choices of nutrient dense dairy foods to avoid TFA  Conclusions A. Strength of Scientific Evidence to Support a Quantitative Recommendation for Limiting Trans Fatty Acid Intake to 1 Percent of Energy Intake or Less In their deliberations on the relationships between trans fat intake and coronary heart disease (CHD), the DGAC concluded that: The relationship between trans fatty acid intake and LDL cholesterol (LDL-C) is direct and progressive, increasing the risk of CHD. Trans fatty acid consumption by all population groups should be kept as low as possible, which is about 1 percent of energy (%En) intake or less. The science suggests that this conclusion is premature. It is inconsistent with positions taken by other expert groups. The science does not support including a quantitative goal for trans fatty acid (TFA) intake in the final Dietary Guidelines for Americans. This is supported by the following reasons: B. There is a lack of compelling data on the LDL-C effects of TFA within the normal range of U.S. intake to substantiate or justify a quantitative recommendation to limit TFA intake to 1 %En or less. The DGAC asserts that there is a progressive dose-dependent relationship between TFA intake and an increase in the LDL:HDL cholesterol ratio over the range of intake from 0.5 to 10 percent of calories and that this effect is greater for TFA than for saturated fatty acids. These conclusions by the DGAC were largely based on a linear regression analysis of the change in the LDL:HDL cholesterol ratio vs. intake of saturated fat and TFA [7] (Fig. 1, Ascherio et al., 1999). This assessment was based on nine randomized clinical trials (RCT’s, eight controlled feeding and one free-living). The majority of the data used for this analysis involved studies that used significantly higher levels of TFA than the current U.S. intake (even in excess of estimates of 90th percentile of TFA consumption in the U.S.). Only two studies in this analysis had TFA levels of less than 3.5 %En. Thus, this analysis had to “force” the regression line through zero even though very few data were available with lower intakes of TFA that reflect current intake levels. Based on this point and further inspection of this published commentary and the clinical studies used in the regression analysis (Table 1) [8 – 16], it is clear that these data do not support the contention that reducing TFA intake from the estimated average U.S. intake of about 2.6 %En [17] (Allison et al., 1999) to the goal of 1 %En recommended by the DGAC will favorably alter LDL-C or improve CHD risk and should not be the basis for setting public policy. Reasons are provided below. • In assessing the studies used in this regression analysis, NDC notes that it is more appropriate to assess these data based the impact of TFA on the individual lipoprotein parameters (LDL-C and HDL-C) rather than the LDL:HDL ratio since the latter is not recognized as either a primary or secondary target for lipid- lowering therapy by the Third Report of the National Cholesterol Education Program (NCEP) Adult Treatment Panel III, whereas LDL-C is the primary target [18]. Table 1 shows that the TFA intake of the RCT’s used in the regression analysis ranged from 0.9 to 11 %En. It is important to note, however, that no significant changes in plasma LDL-C or HDL-C were observed with a TFA intake of 3.3 %En [8] (Lichtenstein et al.,1999), whereas diets containing 3.8 %En as TFA resulted in a significant elevation in LDL-C (P<0.05) and no change in HDL-C [9] (Judd et al.,1994).  These clinical data, albeit small in number, strongly indicate there is a “no effect level” of TFA on LDL-C, such that at or below the level of about 3.3 %En dietary TFA has no significant effects on LDL-C.  Furthermore, the estimated 90th percentile of TFA consumed in the U.S. is 3.1 %En [17]….a level that is below the apparent “no effect level” of 3.3 %En TFA and does not support the DGAC’s recommended goal of 1 %En TFA. Table 1 also shows that above 3.8 %En TFA, 11 out of 12 treatments resulted in significant increases in LDL-C suggesting that these higher levels of TFA intake had a substantial defining impact on the TFA regression reported by Ascherio et al. [7]. Additionally, 13 of the 14 treatments are above the estimated 90th percentile of TFA consumed in the U.S. (3.1 %En). Hence, there is a critical need for studies to evaluate the effect of TFA intake within the range of typical U.S. intake. • It is impossible to fully evaluate the statistical merits of the regression analysis reported in the commentary by Ascherio et al. [7] as no methods are provided. No indication is provided whether the studies were weighted for sample size or variances, gender predominance, ethnicity, age, or residual confounding (e.g. dietary components, CHD status etc.). Also, no indication was given whether efforts were attempted to provide a better fit of this data, say with polynomial regression. • The Appendix herein contains a rigorous assessment of the clinical dataset of RCT’s on the effect of TFA and saturated fatty acids (SFA) on plasma LDL-C and HDL-C. This assessment was conducted by the International Life Sciences Institute in response to an advance notice of proposed rulemaking (ANPR) on Food Labeling [Docket No. 03N-0076] October 9, 2003. A total of 16 RCT’s were reviewed (see references 1-16, Appendix). TFA intake ranged from 0 to 10.9 %En and SFA intake ranged from 3.1 to 22.0 %En. Key findings:  Plots of changes in TFA and SFA intake against changes in plasma LDL-C levels revealed that the slopes of the regression lines are similar for TFA and SFA. These results indicate that “No meaningful distinction can be made between the intake of TFA and SFA with respect to any differential impact on LDL-C” (See Fig’s 3 – 6, in Appendix).  Plots of changes in TFA intake against changes in plasma HDL-C revealed little impact on HDL-C when TFA intake is less than 5 %En, whereas no “threshold effect” of SFA intake on HDL-C is observed (See Fig’s 7 – 10 in Appendix).  In light of an estimated average U.S. intake of TFA of 2.6 %En and a 90th percentile intake estimated at 3.1 %En [17], these data suggest little effect of TFA on HDL-C below intakes of 5 %En and provide little support for a quantitative recommendation to limit TFA intake to 1 %En or less. C. U.S. and Most Non-U.S Expert Health Organizations Have Not Recommended Quantitative Goals to Reduce Trans Fatty Acid intake to 1 %En or Less As pointed out by the DGAC and in Table 2, no quantitative goals or recommendations to limit TFA to 1 %En have been recommended by U.S. expert health organizations including: the Macronutrient DRI Committee (IOM, 2002) [19], the National Cholesterol Education Program Expert Panel (ATP III report, 2002) [18], the American Heart Association (2000) [20], and the American Diabetes Association [21]. Likewise, most non-U.S. expert health organizations have not issued quantitative goals or recommendations to limit TFA to 1 %En including: Health Canada [22], Danish Nutrition Council [23], and Austria (Table 3). Organizations including the World Health Organization [24] and the Health Council of the Netherlands [25] have adopted a quantitative limitation of 1 %En for TFA intake based largely on the types of TFA regression analyses discussed above [7]. Taken together, it is clear that few expert health organizations have adopted a quantitative goal to reduce TFA intake to 1 %En or less. D. Adoption of a Dietary Guideline That Limits TFA Intake to 1 %En Has a High Potential to Reduce Consumer Food Choices of Nutrient Dense Dairy Foods to Avoid TFA A Dietary Guideline recommendation to limit TFA to 1 %En is highly likely to communicate to consumers a message of “zero tolerance” for TFA and to categorically avoid all levels and forms of TFA including those in highly nutrient dense foods such as dairy products. This issue will become real after nutrition labeling mandates even lower levels of TFA to be labeled by adopting a national goal to limit TFA intake to 1 %En or lower. We have already pointed out the lack of scientific substantiation to justify a 1 %En limitation of TFA intake (see above). The scientific rationale to limit all forms of TFA presumes that all TFA isomers have equivalent effects on raising LDL-C. However, ruminant trans fat found naturally in dairy and ruminant meats may not increase CHD risk and may be beneficial based on key observational cohort studies that have consistently shown an inverse association between ruminant trans fat intake and CHD risk whereas the intake of manufactured trans fat increased CHD risk [26-28]. Based on these and other observations, the Danish Veterinary and Food Administration have exempted ruminant trans fats from nutrition labeling. There is a high potential for consumer confusion if communications about trans fat are oversimplified and consumers presume that all trans fats have equivalent health effects. Although ruminant and manufactured trans fats contain many of the same trans fatty acids, the fatty acid distributions are substantially different. Vaccenic acid (18:1, ∆11t) is the primary trans fatty acid in ruminant fat whereas elaidic acid (18:1, ∆9t) is typically highest in manufactured trans fats, although there are several major isomers that occur, including vaccenic acid [29]. Observational cohort data suggest elaidic acid is positively associated with CHD whereas ruminant trans fat is inversely associated with CHD [28]. FDA has already recognized differences in trans fatty acids by exempting conjugated linoleic acid (CLA, 18:2, ∆9c,11t) from the Nutrition Facts Panel. A significant portion of vaccenic acid is converted to CLA via endogenous synthesis in humans and makes a significant contribution to CLA status [30-32]. Several animal studies have characterized the conversion of vaccenic acid to CLA [33-36] as well as its direct effects on decreasing the number of premalignant mammary lesions [33] and the conversion of vaccenic acid to CLA that resulted in a dose dependent increase in CLA in mammary fat that was accompanied by a corresponding decrease in both tumor incidence and number [34]. Although human clinical studies comparing ruminant to manufactured trans fat on plasma cholesterol have not yet been conducted, observational cohort studies have consistently shown an inverse association between ruminant trans fat intake and CHD risk [26-28]. Results from the Nurses Health Study showed that manufactured trans fats increased the risk of CHD whereas a (non-significant) inverse association was reported with ruminant trans fats [27]. In the Alpha-Tocopherol Beta-Carotene Cancer Prevention (ATBC) study, an inverse association between ruminant trans fat intake and coronary death was observed and a direct effect was seen with industrially derived trans fats and elaidic acid [28]. In a case-control study, Hodgson et al reported that the intake of elaidic acid and trans-10 octadecaenoic acid were positively associated with CHD, while intake of other trans fatty acids including vaccenic acid (the primary ruminant trans fatty acid) were not [37]. In summary, ruminant trans fat found naturally in dairy and ruminant meats may not increase CHD risk and may be beneficial based on key observational cohort studies that have consistently suggested an inverse association between ruminant trans fat intake and CHD risk whereas the intake of manufactured trans fat increased CHD risk. NDC respectfully submits that enough data exists to suggest that ruminant and manufactured trans fats have different effects on CHD risk, but these findings need to be confirmed. Studies on the metabolic effects of the major individual trans isomers (e.g. vaccenic and elaidic) should be carried out as soon as these are available in sufficient amounts for clinical trials. E. Conclusions Based on the foregoing discussion, science supports not including in the 2005 Dietary Guidelines a quantitative goal to limit trans fatty acid intake to 1 %En or less. • There is an absence of data on the plasma lipid and lipoprotein cholesterol effects of trans fatty acid within the range of average U.S. and 90th percentile intake. Hence, there is no quantitative scientific evidence to support a recommendation to limit trans fatty acid intake to 1 %En or less. • Inspection of the current clinical dataset indicates that a “no effect level” of TFA on LDL-C occurs below a level of about 3.3 %En of dietary trans fatty acids. This level of intake is above the estimated 90th percentile of trans fatty acid intake of 3.1 %En suggesting little, if any, reduction in CHD risk by reducing the intake of trans fatty acids from the current U.S. average intake of 2.6 %En to the proposed goal of 1 %En or lower. • A Dietary Guideline recommendation to limit trans fatty acids to 1 %En is highly likely to communicate to consumers a message of “zero tolerance” and to categorically avoid all trans fatty acids including the small amounts in highly nutrient dense foods such as dairy products. This is inconsistent with the 2005 Dietary Guidelines to improve inadequate intakes of nutrients such as calcium, potassium, and vitamin D through increased dairy consumptions. Thank you for the opportunity to comment on these important issues. Sincerely, Gregory D. Miller, PhD, FACN Peter J. Huth, PhD Senior Vice President Director Nutrition & Product Innovation Regulatory and Research Transfer National Dairy Council National Dairy Council 847-627-3243 847-627-3306 REFERENCES: 1. Food and Nutrition Board, Dietary Reference Intakes for Water, Potassium, Sodium, Chloride, and Sulfate. Institute of Medicine of the National Academies. The National Academy Press, Washington, D.C. 2004. 2. U.S. Department of Agriculture, Agricultural Research Service. Data Tables: Results from USDA’s 1994–96 Continuing Survey of Food Intakes by Individuals and 1994–96 Diet and Health Knowledge Survey, 1997. www.barc.usda.gov/bhnrc/foodsurvey/ home.htm. February 1999. 3. USDA Continuing Survey of Food Intake by Individuals, 1996. 4. Gerrior, S., and L. Bente. Nutrient Content of the U.S. Food Supply, 1909–94. Home Economics Research Report No. 53. Washington, D.C.: U.S. Department of Agriculture, Center for Nutrition Policy and Promotion, 1997. 5. Final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines of Americans, www.health.gov/dietaryguidelines. August 2004. 6. Heaney RP, Dowell MS, Rafferty K, Bierman J. 2000. Bioavailability of the calcium in fortified soy imitation milk, with some observations on method. Amer. J Clin Nutr 71:1166-1169. 7. Ascherio A, Katan MB, Zock PL, Stampfer MJ, Willett WC. 1999. Sounding Board: Trans fatty acids and coronary heart disease. N Engl J Med 340: 1994-1998, 8. Lichtenstein, A.H., Ausman, L.M., Jalbert, S.M. and Schaefer, E.J. 1999. Effects of different forms of dietary hydrogenated fats on serum lipoprotein cholesterol levels. New Eng. J. Med. 340:1933. 9. Judd, J.T., Clevidence, B.A., Muesing R.A., Wittes, J., Sunkin, M.E. and Podczasy, J.J. 1994. Dietary trans fatty acids: effects on plasma lipids and lipoproteins of healthy men and women. Am. J. Clin. Nutr. 59:861. 10. Lichtenstein, A.H., Ausman, L.M., Carrasco, W., Jenner, J.L., Ordovas. J.M. and Schaefer, E.J. 1993. Hydrogenation impairs the hypolipidemic effect of corn oil in humans. Hydrogenation, trans fatty acids, and plasma lipids. Arterioscler. Thromb. 13:154. 11. Judd, J.T., Baer, D.L., Clevidence, BA, Kris-Etherton, P., Muesing, R.A. and Iwane, R.A. 2002. Dietary cis and trans monounsaturated and saturated fatty acids and plasma lipids and lipoproteins in men. Lipids 37:123. 12. Sundram, K., Ismail, A., Hayes, K.C., Jeyamalar, Rl and Pathmanathan, R. 1997. Trans (Elaidic) fatty acids adversely affect the lipoprotein profile relative to specific saturated fatty acids in humans. J. Nutr. 127:514S. 13. Nestel, P.J., Noakes, M., Belling, G.B., McArthur, R., Clifton, P., Janus, E. and Abbey, M. 1992. Plasma lipoprotein lipid and Lp(a) changes with substitution of elaidic acid for oleic acid in the diet. J. Lipid Res. 33:1029. 14. Zock, P.L. and Katan, M.B. 1992. Hydrogenation alternatives: effects of trans fatty acids and stearic acid versus linoleic acid on serum lipids and lipoproteins in humans. J. Lipid Res. 33:399. 15. Aro A., Jauhiainen M., Partanen R., Salminen, I. and Mutanen, M. 1997. Stearic acid, trans fatty acids, and dairy fat: effects on serum and lipoprotein lipids, apolipoproteins, lipoprotein(a), and lipid transfer proteins in healthy subjects. Am. J. Clin. Nutr. 65:1419. 16. Mensink, R.P. and Katan, M.B. 1990. Effect of dietary trans fatty acids on high-density and low-density lipoprotein cholesterol levels in healthy subjects. New Eng. J. Med. 323:439. 17. Allison, B.D., Egan, S.K., Barraj, L.M., Caughman, C., Infante, M. and Heimbach, J.T. 1999. Estimated intakes of trans fatty acids in the US population. J. Am. Diet. Assn. 99:166. 18. National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). 2002. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults final report. Circulation 106:3143. 19. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Institute of Medicine of the National Academies. The National Academies Press, Washington, D.C. 2002. 20. Krauss, R.M., Eckel, R.H., Howard, B., Appel, L.J., Daniels, S.R., Deckelbaum, R.J., Erdman, J.W. Jr., Kris-Etherton, P., Goldberg, IlJ., Kotchen, T.A., Lichtenstein, A.H., Mitch, W.E., Mullis, R., Robinson, K., Wylie-Rosett, J., St Jeor, S., Suttie, J., Tribble, D.L. and Bazzarre, T.L. 2000. AHA Dietary Guidelines: revision 2000: A statement for healthcare professionals from the Nutrition Committee of the American Heart Association. Circulation 102:2284. 21. Franz, M.J., Bantle, J.P., Beebe, C.A., Brunzell, J.S., Chiasson, J.L., Garg, A., Holzmeister, L.A., Hoogwerg, B., Mayer-Davis, E., Mooradian, A.D., Purnell, J.Q. and Wheeler, M. 2004. American Diabetes Association. Nutrition principles and recommendations in diabetes. Diabetes Care 27:S36. 22. Health Canada, Nutrition Recommendations for Canadians, Draft Recommendations on Dietary Fat. http://www.hc-sc.gc.ca/hpfb-dgpsa/onpp-bppn/comment_period_rec_on_fat_e.html 23. Stender, S. and Dyerbery, J. 2003. The influence of trans fatty acids on health. A Report from the Danish Nutrition Council. 24. Diet, Nutrition and the Prevention of Chronic Diseases. 2003 Report of a Joint FAO/WHO Expert Consultation. World Health Organization, 25. Health Council of the Netherlands 26. Willett WC, Stampfer MJ, Manson JE, Colditz GA, Rosner BA, Sampson LA, Hennekens CH. Intake of trans fatty acids and risk of coronary heart disease among women. Lancet 341:581-585. 1993. 27. Ascherio A, Hennekens CH, Buring JE, Master C, Stampfer MJ, Willett WC. Trans-fatty acids intake and risk of myocardial infarction. Circulation. 89:94-101. 1994. 28. Pietinen P, Ascherio A, Korhonen P, Hartman AM, Willett WC, Albanes D, Virtamo J. Intake of fatty acids and risk of coronary heart disease in a cohort of Finnish men. The Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study. Am J Epidemiol. 145:876-887. 1997. 29. Wolff RL, Precht D, Molkentin. Occurrence and distribution profiles of trans-18:1 acids in edible fat of natural origin. In: Trans fatty acids in human nutrition. Eds. JL Sebedio, WW Christie, The Oily Press, Dundee (UK), pp 1-33. 1998. 30. Turpeinen AM, Mutanen M, Aro A, Salminen I, Basu S, Palmquist DL, Griinari JM. Bioconversion of vaccenic acid to conjugated linoleic acid in humans. Am J Clin Nutr. 76:504-510. 2002. 31. Adolf RO, Duval S, Emken EA. Biosynthesis of conjugated linoleic acid in humans. Lipids. 35:131-135. 2000. 32. Salminen I, Mutanen M, Jauhiainen M, Aro A. Dietary trans fatty acids increase conjugated linoleic acid levels in human serum. J Nutr Biochem. 9:93-98. 1998. 33. Corl BA, Barbano DM, Bauman DE, Ip C. cis-9, trans-11 CLA derived endogenously from trans-11 18:1 reduces cancer risk in rats. J Nutr. 133:2893-2900. 2003. 34. Banni S, Angioni E, Murru E, Carta G, Melis MP, Bauman D, Dong Y, Ip C. Vaccenic acid feeding increases tissue levels of conjugated linoleic acid and suppresses development of premalignant lesions in rat mammary gland. Nutr and Cancer. 41:91-97. 2001. 35. Santora J, Palmquist DL and Roehrig KL. Trans-vaccenic acid is desaturated to conjugated linoleic acid in mice. J Nutr. 130:208-215. 2000. 36. Glaser KR, Wenk C, Scheeder MRL. Effects of feeding pigs increasing levels of C18:1 trans fatty acids on fatty acid composition of backfat and intramuscular fat as well as backfat firmness. Arch Anim Nutr. 56:117-130. 2002. 37. Hodgson JM, Wahlqvist ML, Boxall JA, Balazs ND. Platelet trans fatty acids in relation to angiographically assessed coronary artery disease. Atherosclerosis. 120:147-154. 1996. Table 1 Change in Blood LDL-C and HDL-C in Response to Substitution of Trans for Cis Fatty Acids TFA (% of energy) Source of Trans Fatty Acids ∆LDL-C (mM) Statistical Significance (p-value) ∆HDL-C (mM) Statistical Significance (p-value) Reference 0.91 Semi-liquid margarine (partially hydrogenated soybean oil) 0.025 NSD 0 NSD Lichtenstein et.al. (1999) [7] 3.3 Soft margarine (partially hydrogenated soybean oil) 0.13 NSD 0 NSD Lichtenstein et.al. (1999) [7] 3.8 Partially hydrogenated vegetable oils 0.02 <0.05 -0.02 NSD Judd et.al. (1994) [8] 4.2 Shortening (partially hydrogenated soybean oil) 0.26 <0.05 0 NSD Lichtenstein et.al. (1999) [7] 4.2 Partially hydrogenated corn oil margarine 0.26 NSD (0.058) -0.03 NSD (0.373) Lichtenstein et.al. (1993) [9] 4.2 Partially hydrogenated vegetable oils 0.37 <0.01 -0.07 <0.01 Judd et.al. (2002) [10] 6.6 Partially hydrogenated vegetable oils 0.26 <0.05 -0.04 <0.05 Judd et.al. (1994) [8] 6.7 Stick margarine (partially hydrogenated soybean oil) 0.36 <0.05 -0.025 NSD Lichtenstein et.al. (1999) [7] 6.9 Partially hydrogenated soybean oil 0.64 <0.05 -0.20 <0.05 Sundram et.al. (1997) [11] 7.1 Elaidic acid (hardened canola/palmolein) 0.36 <0.001 0 NSD Nestel et.al. (1992) [12] 7.7 Partially hydrogenated hi-oleic sunflower oil 0.24 <0.02 -0.10 <0.02 Zock and Katan (1992) [13] 8.3 Partially hydrogenated vegetable oils 0.41 <0.01 -0.08 <0.01 Judd et.al. (2002) [10] 8.7 Partially hydrogenated sunflower oil 0.24 <0.05 -0.20 <0.05 Aro et.al. (1997) [14] 11.0 Partially hydrogenated hi-oleic sunflower oil) 0.37 <0.0001 -0.17 <0.0001 Mensink and Katan (1990) [15] Table 2 Trans Fatty Acid Intake Recommendations U.S. Organizations Organization TFA Intake Recommendation National Cholesterol Education Program, Adult Treatment Panel III report (2002) Keep as low as possible Macronutrient DRI Committee, Institute of Medicine, (2002) Keep as low as possible American Heart Association, (2000) Total intake of cholesterol-raising fatty acids not exceed 10 %En American Diabetes Association, (2004) Intake of trans fatty acids be minimized Table 3 Trans Fatty Acid Intake Recommendations Non-U.S. Organizations Organization TFA Intake Recommendation Health Canada, 2004 Keep as low as possible World Health Organization, (2003) < 1 % energy from TFA Health Council of the Netherlands Keep as low as possible, UL 1 % energy Danish Nutrition Council, (2003) Industrial produced trans fatty acids in foodstuffs be ceased as soon as possible APPENDIX October 9, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, rm. 1061 Rockville, MD 20852 RE: [Docket No. 03N-0076] Dear Sir/Madam: The North American branch of the International Life Sciences Institute (ILSI N.A.), respectfully submits the following comments directed to the Federal Register notice on July 11, 2003 (68 FR 41507) regarding the advance notice of proposed rulemaking (ANPR) on Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content Claims and Health Claims and Possible Footnote or Disclosure Statements. ILSI N.A., a public, non-profit scientific foundation, advances the understanding and application of scientific issues related to the nutritional quality and safety of the food supply, as well as health issues related to consumer self-care products. The organization carries out its mission by sponsoring relevant research programs, professional education programs and workshops, seminars, and publications, as well as providing a neutral forum for government, academic, and industry scientists to discuss and resolve scientific issues of common concern for the well-being of the general public. ILSI N.A.’s programs are supported primarily by its industry membership. The comments submitted address the request for information from scientific bodies concerning trans fatty acids (TFA) in nutrition labeling. In response to this request, members of the ILSI N.A. Technical Committee on Dietary Lipids (ILSI Lipids Committee) reviewed various intervention studies cited by the Food and Drug Administration (FDA) in the final rule on Food Labeling: Trans Fatty Acids in Nutrition labeling, Nutrient Content Claims, and Health Claims (68 FR 41434) and the proposed rule on Food Labeling: Trans Fatty Acids in Nutrition labeling, Nutrient Content Claims, and Health Claims (64 FR 62746). Data from 16 intervention trials were reviewed, in which 17 control/comparison (control) and 27 treatment TFA intake levels were identified (1-16). One study (9) not cited by FDA in the ANPR has been included due to its inclusion in the Ascherio et al (17) analysis. All fatty acid intakes, when not reported as %En, were converted to %En, thereby permitting study comparisons on a similar basis. Also, LDL-C and HDL-C values expressed as mg/dL were converted to mM. The fatty acid intake and serum lipid data are summarized in table 1. As a result of this review, ILSI N.A. respectfully submits that: 1) There is sufficient variation in the intake levels of TFA and SFA, across the numerous intervention trials, to allow modeling of fatty acid intake and its impact on serum cholesterol levels; 2) It does not seem possible to make a meaningful distinction between the intake of trans fatty acids and saturated fatty acids (SFA) with respect to any differential impact on LDL cholesterol (LDL-C); 3) It does not seem possible to make a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on HDL cholesterol (HDL-C), when TFA intake is less than 5% of total energy intake (5% En); 4) Published data suggest that the 90th percentile of TFA intake falls below 5%En in the North American diet ; 5) The most effective manner to predict changes in serum cholesterol levels, explaining the majority of the variance, is to consider the sum of TFA and SFA intake. These conclusions are based on observations of the dietary levels of TFA and other fatty acids such as linoleic acid (LA) that were tested in the intervention trials, their associations with serum LDL-C and HDL-C, and how TFA intakes compare to those estimated from representative samples of the U.S. population. It must be acknowledged that differences exist among the studies in design, objectives, test products, and populations, and that these studies have not been subjected to a rigorous meta-analysis. ILSI N.A. has undertaken to examine these studies through a thorough meta-analysis, with completion expected in early December, 2004. Nonetheless, these datasets represent controlled studies of the relation between TFA intake, SFA intake, and serum lipids. As such conclusions drawn from these observations may assist the FDA in deliberations regarding TFA and food labeling. • Sufficient variation in TFA, SFA, and LA intakes across intervention trials exists to model intake effects on serum lipids TFA intakes ranged from 0 to 10.9%En. Control TFA intakes in the intervention studies ranged from 0 to 2.4%En, with 14 of 17 control TFA intakes being less than 1%En. TFA added to the diet for treatment ranged from 0 to 10.9%En, with 19 of 27 being greater than 3%En. The SFA and linoleic acid (LA) intakes across and within studies also varied. In the 44 control plus treatment diets, SFA ranged from 3.1 to 22.9%En, with 23 diets containing 10%En or more and 16 diets containing between 7 and 10%En. LA ranged from 0.8 to 15.6%En, with 31 diets containing at least 4%En and 9 diets having at least 10%En. Changes in intake (treatment minus control) ranged from -1.2 to +10.9%En for TFA, -10.3 to +4.3%En for SFA, and -12.2 to +13.0%En for LA. The changes in TFA intakes were associated with little change in SFA intake (figure 1) but significant decreases in LA intakes (figure 2). • Intake of TFA do not differentially impact serum LDL-C compared to similar intakes of SFA Figures 3 and 4, respectively, plot changes in TFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. Figures 5 and 6, respectively, plot changes in SFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. There are two key points to note. First, in all cases the slopes of the lines are similar. This strongly suggests that the impact on serum LDL-C of TFA intake and SFA intake are essentially indistinguishable. Second, higher order predictive equations provide very little additional explanation of the variance, suggesting that a linear regression is a reasonable model for these data (r2 coefficients are provided for first, second and fourth order equations as examples, though the biological relevance of a fourth order equation may be difficult to interpret). In summary, the data do not permit a meaningful distinction between the intake of trans fatty acids and saturated fatty acids (SFA) with respect to any differential impact on LDL cholesterol (LDL-C). • Intake of TFA do not differentially impact serum HDL-C compared to similar intakes of SFA, when TFA intakes are less than 5%En Figures 7 and 8, respectively, plot changes in TFA intake (%En) against changes in HDL-C in relative (%) and absolute terms. However in contrast to plots of LDL-C, higher order equations provide significantly greater predictive value, explaining a greater proportion of the variance. Most intriguing is the finding that there appears to be little impact on serum HDL-C when TFA intake is less than 5% En, when a second or fourth order equation is employed. Above this threshold, there is a clear inverse relationship, with increasing TFA intakes resulting in decreased serum HDL-C. Not surprisingly, a simple linear regression has negative slope, but this is a poor model of the data. SFA intake (%En) appears to show no such threshold effect on serum HDL-C, in fact showing very little effect at all (figures 9 and 10). In summary, the data do not permit a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on HDL cholesterol (HDL-C), when TFA intake is less than 5% of total energy intake (5% En). • Mean population TFA intakes are below levels that significantly affect HDL-C The difficulties and limitations associated with estimating the TFA intake of free-living individuals, as well as FDA’s caution to avoid over-interpreting dietary intake estimates and relationships to TFA intake levels used in intervention trials, must be acknowledged. (68 FR 41434 at 41446) Nonetheless, we believe the following observations may be useful to FDA in order to place these conclusions within the context of the North American diet. TFA intakes have been estimated from food disappearance and availability data, diet records and food frequency questionnaires from various populations, chemical analysis of formulated or duplicate diets, and chemical analysis of adipose tissue. We believe that TFA intakes estimated from the CSFII are useful for drawing observations because they are derived from a representative sample of the U.S. population and are based on 24-hour recalled food intake, with or without 2-day recorded food intake. Energy intakes from the CSFII are likely to be underestimated by approximately 20 to 40% (18). However, the TFA data expressed as %En represent a reasonable, if not conservative, estimate of intake. Allison et al estimated the mean TFA intake from the 1989-1990 CSFII for the total U.S. population aged 3 years and older to be 2.6%En, and from 2.6 to 2.8%En across various age and gender groups (18). FDA estimated the mean TFA intake for adults to be 2.91%En from the 1994-1996 CSFII. (8 FR 41434 at 41468) These population mean intakes are below the 5% En levels in the intervention trials associated with significant decreases in HDL-C. In addition, further inspection of Allison et al’s results suggest that even the 90th percentile intake of TFA would fall below 5% En, in this population. In summary, published data show that TFA intake, even at the 90th percentile, fall below the 5% En threshold when TFA significantly, and negatively, impact serum HDL-C. • The sum of TFA and SFA intakes provides the most robust predictor of changes in serum LDL-C When TFA and SFA intakes are combined, the most robust predictor of serum LDL-C is obtained, with an r2 coefficient approximately 0.83. This is true when considering either relative (%) or absolute (mM) changes in serum LDL-C (figures 11 and 12 respectively). It is once again very interesting to note that higher order equations do not provide any significant improvement in explaining the variance, indicating that a linear regression presents a viable model of the data. Since there is very little, if any, relation between SFA intake and HDL-C in these intervention trials, and the same is true for TFA intake below 5% En, summing the intake of these two fatty acids did not prove to be an effective predictor of serum HDL-C. In summary, TFA and SFA intakes, when considered together, prove to be the most robust predictor of serum LDL-C. • TFA and SFA intakes must be considered together when examining their impact on serum cholesterol levels, and one is not distinguishable from the other within the context of the North American diet In conclusion, ILSI N.A. respectfully suggests that the data reviewed support the following: 1) Sufficient data exists to model the impact of TFA and SFA intake on serum cholesterol levels; 2) No meaningful distinction can be made between the intake of TFA and SFA with respect to impact on LDL-C; 3) No meaningful distinction can be made between the intake of TFA and SFA with respect to impact on HDL-C, when TFA intake is less than 5% En; 4) Published data indicate that the 90th percentile of TFA intake falls below 5% En 5) The sum of TFA and SFA intake is the most effective predictor of changes in serum lipid profile, explaining the majority of the variance. ILSI N.A. encourages FDA to consider the observations presented regarding TFA and SFA intakes tested in intervention trials and how these intakes relate to changes in the intakes of other fatty acids, to changes in LDL-C and HDL-C, within the context of TFA intakes estimated from representative samples of the U.S. population. Sincerely, Richard M. Black, Ph.D. Executive Director, ILSI North America References 1. Aro A, Jauhiainen M, Partanen R, et al. Stearic acid, trans fatty acids, and dairy fat: effects on serum and lipoprotein lipids, apolipoproteins, lipoprotein(a), and lipid transfer proteins in healthy subjects. Am J Clin Nutr 1997;65:1419-1426. 2. de Roos NM, Bots ML, Katan MB. Replacement of dietary saturated fatty acids by trans fatty acids lowers serum HDL cholesterol and impairs endothelial function in healthy men and women. Arterioscler ThrombVasc Biol 2001;21:1233-1237. 3. Judd JT, Clevidence BA, Muesing RA, et al. Dietary trans fatty acids: effects on plasma lipids and lipoproteins of healthy men and women. Am J Clin Nutr 1994;59:861-868. 4. Judd JT, Baer DL, Clevidence BA, et al. Dietary cis and trans monounsaturated and saturated fatty acids and plasma lipids and lipoproteins in men. Lipids 2002:37:123-131. 5. Lichtenstein AH, Ausman LM, Carrasco W, et al. Hydrogenation impairs the hypolipidemic effect of corn oil in humans. Hydrogenation, trans fatty acids, and plasma lipids. Arterioscler Thromb 1993;13:154-161. 6. Lichtenstein AH, Ausman LM, Jalbert SM, Schaefer EJ. Effects of different forms of dietary hydrogenated fats on serum lipoprotein cholesterol levels. N Eng J Med 1999;340:1933-1940. 7. Mensink RP, Katan MB. Effect of dietary trans fatty acids on high-density and low-density lipoprotein cholesterol levels in healthy subjects. N Eng J Med 1990;323:439-445. 8. Nestel PJ, Noakes M, Belling GB, et al. Plasma lipoprotein lipid and Lp(a) changes with substitution of elaidic acid for oleic acid in the diet. J Lipid Res 1992;33:1029-1036. 9. Sundram K, Ismail A, Hayes KC, et. Al. Trans (Elaidic) fatty acids adversely affect the lipoprotein profile relative to specific saturated fatty acids in humans. J Nutr 1997;127:514S-520S. 10. Wood R, Kubena K, Tseng S, et al. Effect of palm oil, margarine, butter, and sunflower oil on the serum lipids and lipoproteins of normocholesterolemic middle-aged men. J Nutr Biochem 1993;4:286-297. 11. Zock PL, Katan MB. Hydrogenation alternatives: effects of trans fatty acids and stearic acid versus linoleic acid on serum lipids and lipoproteins in humans. J Lipid Res 1992;33:399-410. 12. Almendingen K, Jordal O, Kierulf P, et al. Effects of partially hydrogenated fish oil, partially hydrogenated soybean oil, and butter on serum lipoproteins and Lp(a) in men. J Lipid Res 1995;36:1370-1384. 13. Denke MA, Adams-Huet B, Nguyen BS. Individual cholesterol variation in response to a margarine- or butter-based diet--a study in families. JAMA 2000;284: 2740-2747. 14. Judd JT, Baer DJ, Clevidence BA, et al. Effects of margarine compared with those of butter on blood lipid profiles related to cardiovascular disease risk factors in normolipemic adults fed controlled diets. Am J Clin Nutr 1998:68:768-777. 15. Noakes M, Clifton PM. Oil blends containing partially hydrogenated or interesterified fats: differential effects on plasma lipids. Am J Clin Nutr 1998;68:242-247. 16. Wood R, Kubena K, O'Brien B, et al. Effect of butter, mono- and polyunsaturated fatty acid-enriched butter, trans fatty acid margarine, and zero trans fatty acid margarine on serum lipids and lipoproteins in healthy men. J Lipid Res 1993;34:1-11. 17. Ascherio A, Katan MB, Zock PL, et al. Trans fatty acids and coronary heart disease. N Eng J Med 1999;340:1994-1998. 18. Allison DB, Egan SK, Barraj LM, et al. Estimated intakes of trans-fatty acid and other fatty acids by the U.S. population. J Am Diet Assoc 1999;99:166-174. . Table 1. Fatty Acid Intakes and Serum LDL Cholesterol and HDL Cholesterol Table 1. Fatty Acid Intakes and Serum LDL Cholesterol and HDL Cholesterol Reference Treatment TFA (%En) SFA (%En) LA (%En) LDL-C (mM) HDL-C (mM) ∆ TFA (%En) ∆ SFA (%En) ∆ LA (%En) ∆ LDL-C (mM) ∆ HDL-C (mM) ∆ LDL-C (%) ∆ HDL-C (%) Aro 1997 (1) TFA 8.7 7.1 2.7 3.13 1.22 8.3 -7.9 -0.4 0.24* -0.20* 8.3* -14.1* STE† 0.4 15.0 3.1 2.89 1.42 De Roos 2001 TFA 9.2 12.9 4.1 3.04 1.48 8.9 -10.0 -1.8 -0.01 -0.39* -0.3 -20.9* SFA† 0.3 22.9 5.9 3.05 1.87 Judd 1994 (3) TFA (moderate) 3.8 13.0 6.0 3.54 1.40 3.1 -0.4 -0.1 0.20* -0.02 6.0* -1.4 TFA (high) 6.6 12.7 6.2 3.60 1.38 5.9 -0.7 0.1 0.26* -0.04* 7.8* -2.8* OL† 0.7 13.4 6.1 3.34 1.42 Judd 2002 (4) TFA (moderate) 4.2 16.9 4.3 3.32 1.17 4.1 4.3 0.5 0.37* -0.07* 12.5* -5.6* TFA (high) 8.3 12.9 4.0 3.36 1.16 8.2 0.3 0.2 0.41* -0.08* 13.9* -6.5* OL† 0.1 12.6 3.8 2.95 1.24 Lichtenstein 1993 (5) Margarine 4.2 7.7 7.9 3.49 1.11 3.8 1.3 -0.6 0.26# -0.03 8.0# -2.6 CO† 0.4 6.4 8.5 3.23 1.14 Lichtenstein 1999 (6) Semiliquid margarine 0.9 8.6 12.1 4.01 1.11 0.3 1.3 1.4 0.03 0.00 0.8 0.0 Butter 1.3 16.7 2.1 4.58 1.16 0.7 9.4 -8.6 0.60* 0.05 15.1* 4.5 Soft margarine 3.3 8.4 10.0 4.11 1.11 2.7 1.1 -0.7 0.13 0.00 3.3 0.0 Shortening 4.2 8.6 7.2 4.24 1.11 3.6 1.3 -3.5 0.26* 0.00 6.5* 0.0 Stick margarine 6.7 8.5 5.6 4.34 1.09 6.1 1.2 -5.1 0.36* -0.02 9.0* -1.8 SBO†§ 0.6 7.3 10.7 3.98 1.11 Mensink 1990 (7) TFA 10.9 10.0 4.2 3.04 1.25 10.9 0.5 0.2 0.37* -0.17* 13.9* -12.0* OL† 0.0 9.5 4.0 2.67 1.42 Nestel 1992 (8) TFA 6.7 10.0 6.6 4.27 0.98 4.3 1.0 1.3 0.37* 0.00 9.5* 0.0 OL† 2.4 9.0 5.3 3.90 0.98 Sundram 1997 (9) TFA 6.9 7.4 5.3 3.81 1.05 6.9 -2.1 1.4 0.64* -0.20* 20.2* -16.0* OL† 0.0 9.5 3.9 3.17 1.25 Wood 1993 (10) Hard margarine 6.3 5.0 3.4 3.36 1.00 6.3 1.9 -12.2 0.13 0.00 4.0 0.0 SO† 0.0a 3.1 15.6 3.23 1.00 Zock 1992 (11) TFA 7.7 10.3 3.8 3.07 1.37 7.6 -0.7 -8.2 0.24* -0.10* 8.5* -6.8* LA† 0.1 11.0 12.0 2.83 1.47 Almendingen 1995 (12) PHSBO 8.5 11.0 5.4 3.58 1.05 7.6 -5.4 0.0 -0.23* 0.00 -6.0* 0.0 PHFO 8.0 11.3 5.3 3.94 0.98 7.1 -5.1 -0.1 0.13 -0.07 3.4 -6.7* Butter† 0.9 16.4 5.4 3.81 1.05 Denke 2000 (13) Margarine 1.5b 9.0 10.0c 3.00 1.19 1.0 -7.0 7.0 -0.39* 0.00 -11.5* 0.0 Butter† 0.5 16.0 3.0 3.39 1.19 Judd 1998 (14) TFA margarine 3.9d 7.9d 2.7d 3.27 1.24 1.2 -3.3 1.6 -0.17* -0.03 -4.9* -2.4 PUFA margarine 2.4d 8.3d 4.9d 3.21 1.24 -0.3 -2.9 3.8 -0.23* -0.03 -6.7* -2.4 Butter† 2.7d 11.2d 1.1d 3.44 1.27 Noakes 1998 (15) Canola+TFA 2.1d 8.9d 5.8cd 3.64 1.19 1.4 -6.6 3.0 -0.50* -0.01 -12.1* -0.8 Canola-TFA 0.0d 8.7d 6.0cd 3.61 1.28 -0.7 -6.8 3.2 -0.53* 0.08 -12.8* 6.7 Butter† 0.7d 15.5d 2.8cd 4.14 1.20 Noakes 1998 (15) PUFA+TFA 2.1d 10.2d 10.4cd 4.23 1.17 1.4 -7.5 7.3 -0.47* -0.10 -10.0* -7.9 PUFA-TFA 0.0d 10.3d 10.5cd 3.98 1.23 -0.7 -7.4 7.4 -0.72* -0.04 -15.3* -3.1 Butter† 0.7 d 17.7d 3.1cd 4.70 1.27 Wood 1993 (16) Hard margarine 6.7d 5.0d 0.8d 3.47 1.16 5.5 -10.3 0.0 -0.31* -0.06 -8.2* -4.9 Soft margarine 0.0d 5.0d 13.8d 3.26 1.16 -1.2 -10.3 13.0 -0.52* -0.06 -13.8* -4.9 Butter† 1.2d 15.3d 0.9d 3.78 1.22 Abbreviations: TFA, trans fatty acids; SFA, saturated fatty acids; LA, linoleic acid; LDL-C, LDL cholesterol; HDL-C, HDL cholesterol; %En, percent of energy; STE, stearic acid; OL, oleic acid; SBO, soybean oil; SO, sunflower oil; PHSBO, partially hydrogenated soybean oil; PHFO, partially hydrogenated fish oil; PUFA, polyunsaturated fatty acid * p ≤ 0.05 † Comparison diet # p< 0.058 § Authors used butter as the control diet. For this analysis, treatments were compared to SBO  Authors compared test fats with each other. For this analysis, test fats were compared to butter a Not reported for nontest fat foods common to all diets b Fatty acid intakes based on 3-day food records c Total PUFA d Fatty acid values apply to test fat, not total fatty acids in diet Figure 1. Change in saturated fatty acid intake vs. change in trans fatty acid intake from treatments listed in table 1. Figure 2. Change in linoleic acid intake vs. change in trans fatty acid intake from treatments listed in table 1. Figure 3. Percent change in LDL cholesterol vs. change in trans fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 4. Absolute change in LDL cholesterol vs. change in trans fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 5. Percent change in LDL cholesterol vs. change in saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 6. Absolute change in LDL cholesterol vs. change in saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 7. Percent change in HDL cholesterol vs. change in trans fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 8. Absolute change in HDL cholesterol vs. change in trans fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 9. Percent change in HDL cholesterol vs. change in saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 10. Absolute change in HDL cholesterol vs. change in saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 11. Percent change in HDL cholesterol vs. change in sum of trans and saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order. Figure 12. Absolute change in HDL cholesterol vs. change in sum of trans and saturated fatty acid intake from treatments listed in table 1. Lines plotted represent first, second and fourth order equations, with r2 coefficients presented in that order.
Submission Date 9/27/2004 4:50:00 PM
Author National Dairy Council

