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Dietary Supplements: A Framework for Evaluating Safety
additive regulations and contending that they were unapproved food additives. FDA interpreted the definition of “food additive” as applying to single ingredient supplements in capsule form. For example, FDA argued, unsuccessfully, that black currant seed oil in a capsule was a food additive (United States v Two Plastic Drums … Black Currant Oil, 984 F2d 814 [7th Cir 1993]). The courts eventually struck down FDA’s efforts to broadly interpret the food additive definition (United States v Two Plastic Drums … Black Currant Oil, 984 F2d 814, 819 [7th Cir 1993]; United States v An Article of Food, 792 F Supp. 139 [D Mass 1992]).
1976 “Proxmire Amendments”
Prior to the overturn by the court in 1993 of FDA’s attempts to apply the food additive provisions to dietary supplements, the regulation of botanical, vitamin, and mineral supplements had been inconsistent and was based on a combination of enforcement and judicial decisions. Court actions required long periods of time and considerable resources; thus in the 1970s FDA attempted to have a broader impact on dietary supplement use by implementing tighter regulations of vitamin and mineral supplements, consistent with the U.S. Supreme Court’s endorsement in 1973 of FDA action to control entire product classes with regulations rather than relying only on litigation (FDA, 2002).
In 1973 FDA issued regulations that prohibited certain representations on vitamin and mineral supplement labels, established standards of identity for vitamin and mineral supplements, and established that preparations containing more than 150 percent of the U.S. Recommended Daily Allowance (U.S. RDA) per serving were drugs (FDA, 1973). Both industry and consumers protested the attempts by FDA to set maximum levels (Hutt and Merrill, 1991; Khatcheressian, 1999; Pendergast, 1997), eventually leading Congress to enact the Health Research and Health Services Amendments in 1976. Also known as the “Proxmire Amendments,” these amendments prohibited FDA from “… establishing standards limiting potency of vitamins and minerals in food supplements or regulating them as drugs based solely on potency” (FDA, 2002). FDA revised its vitamin–mineral regulations in response to this legislation and, after a subsequent successful court challenge (National Foods Associations v Matthews, 557 F2d 325 [2d Cir 1977]), ultimately revoked its 1973 regulations about maximum potency and drug status in 1979 (FDA, 1979).
The Nutrition Labeling and Education Act of 1990 and Health Claims
With the suppression of FDA’s attempts at more restrictive rulemaking, the realm of products sold as dietary supplements continued to expand and