What Role Does the FDA Play in Regulating Dietary Supplements?

The FDA is a federal agency responsible for regulating products that affect public health, such as food products, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. Dietary supplements are regulated by the FDA as foods, not as drugs. The FDA does not test dietary supplements before they are sold to consumers, but they do have regulations for manufacturing and labeling. The Dietary Supplements Health and Education Act of 1994 (DSHEA) defined the role of supplements and described what dietary supplement companies can legally say about their products.

The law states that, since supplements are not drugs, supplement companies cannot imply, imply, or declare that their products diagnose, treat, cure, or prevent diseases of any kind. The FDA has also interpreted some normal conditions as precursors or markers of diseases. That's why you might see vague wording about what a supplement does to comply with FDA guidelines for approved dietary supplement statements. Unlike medications, supplements don't require prior approval by the FDA before they go on sale to the consumer. The FDA monitors the manufacturing and labeling of supplements, and regularly inspects companies to ensure that they comply with all regulations. If a supplement company doesn't comply with FDA regulations, the FDA may prohibit it from selling its product.

The Federal Food, Drug and Cosmetic Act (Act FD&C) was amended in 1994 by the Dietary Supplements Health and Education Act (often referred to as DSHEA), which defined the “dietary supplement” and established the authority of the FDA with respect to such products. The FDA is committed to protecting the public by identifying and recalling unsafe and illegal products and ensuring that products marketed as dietary supplements are safe, well-manufactured, and precisely labeled. To ensure public safety, the FDA has defined good manufacturing practices (GMP) that it applies through inspections and has the authority to process, seize and remove hazardous products from the market. Consumers can contact the manufacturer of the dietary supplement or a commercial laboratory to analyze the contents of a product. Because taking supplements can also pose health risks, the FDA recommends that consumers inform themselves and consult with their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement. If you experience an adverse effect while taking a dietary supplement, stop using it immediately, seek medical attention or advice, and report the adverse effect to the FDA. For a list of possible serious reactions to watch out for and how to report an adverse event, see the FDA website, How to Report a Problem with Dietary Supplements.

If you have any general and non-serious complaints or concerns about dietary supplements, contact the local FDA consumer complaints coordinator.

Leave Reply

All fileds with * are required