Summary
Comments September 27, 2004 Ms. Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science 1101 Wootton Parkway Suite LL100 Rockville, Maryland 20852 Dear HHS Office of Disease Prevention and Health Promotion: The Snack Food Association (SFA) is an international trade association representing snack food manufacturers and suppliers. SFA membership includes smaller regionally based snack food companies in addition to large national branded snack food manufacturers. SFA members manufacture potato chips, snack bars, tortilla chips, pretzels, cookies, popcorn, crackers, meat snacks, pork rinds, snack nuts, and other snacks. We are pleased to have the opportunity to provide comments on the Dietary Guidelines Advisory Committee report. SFA appreciates the important role that the committee’s report will play in shaping the 2005 edition of the Dietary Guidelines for Americans, as well as associated educational materials for the public. For this reason, SFA is concerned that certain nutrient data identified in the report suggests that potato chips and similar snacks are a significant source of trans fat in the American diet, when that is not the case. Specifically, the Committee’s report contains tables suggested to identify “major food sources” of trans fat for U.S. adults (Tables D4-1 and E-17). According to these tables, potato chips, corn chips, and popcorn contribute to 5% of the total trans fat consumed by Americans. These tables are based on the July 13, 2003 Food and Drug Administration (FDA) economic analysis for the final trans fatty acids labeling rule (1). FDA’s analysis, in turn, was based in significant part upon a 1995 USDA trans fat database (2). It appears to SFA that the values reported in Tables D4-1 and E-17 of the Committee’s report does not reflect the current composition of potato chips and other foods. In a more recent study by Satchithanandam et al. (3) to determine the trans fat content of a wide range of foods, potato chips and tortilla chips were described as having low levels of trans fat, expressed as grams (g)/100 g fat, compared to other categories. Most potato chips analyzed were found to have little to no trans fat: 7 out of 8 potato chips analyzed in the study were found to contain 0.1 grams or less of trans fat per serving, and only one of the 8 potato chips analyzed contained 0.9 g per serving. Levels reported for tortilla chips were slightly higher, with some samples approximately 1.0 g per serving. Several of the samples studied were actually found to have zero or 0.1g of trans fat per serving. Moreover, SFA is aware of several tortilla chips products from which trans fat has been or will be removed. Indeed, the food industry as a whole, including the snack food industry, is presently engaging in widespread reformulation to reduce or eliminate trans fat, meaning that the trans fat content of the food supply is undergoing rapid change. Accordingly, in developing the Dietary Guidelines for Americans and associated consumer educational materials, the Department of Health and Human Services (DHHS) and U.S. Department of Agriculture (USDA) must exercise caution regarding materials intended to provide guidelines for trans fat intake. SFA urges that the agencies avoid identifying any particular foods or food categories as “major sources of trans fat,” as the food supply is changing rapidly, and such identifications may become quickly outdated. If any specific representations must be made as to trans fat content, it is essential that they be based upon reliable and timely data. SFA generally encourages the agencies to avoid targeting specific foods as either good or bad, but instead to recommend that consumers construct their diets in combination with the broader recommendation of variety, balance and moderation. Finally, SFA supports the Committee’s recommendation that consumers reduce their intake of both saturated and trans fats, and urges the agencies to ensure that proper emphasis is placed on saturated fat in consumer education messaging. As the Committee noted, because intake of saturated fat is much higher than that of trans fat and cholesterol, it is most important to decrease intake of saturated fat. SFA’s members companies are making great strides to reformulate snack foods that not only have little or no trans fat, but that also have lower levels of saturated fat. The snack food industry has made very positive steps in reformulating oils in an effort to enhance the healthfulness of snack products. As a result of these efforts, to date, over 90% of potato chips are trans fat free under FDA guidelines. By reformulating, a major snack manufacturer recently removed 55 million pounds of trans fat from its products. That same manufacturer has calculated that potato chips, corn chips and popcorn represent only 0.9% of trans fat in the American diet—down from the 5% depicted in Tables D4-1 and E-17 SFA thanks the agencies for considering our comments and would be pleased to discuss any of the points made in these comments. Sincerely, James A. McCarthy President and CEO References 1. Food Labeling; Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrition Content and Health Claims and Possible Footnote or Disclosure Statements; Final Rule and Proposed Rule,” Vol. 68, No. 133, P. 41433-41506 (July 11, 2003). 2. USDA, Agricultural Research Services, USDA Food Composition Data, Selected Foods Containing Trans Fatty Acids, 1995 (Internet address: http://www.nal.usda.gov/fnic/foodcomp/Data/index.html). 3. Subramaniam Satchithanandam, Carolyn J. Oles, Carol J. Spease, Mary M. Brandt, Martin P. Yurawecz, Jeanne I. Rader. Trans, Saturated and Unsaturated Fat in Foods in the United States prior to Mandatory Trans-Fat Labeling. American Oil Chemists Society, Journal Lipids. January 2004; Paper No. L9382, 11-18.
Submission Date 9/27/2004 4:53:00 PM
Author Snack Food Association

