Federal Regulation of Dietary Supplements The FDA is the federal agency that oversees both supplements and medications, but the FDA regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Drugs must be approved by the FDA before they can be sold or marketed. The marketing, manufacturing, labeling, and advertising of dietary supplements are regulated by standards enforced by the FDA and the Federal Trade Commission. During an episode of the “AMA Moving Medicine” video series, Cohen discussed dietary supplements and regulations.
The FDA regulates dietary supplements under a different set of regulations than those that govern conventional foods and medications. In 1994, Congress passed the Dietary Supplements Health and Education Act (DSHEA), an important law that provided a regulatory framework to ensure the safety of dietary supplements. The substances that the FDA regulates as foods are subdivided into several categories: foods, food additives, added substances (artificial substances that are not intentionally introduced into foods, but nevertheless end up in them) and dietary supplements. However, the FDA will review the advertising of a product to determine if it should be regulated as a food or as a drug, based on the claims that the manufacturer or seller makes about its properties.
The Dietary Supplements Health and Education Act of 1994 is a 1994 statute of United States federal legislation that defines and regulates dietary supplements. The Health and Education on Dietary Supplements Act of 1994 mandated that the FDA regulate dietary supplements as foods and not as drugs. In the latest edition of the Advocacy Update, a majority of Congress urges CMS to finalize and strengthen prior authorization rules, among other things. Food and Drug Administration (FDA) authority to establish rules on the manufacture of dietary supplements, regulate health claims and labeling.
