What Does the FDA Do to Evaluate Supplements?

The FDA doesn't test dietary supplements before they are sold to consumers. However, the agency does regulate them as foods, not as drugs. This means that many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or a medical condition you may have. Additionally, some products are falsely marketed as dietary supplements, putting consumers at even greater risk.

For these reasons, it's important to consult with a healthcare professional before using any dietary supplement. The FDA is not authorized to approve dietary supplements for their safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA. The agency is responsible for regulating products that affect public health, such as food products, pharmaceutical drugs, medical devices, cosmetics, and even tobacco products. The FDA plays an important role in ensuring the safety of the products we use every day. Unlike medications, dietary supplements are for nutritional purposes only and do not require prior approval by the FDA before they go on sale to the consumer.

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 supplement companies cannot imply or declare that their products diagnose, treat, cure, or prevent diseases of any kind. 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 agency also conducts annual inspections of all facilities that manufacture infant formula and collects and analyzes product samples. When public health concerns arise about the safety of a dietary supplement or ingredient, the FDA has the authority to take steps to protect the public.

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. The FDA classifies devices according to the risk and level of regulatory controls necessary to provide a reasonable guarantee of the safety and effectiveness of the devices. Companies must submit a pre-marketing safety notification to the FDA at least 75 days before marketing dietary supplements containing certain “new dietary ingredients” (which were not marketed in the U. S.).The FDA also regulates tobacco products based on a public health standard that considers the product's risks to the population, including users and non-consumers of tobacco products. Companies that want to add new food additives to foods are responsible for providing the FDA with information demonstrating that the additives are safe.

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