   Total Fat
Summary The total fat recommendation should not be changed from less than 30 percent of calories from fat to the proposed 20 to 35% of calories from fat as it will likely have a negative impact on public health.
Comments The doctor and dietitian members of the Physicians Committee for Responsible Medicince are very concerned about the propsed dietary fat recommendations. The 2000 guidelines recommend that less than 30 percent of calories be derived from fat. Shifting from that standard to recommending that a range of 20 to 35 percent of calories be derived from fat would do the American public a huge disservice. First of all, there is no evidence to support a minimum fat intake of at least 20% of calories per day. One of the main stated goals of the dietary guidelines is to “provide authoritative advice for people two years and older about how good dietary habits can promote health and reduce risk for major chronic diseases,” so it would seem prudent to make dietary recommendations that at the very least include diets known to arrest and reverse chronic disease. As you know, diets containing less than 20 percent of calories from fat have repeatedly been proven experimentally and therapeutically to provide protection from cancer, diabetes, and other chronic conditions- especially heart disease. Doctors Esselstyn, Ornish, Brown, and Gould have reported arrest and regression studies with coronary heart disease patients using plant-based diets that contain approximately 10% of calories from fat. In fact, there are no studies of arrest and reversal of coronary artery disease with dietary fat levels over 20% of calories. Further, Drs Barnard, Campbell, and others have reported striking results showing the importance of very low fat plant-based diets for the prevention and treatment of cancer, diabetes, obesity and other chronic conditions. These diets have also been shown to increase the overall micronutrient quality of the diet, with increased fiber, potassium and vitamin C intake, addressing many of the current concerns voiced by the Committee. In addition, epidemiologic studies have shown that populations with fat intakes lower that 20 percent of calories from fat have much reduced incidence of heart disease and cancer—the number one and number two killers of Americans. Increasing the upper-limit of calories from fat to 35% is inconsistent with the new food patterns and guidelines developed by the committee to help individuals meet nutrient needs while staying with in calorie limits. As the Committee Report states, “At present, Americans are consuming calories in excess of calorie needs (as manifest by the high prevalence of overweight and obesity) but are not meeting recommended nutrient intakes. This pattern of calorie intakes exceeding energy expenditure results because Americans often consume nutrient-poor and energy-dense foods”. This increase to 35% will confuse the public, and make it more difficult for people to meet nutrient needs while staying within calorie limits, and provide poor, if not potentially dangerous, health advice. Increasing the upper limit to 35% may also have serious consequences on heart disease. The American Heart Association has set the maximum daily percentage of fat from calories at 30. Despite this recommendation, no study has shown an effective reversal of heart disease above 20%. Recent data published has also shown that an LDL under 80 is needed to halt plaque progression. This is not achievable even by the 30% recommended by the AHA. The upper limit should be lowered, not increased. The population would be much better served if the guidelines encouraged individuals to limit total fat intake to closer to 10 to 15 percent of calories by building diets from fruits, vegetables, whole grains, and legumes and limiting or avoiding foods from animal sources and added oils. Finally, this increase could have a significant, negative impact on children. The USDA has currently set the maximum at 30% per day for lunches served in schools, and food services have been struggling to meet this. Despite obesity at epidemic proportions, and type II diabetes gaining in prevalence, schools will now be able to put the fryers back in services while meeting the Nutrition Guideline Committee’s “healthy” recommendations.
Submission Date 9/27/2004 4:54:00 PM
Author Physicians Committee for Responsible Medicine

Summary Numerous scientific studies demonstrate that a low-fat (10% of calories), plant-based diet offers the most cancer-fighting protection of any diet regimen. Fat in the diet hinders the immune system, and fatty foods boost the hormones that promote cancer, and decrease cancer survival.
Comments The recommended calories coming from fat range is too high at 20%-35%. Numerous scientific studies demonstrate that a low-fat (10% of calories), plant-based diet offers the most cancer-fighting protection of any diet regimen. Not only does fat in the diet hinder the immune system, but also fatty foods boost the hormones that promote cancer, and decrease cancer survival. Specifically, diets rich in meat, dairy products, fried foods, and even vegetable oils cause a woman’s body to make more estrogen. In turn, that extra estrogen increases cancer risk in the breast and other organs that are sensitive to female sex hormones. A 2003 study, published in the Journal of the National Cancer Institute, found that when girls aged eight to ten reduced the amount of fat in their diet their estrogen levels were held at a lower and safer level during the next several years. By increasing vegetables, fruits, grains, and beans, and reducing animal-derived foods, the amount of estradiol (a principal estrogen) in their blood dropped by 30 percent, compared to a group of girls who did not change their diets. In addition, research also shows that dietary fat influences cancer survival. Breast cancer patients who follow lower-fat diets do tend to live substantially longer. Researchers at the State University of New York in Buffalo tracked the diets of 953 women who had been diagnosed with breast cancer, and concluded that the risk of dying at any point in time increased by 40 percent for every 1,000 grams of fat the women consumed per month. The same dietary fat and prostate cancer connection holds true for men. Men on healthier, low-fat diets are less likely to develop cancer in the first place and, if cancer does strike, more likely to survive it. The typical American diet is already way too high in fat, and cancer rates are on the rise—if the recommended range of fat intake is increased and a lower limit is established, fat intake and cancer rates in this country will continue to be high.
Submission Date 9/27/2004 5:00:00 PM
Author from Washington, DC

   EPA/DHA (Fish)
Summary
Comments 2. The Pritikin Eating Plan is not deficient in essential fatty acids. In their recommendations, the panel states that the “very-low-fat content” of diets like Pritikin and Ornish “may increase the risk of essential fatty acid deficiency.” On the contrary, the Pritikin Eating Plan easily meets the body’s needs for essential fats from foods like seafood, nuts, and dark leafy greens. Below is a nutritional comparison of the Pritikin, Atkins, and South Beach diets we recently prepared that demonstrates that the Pritikin Eating Plan is not deficient in any nutrient, even at fewer than 1600 calories a day. Diet Comparison: Pritikin South Beach Atkins Recommended Levels*Males age 51-70(To maintain healthy weight) Total Weight (g) 2,634 1,806 1,267 Calories 1,590 1,586 1,928 Calorie Density (cal/lb) 274 400 688 % Protein 21% 25% 28% 10-35% % Carbohydrate 65% 31% 23% 45-65% Fat-Total 26 83 114 % Fat 14% 47% 53% <30% Saturated Fat 5 19 36 % Saturated Fat 3% 11% 17% <10% Omega 3 3 11 2 ~ 1.5 Omega 6 5 12 8 ~ 4 Cholesterol 84 392 620 <300 Dietary Fiber 50 22 32 >25 Vitamins Vitamin B6 3 2 2 >1.7 Folate 690 325 369 >400 Vitamin K 259 241 70 >120 Pantothenic Acid 5 4 5 >5 Minerals Calcium 1,108 765 553 1,000-1,200 Iron 18 9 13 >8 Phosphorus 1,094 1,140 1,081 >700 Potassium 5,313 3,050 2,314 >3,500 Sodium 854 1,740 3,387 1,200-1,500 Cost $15.60 $14.90 $15.97 3-Day Averages of Components Highlighted numbers are out of range with recommendations. * Based on the Recommended Dietary Allowances (RDA), Dietary Reference Intakes (DRI), and the Institute of Medicine (IOM) recommended levels of components.
Submission Date 9/27/2004 5:46:00 PM
Author Pritikin Longevity Center

   Total Fat
Summary Encourage traditional, local processing, minimizing preservatives. Use the whole wild or pasture raised animal (organs, bones, AND fat)for its nutrients, and gathered or locally raised fruits, vegetables, and grains. Improve family dinner-time by preparing foods together and eating to satisfaction.
Comments Thank you for allowing input. I would like to see a return to a circle of foods, as done in the Native American symbols with the 4 directions. Here on the reservation those who eat more traditional foods, with hunting and fishing do much better with their health. Our children need whole foods, including all parts of the animal, using the fat for its strength and the bones for their soup. We need the fruits and berries, plants and roots for their healthful properties. We do not need the sugar drinks and alcohol from the supermarket. Even the lard from pigs and tallow from beef has high nutrients when raised as nature meant, without hormones, without additives, out in the sun, and on the range - much better than vegetable oils and margarines and crisco that are little better than plastic to our bodies. Please encourage the use of traditional foods from whatever culture they may come from, as additive free as possible, without the dyes and preservatives that harm our sensitive members. Encourage artisan breads and cheeses, without the current requisite pasteurization. We want clean food from clean facilities, not sterilized food from unknown sources. If it comes from overseas, let it be from quality sources. Above all, healthy wild food being the best, and healthy homegrown or locally grown without the many flavorings and other additives needed to cover the sterile taste of sterile food. Were commodities to change the crisco to the original lard, tallow, butter of the healthy animal or even the coconut and palm oil of early shortenings, and deliver the cow on the hoof again, we would have made a profound start in alleviating the burden of diabetes. God delivered the bounty for our use in carefulness, and not in waste. Even the mediterraneans ate boiled eggs, cheese, olives, tomatoes and cucumbers as a breakfast - traditional foods wherever we are should be remembered. We can only do that by emphasizing the whole animal and allowing small craftmanship to be retailed, as in tiny three cow dairies, 10 pig farms, and makers of traditional foods using real kidney fat for the pemmican, lard for native tortillas, unpasteurized milk for cheeses, and real intestine and bones for the native soups. Please emphasize the use of traditional, home, and small-crafted foods. Even some of the Native American tribes made their own fermented drinks, mostly sour, with any alcohol being counteracted by the high quantity of B-vitamins in these indegenous drinks (example, pulque is undistilled, also unfermented in its traditional state, and not able to be transported very far - by distilling something similar to make Tequila, you develop the problems of severe intoxication. The Cherokees fermented a sour corn drink for visitors, releasing its nutrients to the highest advantage. Alcoholism is a plague killing many, and disabling many others. By returning even to the traditions of unpasteurized beer on the tap, we would have at least maintained the B-vitamins and kept the drunkenness to the taverns, minimizing its presence behind the wheels. Traditional drinks, including traditionally fermented ginger ale and native herbal flavored teas contain nutrients that strengthen constitution and also provide much less sugar than do the soft drinks of the convenience store. One last item that may be of interest - our main diabetes did not start until after the second world war. Part can be attributed to the employment in factories to build armament, but remember also that dried yeast was transmitted to us after Germany was defeated. Before that, bread in all countries was made by a slow-rise, equivalent to what we call sour-doughs today, even though many slow-rise breads are not sour. The grandmas here call them Gabubu bread. You start by mixing flour and water and over a few days it starts to rise, and that is used as a start for whatever bread you may make. 24 hour plus fermentations allow the bacteria to eat starch and make the goo that allows even rye breads to rise. The bacteria also decrease the glycemic index, decrease many nutrients that originally are bound by phytic acid such as iron, and make it a healthy food for diabetics. In international aid, private foundations have started to send prefermented grains, knowing that to save children on limited protein and fats, they must have the maximum available nutrition from the limited food they do receive, which necesitates fermentations of grains. Native americans consuming the flour delivered in bags in the first commodities didn't get diabetes partly because they had to ferment the flour in order to make some breads taught to them by the whites, except for times when soda ash and baking soda were used, and even then they were often used with soured milk/buttermilk from the cows delivered to them. When frying started, they used real beef tallow, which is absorbed less into the fried substance than vegetable oils do. The mennonite colonies here in NE Montana also cook sourdough breads for themselves, although they bake quick yeast leavened breads for the outside farmers markets. They have broad straight jaws and teeth, and healthy trim but strong figures. The homemade, homegrown diet includes garden items, chicken eggs, milk products, and meat all from their own colony. The health of the traditional foods, although quite different from the Native American tribal foods, is still very evident. Although a colony existence is not the mainstream, we can encourage local neighborhood artisanship. In the larger community nationwide, we can start by encouraging traditional, lesser processed foods with natural preservation techniques such as salting, natural pickling, drying, and sour fermenting. We can also require the use of strong labeling for any chemical preservatives. Bright labeling of hydrogenated and partially hydrogenated fats would be helpful. An encouragement of organic, animal or tropical natural fats in place of vegetable oils, especially in frying, would also be appreciated. Again, an emphasis on the traditional foods, homegrown or healthily grown and prepared would be appreciated. When we tell people that fats are bad, especially the ones with the vitamins A and D, and the CLA that is so beneficial to the body, we set them up to eat carbohydrates using quick leavens and vegetable oils that encourages that leaves them unsatisfied, thus driving them towards sodas and alcohol. Kibbe Conti, a dietician from the Rosebud reservation, taught the 4 winds concept, a circle of nutrition. Other than the fact she thought that the traditional diet is low fat, she was right on. She forgot that 'taneega' (intestines soup saved for the elders of tribe first)and 'was-na'(8 parts pounded dried meat and berries to one part melted fat from above the kidneys)are just prime examples of how traditional native american foods valued the whole animal. I am a newcomer, having only been on the reservation for two years, but in that time have been priveled to learn how valuable the Native American traditional foods are, as well as the traditional foods from the American, Mexican, and middle-eastern traditions I grew up with. Sincerely, Julene McCurry
Submission Date 9/27/2004 9:47:00 PM
Author Indian Health Service/Tribal Diabetes Program

