Regulatory & Compliance
FDA
FDA
The US agency responsible for regulating food, drugs, and dietary supplements.
The Food and Drug Administration (FDA) is the US federal agency within the Department of Health and Human Services responsible for protecting public health through regulation of food, drugs, medical devices, and dietary supplements. Under DSHEA, the FDA's role in supplement regulation is primarily post-market: it can take action against adulterated or misbranded products, issue warning letters for unauthorized health claims, and remove unsafe products from the market. Unlike drugs, supplements do not require FDA pre-market approval for safety or efficacy. The FDA's Office of Dietary Supplement Programs oversees supplement regulation.