What Does It Mean That Dietary Supplements Are Not Regulated? A Comprehensive Guide

The dietary supplement industry is a booming sector, with surveys showing that half to two-thirds of Americans taking a supplement regularly. Despite this, the industry is largely unregulated by the Food and Drug Administration (FDA), primarily under the provisions of the Dietary Supplement Health and Education Act (DSHEA). This lack of oversight has caused confusion among consumers, who may not understand what is safe and what isn't. The FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used on dietary supplement labels require pre-marketing review and authorization.

This means that the composition and quality of the ingredients cannot be reliably guaranteed, making research on dietary supplements questionable. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the agency's oversight of these products. Dietary supplements cannot claim to treat, prevent, diagnose, mitigate, or cure a specific disease (statements about diseases). The FDA's role in the regulation of dietary supplements includes (among other things) inspecting manufacturing facilities, reviewing notifications of new dietary ingredients (NDI) and other regulatory requests on dietary supplements, investigating complaints, monitoring the market, examining dietary supplements offered for import to determine if they meet the requirements of U.

S. law, and more. The rapidly expanding “dietary supplement” industry includes not only vitamin and mineral formulas, but also those derived from herbs, glands, amino acids and enzymes of all kinds, in any combination and quantity, sold in the form of tablets, capsules, gel capsules, powders or liquids. While states have passed some laws to achieve tighter control over ephedrine, state legislation may not be a viable mechanism for strengthening supplement regulation. In the absence of leadership from the FDA and given the unwillingness of the supplement industry to control itself, legislators should step in.

Supplements are marketed together with drugs that claim that they are FDA-approved treatments and reveal their side effects, which has persuaded the American public that supplements and medications are two equally effective alternatives. For more detailed information on the subject, see a recent report from the American Medical Association (AMA) Council on Science and Public Health that updated and modernized the AMA's dietary supplement policy.