Chapter II

Background on Dietary Supplements

PERTINENT LEGISLATION AND REGULATIONS

The Federal Food, Drug, and Cosmetic Act of 1938, as amended by DSHEA, is the principal law governing dietary supplements. Under FDCA, FDA has jurisdiction over product safety and labeling issues. This chapter provides background on FDA's regulation of dietary supplements.

Dietary supplements are also subject to other Federal laws. The most relevant of these, the Federal Trade Commission Act (5 U.S.C. 45), provides the Federal Trade Commission (FTC) with the authority to regulate advertisements for all consumer products, including supplements. Relevant FTC policies are discussed in Chapter III.

Currently, Congress is considering changes in some provisions related to dietary supplements, such as health claims under NLEA; however, this report deals with FDCA as amended by DSHEA, as it existed on September 2, 1997.

1. 1906 Through 1994

The legislative and regulatory history concerning dietary supplements since 1906 is extensive. A brief synopsis of events that led up to the passage of NLEA in 1990 and DSHEA in 1994 may be instructive.

The Pure Food and Drug Act of 1906 dealt with unsafe foods, unregulated elixirs, and misbranded products. The 1938 FDCA established a category of foods for special dietary use and required the labels of such foods to provide information on their vitamin, mineral, or other dietary properties.

In 1941, FDA established regulations governing the labeling of vitamin and mineral supplements and other foods for special dietary use containing added vitamins and/or minerals (66). The minimum daily requirement (MDR) was established as the reference standard for expressing the daily need for a vitamin or mineral. The 1941 regulations placed no restriction on the amount or variety of nutrients that could be included in a supplement or a fortified food.

From 1962 to 1976, FDA attempted to revise these regulations to replace the MDR with a new reference standard—the U.S. Recommended Daily Allowance (U.S. RDA)—and to establish a standard of identity restricting the amounts and combinations of vitamins and minerals that could be marketed as dietary supplements. FDA also proposed to require a label disclaimer on vitamin or mineral supplements stating that:

Vitamins and minerals are supplied in abundant amounts by commonly available foods. Except for persons with special medical needs, there is no scientific basis for recommending routine use of dietary supplements (65).

Two years of hearings, from 1968 to 1970, led FDA to abandon the proposed disclaimer, but the bulk of the proposal remained intact. Quantities of vitamins and minerals were to be limited generally to 150 percent of the U.S. RDA, and only a few combinations of vitamins and minerals were to be allowed. Products with higher levels of nutrients or different combinations of nutrients would be subject to review by an expert advisory committee as part of FDA's over-the-counter (OTC) drug review.

These special dietary use regulations and the dietary supplement standards of identity were finalized in 1973, overturned and remanded to the agency by the courts in 1974, revised and reproposed in 1975, largely invalidated by legislation early in 1976, revised and reissued late in 1976, again overturned by the courts in 1978, and ultimately withdrawn by FDA in 1979 (62,64,93,94). When FDA withdrew those regulations, it withdrew them in their entirety—the basic labeling provisions that had been upheld as well as the provisions that had been overturned by the courts.

In 1976, Congress passed vitamin and mineral legislation (the Rogers/Proxmire amendment) that prohibited FDA from classifying vitamin and mineral supplements as drugs based solely on their combinations or potency (unless drug claims were made), from establishing a standard of identity for these products, and from limiting the quantity or combination of nutrients in them, except for reasons of safety. The 1976 legislation also incorporated FDA's 1941 definition of special dietary use into FDCA.

Since the 1973 regulations were stayed pending judicial review and ultimately withdrawn, no formal labeling regulations for dietary supplements were in effect from 1973 to 1994, but most manufacturers adopted the format set forth in the 1973 regulations. FDA finalized nutrition labeling regulations for dietary supplements in January 1994 (45,46,47), but these labeling provisions were amended by DSHEA in October 1994. Revised nutrition labeling regulations for dietary supplements were proposed in December 1995 (40-43). The final rules were published on September 23, 1997, as this report was being completed (26-31).

In 1990, Congress passed landmark legislation (NLEA) that affected nutrition labeling of food and dietary supplements. NLEA mandated that virtually all food labels not only must contain specific information on nutrient content but also could make claims relating specific nutrients to diseases or disorders. Such "health claims" were to be based on significant scientific agreement on the validity of the claimed relationship between the nutrient and the disease. In developing the process for approval of health claims, FDA established standards for the types and levels of evidence necessary to meet the criteria for approval of health claims.

NLEA directed FDA to consider a different approval procedure and scientific evaluation standard for health claims made about dietary supplements than those used for foods. NLEA also directed FDA to consider a list of 10 potential health claims for specific nutrient/disease relationships.

In the process of establishing mandatory nutrition labeling requirements (55), FDA proposed to replace the U.S. RDAs with new RDIs based on "mean requirements" for vitamins and minerals, which would have had the effect of lowering the daily reference amounts for many nutrients. FDA also proposed some basic requirements for health claims that appeared to disallow health claims for many dietary supplements.

