While the media often refers to the dietary supplement industry as unregulated, this is a misleading and inaccurate reference. The Food and Drug Administration (FDA), as part of the Department of Health and Human Services, and the Federal Trade Commission (FTC) share oversight of dietary supplement manufacturers and their products under a variety of regulations.
FDA regulates the safety, manufacturing and labeling of dietary supplements, while FTC has primary responsibility for regulating the advertising of these products. Over the last few years, FDA and FTC have worked together to ensure there is combined jurisdiction over these products. With the mutual goal of consumer protection, FDA and FTC chair an interagency health fraud steering committee that includes Federal agencies in the U.S., Canada and Mexico.
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and over-the-counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market including products that use ingredients banned by the FDA. In addition, manufacturers must make sure that product label information is truthful and not misleading.
FDA's responsibilities include monitoring safety, mandatory adverse event reporting, and product information such as labeling, claims, package inserts and accompanying literature. Domestic and foreign facilities that manufacture/process, pack or hold food for human or animal consumption in the United States, are required pursuant to the Bioterrorism Act to register their facility with the FDA and follow its regulations for safety and quality.
In June 2007 the FDA published comprehensive regulations for current Good Manufacturing Practices (cGMPs) for those who manufacture, package or hold dietary supplement products. cGMPs are strict, detailed procedures used to ensure safety and quality manufacturing processes for products intended for human consumption such as drugs, dietary supplements and food. cGMPs require systems that help prevent product contamination, inconsistency from batch-to-batch, unsanitary manufacturing, errors in product labeling and a great number of other important production processes that can affect human health. If problems do arise, they can be identified, tracked and resolved quickly, through cGMP-mandated documentation for all processes, from production of raw ingredients to distribution of finished product.
The FTC, in cooperation with the FDA, ensures that advertising for dietary supplements is accurate and not misleading. As with advertisements for therapeutic drugs, advertisements for dietary supplements must not make claims without substantiation by scientific evidence and must not be intended to diagnose, treat, cure, or prevent any disease.