Still attempting to reduce indiscriminant food fortification and dietary supplement products, in 1966 the FDA proposed to limit the number of food products that could be fortified to eight classes and to specify the nutrients that could be used with each class. This proposed regulation was worded in the context of two new standards of identity: one for vitamin and mineral dietary supplements and the other for a limited number of food products (FDA, 1966). FDA convened public hearings on these proposed regulations in 1968 and 1969 (Hutt, 1980). This proposed regulation and a subsequent proposal in 1974 of general rules governing the addition of nutrients to food, along with provisions to enforce the rules (FDA, 1974), were eventually abandoned due to objections and comments in public hearings and due to other events.

Two events in particular changed the course of FDA’s regulatory approach in the 1960s and 1970s: President Nixon’s White House Conference on Food, Nutrition and Health in 1969 and Congress’s enactment of the new Section 411 of the Food, Drug, and Cosmetic Act (FD&C) in 1976. The White House Conference issued a report that recommended fortification of existing and new food products to reduce malnutrition, which was in many ways the opposite of the 1966 FDA proposed regulation (Hutt, 1980; WHC, 1970). After FDA published regulations based on its 1968 and 1969 hearings, Congress was persuaded in 1976 to amend the FD&C Act to limit FDA’s authority over vitamin and mineral supplements. This amendment explicitly prohibited FDA from imposing maximum limits on the potency of any vitamin or mineral in a dietary supplement in tablet, capsule, or small measured liquid form except for safety reasons. The 1976 statute also prohibited FDA from limiting the combination or number of safe nutrients in a dietary supplement (21 U.S.C. §350). The FDA Modernization Act of 1997 extended this to include dietary supplements in food form (P.L. 105-115). When FDA attempted to limit the amount of vitamin A and vitamin D fortification by declaring any level higher than 150 percent of the U.S. Recommended Daily Allowances (US RDAs) to be a prescription drug, this approach was also struck down by the courts.2

Current Fortification Policies

In 1943, due to the heightened interest in fortified food, FDA issued a policy statement (which has never been withdrawn) on the

2  

National Nutritional Foods Association v. Mathews, 557 F.2d 325 (2d Cir. 1977).



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