In 1992, Congress passed the Dietary Supplement Act which essentially prohibited the implementation of NLEA with respect to dietary supplements except for the approved health claims. This legislation, in effect, established a moratorium on the labeling of dietary supplements to permit Congress and FDA time to consider various related issues. It also required that regulations pursuant to NLEA regarding dietary supplements be reproposed.

On June 18, 1993, FDA published a comprehensive ANPR concerning the regulation of dietary supplements (52). This ANPR referenced a number of factors, including increased consumer use of dietary supplements, an internal FDA three-year review of possible regulatory approaches, occurrence of eosinophilia myalgia syndrome as a consequence of L-tryptophan use, and reports of serious illness as a result of using certain botanical supplements.

The 1993 ANPR suggested, among other provisions, that vitamins and minerals be limited to low multiples of the RDIs, that some botanical products were inherently drugs and not dietary supplements, and that many dietary supplements, including amino acids, were unapproved food additives. The ANPR elicited considerable protest from the public and the dietary supplement industry because FDA appeared to be reproposing regulatory provisions withdrawn or struck down by court actions in previous years. The ANPR was a significant motivating factor in industry and congressional efforts to develop and secure passage of DSHEA in 1994.

2. 1994 to the Present

Since the passage of DSHEA, both Congress and FDA have put forth related legislative and regulatory initiatives. In 1995, the Food and Dietary Supplement Consumer Act (HR 1951) was introduced in the U.S. House of Representatives. The bill would have repealed certain provisions of NLEA and DSHEA and would have established a single claims category that would encompass statements that currently fall under the classification of health claims, as well as statements of nutritional support. No action on HR 1951 was taken by either House of Congress. In 1997, the Food and Drug Administration Modernization and Accountability Act (S 830) was introduced into the Senate and the Food and Nutrition Information Reform Act (HR 2469) was introduced into the House of Representatives. Both 1997 bills include changes to procedures for the authorization of health claims by allowing other Federal agencies to determine whether significant scientific agreement exists. Action on both bills is pending. FDA has advanced various regulatory actions resulting from the passage of DSHEA (Table 1).

CONSUMER USE

President Clinton attributed the move toward legislative and regulatory reform for dietary supplements to a growing interest on the part of the American public in the use of dietary supplements. In signing DSHEA into law, he stated:

. . . in an era of greater consciousness among people about the impact of what they eat on how they live, indeed, how long they live, it is appropriate that we have finally reformed the way the Government treats consumers and these supplements in a way that encourages good health (12).

In enacting DSHEA, Congress estimated that "almost 50 percent of the 260,000,000 Americans regularly consume dietary supplements of vitamins, minerals, or botanicals as a means of improving their nutrition" (Appendix A). In that same year, the United States was expected to spend more than $1 trillion on health care—about 12 percent of the country's gross national product. Congressional findings reported in DSHEA state that "preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures." The Act adds that "consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements."

A variety of sources confirm the congressional finding that a significant portion of the U.S. population uses dietary supplements. Data from a large probability sample of the U.S. population from the third National Health and Nutrition Examination Survey for 1988-94 indicated that a substantial percentage of the U.S. population used dietary supplements (defined as including vitamins, minerals, amino acids, botanicals, and other products) (142). Data from this survey suggest that for the total U.S. population, the prevalence of dietary supplement use by children 3-5 years of age is about 48 percent, while the prevalence of use by adults 20 years of age to over 80 years of age ranges from about 36 percent to 51 percent. Dietary supplement usage appears to differ by age, with increasing use by older adults (35.8 percent for ages 20-29 years, 46.2 percent for ages 50-59 years, and 50.6 percent for ages 80 years and older). In the total sample surveyed, the prevalence of supplement use by women of all ages and ethnicities was higher than that by men (42.9 percent versus 34.5 percent on an age-adjusted basis, respectively).

Similarly, use of dietary supplements by all age groups appears to be greater in non-Hispanic whites (41.6 percent) than in non-Hispanic blacks (30.2 percent) or Mexican-Americans (30.5 percent). In addition, for all groups, the higher the income, the greater the use of dietary supplements. Further, the prevalence of dietary supplement use increases with years of education in all groups.

According to National Health Interview Surveys from 1987 to 1992, regular daily use of certain specified supplements (multivitamins, vitamin A, vitamin C, vitamin E, or calcium) remained at about 24 percent. In both 1987 and 1992, 9 percent of the population reported daily intake of more than one type of the specified supplements, 5 percent took two types of supplements, and 0.3 percent took all five of the types of supplements included in the survey. A comparison of the 1987 and 1992 National Health Interview Survey results indicates a 4.9 percent decline in the total population reporting use of any vitamin or mineral supplement (51.1 percent versus 46.2 percent) (130).

