Understanding the FDA's Classification of Dietary Supplements

The Food and Drug Administration (FDA) regulates dietary supplements differently from conventional foods. The Federal Food, Drug and Cosmetic Act (Act FD&C) was amended in 1994 by the Dietary Supplements Health and Education Act (DSHEA), which defined the term “dietary supplement” and established FDA authority with respect to such products. Supplements are ingested and come in many forms, such as tablets, capsules, soft capsules, gel capsules, powders, sticks, gummies, and liquids. The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement.

Both the FDA and the FTC have the authority to take enforcement action against dietary supplements and companies if they identify violations. On the other hand, consumers were expected to report directly to the FDA about potential adverse effects related to supplements. Dietary supplement companies must report serious adverse effects they receive from their dietary supplements to the FDA within 15 days. The FDA requires specific safety information from the manufacturer who intends to market a dietary supplement containing a new dietary ingredient. The FDA recommends that consumers talk to their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement.

Whether a product is classified as a dietary supplement, conventional food, or medication depends on its intended use. FDA regulations require that dietary supplement labels bear the name of the product and a statement stating that it is a dietary supplement or equivalent term that replaces the diet with the name or type of dietary ingredient in the product (e.g., vitamins, minerals, herbs). These three types of statements are not approved by the FDA and do not require an FDA evaluation before they are used in the labeling of dietary supplements. The FDA evaluates reports of potential adverse effects related to supplements and any other information about adverse events reported by the health department, care providers, or consumers to identify early signs that a product may present safety risks to consumers. If you have a general complaint or concern about food products, including dietary supplements, you can contact the consumer complaint coordinator at the local FDA district office closest to you. Once a dietary supplement is marketed, the FDA must prove that the product is not safe to restrict its use or recall it from the market. If you experience an adverse event while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse event to the FDA.

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