How Are Dietary Supplements, And Ephedra Products In Particular, Regulated Under The Federal Food, Drug, And Cosmetic Act (FDC Act)?
As the Commissioner of the FDA has repeatedly confirmed, the FDC Act provides substantial and sufficient authority to the FDA to regulate dietary supplements and to assure their safety and usefulness to the American public. Repeated statements of critics of dietary supplements to the contrary reflect a simple failure to understand the law, and also reflect FDA’s acknowledged failure to enforce the considerable authority that the agency has.
Under the FDC Act, FDA has regulatory authority over drugs, devices, foods and cosmetics. Dietary supplements are a subcategory of “food” under the FDC Act. The degree of regulation for each product category is that which Congress deemed appropriate to assure public safety. Most drugs and devices, because of their inherent risks, cannot be marketed without FDA’s premarket approval. Most foods and dietary supplements, because of their inherent safety, do not require premarket approval, as Congress recognized that such a requirement would be an enormous waste of limited public and private funds. However, under current law, data for any new dietary ingredient that is included in a dietary supplement must be submitted for review by FDA prior to marketing.
In the 1980s and early 1990s, FDA attempted to require premarket approval of safe foods and dietary supplements even though the agency did not have authority to do so. FDA argued that Congress, when it had granted FDA authority to approve chemical additives such as preservatives prior to marketing, also provided FDA with broad authority to approve any food that was added to another food. This FDA legal theory led to widespread agency misuse of the “food additive” premarket approval requirements of the FDC Act, and made it virtually impossible for the food and dietary supplement industry to market many products that are widely consumed today, including St. John’s Wort, saw palmetto, ginkgo, ephedra and even folic acid to prevent neural tube defects and natural food oils such as fish oil and evening primrose oil.
In the early 1990s, both the courts and Congress took notice of FDA’s misuse of its authority. Two United States Courts of Appeals ruled that FDA could not regulate pure foods as food additives, and accusing FDA, as a result of the agency’s vigorous defense of its “food additive” legal theories, of “trafficking in absurdities” and “Alice-in-Wonderland” thinking. Then, in 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), a landmark law that recognized FDA’s longtime misuse of its authority, and that reaffirmed the original intent of the FDC Act to make it clear that, for dietary supplement ingredients that had been on the market prior to 1994, FDA did not have premarket approval authority over those ingredients.
Contrary to critics of DSHEA, this law does not remove dietary supplements from FDA’s regulatory sphere. As FDA officials have repeatedly recognized, under the FDC Act as revised by DSHEA, dietary supplements are heavily regulated, and FDA has the regulatory authority and power to assure safety, and accurate and truthful labeling.
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