Summary Encourage traditional, local processing, without preservatives. Use the whole wild or pasture raised animal (organs, bones, AND fat), and gathered or locally raised fruits, vegetables, and grains. Improve family dinner-time by preparing God-given foods together and eating to satisfaction.
Comments Corrected version - original version I stated that fermenting decreases nutrients such as iron, which was a typographical error, please note, iron availability increases with slow fermentation of grains! Thank you for allowing input. I would like to see a return to a circle of foods, as done in the Native American symbols with the 4 directions with buffalo (or animals) from the north, gathered ones (fruits, berries, vegetables, herbs) from the east, traded ones (squashes, corn, beans, starchy vegetables) from the south, and water from the west,if I remember right! Here on the reservation those who eat more traditional foods, with hunting and fishing do much better with their health. Our children need whole foods, including all parts of the animal, using the fat for its strength and the bones for their soup. We need the fruits and berries, plants and roots for their healthful properties. We do not need the sugar drinks and alcohol from the supermarket. Even the lard from pigs and tallow from beef has high nutrients when raised as nature meant, without hormones, without additives, out in the sun, and on the range - much better than vegetable oils and margarines and crisco that are little better than plastic to our bodies. Please encourage the use of traditional foods from whatever culture they may come from, as additive free as possible, without the dyes and preservatives that harm our sensitive members. Encourage artisan breads and cheeses, without the current requisite pasteurization. We want clean food from clean facilities, not sterilized food from unknown sources. If it comes from overseas, let it be from quality sources. Above all, healthy wild food being the best, and healthy homegrown or locally grown without the many flavorings and other additives needed to cover the sterile taste of sterile food. Were commodities to change the crisco to the original lard, tallow, butter of the healthy animal or even the organic coconut and palm oil of early shortenings, and deliver the cow on the hoof again, we would have made a profound start in alleviating the burden of diabetes. God delivered the bounty for our use in carefulness, and not in waste. Even the mediterraneans ate boiled eggs, cheese, olives, tomatoes and cucumbers as a breakfast - traditional foods wherever we are should be remembered. We can only do that by emphasizing the whole animal and allowing small craftmanship to be retailed, as in tiny three-cow dairies, ten-pig farms, and makers of traditional foods using real kidney fat for the pemmican, lard for native tortillas, unpasteurized milk for cheeses, and real intestine and bones for the native soups. Please emphasize the use of traditional, home, and small-crafted foods. Even some of the Native American tribes made their own fermented drinks, mostly sour, with any alcohol being counteracted by the high quantity of B-vitamins in these indegenous drinks (example, pulque is undistilled, also unfermented in its traditional state, and not able to be transported very far - by distilling something similar to make Tequila, you develop the problems of severe intoxication). The Cherokees fermented a sour corn drink for visitors, releasing its nutrients to the highest advantage. Alcoholism is a plague killing many, and disabling many others. By returning even to the traditions of unpasteurized beer on the tap, we would have at least maintained the B-vitamins and kept the drunkenness to the taverns, minimizing its presence behind the wheels. Traditional drinks, including traditionally fermented ginger ale and native herbal flavored teas contain nutrients that strengthen constitution and also provide much less sugar than do the soft drinks of the convenience store. One last item that may be of interest - our main diabetes did not start until after the second world war. Part can be attributed to the employment in factories to build armament reducing physical activity, but remember also that dried yeast was transmitted to us after Germany was defeated. Before that, bread in all countries was made by a slow-rise, equivalent to what we call sour-doughs today, even though many slow-rise breads are not sour. The grandmas here call them Gabubu bread. You start by mixing flour and water and over a few days it starts to rise, and that is used as a start for whatever bread you may make. 24-hour plus fermentations allow the bacteria to eat starch and make the goo that allows even rye breads to rise. The bacteria also decrease the glycemic index, increasing many nutrients such as iron that originally had been bound by phytic acid, and make it a healthy food for diabetics. In international aid, private foundations have started to send prefermented grains, knowing that to save children on limited protein and fats, they must have the maximum available nutrition from the limited food they do receive, which necesitates fermentations of grains. Native americans consuming the flour delivered in bags in the first commodities didn't get diabetes partly because they had to ferment the flour in order to make some breads taught to them by the whites, except for times when soda ash and baking soda were used, and even then they were often used with soured milk/buttermilk from the cows delivered to them. When frying started, they used real beef tallow, which is absorbed less into the fried substance than vegetable oils do. The Mennonite colonies here in NE Montana also cook sourdough breads for themselves, although they bake quick yeast leavened breads for the outside farmers markets. They have broad straight jaws and teeth, and healthy trim but strong figures. The homemade, homegrown diet includes garden items, chicken eggs, milk products, and meat all from their own colony. The health of the traditional foods, although quite different from the Native American tribal foods, is still very evident. Although a colony existence is not the mainstream, we can encourage local neighborhood artisanship. In the larger community nationwide, we can start by encouraging traditional, lesser processed foods with natural preservation techniques such as salting, natural pickling, drying, and sour fermenting. We can also require the use of strong labeling for any chemical preservatives. Bright labeling of hydrogenated and partially hydrogenated fats would be helpful. An encouragement of organic, animal or tropical natural fats in place of vegetable oils, especially in frying, would also be appreciated. Again, an emphasis on the traditional foods, homegrown or healthily grown and prepared would be appreciated. When we tell people that fats are bad, especially the ones with the vitamins A and D, and the CLA that is so beneficial to the body, we set them up to eat carbohydrates using quick leavens and vegetable oils that encourages that leaves them unsatisfied, thus driving them towards sodas and alcohol. Kibbe Conti, a dietician from the Rosebud reservation, taught the 4 winds concept, a circle of nutrition. Other than the fact she thought that the traditional diet is low fat, she was right on. She forgot that 'taneega' (intestines soup saved for the elders of tribe first)and 'was-na'(8 parts pounded dried meat and berries to one part melted fat from above the kidneys)are just prime examples of how traditional native american foods valued the whole animal. I am a newcomer, having only been on the reservation for two years, but in that time have been priveleged to learn how valuable the Native American traditional foods are, as well as the traditional foods from the American, Mexican, and middle-eastern traditions I grew up with. Sincerely, Julene McCurry
Submission Date 9/27/2004 10:08:00 PM
Author Indian Health Service/Tribal Diabetes Program

