special subjects
Overview of Dietary Supplements
Safety and Efficacy
The FDA does not require manufacturers of dietary supplements to prove safety or efficacy, although supplements must have a history of safety. Manufacturers and distributors of supplements must report serious adverse events to the FDA through theMedWatchsystem, a medical product safety reporting program. Most people who use dietary supplements assume that they are good for health generally, are safe and effective for treating and/or preventing specific conditions, or both. People may think this because dietary supplements are natural (ie, derived from plants or animals) and because some are supported by centuries of use in traditional systems of medicine. Although more and more clinically based studies are now being done, most supplements have not been rigorously studied. Information about studies being done is available from theNIH National Center for Complementary and Integrative Health(NCCIH). For most dietary supplements, evidence suggesting safety or efficacy comes from Traditional use In vitro studies Certain case reports Animal studies 