In 1993, following the passage of the NLEA, FDA issued an advance notice of proposed rulemaking regarding dietary supplements, which was accompanied by the suggestion that some products marketed as dietary supplements might be more appropriately considered under other regulatory categories (FDA, 1993). Amino acids, for example, might be considered unapproved food additives, and some botanicals might be more appropriately considered as drugs (FDA, 1993). Vitamins and minerals were also considered a potential target of regulation, as FDA suggested that their strength should be limited to levels that approximated the U.S. RDA (FDA, 1993).
The dietary supplement industry and consumers reacted strongly to these potential regulatory restrictions (Khatcheressian, 1999). Extensive public debate ensued over the importance of dietary supplements in health, consumers’ freedom to access information about supplements, and the controversy over FDA’s regulatory approach. Subsequently, Congress passed DSHEA, signed into law October 15, 1994, which limited and proscribed the regulation of dietary supplements by FDA (DSHEA, P.L. 103-417, § 2 ).
DSHEA can be characterized as the most important dietary supplement legislation enacted to date. In its findings, Congress recognized the wide use of dietary supplements and stated in the legislation that currently available dietary supplements are generally safe. Passage of DSHEA was based on the concept that “… legislative action that protects the right of access of consumers to safe dietary supplements is necessary to promote wellness” (DSHEA, P.L. 103-417, § 2 ; OIG, 2001). DSHEA established the first comprehensive definition of dietary supplements (see Box 1-1), resulting in botanicals and amino acids being considered as foods based on intended use, as were vitamins and minerals, which were already classified as food based on intended use. Importantly, DSHEA established a new regulatory framework for dietary supplements that limited FDA’s authority over these products to that of conventional foods, as compared with its authority over food additives or new drugs (see Table 1-1 for comparison and Box 1-3 for discussion of an example).
DSHEA specifically exempted dietary ingredients in dietary supplement products from being regulated under the category of food additives (DSHEA, P.L. 103-417 ). Because FDA does not have the authority to consider dietary supplement ingredients as food additives unless they are added to a conventional food and marketed as a food, there is no requirement for a manufacturer to obtain premarket approval (Khatcheressian, 1999) or establish GRAS status (McNamara, 1995; Pendergast, 1997). Thus DSHEA eliminated one of the key approaches FDA had taken to