   EPA/DHA (Fish)
Summary Dietary guidelines should encourage consumers to select foods that are significant sources of DHA and EPA and not be limited to fish. Guidelines should reflect Executive Summary and address concerns with methyl mercury in fish.
Comments September 27, 2004 VIA ELECTRONIC SUBMISSION Kathryn McMurry HHS Office of Disease Prevention and Health Promotion Office of Public Health and Science 1101 Wootton Parkway, Suite LL100 Rockville, MD 20852 Re: Final Report of the Dietary Guidelines Advisory Committee (69 Fed. Reg. 52697 (August 27, 2004)) Dear Ms. McMurry: Thank you for the opportunity to comment on the final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2005. Martek Biosciences Corporation (Martek) develops, manufactures, and sells products from microalgae, including specialty nutritional oils for infant formula that aid in the development of the eyes and central nervous system in newborns and nutritional supplements and food ingredients that may play a beneficial role in promoting mental and cardiovascular health throughout life. Martek appreciates the efforts of the Dietary Guidelines Advisory Committee and the Departments of Health and Human Services and Agriculture to formulate sound dietary guidance for consumers. Martek is submitting its full comments in this letter and attaching a bibliography of the scientific studies referenced in the comments and a one-page comment summary, as requested. The Executive Summary of the 2005 Report of the Dietary Guidelines Advisory Committee (¡§the Committee¡¨) suggests that consumers eat two servings of fish per week, particularly fish that are rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), for cardiovascular protective effects. More specifically, a reduced risk of both sudden death and coronary heart disease (CHD) death in adults was noted as being associated with consumption of two servings (approximately eight ounces) per week of fish high in the omega-3 fatty acids EPA and DHA. The Report then went on to state that it is advisable for pregnant women, lactating women, and children to avoid eating fish with a high mercury content and to limit their consumption of fish with moderate mercury content, and pointed to current consumer advisories to identify fish species to limit or avoid in order to reduce exposure to environmental contaminants. Martek commends the Committee for recognizing the important relationship between DHA and EPA consumption and a reduced risk of CHD. Martek believes that the Committee¡¦s recommendation, however, is inconsistent with the larger body of evidence because it focuses exclusively on fish rather than DHA and EPA. The Committee recognized that the DHA and EPA content of fish is largely responsible for the cardiovascular benefits. The Committee also acknowledged that CHD risk reduction has been demonstrated by clinical studies with dietary supplements of DHA and EPA. The Committee, nonetheless, limited its recommendation to fish consumption. Martek believes that a review of the available data establishes convincingly that it is the DHA and EPA in fish that is largely responsible for the effect of fish on reducing the risk of CHD. Indeed, in its review of the relationship between DHA and EPA consumption and a reduced risk of CHD, FDA concluded that there are sufficient data to support the qualified health claim on foods and dietary supplements that provide DHA and EPA. In light of the compelling data and information establishing the relationship between DHA and EPA and a reduced risk of CHD, the final dietary guidelines should be broader than they are by encouraging Americans to select foods that contain EPA and DHA. As structured, the narrow reference to fish intake is likely to result in fewer Americans actually consuming DHA and EPA, obviously an undesirable result. Buried in the Report¡¦s Fats section under information regarding the relationships between omega-3 fatty acid intake and health (Question 6), the Committee made a passing reference to the fact that other sources of EPA and DHA are on the market. However, the references left the inaccurate impression that sources other than fish were more experimental, not necessarily effective, and not widely available. It is critically important that HHS and USDA make it clear that the essential nutrients needed in the diets of consumers are DHA and EPA, which can be found in numerous sources, including fish. DHA can be found in a broad number of sources other than fish, such as DHA-enriched eggs, foods that are fortified with DHA and dietary supplements. A message that focuses on fish, rather than DHA and EPA, will fail to inform consumers of the importance of looking for other foods that may be significant sources of these nutrients. Martek also believes it is imperative that the final dietary guidelines alert pregnant and lactating women and children to limit intake of fish due to concerns with methylmercury. The Committee recognized the importance of this issue and included a statement in the Executive Summary alerting pregnant women, lactating women, and children to avoid eating fish with a high mercury content and limit their consumption of fish with moderate mercury content, and pointed to current consumer advisories to identify fish species to limit or avoid in order to reduce exposure to environmental contaminants. The Committee¡¦s recommendation mirrors the advisories issued by FDA and the Environmental Protection Agency regarding methylmercury in fish and shellfish and their consumption by women who are or may become pregnant, nursing mothers and young children. / When a food, like fish, is being actively promoted for its health benefits in the diet, there is a critical need for a balanced representation of benefits and risks. / Education about, and promotion of, the intake of DHA will help ensure that consumers obtain this nutrient from a variety of sources in the diet, which will decrease the ultimate risks to infants and young children associated with consumption of more than 2 servings of fish per week. An informational message similar to that found in the Committee¡¦s Executive Summary must be included in the final dietary guidelines to ensure that this vulnerable subpopulation has the information that is needed when selecting the foods that will be incorporated into their diets. Martek also believes that the Dietary Guidelines should focus on DHA, rather than fish as a source of DHA, because of the extensive data and information establishing the importance of selecting diets that contain pre-formed DHA for reasons other than CHD risk reduction. What the Committee overlooked, and did not include in the Report, is the important role DHA plays as a major structural component in the development and continuing performance of the brain and eyes from the very early stages of a baby¡¦s development (pre-birth) and throughout the life of an adult. Extensive studies, of which an overview and bibliography are provided below, demonstrate the importance of choosing a diet that contains DHA for many reasons, in addition to its well-recognized role in reducing the risk of cardiovascular disease. For example, during the past five years, epidemiologic studies have consistently shown an association between increased DHA consumption and decreased risk for chronic disease, including dementia and age-related macular degeneration, as well as cardiovascular disease. Martek strongly encourages HHS to recognize the essentiality and numerous health benefits of consumption of DHA, along with the variety of sources from which DHA can be obtained, in its final Dietary Guidelines. As Nutrition and Your Health: Dietary Guidelines for Americans, 2005 is prepared, HHS and USDA should actively and directly encourage the use of DHA, not merely fish consumption, for the reasons outlined above. Consumers should be provided with full information regarding DHA and the array of sources for this nutrient. In support of Martek¡¦s comments and suggestions, we are providing substantial data set forth below to further demonstrate DHA¡¦s importance in eye and brain development and the significant role it plays in supporting brain, eye and cardiovascular health throughout life. A bibliography of the studies outlined below is attached to this letter. These data support the development of a Dietary Guideline that focuses on increasing intake of dietary sources of DHA. DHA omega-3 is a major structural fat in brain and eyes and is a key component of the heart. DHA is an integral component of all membranes in the body. Unlike other omega-3 fatty acids, DHA is significantly enriched in tissues such as the brain and retina and is essential for optimal function. DHA represents up to 20% of total fatty acids or approximately 1% of the total dry weight of the brain and up to 50% of the fatty acids in the retina (Uauy, Hoffman et al., 2001). The total DHA ¡§content¡¨ within tissues is likely greater than that reported in most studies because conventional gas and thin-layer chromatography methods cannot detect DHA conversion products such as resolvins, plasmologens, and docosatriene products (Beaumelle and Vial, 1986; Gronert, Clish et al., 1999; Hong, Gronert et al., 2003). Concentrations of the other omega-3 fatty acids, specifically ALA and EPA, in the brain and retina are minimal (Lauritzen, Hansen et al., 2001). In fact, ALA typically represents less than 0.5% of the total fatty acids in cell membranes of any tissue in healthy human adults (Lauritzen, Hansen et al., 2001). While ALA is termed an ¡§essential¡¨ fatty acid, its only known biological roles in the body are to supply energy to tissues and to serve as a substrate for formation of long-chain omega-3 fatty acids. The 2002 Institute of Medicine¡¦s, Dietary Reference Intakes: Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids (IOM Macronutrients Report) states that ¡§the physiological potency of EPA and DHA is much greater than that for [ALA]¡K.¡¨ (p. 11-2) and concludes ¡§the essential role of [ALA] appears to be its role as precursor for synthesis of [EPA] and DHA¡¨ (p. 8-18) and ¡§[ALA] is not known to have any specific functions other than to serve as a precursor for synthesis of EPA and DHA¡¨ (p. 8-11). Conversion of ALA to DHA can be highly variable between individuals, however, it is clear that conversion of ALA to DHA is particularly inefficient in the U.S. population that consumes high levels of omega-6 fatty acids, predominantly linoleic acid (Burdge, 2004). Moreover, uptake of DHA by tissues such as the brain, retina, mammary gland and placenta is highly efficient, whereas uptake of ALA is significantly reduced in these tissues compared to pre-formed DHA (Bazan and Scott, 1990; Greiner, Winter et al., 1997; Haggarty, Ashton et al., 1999; Su, Bernardo et al., 1999; Lauritzen, Hansen et al., 2001; Larque, Demmelmair et al., 2003). In adult humans, Pawlosky et al. (Pawlosky, Hibbeln et al. 2003) calculated the half-life (18¡Ó8 hr) and the mean flow rate (7.2 mg/hr) for the removal of deuterated-DHA from plasma. Over a 24-hour period, about 173 mg of DHA was lost from plasma and either catabolized or taken up into other organ systems. This level may provide a very conservative estimate of the amount of DHA required on a daily basis to maintain the plasma DHA concentration; however, demands by the whole body for DHA would be significantly higher. DHA omega-3 is important for brain and eye development in infants and supports brain, eye and cardiovascular health throughout life. Delayed visual acuity has been repeatedly demonstrated in term and preterm neonates fed formula containing ALA as the sole source of omega-3 fatty acids (Makrides, Neumann et al., 1996). Supplementation of infants with formula containing pre-formed DHA in the first four months of life or after weaning from breast-milk at 4 to 6 months of age through the first year of life leads to significantly improved visual acuity compared to neonates fed formula without pre-formed DHA (Birch, Hoffman et al., 1998; SanGiovanni, Parra-Cabrera et al., 2000; Uauy, Hoffman et al., 2003). Brain growth and the rate of DHA uptake by the human brain are maximal in the third trimester of pregnancy to birth. Between birth and 5 years of age, the human brain increases approximately 3.5-fold in mass and DHA content increases from 1 g to approximately 4.5 g (calculated from Martinez, 1992). While the rate of DHA accretion slows after 3 years, significant accretion continues between 3 and 5 years of age (Martinez, 1992). Based on DHA accretion curves from autopsy brains, and estimates of DHA uptake in primates, average daily dietary DHA intake required for the brain to accrete 3.5 g of DHA between birth and 5 years of age would be greater than 120 mg per day (calculated from Martinez, 1992). Data were adjusted for DHA uptake as referenced in Su et al., 1999. A small amount of DHA is lost from tissues daily and must be replaced to maintain optimal tissue DHA levels. Turnover can be estimated from isotopic studies that measure the amount of fatty acid extracted from plasma and retained by a tissue. Rates of DHA turnover in brain and other tissues of the body have not been studied in primates, but data from rodents suggests that between 2 and 8% of esterified DHA present in brain is replaced daily (Rappoport, 2001). Although estimates of DHA turnover in human brain have not been experimentally derived, turnover of arachidonic acid (ARA) in the human brain has been measured and is known to be approximately 10-fold lower than turnover of ARA in rodents. Therefore, a conservative estimate of DHA turnover in humans would likely mirror the relative magnitude that is observed for ARA turnover in humans. Rappoport estimated that the uptake of DHA from plasma to rat brain was 2-8% of the total brain esterified DHA. Thus, if it were assumed that the same 10-fold difference in amount of fatty acid turnover observed between human and rat brain ARA also applied to turnover of DHA, then 0.2-0.8% of brain DHA would be replaced daily in the human brain. The amount of DHA lost from the brain due to turnover on a daily basis would therefore range between 10 and 50 mg per day. Given that average daily DHA intakes of American children range between 20 to 30 mg daily, dietary intake of pre-formed DHA alone would unlikely be able to provide sufficient DHA to support brain growth, and, more significantly, would not even be able to supply the brain with sufficient DHA to replace DHA losses due to turnover. Reliance on ALA as the sole source of DHA for children would not provide adequate DHA to support growth and DHA turnover in tissues. The IOM Macronutrient Report summarizes the data on health benefits associated with diets containing omega-3 fatty acids and states ¡§[a] growing body of literature suggests that higher intakes of ALA, EPA and DHA may afford some degree of protection against coronary heart disease¡¨ (p. 11-1 to 11-2) and ¡§Growing evidence suggests that dietary omega-3 polyunsaturated fatty acids (EPA and DHA) reduce the risk of coronary heart disease and stroke¡¨ (p. 11-40). The Macronutrient Report identifies the mechanisms that may affect the ability of omega-3 fatty acids to reduce the risk of cardiovascular disease by preventing arrhythmias, reducing atherosclerosis, decreasing platelet aggregation by inhibiting the production of thromboxane, decreasing plasma triacylglycerol concentrations, producing a small increase in high-density lipoprotein (HDL) cholesterol with an accompanying decrease in triacylglycerol concentrations, decreasing proinflammatory eicosanoids and moderately decreasing blood pressure (p. 11-40 to 11-43). Additionally, DHA exerts numerous effects on cardiac and vascular tissue, including reduction of heart rate and heart muscle contractility, (Sergiel, Martine et al., 1998; Kang and Leaf, 1994), reduced vascular wall thickness (Engler, Engler et al., 2003), and improved vascular relaxation (Grimsgaard, Bonaa et al., 1998 ; Hirafuji, Ebihara et al., 1998; Mori, Watts et al., 2000; Leeson, Mann et al., 2002). Moreover, a prospective, open-label trial of LC-PUFA supplementation has shown that LC-PUFA supplementation reduces mortality, nonfatal myocardial infarction and nonfatal stroke (Stone, 2000). The essential nutrient DHA can be obtained from numerous foods fortified with DHA, dietary supplements, and from fish. Current food consumption patterns suggest that pre-formed DHA in the U.S. diet is progressively decreasing. Consumption of high DHA sources, such as canned sardines, have decreased by half since 1970 (USDA, 1999) and while fish consumption has increased from 1970, 48% of that increase is from fresh/frozen shellfish, a low fat/low DHA source (USDA, 1999). Pre-formed DHA is the most reliable way to ensure that sufficient DHA is available to meet requirements imposed by growth and nutrient turnover content in tissues. The current CSFII data indicate that the DHA intake in the U.S. averages about 57 mg/day for all individuals. The recent NHANES specifically over-sampled children 5 years or younger to produce more precise nutrition information in this population group. NHANES data indicate that children in this age group consume only 20-30 mg/day of pre-formed DHA. The NHANES data also provides pre-formed DHA intakes not available from the current CSFII data. Specifically, Mexican American women of child-bearing age seem to be particularly at risk for low DHA status as their estimated intake of pre-formed DHA is only 45 mg/day and their dietary LA:ALA ratio is the highest among all women at 12.1:1. It appears that youth in America (< 18 years) may also be at risk for compromised DHA status as the estimated intake of pre-formed DHA for this population is 30 mg/day with a ratio of LA:ALA of 10.5:1. Given that the conversion of ALA to DHA may be as low as 8% (Burdge 2004) a maximum of 128 mg of DHA may be derived from ALA assuming an ideal LA:ALA intake. While a dose response study of varying LA:ALA ratios on DHA derivation has not been completed, it has been suggested that a range of 5:1-10:1 is ideal. Current LA:ALA ratios in the U.S. meet or exceed these recommendations in several subpopulations. Regardless, if one assumes that 128 mg of DHA are provided daily from ALA and that the average intake of preformed DHA may be as low as 20-50 mg for certain vulnerable subpopulations, the net DHA status for many may be as low as 148-178 mg. Women who are pregnant or lactating should increase their DHA omega-3 intake by selecting foods that are significant sources of DHA, such as foods supplemented with DHA, dietary supplements, or fish (keeping in mind mercury concerns and recommended FDA consumption limits). Current literature clearly supports the need for higher levels of DHA during pregnancy, lactation, and growth and development. The data also indicate that intake of pre-formed DHA among these subpopulations is quite low. For example, pregnant and lactating women are reported to have the lowest DHA intake among women of childbearing age with a mean of 52 „b 12 mg/day vs. 62-71 mg/day among women of child-bearing age (14-50 yrs). Children ages 1-5 years also are reported to have low intakes of DHA ranging from 30-50 mg/day. The fetus has a high requirement for DHA, particularly during the last trimester of gestation when brain tissue expansion is maximal. The brain of a full-term infant at birth weighs approximately 370 g and contains approximately 1 g of DHA (calculated from information provided in Martinez, 1992). If a constant rate of DHA uptake was maintained by the fetus throughout gestation, the fetal brain would deposit approximately 3.5 mg of DHA per day into tissue. It should be noted that plasma DHA does not efficiently cross the blood-brain barrier, and approximately 1 in 60 molecules of DHA present in plasma actually reaches the brain in neonatal primates (Su et al., 1999). Assuming that a similar rate of DHA uptake is observed in fetal brain, approximately 210 mg of DHA per day, throughout pregnancy, would be required to produce the desired DHA accretion in brain. The requirement for DHA by the human fetus is not constant, however, because the most significant rate of brain growth and retinal development occurs during the last trimester (Martinez, 1992). If 75% of the DHA (or approximately 0.75 g) required for intrauterine brain growth is deposited in the last trimester, the brain would accrete approximately 8 mg per day which translates into approximately 480 mg of DHA in plasma daily if the rate of DHA uptake by the fetal brain is similar to that of the baboon neonate. Higher maternal and infant DHA status at delivery has been related to improved neurodevelopment and function in the newborn. Cheruku et al. (2002) have reported that sleep patterns of full-term infants born to U.S. mothers with higher plasma phospholipid DHA at delivery are suggestive of greater infant central nervous system (CNS) maturity. Helland et al. (2001) have also reported higher EEG maturity scores for term neonates with higher concentrations of DHA in umbilical plasma phospholipids. Increased umbilical fatty acid composition is directly related to maternal status during pregnancy (Helland et al., 2001). Enhanced CNS maturity at birth appears to predict visual function later in life. DHA status at delivery has been linked to early postnatal development of the pattern-reversal visual evoked potential among term infants suggesting that DHA status may influence maturation of central visual pathways (Malcom et al., 2003). This pattern continues to be evident in later life as visual stereoacuity has been found to be significantly enhanced among 3.5 year olds whose mothers reported consuming high DHA diets during pregnancy and who exhibited significantly higher red blood cell phospholipid DHA (Williams et al. 2001). Maternal intake of DHA during pregnancy has also been reported to significantly enhance mental processing scores of children at 4 years of age (Helland et al., 2003). Most recently, Colombo and coworkers (2004) reported a significant enhancement of cognitive development at 18 months among children whose mothers had high DHA status at birth. Similar effects have been shown for long-term neurodevelopmental outcomes in newborns fed DHA-supplemented formula or DHA-enriched maternal milk. Not all studies, however, have found a significant association between maternal DHA status at delivery and infant developmental outcomes (Ghys et al., 2002; Bakker et al., 2003). Recently, the UK Scientific Advisory Committee on Nutrition suggested that a woman would need to accumulate 22-25 g of DHA during her pregnancy to meet fetal demands, support lactation, and satisfy her own intrinsic requirements for DHA. To meet increased needs, pregnant women in the U.S. would need to at least double their intake of DHA, yet CSFII data suggests that pregnant and lactating women actually consume less DHA than their non-pregnant counterparts. Production of milk during lactation places tremendous nutritional demands on the female. DHA levels in breast milk decline during the first several weeks postpartum in women consuming a typical North American diet (Fidler et al., 2000), most likely because dietary DHA consumption and DHA stores are insufficient in maintaining high levels of DHA in milk beyond periods of lactation > 8 weeks (Otto et al., 2001). Otto et al. (2001) have indicated that dietary intakes of approximately 90 mg DHA, 1.1 g ALA, and a LA:ALA ratio of 12.5:1 per day fail to support the DHA requirements of lactating women. In the U.S., lactating women consume about 50 mg of DHA, 1.4 g ALA per day against a 10:1 LA:ALA ratio (CSFII Tables). Importantly, Francois et al. (2003) reported that dietary ALA supplementation (10.7 g/day) of women living in North America has no effect on breast milk or maternal plasma phospholipid DHA indicating that support of maternal DHA status post-partum relies directly on DHA from the diet. Several studies have found that increasing the level of DHA an additional 200 mg (total intake about 300 mg/day) in the diet of lactating women maintains higher breast milk DHA levels (Jensen et al, 2000; Fidler et al., 2000). Consumption of high levels of DHA, either from breast milk or from formula, appears to have a significant impact on visual and neurological development, not only in the neonatal period, but also in later life. These ranges of observed benefits include improved visual acuity (Uauy, Hoffman et al., 2003), motor development (Birch, Garfield et al., 2000), maturation of sleep patterns (Cheruku, Montgomery-Downs et al. 2002), sustained attention and problem-solving (Willatts, Forsyth et al., 1998; Willatts, Forsyth et al., 2003) and other cognitive measures (Colombo, 2004). Additional studies have reported that supplementation with DHA beyond the neonatal period may improve cardiovascular health and reduce aggressive behavior in children (Hamazaki, Sawazaki et al., 1996; Hamazaki, Sawazaki et al., 1998; Hamazaki, Sawazaki et al., 1999; Engler, Engler et al., 2002; Forsyth, Willatts et al., 2003). The data establish the importance of increasing DHA intake for women in this subgroup of the population. It is important, however, that these women be informed of the risks associated with fish consumption due to concerns with methylmercury¡Xa contaminant that can harm an unborn baby¡¦s or developing child¡¦s nervous system. Women in this group must be cautioned to limit intake of those fatty fish that are significant sources of methylmercury. The Environmental Protection Agency and FDA have issued a joint advisory that provides recommendations on fish intake for women who may become pregnant, pregnant women, nursing mothers, and young children. This advisory language must be included in any recommendation about increasing fish intake in order to make certain that this population is advised of the risks. Increased DHA consumption is associated with decreased risk for chronic disease, including dementia, age-related macular degeneration, and cardiovascular disease. In the past five years, epidemiologic studies in humans have consistently reported that fish consumption, and more specifically, dietary DHA may modify risk of dementia or Alzheimer¡¦s Disease (AD) progression. These studies are briefly reviewed below: Kalmijn et al. (1997) conducted a prospective, population-based study to assess whether dietary fat consumption by 5,386 elderly individuals in the Netherlands was related to the risk of incident dementia or AD. In this study, consumption of more than 18.5 g of fish per day provided a significant reduction in the risk of incident dementia (RR = 0.4; p<0.05) and of Alzheimer¡¦s Disease (RR=0.3; p=0.005), compared to consumption of less than 3 g of fish daily. Barberger-Gateau et al. (2002) conducted a study of 1416 home-bound elderly in southwestern France and reported that consumption of fish or seafood at least once per week was positively correlated with reduced risk of dementia (P <0.009). Those individuals who reported never eating fish had a 6.6-fold higher risk of developing dementia and a 5.3-fold greater risk of developing AD. This roughly translates into a 70% reduction in risk of incident AD by those individuals consuming more than one serving of fish per week as compared to those consuming less than one serving of fish weekly. Morris et al. (2003) reported that higher fish consumption was positively correlated with reduced risk of developing AD. In this study, consumption of 1 or more servings of fish per week (equivalent to >100 mg DHA daily) was associated with a 60% reduction in the risk of developing AD as compared to individuals who consumed less than 1 serving of fish per week (p value for trend = 0.07). When regression analyses were performed to evaluate whether estimated individual fatty acid intakes had an effect on incident AD cases, reduced risk of AD was shown only for DHA (p<0.02) but not by EPA or linolenic acid content of the diet when data were adjusted to minimize the effect due to differences in age, sex, race, education, APOE-e4, and length of observation. Tully et al. (2003) reported that serum cholesteryl-ester DHA and EPA levels were significantly lower in patients with AD, as indicated by score on the mini mental state examination, compared to controls. However, step-wise regression analysis showed that serum cholesteryl ester-DHA and total saturated fatty acid levels were the important determinants of the mini mental state exam score and the clinical dementia rating of patients with AD. In a prospective study to assess interrelationships between dietary DHA, fish consumption, plasma phosphatidylcholine (PC)-DHA and the risk of dementia or AD, Schaefer et al. (in press) recently showed that both mean DHA intake (g/day) and mean fish intake (servings per week) estimated from food frequency questionnaires were positively correlated with plasma phosphatidylcholine-DHA levels in the study cohort. In this study, individuals having plasma PC-DHA in the highest quartile had a reduced risk of developing dementia (47% reduction; significant at p<0.05) and AD (41% reduction; p=0.118), compared to individuals whose plasma PC-DHA was within the lower 3 quartiles. When fish consumption, rather than plasma PC-DHA, was used as the predictor of disease risk, the study showed that consumption of more than 2 servings per week of fish (equivalent to >180 mg DHA daily) was associated with a reduced risk of developing dementia (43% reduction; p=0.12) and AD (59% reduction; significant at p<0.05) compared to individuals consuming less than 2 servings of fish per week. The fact that in this study, plasma PC-DHA was a significant predictor for risk of dementia, while fish consumption was a significant predictor of AD, is intriguing and suggests that (1) a longer follow-up time may have been important to show that plasma PC-DHA is a predictor of AD risk and (2) future studies should not ignore the potential impact of plasma EPA and linolenic acid as predictors of AD-risk. Prior cross-sectional studies conducted by Conquer et al. (2000) demonstrated that blood phospholipid fatty-acid profiles are altered in individuals with various types of cognitive impairment. Results from this study showed that the weight percentage of plasma phosphatidylcholine and phosphatidylethanolamine DHA and EPA were significantly lower in patients with AD compared to normal individuals of similar age. The relationship between tissue DHA status and severity or type of dementia is not related to age. Although age is a significant risk factor for AD, brain fatty acid profiles do not significantly change with age in healthy elderly individuals. In contrast, brain phospholipid fatty acid profiles are significantly altered in AD. Soderberg et al. (1992) found that brain PE-arachidonic acid (ARA), PE-DHA, and PC-ARA were significantly reduced in the frontal gray, white matter, and hippocampus of AD patients compared to controls. In the pons region, the percent of total fatty acids as PE-ARA and PE-DHA were significantly lower in AD compared to controls, but PC-fatty acid composition of the pons did not differ significantly between AD and controls. Two supplementation studies have been conducted in the elderly with beneficial effects observed in cognitive or behavioral outcomes. In a study to evaluate the benefits of DHA on cognitive performance and visual acuity in the elderly, Suzuki et al. (2001) provided an oil supplement containing 15% purified DHA and 3% purified EPA for six months by addition to food to 30 volunteers between the age of 67 and 92 years. Of the 30 subjects, 22 had dementia. DHA intake was 0.64 to 0.8 g per day and EPA intake was approximately 0.47 g per day. Intelligence was measured before and after supplementation using a revised Hasegawa¡¦s dementia scale. At the end of the six month supplementation period, 18 of 30 subjects (60%) showed intellectual improvement. Intellectual improvement was observed in 6 of 8 (75%) patients without dementia and in 12 of 22 patients (54%) with dementia. In a second cohort of 15 volunteers aged 58 to 84 years, supplementation with 0.73 g of DHA and 0.53 g of EPA per day for 3 months was associated with an improvement in visual acuity in 10 of 15 patients (67%) by 1 month of DHA supplementation. It should be noted, however, that Suzuki et al. (2001) failed to use a placebo in the performance of the study. Age-related macular degeneration (AMD) is the leading cause of blindness in individuals over 75 years of age living in westernized countries. Few studies have fully investigated the relationship between DHA and macular degeneration. Gu et al. (2003) reported that carboxyethylpyrrole, an adduct of DHA, was higher in sera from AMD patients than age-matched controls, and likewise, anti-CEP autoantibodies followed a similar trend. The association between dietary fat intake and AMD incidence is complex. For example, high fish intake is associated with a reduced risk for AMD, but only when the diet is low in linoleic acid. Furthermore, linoleic acid intake itself was associated with increased risk for AMD (Seddon, Rosner et al. 2001). The relationship between the frequency of fish consumption and risk of developing early or later AMD has also been reported in the Blue Mountain Eye Study. In this study, consumption of 1 to 3 servings of fish per month was associated with reduced risk for advanced age-related maculopathy, after adjusting for age and smoking. The risk reduction was greatest in individuals that consumed 1 to 3 servings per month (0.23). * * * Martek appreciates the Agency¡¦s consideration of these comments and looks forward to the development of the 2005 Dietary Guidelines for Americans. Please contact us if we can answer any questions or be of assistance as you move toward finalization of the Dietary Guidelines. Sincerely, Sam Zeller, Ph.D. Director, Regulatory Affairs Martek Biosciences Corporation Bibliography Bakker EC, Ghys AJ, Kester AD, Vles JS, Dubas JS, Blanco CE, and Hornstra G. (2003). Long-chain polyunsaturated fatty acids at birth and cognitive function at 7 y of age. Eur J Clin Nutr 57: 89-95. Bazan NG, and Scott BL. (1990). 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Effect of maternal polyunsaturated fatty acid concentration on transport by the human placenta. Biol Neonate 75(6): 350-9. Hamazaki T, Sawazaki S, Itomura M, Asaoka E, Nagao Y, Nishimura N, Yazawa K, Kuwamori T, and Kobayashi M. (1996). The effect of docosahexaenoic acid on aggression in young adults. A placebo-controlled double-blind study. J Clin Invest 97: 1129-1133. Hamazaki T, Sawazaki S, Nagao Y, Kuwamori T, Yazawa K, Mizushima Y, and Kobayashi M. (1998). Docosahexaenoic acid does not affect aggression of normal volunteers under nonstressful conditions. A randomized, placebo-controlled, double- blind study. Lipids 33: 663-667. Hamazaki T, Sawazaki S, Nagasawa T, Nagao Y, Kanagawa Y, and Yazawa K. (1999). Administration of docosahexaenoic acid influences behavior and plasma catecholamine levels at times of psychological stress. Lipids 34: S33-37. Helland IB, Saugstad OD, Smith L, Saarem K, Solvoll K, Ganes T, and Drevon CA. (2001). 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Relationship between circulating n-3 fatty acid concentrations and endothelial function in early adulthood. Eur Heart J 23(3): 216-22. Malcolm CA, McCulloch DL, Montgomery C, Shepherd A, and Weaver LT. (2003). Maternal docosahexaenoic acid supplementation during pregnancy and visual evoked potential development in term infants: a double blind, prospective, randomised trial. Arch Dis Child Fetal Neonatal Ed 88: F383-390. Makrides M, Neumann MA, et al. (1996). Is dietary docosahexaenoic acid essential for term infants? Lipids 31(1): 115-9. Martinez M. (1992). Tissue levels of polyunsaturated fatty acids during early human development. J Pediatr 120: S129-138. Morris M, Evans D, Bienias J, Tangney C, Bennett D, Wilson R, Aggarwal N, and J. S. (2003). Consumption of fish and n-3 fatty acids and risk of incident Alzheimer disease. Arch Neurol 60: 940-946. Mori TA, Watts GF, et al. (2000). Differential effects of eicosapentaenoic acid and docosahexaenoic acid on vascular reactivity of the forearm microcirculation in hyperlipidemic, overweight men. Circulation 102(11): 1264-9. Otto SJ, van Houwelingen AC, Badart-Smook A, and Hornstra G. (2001). Comparison of the peripartum and postpartum phospholipid polyunsaturated fatty acid profiles of lactating and nonlactating women. Am J Clin Nutr 73: 1074-1079. Pawlosky RJ, Hibbeln JR, Lin Y, Goodson S, Riggs P, Sebring N, Brown GL, and Salem NJ. (2003). Effects of beef- and fish-based diets on the kinetics of n-3 fatty acid metabolism in human subjects. Am J Clin Nutr 77: 565-572. Rappoport SI, Chang MC, and Spector AA. (2001). Delivery and turnover of plasma-derived essential PUFAs in mammalian brain. J Lipid Res 42: 678-685. SanGiovanni JP, Parra-Cabrera S, et al. (2000). Meta-analysis of dietary essential fatty acids and long-chain polyunsaturated fatty acids as they relate to visual resolution acuity in healthy preterm infants. Pediatrics 105(6): 1292-8. Schafer EJ, Kyle DJ, Singer J, Patton GM, Bongard V, Tucker K, Beiser A, Wolf PA. (2003). Plasma phosphatidylcholine (PC) docosahexaenoic acid (DHA), fish intake and risk of dementia. American Heart Assoc Meeting, 2003 (abstract). Seddon JM, Rosner B, Sperduto RD, Yannuzzi L, Haller JA, Blair NP, and Willett W. (2001). Dietary fat and risk for advanced age-related macular degeneration. Arch Ophthalmol 119: 1191-1199. Sergiel JP, Martine L, et al. (1998). Individual effects of dietary EPA and DHA on the functioning of the isolated working rat heart. Can J Physiol Pharmacol 76(7-8): 728-36. Soderberg M, Edlund C, Alafuzoff I, Kristensson K, and Dallner G. (1992). Lipid composition in different regions of the brain in Alzheimer's disease/senile dementia of Alzheimer's type. J Neurochem 59: 1646-1653. Stone, N. J. (2000). The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardio (GISSI)-Prevenzione Trial on fish oil and vitamin E supplementation in myocardial infarction survivors. Curr Cardiol Rep 2(5): 445-51. Su HM, Bernardo L, Mirmiran M, Ma XH, Nathanielsz PW, and Brenna JT. (1999). Dietary 18:3n-3 and 22:6n-3 as sources of 22:6n-3 accretion in neonatal baboon brain and associated organs. Lipids 34: S347-350. Suzuki H, Morikawa Y, and Takahashi H. (2001). Effect of DHA oil supplementation on intelligence and visual acuity in the elderly. World Rev Nutr Diet 88: 68-71. Tully AM, Roche HM, Doyle R, Fallon C, Bruce I, Lawlor B, Coakley D, and Gibney MJ. (2003). Low serum cholesteryl ester-docosahexaenoic acid levels in Alzheimer's disease: a case-control study. Br J Nutr 89: 483-490. Uauy R, Hoffman DR, Mena P, Llanos A, and Birch EE. (2003). Term infant studies of DHA and ARA supplementation on neurodevelopment: results of randomized controlled trials. J Pediatr 143: S17-25. Uauy R, Hoffman DR, Peirano P, Birch DG, and Birch EE. (2001). Essential fatty acids in visual and brain development. Lipids 36: 885-895. USDA Food Consumption Data System, Economic Research Service, available at http://www.ers.usda.gov/data (accessed Aug. 27, 2004). Willatts P, Forsyth J, Agostoni C, Bissenden J, Casaear P, and Behm G. (2003). Effects of long-chain polyunsaturated fatty aid supplementation in infancy on cognitive function in later childhood. Maternal and Infant LCPUFA Workshop, Kansas City, MO. AOCS. Willatts P, Forsyth JS, DiModugno MK, Varma S, and Colvin M. (1998). Effect of long-chain polyunsaturated fatty acids in infant formula on problem solving at 10 months of age. Lancet 352: 688-691. Williams C, Birch EE, Emmett PM, and Northstone K. (2001). Stereoacuity at age 3.5 y in children born full-term is associated with prenatal and postnatal dietary factors: a report from a population- based cohort study. Am J Clin Nutr 73: 316-322. Martek Biosciences Corporation Final Report of the Dietary Guidelines Advisory Committee (69 Fed. Reg. 52697 (Aug. 27, 2004)) Comment Summary The Executive Summary of the final Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2005, suggests that consumers eat two servings of fish per week, particularly fish that are rich in EPA and DHA, for cardiovascular protective effects. Martek believes that this recommendation is too narrow in that it fails to recognize that there are other dietary sources of DHA and EPA. The recommendation also implies that the cardioprotective effects are limited to fish while the data convincingly establish that it is the DHA and EPA in fish that play a significant role in reducing CHD risk factors. Indeed, in the recently issued qualified health claim for DHA and EPA, FDA acknowledges that any source of DHA and EPA is eligible for the qualified health claim. When developing the final dietary guidelines, Martek urges the agencies to harmonize the dietary guidelines with the science and recognize that foods other than fish can be valuable sources of DHA and EPA and provide cardiovascular protective effects. Martek also believes it is imperative that the final dietary guidelines alert pregnant and lactating women and children to limit intake of fish due to concerns with methylmercury. The Committee recognized the importance of this issue and included a statement in the Executive Summary alerting pregnant women, lactating women, and children to avoid eating fish with a high mercury content, limit their consumption of fish with moderate mercury content, and pointed to current consumer advisories to identify fish species to limit or avoid in order to reduce exposure to environmental contaminants. An informational message about the concerns of methylmercury must be included in the dietary guidelines to ensure that this vulnerable population does not inadvertently increase intake of fish that are high in methylmercury. In addition, Martek believes that the Dietary Guidelines should focus on DHA, rather than fish as a source of DHA, because extensive data and information establish the importance of selecting diets that contain pre-formed DHA for reasons other than CHD risk reduction. The Committee did not include in its Report the extensive studies establishing the importance of maintaining dietary sources of DHA, which are summarized in the attached comment. These studies establish that DHA is a major structural component in the development and continuing performance of the brain and eyes from the very early stages of a baby¡¦s development (pre-birth) and throughout the life of an adult. By focusing the dietary guidelines on the section of foods that are significant sources of DHA and EPA, rather than limiting the guidelines merely to increased fish intake, the agencies will help consumers identify foods that provide this valuable nutrient. In conclusion, Martek believes that the final dietary guidelines should encourage consumers to select foods that are significant sources of DHA and EPA such as foods fortified with DHA, dietary supplements and fish that are rich in DHA and EPA, for cardiovascular protective effects. The guidelines also should alert pregnant and lactating women and young children to avoid fish with a high mercury content, to limit consumption of fish with a moderate mercury content and to consult consumer advisories for more information on fish species to limit or avoid.
Submission Date 9/29/2004 10:29:00 AM
Author Anonymous

