Regulation

Federal regulation of dental amalgam and elemental mercury as an amalgam component resides with the Food and Drug Administration. Both products are regulated under the mandate of the Medical Device Amendments of 1976 and the Safe Medical Devices Amendments of 1990. The basic framework of these device laws is a three-tiered regulatory scheme, which classifies devices on the basis of health risk and sets corresponding levels of regulatory controls.

Historically, FDA has regulated dental mercury and amalgam alloys separately, with mercury treated as a class I device and the alloy as a class II device. (Medical devices are assigned to class I, II, or III, depending on the degree of regulatory control needed to assure the safety and effectiveness of the device, with class I requiring the least degree of regulatory control and class III the greatest. Mercury was placed in class I because, as an element, it could be regulated by establishing a standard of purity. The alloy was assigned to class II because of the potential safety and effectiveness risk that could result from variations in chemical formulation in terms of percent composition and types of materials.)

The FDA Dental Products Panel, convened in March 1991, unanimously agreed that sufficient scientific data do not presently exist to establish dental amalgam as a human health hazard. The Panel also noted that although the evidence was anecdotal and inconclusive in establishing that persons with amalgam restorations develop any toxic reactions, this potential had not been adequately studied and warranted further investigation. This conclusion is consistent with the PHS evaluation of amalgam risks attached to this report.

For this reason, a Regulatory Work Group (operating under the auspices of the Subcommittee on Risk Management) believes FDA should administratively combine dental mercury and amalgam alloys into a single product for regulatory purposes. This would enable dental amalgam, with the mercury component, to be regulated at the higher, class II level. Based on the absence of scientific data establishing a causal link between amalgam restorations and any health problems, class II provides satisfactory regulatory control of dental amalgam at this time.

There are two other steps the FDA should consider to assist dental practitioners to better manage their patients and to induce providers of dental care to report adverse reactions to both dental amalgam and other restorative materials.

For a fuller discussion of the above issues, see the Regulatory Work Group report (Appendix VI).

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