The Food and Drug Administration (FDA) regulates dietary supplements as foods, not drugs. This means that while the FDA has regulations for manufacturing and labeling, dietary supplements have different guidelines for testing, safety, and efficacy than pharmaceutical drugs. The Dietary Supplement Health and Education Act (DSHEA) classifies dietary supplements into a special category within the general scope of food, and the FDA is responsible for helping to regulate the industry. The FDA has limited resources to analyze the composition of food products, including dietary supplements, and therefore focuses its resources first on public health emergencies and on products that may have caused injury or illness. DSHEA requires that when the label of a dietary supplement or other label includes a claim, it must be accompanied by a disclaimer informing consumers that the FDA has not evaluated the claim. In addition to the manufacturer's responsibility to comply with safety regulations and labeling requirements of dietary supplements and to comply with current standards of good manufacturing, there are no laws or regulations that limit the serving size of a dietary supplement or the amount of a dietary ingredient that a serving of a dietary supplement can contain.
The FDA also considers advertising when evaluating the intended use of a product labeled as a dietary supplement. The FDA (Center for Food Safety and Applied Nutrition) and the Federal Trade Commission (FTC) both have authority to take enforcement action against dietary supplements and companies if they detect violations. The FDA oversees the manufacture and labeling of supplements, and regularly inspects companies to ensure they comply with all regulations. Anyone can report an adverse event related to a dietary supplement directly to the FDA through the safety reporting portal. Finally, dietary supplements, like conventional foods, may include other labeling claims that are not defined by law or regulation. If a supplement company does not comply with FDA regulations, the FDA may prohibit it from selling its product.