Summary Flax seeds are an excellent source of omega 3's whereas fish and consumption of other sea animals have the downside of potential mercury content, other contaminants, and significant cholesterol
Comments Flax seeds are an excellent source of omega 3's whereas fish and consumption of other sea animals have the downside of potential mercury content, other contaminants, and significant cholesterol
Submission Date 9/21/2004
Author International Vegetarian Union

   Trans Fat
Summary Bread contains very little total fat and therefore cannot be a major contributor of trans fats. Please remove bread from the "foods high in trans fat" category.
Comments We are also concerned about the chart, Table E-17 which discusses the sources of trans fats in the diet. All baked goods appear to be lumped into one category. While we realize that high fat baked goods often contain trans fats, most breads (white, wheat, whole wheat and multi-grain) contains 0 grams of trans fat. Bread contains very little total fat and therefore cannot be a major contributor of trans fats. Please remove bread from that category. The industry is making incredible strides to remove trans fats from all foods, including those baked goods which are actually high in fat.
Submission Date 9/21/2004
Author The Foundation for the Advancement of Grain Based Foods

Summary Trans fatty acids in the diet, created from partially hydrogenating vegetable oils, have been implicated as causing or exacerbating most of our modern diseases, including heart disease, cancer, diabetes, obesity, immune dysfunction and bone loss
Comments During the early 20th century, most of the fatty acids in the diet were either saturated or monounsaturated, primarily from butter, lard, tallows, coconut oil and small amounts of olive oil; heart disease and obesity were virtually non-existent. Today, most of the fats in our diet are polyunsaturated, primarily from vegetable oils derived from soy, corn, safflower, sunflower, cottonseed and rape seed (canola – primarily monounsaturated).Polyunsaturated fatty acids are very fragile. When exposed to heat and oxygen, as during commercial processing, they form free radicals and other harmful breakdown products that damage the human body in many ways. Trans fatty acids in the diet, created from partially hydrogenating vegetable oils, have been implicated as causing or exacerbating most of our modern diseases, including heart disease, cancer, diabetes, obesity, immune dysfunction and bone loss. In addition, a number of researchers have argued that along with a surfeit of omega-6 essential fatty acids from vegetable oils the American diet is deficient in the more unsaturated omega-3 linolenic acid.
Submission Date 9/21/2004
Author Weston A Price Foundation

   EPA/DHA (Fish)
Summary a number of researchers have argued that along with a surfeit of omega-6 essential fatty acids from vegetable oils the American diet is deficient in the more unsaturated omega-3 linolenic acid.
Comments During the early 20th century, most of the fatty acids in the diet were either saturated or monounsaturated, primarily from butter, lard, tallows, coconut oil and small amounts of olive oil; heart disease and obesity were virtually non-existent. Today, most of the fats in our diet are polyunsaturated, primarily from vegetable oils derived from soy, corn, safflower, sunflower, cottonseed and rape seed (canola – primarily monounsaturated).Polyunsaturated fatty acids are very fragile. When exposed to heat and oxygen, as during commercial processing, they form free radicals and other harmful breakdown products that damage the human body in many ways. Trans fatty acids in the diet, created from partially hydrogenating vegetable oils, have been implicated as causing or exacerbating most of our modern diseases, including heart disease, cancer, diabetes, obesity, immune dysfunction and bone loss. In addition, a number of researchers have argued that along with a surfeit of omega-6 essential fatty acids from vegetable oils the American diet is deficient in the more unsaturated omega-3 linolenic acid.
Submission Date 9/21/2004
Author Weston A Price Foundation

   Saturated Fat
Summary Animal fats, such as butter, lard and tallows, as well as fruit/nut-derived saturated fats – coconut and palm oils - are stable, do not easily develop free radicals, and contain nutrients that are vital for good health.
Comments Animal fats, such as butter, lard and tallows, as well as fruit/nut-derived saturated fats – coconut and palm oils - are stable, do not easily develop free radicals, and contain nutrients that are vital for good health. Children, in particular, require high levels of quality animal fats, such as butter and whole milk products, to achieve optimal physical and neurological development.
Submission Date 9/21/2004
Author Weston A Price Foundation

   Total Fat
Summary Beneficial fats include the primarily saturated butter and other animal fats, coconut and palm oils; monounsaturated fats such as olive oil and peanut oil; and the polyunsaturated omega-3 essential fatty acid from flaxseed oil and fish
Comments Naturally occurring unprocessed fruits, vegetables, whole grains and legumes with non-factory farmed animal and fish protein sources are recommended for longevity and well being. Beneficial fats include the primarily saturated butter and other animal fats, coconut and palm oils; monounsaturated fats such as olive oil and peanut oil; and the polyunsaturated omega-3 essential fatty acid from flaxseed oil and fish
Submission Date 9/21/2004
Author Weston A Price Foundation

   EPA/DHA (Fish)
Summary When developing the final dietary guidelines, we urge the agencies to harmonize the dietary guidelines with the science and recognize that foods other than fish can be valuable sources of DHA and EPA.
Comments We were surprised that the Dietary Guidelines Committee limited their recommendation to fish intake given the extensive discussion establishing that it is the DHA and EPA in fish that are primarily responsible for the cardiovascular benefits. Indeed, in the recently issued qualified health claim for DHA and EPA, FDA acknowledges that any source of DHA and EPA is eligible for the qualified health claim. When developing the final dietary guidelines, we urge the agencies to harmonize the dietary guidelines with the science and recognize that foods other than fish can be valuable sources of DHA and EPA.
Submission Date 9/21/2004
Author Martek Biosciences Corporation

Summary DHA is important for maintaining mental and visual performance in addition to its well-recognized role in reducing the risk of cardiovascular disease. By acknowledging that DHA is present in foods other than fish, the dietary guidelines would help consumers select diets that are rich sources of DHA
Comments DHA is a structural component of many body tissues, including the brain, eye, and heart. While the body can synthesize DHA, the synthesis is slow and inefficient, thereby making it important to get pre-formed sources of DHA in the diet. There are extensive studies demonstrating the importance of choosing a diet that contains DHA from infancy throughout life. These studies establish that DHA is important for maintaining mental and visual performance in addition to its well-recognized role in reducing the risk of cardiovascular disease. By acknowledging that DHA is present in foods other than fish, the dietary guidelines would help consumers select diets that are rich sources of DHA. The ability to identify sources of DHA other than fish is particularly important for pregnant women, lactating women, and children because of the methyl mercury risks presented by certain fish. The concerns with methyl mercury are included in the Executive Summary of the Final Report. It is imperative that the dietary guidelines and educational materials mirror this concern. The failure to include this important, balanced, educational message could result in this vulnerable population inadvertently increasing intake of fatty fish.
Submission Date 9/21/2004
Author Martek Biosciences Corporation

Summary In the key messages on dietary fats, for instance, the recommendation to increase intake of fish should come first.
Comments In the key messages on dietary fats, for instance, the recommendation to increase intake of fish should come first. Being first in order is more likely to lead to compliance with the recommended increase in fish consumption. Capturing consumers’ attention with positive messages increases the likelihood of keeping their interest through the full message.
Submission Date 9/21/2004
Author National Food Processors Association

   Trans Fat
Summary With respect to the recommendation to limit trans fat intake to one percent of calories, NFPA believes that the science base may not be adequate to support the level, and that stronger scientific justification be expressed.
Comments With respect to the recommendation to limit trans fat intake to one percent of calories, NFPA believes that the science base may not be adequate to support the level, and that stronger scientific justification be expressed.
Submission Date 9/21/2004
Author National Food Processors Association

   Saturated Fat
Summary In the more detailed part of the report the statements are all in opposition to choosing saturated fats even though there is ample published evidence that saturated fats are quite healthful and even essential under many circumstances. Coconut oil is an important medium-chain saturated fat, which has
Comments The Key Findings of the 2005 DGA Committee contain the recommendation to ³Choose fats wisely for good health.²  In the more detailed part of the report the statements are all in opposition to choosing saturated fats even though there is ample published evidence that saturated fats are quite healthful and even essential under many circumstances.  This is especially true for coconut oil and its medium-chain tryglyceride fatty acids, which serve as antimicrobial fats, as anti-obesity energy sources, anti-inflammatory fats to fight coronary heart disease, and as fatty acids needed for cellular signaling. Coconut oil is an important medium-chain saturated fat, which has been shown by research to benefit humans by maintaining or increasing HDL cholesterol, by increasing  appropriate weight loss, and by providing antimicrobial benefits. Coconut oil has been recognized  in numerous studies for beneficial effects on CHD risk factors, such as: Sundram et al (1994), who added coconut oil  to diets, found (good) HDL cholesterol  increasing  6.3% and (bad) LDL cholesterol decreasing 0.1%, which clearly showed a desirable effect.  In other trials,  Ng et al (1991) fed 75% of the fat ration as coconut oil (24% of energy) to 83 adult normocholesterolemics (61 males and 22 females).  Relative to baseline values,  HDL cholesterol was increased 21.4% , and the LDL/HDL ratio was decreased 3.6%. Medium-chain saturated fatty acids contained in coconut oil have also been shown in recent years¹ research in both humans and animals to have beneficial effects with respect to weight loss  and maintenance of that weight loss. This research has been done in the United States, Canada, Japan, and several parts of Europe. The antimicrobial effects of lauric acid and other medium-chain saturates from coconut oil have been well-studied and published in numerous journals. The initial effort to demonize saturated fatty acids in general was directed at coconut oil, which contains about 90% saturates and, therefore, the highest of saturated fats.   It should be noted that coconut oil has only 28% long-chain saturates whereas, for example, cottonseed oil has about 30% long-chain saturates (Enig 1991), and other longer-chain saturates can make up close to 65% of some other oils.  These long chain saturates, having desirable cooking, baking, and other functional characteristics, were the competition to the trans fatty acids ­ which HHS now seeks to minimize or remove from in the diet -- and it was the trans fatty acid products the food industry wanted to protect at all costs from even legitimate criticism
Submission Date 9/21/2004
Author Granex Corporation USA

   Total Fat
Summary In order to understand how inappropriate are the 2005 Dietary Guidelines Recommendations regarding saturated fat, you need to know the history of the recommendations beginning with the McGovern Committee Dietary Goals of the late 1970s.
Comments In order to understand how inappropriate are the 2005 Dietary Guidelines Recommendations regarding saturated fat, you need to know the history of the recommendations beginning with the McGovern Committee Dietary Goals of the late 1970s. You need to know that the original recommendations regarding fat were developed by lawyers who had no scientific background and by industry lobbyists whose economic agenda was to push polyunsaturated oils and partially hydrogenated oils into the guidelines while pushing out saturated fats from the recommended foods.  This agenda was not understood by the Congressional audience as a marketing grab by corn oil and soybean oil interests, while giving the impression that they were health-related items.
Submission Date 9/21/2004
Author Granex Corporation USA

   Trans Fat
Summary Now HHS is waking up to the overwhelming science that trans fats from partially hydrogenated vegetable oils are bad for human health. 
Comments Now HHS is waking up to the overwhelming science that trans fats from partially hydrogenated vegetable oils are bad for human health.  Yet the perception of tarred saturates like coconut oil remains uncorrected. Saturates are (i) an integral part of mother¹s milk, (ii) the principal fatty acid group in the brain, (iii) a necessary component in cell structure, and (iv) are the chief fatty acid for the muscles¹ energy.  The list goes on.  Yet saturates are still deemed by HHS as ³bad.²
Submission Date 9/21/2004
Author Granex Corporation USA

   Total Fat
Summary CSPI strongly urges HHS and USDA to edit and then test the main message regarding fat to something like choose a diet that is low in saturated fat, trans fat, and cholesterol, and moderate and total fat.
Comments CSPI strongly urges HHS and USDA to edit and then test the main message regarding fat to something like choose a diet that is low in saturated fat, trans fat, and cholesterol, and moderate and total fat. It would be even clearer to the public if that advice were expressed not in terms of nutrients, but in terms of food, and read something like, eat less cheese, beef, pork, whole and 2 percent milk, egg yolks, pastries, and other foods that are high in saturated fat, transfat, or cholesterol. People don’t eat nutrients, they eat food. Providing advice about which foods to eat more of and less of would be much easier to understand and more effective than focus on nutrients.
Submission Date 9/21/2004
Author Center for Science in the Public Interest

   Trans Fat
Summary General Mills supports the Committee’s conclusion that trans fat consumption (as well as saturated fat and cholesterol) should be as low as possible. We believe that greater or at least equal emphasis should be placed on saturated fat in the Committee’s recommendations and in the next phase of comm
Comments General Mills supports the Committee’s conclusion that trans fat consumption (as well as saturated fat and cholesterol) should be as low as possible. We are, however, very concerned that the Committee has defined a recommended intake level of trans fat at 1% or less of energy intake. We are not convinced that the scientific data supports defining 1% as the goal. The Committee states that “the dose-response relationship for trans fatty acid intake and the LDL:HDL cholesterol ratio begins to become greater than that observed for saturated fatty acids at about 2.5 percent of energy intake”. There is no evidence provided to support differentiating the effects of trans from saturated fat at levels below 2.5% of calories. Based on the evidence provided, we propose that trans fat intake should not exceed 2.5% of total calories (instead of 1% or less), and that the recommendations for saturated fat and trans fat be combined, with the total not to exceed 10-12% of total calories (10% is the current recommended limit for saturated fat while 12% is the current total sat + trans recommendation from the report). In addition, by setting such a strict limit on trans fat and due to limited ingredient alternatives, food manufacturers may need to use saturated fat-containing ingredients for many products. Such a shift could lead to an unintended consequence of increasing saturated fat intakes. This does not meet the overarching goal of decreasing both saturated and trans fat established by the IOM Macronutrient Report and reaffirmed by the Dietary Guidelines Committee. We believe that greater or at least equal emphasis should be placed on saturated fat in the Committee’s recommendations and in the next phase of communications of the Dietary Guidelines. The Report appropriately states that “although saturated fat, trans fat, and cholesterol all should be decreased, saturated fat should be the primary focus of dietary modification due to the higher proportion in the diet”. We firmly believe this message should be emphasized in guidance given to consumers to help them make healthier dietary choices concerning saturated and trans fat. The information should be balanced, realistic and based on sound, scientific evidence.
Submission Date 9/27/2004
Author General Mills

   Total Fat
Summary Change key message #5, "Choose fats wisely for good health," to "Limit the intake of animal fats, organ meats, eggs, and partially hydrogenated vegetable oils."
Comments Change key message #5, "Choose fats wisely for good health," to "Limit the intake of animal fats, organ meats, eggs, and partially hydrogenated vegetable oils." The current message is extremely vague and, therefore, ineffective. The key messages should be capable of conveying essential guidance to consumers in making food choices. This message, as well as the one for carbohydrates, is virtually meaningless without an additional explanation. While the current message, "Choose fats wisely for good health," is ambiguous, the alternative message, "Limit the intake of animal fats, organ meats, eggs, and partially hydrogenated vegetable oils," is clear and will be readily understood by consumers. The Report acknowledges that the intake of saturated fat, trans fat, and cholesterol should be kept low in order to reduce the risk of coronary heart disease. The Report further acknowledges that the major way to keep saturated fat low is to limit the intake of animal fats; the major way to limit cholesterol is to limit the intake of eggs and organ meats, and the best way to limit trans fat is to keep down the intake of foods made with partially hydrogenated vegetable oils. This information can be easily summarized in the alternative key message suggested above.
Submission Date 9/27/2004
Author

Summary Choose fats wisely for good health. • Suggest changing key message to “Choose fats wisely for good health, including to help manage body weight”. • Supporting text should emphasize substituting monounsaturated and polyunsaturated fat for most of the saturated fat in the diet and include a recommenda
Comments Choose fats wisely for good health. • Suggest changing key message to “Choose fats wisely for good health, including to help manage body weight”. • Supporting text should emphasize substituting monounsaturated and polyunsaturated fat for most of the saturated fat in the diet and include a recommendation to consume more fish (preferably fatty fish).
Submission Date 9/27/2004
Author American Cancer Society, American Diabetes Association, American Heart Association

Summary Fat intake guideline.
Comments Quantitatively expressing fat (20-35% of calories) is very reasonable, and of benefit to both professionals who need standards, and to the public.
Submission Date 10/7/2004 4:17:00 PM
Author from Hartford, CT

   Saturated Fat
Summary Upper limit on saturated fat
Comments Set an upper limit on saturated fat of 10% of calories. This is a reachable, practical upper limit. Of course, continue to stress that lesser amounts may be even more beneficial.
Submission Date 10/7/2004 4:19:00 PM
Author from Hartford, CT

   Alpha-Linolenic Acid
Summary Two essential fatty acids that MUST be acquired through the diet, as our bodies cannot make them.
Comments Please inform the public that the human body does not make this fatty acid, nor does it make alpha-linoleic acid. Therefore, it is essential that we get these fatty acids from our diet - through things like flax oil and extra virgin olive oil.
Submission Date 10/28/2004 11:28:00 AM
Author Department of Human Nutrition, Foods and Exercise at Virginia Tech

   Trans Fat
Summary
Comments
Submission Date 10/28/2004
Author Anonymous

Summary NAMM, therefore, encourages the Departments not to include relative rankings of sources of trans fat in its Dietary Guidelines for Americans, nor to reference quantitative information (e.g., such as percent contributions of trans fat) that is knows to be significantly out-of-date and no longer repre
Comments The following responds to the Departments of Health and Human Services and Agriculture (the Departments) request for comments on the recent report of the Dietary Guidelines Advisory Committee (the Committee). Founded in 1936, the National Association of Margarine Manufacturers (NAMM) is the national trade association representing manufacturers and marketers of margarine and vegetable oil spreads and their suppliers. NAMM has joined other industry associations, as part of the Trans Fat Industry Coalition, in responding to the Committee’s report relative to its commentary and recommendations on trans fat. However, NAMM wishes to address an additional point not covered in the Coalition’s response. In its report, the Committee chose to include a relative ranking of product categories contributing to trans fat in the diet in the form of Table D4-1 “Major Food Sources of Trans Fats for U.S. Adults. This information came from a previous FDA Federal Register notice on trans fat (68 Fed. Reg. 41443). NAMM believes the inclusion of this table in the report is not only misleading, but will be confusing to consumers likely pushing them toward poor rather than better dietary choices should the table’s content be included in the Dietary Guidelines for Americans. The source of this data is USDA’s Continuing Survey of Food Intakes ’94-’96. Some of this data is a decade old. During the past decade we have witnessed an incredible change in product formulations in response to consumer demand for healthier products. The removal of trans fat from many products and significant reductions in many others – with the margarine category leading the way -- are among the biggest improvements. Yet, there is no acknowledgement in this report that these consumption figures are very outdated, and in categories like margarine, no longer representative. Table D4-1 shows that margarine supplies 17% of the trans fat to the U.S. adult diet. Approximately six months ago, NAMM collected weighted-average market share data on the nutrient components of margarine products from its members. Using the 2.6% of energy (i.e., a 2,000 calorie diet) in the Committee’s report as the average per capita daily intake of trans fat, NAMM estimates the contribution of trans fat from margarine products to be much lower than 17%. And that is based on data from six to nine months old, including many products that have since been reformulated to eliminate or significantly reduce trans fats. We believe that it is very likely that margarine products now contribute less than 10% to the average per capita intake of trans fat, and that number continues to drop every month. Throughout the Committee’s deliberations, the importance of consumer understanding of dietary guidance was highlighted. We believe the Departments also endorse consumer communications about dietary guidelines that are easy to understand, not confusing and do not result in unintended dietary choices. The Departments will likely rely heavily on many influential organizations and health and communications professionals to promote the Dietary Guidelines for Americans. A relative ranking of products contributing trans fat to the diet, particularly one based on information that is not even close to a the current marketplace will likely result in misleading communications and unintended dietary choices. More than 90% of households in the United States use either butter or margarine or both. When compared to a serving of butter with 7 grams of saturated fat, 31 milligrams of cholesterol and approximately 0.5 grams of trans fat, a serving of an average margarine product with 1.1 grams of saturated fat1, 0.7 grams of trans fat1 and no cholesterol is by far the healthier choice. Thus, consumers who see or hear messages erroneously implying that all margarine products are a major source of trans fats and who decide as a result to choose butter will be making the wrong dietary choice for their health. NAMM, therefore, encourages the Departments not to include relative rankings of sources of trans fat in its Dietary Guidelines for Americans, nor to reference quantitative information (e.g., such as percent contributions of trans fat) that is knows to be significantly out-of-date and no longer representative of current products on the market.
Submission Date 10/28/2004
Author Anonymous