According to data collected by Multi-Sponsor Surveys, Inc., presented during a Commission hearing by Hoffman-La Roche Inc., between 30 and 40 percent of the U.S. population use vitamin and mineral supplements (72). In 1995, 38 percent of adults used vitamin and mineral supplements. This represents approximately 73 million adults, an increase of some 13 million users since 1991. These data suggest that about 33 percent of adults, or 63 million people, take supplements every day or nearly every day. Of these, approximately 49 percent consume one vitamin and mineral supplement per day that supplies the U.S. RDA. Another 27 percent take two or three supplements per day, usually a multivitamin plus calcium, vitamin C, or vitamin E. One adult user in ten takes six or more supplement products of any kind per day (72).

While the usage of vitamin and mineral supplements is well documented, collection of data on the use of other categories of supplements (e.g., botanicals and amino acids) began only recently. A survey of 1,945 individuals conducted by FDA in 1994 indicated that 51 percent of adults 18 years of age and older used some type of supplement (127). Of those supplement users, 73 percent were considered to be "light users" (used one or two supplements) and 27 percent "heavy users" (used three or more supplements), 10 percent were amino acid users, and 16 percent were botanical product users. In 1995, FDA conducted a similar survey and found an increase in the use of some supplements. Of 1,001 adults queried, the survey indicated that 55 percent used some type of supplement. Of those, 72 percent were light users, 28 percent were heavy users, 16 percent used amino acids, and 22 percent used botanical products (127).

According to a telephone survey of 1,000 individuals conducted by Applied Biometrics, some of the reasons reported by consumers as to why they take supplements are to prevent disease or boost immunity, to increase energy, to improve fitness, to increase alertness or mental activity, to reduce stress, and to treat a medical problem (131).

The sources cited above vary in their estimates but are consistent in revealing that a substantial percentage of the U.S. population takes dietary supplements of some kind.

CHARACTERISTICS OF THE U.S. DIETARY SUPPLEMENT INDUSTRY

According to congressional estimates at the time DSHEA was enacted in 1994, some 600 dietary supplement manufacturers in the United States were producing approximately 4,000 products, with total annual sales of such products reaching at least $4 billion (Appendix A).

The supplement industry in the United States is represented, for the most part, by five trade organizations. The American Herbal Products Association represents some 200 companies and individuals who grow, import, process, market, and/or manufacture botanical products (3,87). The Council for Responsible Nutrition represents over 80 companies in the dietary supplement industry (14). The National Nutritional Foods Association has some 4,000 members representing manufacturers, wholesalers, distributors, and retailers of natural products (75). The Utah Natural Products Alliance represents the interests of dietary supplement companies in Utah, which generate sales in excess of $1 billion per year (77). The Nonprescription Drug Manufacturers Association is composed of manufacturers and distributors of nonprescription drugs and combination or single-ingredient vitamin and mineral products (143).

A number of factors, including rapid growth of the dietary supplement industry, an increase in consumer interest in such products, particularly botanical products, and the variety of avenues through which consumers may obtain supplements, have hampered efforts to collect accurate data on the sale and use of such products.

A review of the global dietary supplement industry (vitamins and minerals, herbs and botanicals, sports nutrition) conducted by the Nutrition Business Journal and its affiliate EuroConsult, Inc., indicated that the worldwide dietary supplement industry registered $28.2 billion in consumer sales in 1995 (6). Of that total, Europe accounted for $9.5 billion, the United States $8.2 billion, Japan $5.2 billion, other Asian countries $3.2 billion, and Canada $0.7 billion. In the United States, sales of vitamins and minerals alone were $4.8 billion in 1995, followed by botanical products at $2.5 billion and sports nutrition supplements at $0.8 billion. However, in Europe, consumer sales were highest for botanicals ($6 billion), followed by vitamins and minerals ($3.1 billion) and sports nutrition products ($0.4 billion) (6).

Vitamin and mineral products include single-nutrient supplements as well as a multiplicity of combination products. Within the vitamin and mineral category, the top six product types are multivitamins (with or without minerals), vitamin E, vitamin C, iron, calcium, and B vitamins (15). Multivitamin preparations constitute about 31 percent of all retail sales in the vitamin and mineral category. These data are consistent with information on extent of use by adults presented in testimony to the Commission (72).

Some 1,500 to 1,800 botanicals are sold in the United States as dietary supplements or ethnic traditional medicines (77). According to a survey of the U.S. botanical supplements market, the top 10 botanical products sold at selected U.S. health food stores in 1995 were echinacea, garlic, goldenseal, ginseng, ginkgo, saw palmetto, aloe, ma huang, Siberian ginseng, and cranberry (9).

The dietary supplement industry also represents a major segment of the U.S. import and export trade market. According to 1994 trade data from the Bureau of Census, U.S. Department of Commerce, "medicinal herbs" imported into the United States included licorice roots, oriental ginseng roots (cultivated and wild), mint leaves, plants and plant parts used as herbal teas, ephedra powder, and substances used principally to promote healing. "Medicinal herbs" exported from the United States include American ginseng, echinacea, ginkgo, goldenseal, peppermint, and saw palmetto (9).


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Commission on Dietary Supplement Labels