Foreword: Dietary Supplement Regulation in Flux

Dietary supplements-vitamins, minerals, herbs, amino acids, and sundry other substances-have soared in popularity over the past decade, resulting in a $20 billion industry with over 1,000 manufacturers marketing 29,000 products.1 A recent survey conducted by the National Center for Complementary and Alternative Medicine (\"NCCAM\") found that approximately one-fifth of Americans use supplements.2 These products present vexing regulatory challenges for the Food and Drug Administration (\"FDA\"), and, for many years, the agency struggled to formulate an effective regulatory approach.3 In 1993, the FDA published a notice that summarized its safety concerns associated with various categories of dietary supplements and delineated the rather aggressive regulatory recommendations of an agency task force.4 Congress quickly reacted to these proposed regulatory initiatives. In 1994, it enacted the Dietary Supplement Health and Education Act (\"DSHEA\"),5 which sharply limits the PDA\u0027s express authority to regulate covered products. Congress apparently acted in response to anxious lobbying from the dietary supplement industry and the public, both of which were concerned that the PDA\u0027s notice signaled the agency\u0027s intention to regulate these products aggressively.6 Purporting to balance concerns about the safety of supplements and consumer freedom to purchase them, DSHEA\u0027s highly deregulatory approach won effusive praise from commentators who profess strong faith in the ability of consumers to make intelligent choices about supplement use.7 Other observers remain dubious, however, that the typical consumer will exercise informed skepticism when it comes to claims about the safety and utility of these products.8 In order to understand the possibilities and limitations of DSHEA with respect to dietary supplement risk regulation, one must first consider the larger context in which the statute operates. The FDA supervises a wide range of products, including foods, items that are processed in certain ways to deliver more than a simple caloric effect (e.g., caffeinated beverages), products designed to have a quasi-therapeutic effect (e.g., dietary supplements), and carefully designed and processed substances that are designed solely for therapeutic purposes (e.g., prescription and over-the-counter drugs). In drafting DSHEA, Congress chose not to create an entirely new category of products subject to agency controls. Instead, Congress accomplished its deregulatory goals by declaring that dietary supplements constitute a subcategory of food.9 In choosing to characterize supplements in this way, Congress also explicitly rejected past FDA efforts to treat these products as drugs or food additives under the federal Food, Drug, and Cosmetic Act (\"FDCA\"). Prior to the enactment of DSHEA, the FDA had attempted to use the food additive pre-approval requirement as one means to regulate certain dietary supplements.10 DSHEA explicitly exempts these products from regulation as food additives.\" Congress also opted against treating dietary supplements as drugs under the FDCA.12 In contrast to the regulatory scheme for drugs, which requires substantial premarket evaluation of safety and efficacy before the granting of a license,13 DSHEA allows dietary supplement manufacturers to market their products without receiving any premarket clearance from the FDA. A company wishing to sell a supplement containing a \"new dietary ingredient\" (\"NDI\") (defined as one not marketed before October 15, 1994), however, must file a notification with the FDA at least seventy-five days prior to market introduction, which provides the basis for the manufacturer\u0027s conclusion that the supplement will \"reasonably be expected to be safe\" and must demonstrate only that \"[fjhere is a history of use or other evidence of safety.\"14 DSHEA also permits manufacturers to include so-called \"structure or function\" claims in their product labeling, as long as the manufacturer \"has substantiation that such statement is truthful and not misleading,\"15 and it does not require that manufacturers pre-clear these claims with the agency. …