Summary The Trans Fat Coalition respectfully recommends that the 2005 Dietary Guidelines for Americans refrain from providing a quantitative recommendation for limiting intake of trans fat. This recommendation is based on the following facts: ? There are virtually no experimental data on the effect of tra
Comments These comments pertain to the report submitted to your office by the Dietary Guidelines Advisory Committee (the Committee) and reflect the opinions of the Trans Fat Coalition (the Coalition). The Coalition is a confederation of industry associations whose memberships have considerable technical expertise regarding the nutritional properties of trans fat and a keen interest in the dietary fats section of the 2005 Dietary Guidelines for Americans (DGA). Executive Summary The Trans Fat Coalition strongly objects to the conclusion of the Dietary Guidelines Advisory Committee that intake of trans fat in the United States be limited to one percent of total energy or less. This conclusion is not supported by the available scientific information, is inconsistent with the position taken by other scientific panels and may have unintended public health consequences. There are very few studies that have investigated the effect of trans fat on coronary heart disease (CHD) risk factors at levels at or below the current average daily intake in the U.S. of approximately 2.6% of total energy. Nevertheless, intervention trials using higher amounts of dietary trans fat suggest that there is no significant difference between the effect of saturated and trans fat on blood low-density lipoprotein cholesterol (LDL-C) concentrations at levels below approximately five percent of total energy (approximately twice the typical daily intake level). Similarly, these same trials suggest that trans fat does not affect serum high-density lipoprotein cholesterol (HDL-C) concentrations at levels below five percent of energy. In addition, the observational studies show that trans fat is only associated with CHD incidence at the highest levels of intake. The Institute of Medicine’s Daily Reference Intake (DRI) panel on macronutrients rejected the notion of a quantitative limit on trans fat intake, and the Nutrition Subcommittee of the Food and Drug Administration’s Food Advisory Committee concluded that there was insufficient scientific evidence to support a recommendation to limit trans fat intake to one percent of total energy. The National Heart, Lung and Blood Institute’s National Cholesterol Education Program, the American Heart Association and the American Diabetes Association have also not made quantitative recommendations for trans fat intake. Finally, the imposition of a strict quantitative limitation on trans fat intake by the Dietary Guidelines for Americans is likely to cause many consumers to increase saturated fat intake in an over zealous effort to eliminate sources of trans fat from their diets. As emphasized in the Committee’s report, the current high intake of saturated fat in the U.S. dictates that it be the primary focus of dietary modification. In that regard, there are very few assurances that their trans fat recommendation will not have unintended public health consequences for American consumers. The Coalition recommends that the Departments engage the appropriate stakeholders to gather additional nutritional and dietary data so that a scientifically defensible recommendation regarding trans fat intake can be made in the future. Introduction The Committee unanimously supported the following conclusive statement with respect to trans fat, The relationship between trans fatty acid intake and LDL cholesterol is direct and progressive, increasing the risk of CHD. Trans fatty acid consumption by all population groups should be kept as low as possible, which is about 1 percent of energy intake or less. The Coalition emphatically disagrees with the Committee’s recommendation to limit trans fat in the diet to “about 1% of energy intake or less” because it cannot be justified on the basis of available scientific information. Sustained, high intake of trans fat can increase the risk of coronary heart disease (CHD) by increasing the concentration of LDL-C and/or decreasing the concentration of HDL-C in the blood. However, there are very few data on the effect of trans fat at or below the average daily U.S. intake, and considerable evidence that a threshold exists for its effect on HDL-C. Furthermore, the Coalition questions the Committee’s conclusion that there is a progressive, dose-dependent relationship between trans fat intake and the LDL:HDL cholesterol ratio in the range of 0.5 to 10 percent of calories. The Committee did not provide specific literature citations to document this relationship (particularly at the low end of the range), and we are aware of no data that demonstrate intakes of trans fat up to 3.3 percent of total energy have a significant effect on either LDL-C or HDL-C (see discussion below). Even if data were available to prove the existence of a linear relationship between trans fat intake and risk of CHD in the range typical of U.S. dietary intakes, there is currently no objective basis on which to establish a minimum recommended intake. Dietary patterns are complex, and the establishment of a quantitative limitation for trans fat will only promote public health if consumers respond to it by decreasing their intake of trans and saturated fats. However, the Committee provided no evidence that a recommendation to limit trans fat intake to one percent of calories or less would achieve such a reduction, or that it would be sustainable given the nature of the food supply and the consumer’s capacity to understand and implement it. There is a very real possibility that consumers will focus on the elimination of trans fat rather than the more pressing need to reduce the intake of saturated fat. A one percent of calories cutoff level may be less effective than a two or three percent value depending on how dietary selections are affected. Until such tradeoffs are understood, the establishment of a quantitative cutoff point for trans fat intake is arbitrary, and its impact on public health is unknown. Finally, the DRI macronutrient panel (Institute of Medicine, 2002) did not establish a quantitative limit on trans fat intake but recommended that it be “as low as possible while consuming a nutritionally adequate diet”. This panel observed that efforts to eliminate dietary trans fat could introduce “undesirable effects” that could compromise the nutritional quality of the diet and lead to “unknown and unquantifiable health risks”. This position was reiterated by the Food and Nutrition Board’s Committee on Use of Dietary Reference Intakes in Nutrition Labeling (Institute of Medicine, 2003) who concluded it would be inappropriate to establish a DRI for saturated and trans fat until additional “experimental data on acceptable diets that contain minimal levels of these food components” are available. The Committee, in its report, did not acknowledge the IOM’s concern in this area, and to the best of our knowledge no such data have become available. A quantitative recommendation in the 2005 DGA would usurp those of the IOM panels assigned to deliberate this issue. In conclusion, we urge the Departments to avoid incorporating a quantitative recommendation for trans fat intake in the final DGA document. To do so at this time would be premature in light of the current scientific and consumer uncertainties. We recommend that the Departments engage the appropriate stakeholders to resolve such uncertainties so that a scientifically-defensible, consumer-beneficial recommendation can be made in a future DGA. Our rationale for this recommendation is provided below. Individual intervention studies suggest there is a threshold for the effect of trans fat on serum HDL-C The Committee considered intervention studies cited by the macronutrient DRI panel (Institute of Medicine, 2002) as well as several more recent publications (Lovejoy et.al., 2002; de Roos et.al., 2001, 2002, 2003) in assessing the effect of trans fat on blood LDL-C and HDL-C concentrations. The interpretation of these studies appeared to be heavily influenced by a commentary published by Ascherio et.al. (1999). This commentary included a plot of the change in LDL:HDL ratio vs. intake of saturated and trans fat from nine randomized, controlled feeding studies (see Figure 1). Linear regression analysis of these studies showed that the slope for trans fat was significantly greater than that for saturated fat. The Committee used this analysis as the primary source of evidence that trans fat is deleterious even at very low intakes. The Coalition believes that this analysis does not provide compelling evidence that low levels of trans fat is detrimental, and that it cannot be used to support the recommendation to limit intake to one percent of calories or less. The regression line is heavily influenced by data from high intakes of trans fat because there is a paucity of data at intakes below those typical in the U.S. In addition, Ascherio et.al. assumed a linear relationship with no threshold by extrapolating the regression lines through the origin. Furthermore, this analysis does not consider the separate effects of dietary fatty acids on blood LDL-C and HDL-C concentrations. As the Committee observed, both trans and saturated fat are associated with increased LDL-C while only trans fat has been shown to lower HDL-C. However, by considering only the LDL:HDL ratio, it is not possible to determine how each parameter contributes to the overall effect. The Coalition believes that a much more meaningful assessment of the literature can be made by examining the separate effects of trans fat on serum LDL-C and HDL-C. Table 1 summarizes the change in blood LDL-C and HDL-C in response to substitution of trans for cis fats in the randomized feeding studies included in the Ascherio et.al. analysis. The studies summarized in this table have been ranked according to percent of energy from trans fat provided in the experimental diets. The level of statistical significance reported by the authors when comparing the trans fat diets to their respective control groups is also provided. Trans fat intake ranged from 0.91 to 11.0% of total energy. Only one of the experimental diets (Lichtenstein et.al., 1999) used an intervention below the current estimated average U.S. daily intake of 2.6% of total energy cited by the Committee (Allison et.al., 1999). The scarcity of data that reflect typical diets is evident from the fact that there are no studies between 0.91 and 3.3% of total energy from trans fat. The data summarized in Table 1 strongly suggest there is a threshold for the effect of trans fat on blood HDL-C concentrations. Seven of the 10 experimental diets (ranging from 0.91 to 7.1% of energy from trans fat) reported no significant effect on HDL-C. Only diets with trans fat concentrations above this range consistently showed a significant effect. More recent studies not included in the Ascherio analysis by Louherantra et.al. (1999) and Lovejoy et.al. (2002) provide further evidence of such a threshold. These studies found no significant effect of trans fat on blood HDL-C concentrations at 5.1 and 7.3 percent of total energy, respectively. In summary, this direct assessment of the data does not support the Committee’s conclusion that low trans fat diets (=1% of energy) are necessary to manage the risk of CHD. It is clear that the regression line for trans fat reported by Ascherio et.al. was heavily influenced by its effect on HDL-C at very high intake levels (up to 4.2 times the average daily U.S. intake), and that it ignored evidence of a likely threshold level for this effect at approximately five percent of total energy. Allison et.al. (1999) have shown that the 90th percentile intake of trans fat in the American diet falls below this apparent threshold – a fact that fails to support the Committee’s overall conclusions. Additional evidence of a threshold for the effect of trans fat on blood HDL-C concentrations was provided by a rigorous assessment of the literature commissioned by the International Life Sciences Institute (ILSI). This assessment was submitted to the Food and Drug Administration (FDA) in response to an advanced notice of proposed rulemaking (68 FR 41507, July 11, 2003) pertaining to trans fat labeling and is appended to this document. This assessment utilized data from 16 randomized intervention studies in which 17 control/comparison (control) and 27 treatment trans fatty acid (TFA) intake levels were identified (Almendingen et.al., 1995; Aro et.al., 1997; Denke et.al., 2000; de Roos et.al., 2001; Judd et.al., 1994, 1998, 2002; Lichtenstein et.al., 1993, 1999; Mensink et.al., 1990; Nestel et.al., 1992; Noakes and Clifton, 1998; Sundram et.al., 1997; Wood et.al., 1993, 1993a; Zock and Katan,1992). All fatty acid intakes, when not reported as percent of energy (%En), were converted to these units, thereby permitting study comparisons on a similar basis. Also, LDL-C and HDL-C values expressed as mg/dL were converted to mM. This analysis shows that trans and saturated fatty acids (SFA) have similar effects on serum LDL-C concentrations and that trans fat does not differentially impact serum HDL-C concentrations compared to similar intakes of saturated fat. The specific bases for these conclusions are provided below: ? Intake of trans fat does not differentially impact serum LDL-C compared to similar intakes of saturated fat Figures 2 and 3, respectively, plot changes in TFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. Figures 4 and 5, respectively, plot changes in SFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. There are two key points to note. First, in all cases the slopes of the lines are similar. This observation strongly suggests that the impact on serum LDL-C of TFA intake and SFA intake are essentially indistinguishable. Second, higher order predictive equations provide very little additional explanation of the variance, suggesting that a linear regression is a reasonable model for these data (r2 coefficients are provided for first, second and fourth order equations as examples, though the biological relevance of a fourth order equation may be difficult to interpret). In summary, the data do not permit a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on LDL-C. Consequently, the differential effects between trans and saturated fat is due exclusively to their effect on blood HDL-C concentrations. ? Trans fat does not have a significant impact on blood HDL-C concentrations, compared to saturated fatty acids at intakes less than 5% of total calories Figures 6 and 7, respectively, plot changes in TFA intake (%En) against changes in HDL-C in relative (%) and absolute terms. However in contrast to plots of LDL-C, higher order equations provide significantly greater predictive value, explaining a greater proportion of the variance. Most intriguing is the finding that there appears to be little impact on serum HDL-C when TFA intake is less than 5% En, when a second or fourth order equation is employed. Above this threshold, there is a clear inverse relationship, with increasing TFA intakes resulting in decreased serum HDL-C. Not surprisingly, a simple linear regression as reported by Ascherio et.al. (1999) has negative slope, but this analysis is a poor model of the data because the relationship is better explained by higher order equations. SFA intake (%En) appears to show no such threshold effect on serum HDL-C, in fact showing very little effect at all (figures 8 and 9). In summary, the data do not permit a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on HDL-C, when TFA intake is less than 5% of total energy intake (5% En). In addition, as noted previously, the current U.S. average daily intake of trans fat (2.6 % En) acknowledged by the Committee (Allison et.al., 1999) is substantially below the threshold suggested by the available data. The Coalition strongly believes that this thorough analysis of the existing scientific information fails to support the Committee’s recommendation to limit trans fat intake to one percent of calories or less, and we urgently recommend that the 2005 DGA not provide a quantitative recommendation with respect to trans fat intake. Observational data also fail to support the recommendation to limit trans fat to one percent or less of total calories Observational studies provide weaker evidence than randomized, controlled intervention studies because they are not capable of demonstrating a cause and effect relationship. Nevertheless, such studies are useful for identifying associations in free-living populations and were considered by the Committee in developing their recommendations in the area of trans fat and CHD. The Committee noted that six cohort studies cited by the DRI Macronutrient Committee (Institute of Medicine, 2002) suggest that “high trans fat intake is associated with an increased risk of coronary artery disease” (Ascherio et.al., 1996; Gilman et.al., 1007; Hu et.al., 1997; Kromhout et.al., 1995; Pietinen et.al., 1997; Willett et.al., 1993). Two case-control studies (Ascherio et.al., 1994; Tavini et.al., 1997) were also included in the IOM table. Table 2 summarizes the studies noted above that reported relative risk (RR) ratios for trans fat intake and incidence of CHD. Without exception, these studies show that the significant associations occur only at the highest level of trans fat consumption after adjustment for common CHD risk factors. This observation is consistent with the analysis of dietary intervention studies discussed above that shows high levels of dietary trans fat is necessary before serum HDL-C concentrations are affected, and that the effect of trans and saturated fat is similar below this threshold. Clearly, the epidemiological data do not provide a compelling justification for the Committee’s recommendation that trans fat intake be restricted to one percent of energy or less. Positions taken by other outside groups The Coalition believes there is little precedent for the Committee’s recommendation to restrict intake of trans fat to one percent of calories or less from other organizations. As the Committee observed, the Macronutrient DRI Committee (Institute of Medicine, 2002) did not issue a quantitative benchmark (i.e. Upper Level) to limit trans fat consumption. Similarly, although the desirability of reducing trans fat intake was recognized, quantitative recommendations were not issued by the National Cholesterol Education Program (2002) in its Adult Treatment Panel III report, or by the American Diabetes Association (Franz et.al., 2004) or the American Heart Association (Kraus et.al., 2000). Furthermore, we believe the Committee egregiously mischaracterized the recent conclusions of the Nutrition Subcommittee of FDA’s Food Advisory Committee. The statement regarding limiting trans fat quoted in the Committee’s report was a secondary position passed after the Subcommittee concluded that there was insufficient scientific information to justify a strict, quantitative recommendation. The formal question that was addressed according to the transcript of this group’s April 28, 2004 meeting reads, The Dietary Guidelines Committee may suggest that less than 1 percent of energy should be obtained from trans fat (2 grams per day for a 2,000 kcal diet). Does the scientific evidence support this level? The Subcommittee voted “no” to this question by a vote of 5 to 3. As the Committee observed, the Danish Nutrition Council (Stender and Dyerbery, 2003) recommended that the use of “industrially produced” trans fat be discontinued based largely on the prospective observational studies and the Ascherio et.al. (1999) analysis of nine dietary intervention trials. As discussed above, the Coalition believes this interpretation of the data is incorrect. In addition, the Committee has already rejected the notion that “industrial sources” of trans fat be eliminated because it would be impractical (if not impossible) to do so given the constraints of food technology. The Dietary Guidelines Committee report cites the World Health Organization Report (WHO, 2003) as recommending a quantitative (i.e. 1% of energy) limit for trans fat intake. This report included a general review of the observational and dietary intervention literature, but did not provide a specific rationale for their quantitative recommendation. The evidence cited by the WHO report has the same scientific limitations as that used by the Committee. These limitations contributed to the macronutrient DRI panel’s decision not to establish quantitative benchmarks for trans fat intake. Public health concerns The ultimate goal of the DGA is to provide the American population with the best information possible to assist in the selection of a healthy diet. Goals should be established that will have the greatest impact on public health. It is well known that both trans fat and saturated fat increases serum LDL-C. Although data are limited trans fat intakes above a threshold of approximately five percent of energy appear to have a negative impact on HDL cholesterol while intakes below this level have little impact. Published data (Allison et.al., 1999) indicate that the average intake of trans fat in the American diet is 2.6% of energy and the 90th percentile falls below five percent of total energy. As noted previously, even if data in the range of trans fat intakes typical in the U.S. were available to show that there is a linear relationship with risk of CHD, we believe it would be premature to establish a quantitative dietary recommendation at this time. The cutoff point for such a recommendation cannot be objectively determined without a more thorough understanding of how it would affect consumer behavior in the context of the food supply. The Coalition is concerned that the attention that will be directed toward trans fat if the Committee’s recommendation is enacted will distract from the well-established need to address saturated fat intake. For example, replacing butter with trans fat-containing margarine results in an improvement in serum lipid profiles (Chisholm et.al., 1996; Denke, et.al., 2000; Judd et.al., 1998). However, paranoia about trans fat generated by the DGA could easily prompt consumers to make poor dietary choices. The Committee also expressed concern regarding this issue, Although intakes of saturated fat, trans fat and cholesterol all should be decreased, because saturated fat consumption is proportionately much greater than that of these other fats, saturated fat should be the primary focus of dietary modification. We agree completely with this concern, and believe that the Committee’s recommendation for limiting intake of trans fat will exacerbate it. Food Industry Actions to Reduce Trans Fat in the Diet The U.S. food industry has been very responsive to public health concerns about trans fat, rapidly developing many new food products that contain no trans fat or significantly reduced trans fat. These products are the result of considerable investment in product reformulations and new processing techniques. These efforts continue on a fast track. Other methods by which dietary trans fat will be further reduced in the future include the development of new oilseed varieties, the oils from which will be more stable and not require hydrogenation to make them technologically acceptable. But the promise of these oils is not yet reality. It would be a major step backward for public health and an enormous disservice to the American consumer if trans fat was simply replaced with greater levels of saturated fat in the diet. Care must be taken to avoid unintended consequences in making dietary choices. The Committee clearly emphasized a much higher relative concern about reducing the intake of saturated fat (as noted above), and there are very few assurances that a quantitative limitation of trans fat intake will not be counterproductive from a public health perspective. Efforts by industry to remove, or otherwise minimize to the extent possible, trans fat in food products along with quantitative labeling pursuant to a final rule on trans fat labeling will have a much more positive impact on consumer nutrition than will the confusion created, including the likely consumption of higher levels of saturated fat, if inappropriate and scientifically-unsupportable, quantitative trans fat levels are included in the 2005 Dietary Guidelines for Americans. Efforts by industry to remove, or otherwise minimize to Efforts by industry to remove, or otherwise minimize to the extent possible, trans fat in food products along with quantitative labeling pursuant to a final rule on trans fat labeling will have a much more positive impact on consumer nutrition than will the confusion created, including the likely consumption of higher levels of saturated fat, if inappropriate and scientifically-unsupportable, quantitative trans fat levels are included in the 2005 Dietary Guidelines for Americans. the extent possible, trans fat in food products along with quantitative labeling pursuant to a final rule on trans fat labeling will have a much more positive impact on consumer nutrition than will the confusion created, including the likely consumption of higher levels of saturated fat, if inappropriate and scientifically-unsupportable, quantitative trans fat levels are included in the 2005 Dietary Guidelines for Americans. Summary and conclusions The Trans Fat Coalition respectfully recommends that the 2005 Dietary Guidelines for Americans refrain from providing a quantitative recommendation for limiting intake of trans fat. This recommendation is based on the following facts: ? There are virtually no experimental data on the effect of trans fat on serum lipid biomarkers at levels at or below current average daily intakes in the United States. ? The prospective observational studies consistently show a positive association between trans fat and CHD, but only at the upper intake levels. ? Informal inspection and more rigorous statistical analysis of the existing dietary intervention studies suggest that trans fat does not lower blood HDL-C concentrations when substituted for saturated fatty acids unless intakes substantially exceed current estimated amounts. ? The Nutrition Subcommittee of FDA’s Food Advisory Committee concluded that there is insufficient science to support limiting trans fat to one percent of energy or lower. ? Two recent National Academies Institute of Medicine panels concluded that it is inappropriate to establish a quantitative benchmark for trans fat intake until more data are available on the nutritional adequacy of diets largely devoid of trans fat-containing foods. Such data should be made publicly available for thorough review. ? The Committee’s proposed quantitative recommendation regarding trans fat is likely to have unintended consequences by detracting from consumer’s efforts to reduce the intake of saturated fat. ? The Coalition recommends that the Departments spearhead an effort to resolve the current uncertainties regarding the scientific evidence and consumer response so that a well-considered quantitative recommendation for trans fat can be made in the future. The Coalition very much appreciates the opportunity to provide these comments, and would be pleased to answer any questions the Departments may have.
Submission Date 10/28/2004
Author Anonymous

Summary Summary attached after comments.
Comments The following responds to the Departments of Health and Human Services and Agriculture (the Departments) request for comments on the recent report of the Dietary Guidelines Advisory Committee (the Committee). Founded in 1936, the National Association of Margarine Manufacturers (NAMM) is the national trade association representing manufacturers and marketers of margarine and vegetable oil spreads and their suppliers. NAMM has joined other industry associations, as part of the Trans Fat Industry Coalition, in responding to the Committee’s report relative to its commentary and recommendations on trans fat. However, NAMM wishes to address an additional point not covered in the Coalition’s response. In its report, the Committee chose to include a relative ranking of product categories contributing to trans fat in the diet in the form of Table D4-1 “Major Food Sources of Trans Fats for U.S. Adults. This information came from a previous FDA Federal Register notice on trans fat (68 Fed. Reg. 41443). NAMM believes the inclusion of this table in the report is not only misleading, but will be confusing to consumers likely pushing them toward poor rather than better dietary choices should the table’s content be included in the Dietary Guidelines for Americans. The source of this data is USDA’s Continuing Survey of Food Intakes ’94-’96. Some of this data is a decade old. During the past decade we have witnessed an incredible change in product formulations in response to consumer demand for healthier products. The removal of trans fat from many products and significant reductions in many others – with the margarine category leading the way -- are among the biggest improvements. Yet, there is no acknowledgement in this report that these consumption figures are very outdated, and in categories like margarine, no longer representative. Table D4-1 shows that margarine supplies 17% of the trans fat to the U.S. adult diet. Approximately six months ago, NAMM collected weighted-average market share data on the nutrient components of margarine products from its members. Using the 2.6% of energy (i.e., a 2,000 calorie diet) in the Committee’s report as the average per capita daily intake of trans fat, NAMM estimates the contribution of trans fat from margarine products to be much lower than 17%. And that is based on data from six to nine months old, including many products that have since been reformulated to eliminate or significantly reduce trans fats. We believe that it is very likely that margarine products now contribute less than 10% to the average per capita intake of trans fat, and that number continues to drop every month. Throughout the Committee’s deliberations, the importance of consumer understanding of dietary guidance was highlighted. We believe the Departments also endorse consumer communications about dietary guidelines that are easy to understand, not confusing and do not result in unintended dietary choices. The Departments will likely rely heavily on many influential organizations and health and communications professionals to promote the Dietary Guidelines for Americans. A relative ranking of products contributing trans fat to the diet, particularly one based on information that is not even close to a the current marketplace will likely result in misleading communications and unintended dietary choices. More than 90% of households in the United States use either butter or margarine or both. When compared to a serving of butter with 7 grams of saturated fat, 31 milligrams of cholesterol and approximately 0.5 grams of trans fat, a serving of an average margarine product with 1.1 grams of saturated fat1, 0.7 grams of trans fat1 and no cholesterol is by far the healthier choice. Thus, consumers who see or hear messages erroneously implying that all margarine products are a major source of trans fats and who decide as a result to choose butter will be making the wrong dietary choice for their health. NAMM, therefore, encourages the Departments not to include relative rankings of sources of trans fat in its Dietary Guidelines for Americans, nor to reference quantitative information (e.g., such as percent contributions of trans fat) that is knows to be significantly out-of-date and no longer representative of current products on the market. Summary - NAMM, therefore, encourages the Departments not to include relative rankings of sources of trans fat in its Dietary Guidelines for Americans, nor to reference quantitative information (e.g., such as percent contributions of trans fat) that is knows to be significantly out-of-date and no longer representative of current products on the market.
Submission Date 10/28/2004 12:41:00 PM
Author Anonymous

Summary Summary attached to comments.
Comments These comments pertain to the report submitted to your office by the Dietary Guidelines Advisory Committee (the Committee) and reflect the opinions of the Trans Fat Coalition (the Coalition). The Coalition is a confederation of industry associations whose memberships have considerable technical expertise regarding the nutritional properties of trans fat and a keen interest in the dietary fats section of the 2005 Dietary Guidelines for Americans (DGA). Executive Summary The Trans Fat Coalition strongly objects to the conclusion of the Dietary Guidelines Advisory Committee that intake of trans fat in the United States be limited to one percent of total energy or less. This conclusion is not supported by the available scientific information, is inconsistent with the position taken by other scientific panels and may have unintended public health consequences. There are very few studies that have investigated the effect of trans fat on coronary heart disease (CHD) risk factors at levels at or below the current average daily intake in the U.S. of approximately 2.6% of total energy. Nevertheless, intervention trials using higher amounts of dietary trans fat suggest that there is no significant difference between the effect of saturated and trans fat on blood low-density lipoprotein cholesterol (LDL-C) concentrations at levels below approximately five percent of total energy (approximately twice the typical daily intake level). Similarly, these same trials suggest that trans fat does not affect serum high-density lipoprotein cholesterol (HDL-C) concentrations at levels below five percent of energy. In addition, the observational studies show that trans fat is only associated with CHD incidence at the highest levels of intake. The Institute of Medicine’s Daily Reference Intake (DRI) panel on macronutrients rejected the notion of a quantitative limit on trans fat intake, and the Nutrition Subcommittee of the Food and Drug Administration’s Food Advisory Committee concluded that there was insufficient scientific evidence to support a recommendation to limit trans fat intake to one percent of total energy. The National Heart, Lung and Blood Institute’s National Cholesterol Education Program, the American Heart Association and the American Diabetes Association have also not made quantitative recommendations for trans fat intake. Finally, the imposition of a strict quantitative limitation on trans fat intake by the Dietary Guidelines for Americans is likely to cause many consumers to increase saturated fat intake in an over zealous effort to eliminate sources of trans fat from their diets. As emphasized in the Committee’s report, the current high intake of saturated fat in the U.S. dictates that it be the primary focus of dietary modification. In that regard, there are very few assurances that their trans fat recommendation will not have unintended public health consequences for American consumers. The Coalition recommends that the Departments engage the appropriate stakeholders to gather additional nutritional and dietary data so that a scientifically defensible recommendation regarding trans fat intake can be made in the future. Introduction The Committee unanimously supported the following conclusive statement with respect to trans fat, The relationship between trans fatty acid intake and LDL cholesterol is direct and progressive, increasing the risk of CHD. Trans fatty acid consumption by all population groups should be kept as low as possible, which is about 1 percent of energy intake or less. The Coalition emphatically disagrees with the Committee’s recommendation to limit trans fat in the diet to “about 1% of energy intake or less” because it cannot be justified on the basis of available scientific information. Sustained, high intake of trans fat can increase the risk of coronary heart disease (CHD) by increasing the concentration of LDL-C and/or decreasing the concentration of HDL-C in the blood. However, there are very few data on the effect of trans fat at or below the average daily U.S. intake, and considerable evidence that a threshold exists for its effect on HDL-C. Furthermore, the Coalition questions the Committee’s conclusion that there is a progressive, dose-dependent relationship between trans fat intake and the LDL:HDL cholesterol ratio in the range of 0.5 to 10 percent of calories. The Committee did not provide specific literature citations to document this relationship (particularly at the low end of the range), and we are aware of no data that demonstrate intakes of trans fat up to 3.3 percent of total energy have a significant effect on either LDL-C or HDL-C (see discussion below). Even if data were available to prove the existence of a linear relationship between trans fat intake and risk of CHD in the range typical of U.S. dietary intakes, there is currently no objective basis on which to establish a minimum recommended intake. Dietary patterns are complex, and the establishment of a quantitative limitation for trans fat will only promote public health if consumers respond to it by decreasing their intake of trans and saturated fats. However, the Committee provided no evidence that a recommendation to limit trans fat intake to one percent of calories or less would achieve such a reduction, or that it would be sustainable given the nature of the food supply and the consumer’s capacity to understand and implement it. There is a very real possibility that consumers will focus on the elimination of trans fat rather than the more pressing need to reduce the intake of saturated fat. A one percent of calories cutoff level may be less effective than a two or three percent value depending on how dietary selections are affected. Until such tradeoffs are understood, the establishment of a quantitative cutoff point for trans fat intake is arbitrary, and its impact on public health is unknown. Finally, the DRI macronutrient panel (Institute of Medicine, 2002) did not establish a quantitative limit on trans fat intake but recommended that it be “as low as possible while consuming a nutritionally adequate diet”. This panel observed that efforts to eliminate dietary trans fat could introduce “undesirable effects” that could compromise the nutritional quality of the diet and lead to “unknown and unquantifiable health risks”. This position was reiterated by the Food and Nutrition Board’s Committee on Use of Dietary Reference Intakes in Nutrition Labeling (Institute of Medicine, 2003) who concluded it would be inappropriate to establish a DRI for saturated and trans fat until additional “experimental data on acceptable diets that contain minimal levels of these food components” are available. The Committee, in its report, did not acknowledge the IOM’s concern in this area, and to the best of our knowledge no such data have become available. A quantitative recommendation in the 2005 DGA would usurp those of the IOM panels assigned to deliberate this issue. In conclusion, we urge the Departments to avoid incorporating a quantitative recommendation for trans fat intake in the final DGA document. To do so at this time would be premature in light of the current scientific and consumer uncertainties. We recommend that the Departments engage the appropriate stakeholders to resolve such uncertainties so that a scientifically-defensible, consumer-beneficial recommendation can be made in a future DGA. Our rationale for this recommendation is provided below. Individual intervention studies suggest there is a threshold for the effect of trans fat on serum HDL-C The Committee considered intervention studies cited by the macronutrient DRI panel (Institute of Medicine, 2002) as well as several more recent publications (Lovejoy et.al., 2002; de Roos et.al., 2001, 2002, 2003) in assessing the effect of trans fat on blood LDL-C and HDL-C concentrations. The interpretation of these studies appeared to be heavily influenced by a commentary published by Ascherio et.al. (1999). This commentary included a plot of the change in LDL:HDL ratio vs. intake of saturated and trans fat from nine randomized, controlled feeding studies (see Figure 1). Linear regression analysis of these studies showed that the slope for trans fat was significantly greater than that for saturated fat. The Committee used this analysis as the primary source of evidence that trans fat is deleterious even at very low intakes. The Coalition believes that this analysis does not provide compelling evidence that low levels of trans fat is detrimental, and that it cannot be used to support the recommendation to limit intake to one percent of calories or less. The regression line is heavily influenced by data from high intakes of trans fat because there is a paucity of data at intakes below those typical in the U.S. In addition, Ascherio et.al. assumed a linear relationship with no threshold by extrapolating the regression lines through the origin. Furthermore, this analysis does not consider the separate effects of dietary fatty acids on blood LDL-C and HDL-C concentrations. As the Committee observed, both trans and saturated fat are associated with increased LDL-C while only trans fat has been shown to lower HDL-C. However, by considering only the LDL:HDL ratio, it is not possible to determine how each parameter contributes to the overall effect. The Coalition believes that a much more meaningful assessment of the literature can be made by examining the separate effects of trans fat on serum LDL-C and HDL-C. Table 1 summarizes the change in blood LDL-C and HDL-C in response to substitution of trans for cis fats in the randomized feeding studies included in the Ascherio et.al. analysis. The studies summarized in this table have been ranked according to percent of energy from trans fat provided in the experimental diets. The level of statistical significance reported by the authors when comparing the trans fat diets to their respective control groups is also provided. Trans fat intake ranged from 0.91 to 11.0% of total energy. Only one of the experimental diets (Lichtenstein et.al., 1999) used an intervention below the current estimated average U.S. daily intake of 2.6% of total energy cited by the Committee (Allison et.al., 1999). The scarcity of data that reflect typical diets is evident from the fact that there are no studies between 0.91 and 3.3% of total energy from trans fat. The data summarized in Table 1 strongly suggest there is a threshold for the effect of trans fat on blood HDL-C concentrations. Seven of the 10 experimental diets (ranging from 0.91 to 7.1% of energy from trans fat) reported no significant effect on HDL-C. Only diets with trans fat concentrations above this range consistently showed a significant effect. More recent studies not included in the Ascherio analysis by Louherantra et.al. (1999) and Lovejoy et.al. (2002) provide further evidence of such a threshold. These studies found no significant effect of trans fat on blood HDL-C concentrations at 5.1 and 7.3 percent of total energy, respectively. In summary, this direct assessment of the data does not support the Committee’s conclusion that low trans fat diets (≤1% of energy) are necessary to manage the risk of CHD. It is clear that the regression line for trans fat reported by Ascherio et.al. was heavily influenced by its effect on HDL-C at very high intake levels (up to 4.2 times the average daily U.S. intake), and that it ignored evidence of a likely threshold level for this effect at approximately five percent of total energy. Allison et.al. (1999) have shown that the 90th percentile intake of trans fat in the American diet falls below this apparent threshold – a fact that fails to support the Committee’s overall conclusions. Additional evidence of a threshold for the effect of trans fat on blood HDL-C concentrations was provided by a rigorous assessment of the literature commissioned by the International Life Sciences Institute (ILSI). This assessment was submitted to the Food and Drug Administration (FDA) in response to an advanced notice of proposed rulemaking (68 FR 41507, July 11, 2003) pertaining to trans fat labeling and is appended to this document. This assessment utilized data from 16 randomized intervention studies in which 17 control/comparison (control) and 27 treatment trans fatty acid (TFA) intake levels were identified (Almendingen et.al., 1995; Aro et.al., 1997; Denke et.al., 2000; de Roos et.al., 2001; Judd et.al., 1994, 1998, 2002; Lichtenstein et.al., 1993, 1999; Mensink et.al., 1990; Nestel et.al., 1992; Noakes and Clifton, 1998; Sundram et.al., 1997; Wood et.al., 1993, 1993a; Zock and Katan,1992). All fatty acid intakes, when not reported as percent of energy (%En), were converted to these units, thereby permitting study comparisons on a similar basis. Also, LDL-C and HDL-C values expressed as mg/dL were converted to mM. This analysis shows that trans and saturated fatty acids (SFA) have similar effects on serum LDL-C concentrations and that trans fat does not differentially impact serum HDL-C concentrations compared to similar intakes of saturated fat. The specific bases for these conclusions are provided below:  Intake of trans fat does not differentially impact serum LDL-C compared to similar intakes of saturated fat Figures 2 and 3, respectively, plot changes in TFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. Figures 4 and 5, respectively, plot changes in SFA intake (%En) against changes in LDL-C in relative (%) and absolute terms. There are two key points to note. First, in all cases the slopes of the lines are similar. This observation strongly suggests that the impact on serum LDL-C of TFA intake and SFA intake are essentially indistinguishable. Second, higher order predictive equations provide very little additional explanation of the variance, suggesting that a linear regression is a reasonable model for these data (r2 coefficients are provided for first, second and fourth order equations as examples, though the biological relevance of a fourth order equation may be difficult to interpret). In summary, the data do not permit a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on LDL-C. Consequently, the differential effects between trans and saturated fat is due exclusively to their effect on blood HDL-C concentrations.  Trans fat does not have a significant impact on blood HDL-C concentrations, compared to saturated fatty acids at intakes less than 5% of total calories Figures 6 and 7, respectively, plot changes in TFA intake (%En) against changes in HDL-C in relative (%) and absolute terms. However in contrast to plots of LDL-C, higher order equations provide significantly greater predictive value, explaining a greater proportion of the variance. Most intriguing is the finding that there appears to be little impact on serum HDL-C when TFA intake is less than 5% En, when a second or fourth order equation is employed. Above this threshold, there is a clear inverse relationship, with increasing TFA intakes resulting in decreased serum HDL-C. Not surprisingly, a simple linear regression as reported by Ascherio et.al. (1999) has negative slope, but this analysis is a poor model of the data because the relationship is better explained by higher order equations. SFA intake (%En) appears to show no such threshold effect on serum HDL-C, in fact showing very little effect at all (figures 8 and 9). In summary, the data do not permit a meaningful distinction between the intake of TFA and SFA with respect to any differential impact on HDL-C, when TFA intake is less than 5% of total energy intake (5% En). In addition, as noted previously, the current U.S. average daily intake of trans fat (2.6 % En) acknowledged by the Committee (Allison et.al., 1999) is substantially below the threshold suggested by the available data. The Coalition strongly believes that this thorough analysis of the existing scientific information fails to support the Committee’s recommendation to limit trans fat intake to one percent of calories or less, and we urgently recommend that the 2005 DGA not provide a quantitative recommendation with respect to trans fat intake. Observational data also fail to support the recommendation to limit trans fat to one percent or less of total calories Observational studies provide weaker evidence than randomized, controlled intervention studies because they are not capable of demonstrating a cause and effect relationship. Nevertheless, such studies are useful for identifying associations in free-living populations and were considered by the Committee in developing their recommendations in the area of trans fat and CHD. The Committee noted that six cohort studies cited by the DRI Macronutrient Committee (Institute of Medicine, 2002) suggest that “high trans fat intake is associated with an increased risk of coronary artery disease” (Ascherio et.al., 1996; Gilman et.al., 1007; Hu et.al., 1997; Kromhout et.al., 1995; Pietinen et.al., 1997; Willett et.al., 1993). Two case-control studies (Ascherio et.al., 1994; Tavini et.al., 1997) were also included in the IOM table. Table 2 summarizes the studies noted above that reported relative risk (RR) ratios for trans fat intake and incidence of CHD. Without exception, these studies show that the significant associations occur only at the highest level of trans fat consumption after adjustment for common CHD risk factors. This observation is consistent with the analysis of dietary intervention studies discussed above that shows high levels of dietary trans fat is necessary before serum HDL-C concentrations are affected, and that the effect of trans and saturated fat is similar below this threshold. Clearly, the epidemiological data do not provide a compelling justification for the Committee’s recommendation that trans fat intake be restricted to one percent of energy or less. Positions taken by other outside groups The Coalition believes there is little precedent for the Committee’s recommendation to restrict intake of trans fat to one percent of calories or less from other organizations. As the Committee observed, the Macronutrient DRI Committee (Institute of Medicine, 2002) did not issue a quantitative benchmark (i.e. Upper Level) to limit trans fat consumption. Similarly, although the desirability of reducing trans fat intake was recognized, quantitative recommendations were not issued by the National Cholesterol Education Program (2002) in its Adult Treatment Panel III report, or by the American Diabetes Association (Franz et.al., 2004) or the American Heart Association (Kraus et.al., 2000). Furthermore, we believe the Committee egregiously mischaracterized the recent conclusions of the Nutrition Subcommittee of FDA’s Food Advisory Committee. The statement regarding limiting trans fat quoted in the Committee’s report was a secondary position passed after the Subcommittee concluded that there was insufficient scientific information to justify a strict, quantitative recommendation. The formal question that was addressed according to the transcript of this group’s April 28, 2004 meeting reads, The Dietary Guidelines Committee may suggest that less than 1 percent of energy should be obtained from trans fat (2 grams per day for a 2,000 kcal diet). Does the scientific evidence support this level? The Subcommittee voted “no” to this question by a vote of 5 to 3. As the Committee observed, the Danish Nutrition Council (Stender and Dyerbery, 2003) recommended that the use of “industrially produced” trans fat be discontinued based largely on the prospective observational studies and the Ascherio et.al. (1999) analysis of nine dietary intervention trials. As discussed above, the Coalition believes this interpretation of the data is incorrect. In addition, the Committee has already rejected the notion that “industrial sources” of trans fat be eliminated because it would be impractical (if not impossible) to do so given the constraints of food technology. The Dietary Guidelines Committee report cites the World Health Organization Report (WHO, 2003) as recommending a quantitative (i.e. 1% of energy) limit for trans fat intake. This report included a general review of the observational and dietary intervention literature, but did not provide a specific rationale for their quantitative recommendation. The evidence cited by the WHO report has the same scientific limitations as that used by the Committee. These limitations contributed to the macronutrient DRI panel’s decision not to establish quantitative benchmarks for trans fat intake. Public health concerns The ultimate goal of the DGA is to provide the American population with the best information possible to assist in the selection of a healthy diet. Goals should be established that will have the greatest impact on public health. It is well known that both trans fat and saturated fat increases serum LDL-C. Although data are limited trans fat intakes above a threshold of approximately five percent of energy appear to have a negative impact on HDL cholesterol while intakes below this level have little impact. Published data (Allison et.al., 1999) indicate that the average intake of trans fat in the American diet is 2.6% of energy and the 90th percentile falls below five percent of total energy. As noted previously, even if data in the range of trans fat intakes typical in the U.S. were available to show that there is a linear relationship with risk of CHD, we believe it would be premature to establish a quantitative dietary recommendation at this time. The cutoff point for such a recommendation cannot be objectively determined without a more thorough understanding of how it would affect consumer behavior in the context of the food supply. The Coalition is concerned that the attention that will be directed toward trans fat if the Committee’s recommendation is enacted will distract from the well-established need to address saturated fat intake. For example, replacing butter with trans fat-containing margarine results in an improvement in serum lipid profiles (Chisholm et.al., 1996; Denke, et.al., 2000; Judd et.al., 1998). However, paranoia about trans fat generated by the DGA could easily prompt consumers to make poor dietary choices. The Committee also expressed concern regarding this issue, Although intakes of saturated fat, trans fat and cholesterol all should be decreased, because saturated fat consumption is proportionately much greater than that of these other fats, saturated fat should be the primary focus of dietary modification. We agree completely with this concern, and believe that the Committee’s recommendation for limiting intake of trans fat will exacerbate it. Food Industry Actions to Reduce Trans Fat in the Diet The U.S. food industry has been very responsive to public health concerns about trans fat, rapidly developing many new food products that contain no trans fat or significantly reduced trans fat. These products are the result of considerable investment in product reformulations and new processing techniques. These efforts continue on a fast track. Other methods by which dietary trans fat will be further reduced in the future include the development of new oilseed varieties, the oils from which will be more stable and not require hydrogenation to make them technologically acceptable. But the promise of these oils is not yet reality. It would be a major step backward for public health and an enormous disservice to the American consumer if trans fat was simply replaced with greater levels of saturated fat in the diet. Care must be taken to avoid unintended consequences in making dietary choices. The Committee clearly emphasized a much higher relative concern about reducing the intake of saturated fat (as noted above), and there are very few assurances that a quantitative limitation of trans fat intake will not be counterproductive from a public health perspective. Efforts by industry to remove, or otherwise minimize to the extent possible, trans fat in food products along with quantitative labeling pursuant to a final rule on trans fat labeling will have a much more positive impact on consumer nutrition than will the confusion created, including the likely consumption of higher levels of saturated fat, if