What is the FDA's Role in Dietary Supplements?

The FDA does not have the authority to approve dietary supplements for safety and effectiveness, or to approve their labeling, before they are sold to the public. Dietary supplements are regulated by the FDA as foods, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Products that contain hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk. For these reasons, it is important to consult with a health professional before using any dietary supplement.

Read these consumer updates for more information. The FDA is not authorized to approve dietary supplements because of their safety and effectiveness. In fact, many dietary supplements can be marketed without even notifying the FDA. The Food and Drug Administration 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. The FDA plays an important role in ensuring the safety of the products we use every day, but it doesn't pre-approve all the sectors it oversees.

More on that in a minute. According to the FDA, drugs are meant to treat, prevent, mitigate, diagnose, or cure diseases. Human clinical trials must demonstrate that a drug is safe and effective for its intended use. The drug must then be manufactured under controlled conditions and packaged to meet strict labeling regulations before it is pre-approved by the FDA for consumer use. Unlike drugs, the FDA states that supplements are for nutritional purposes only. Because supplements aren't considered drugs, they aren't controlled the same way.

While the FDA has regulations for manufacturing and labeling, dietary supplements have different testing, safety, and efficacy guidelines than pharmaceutical drugs. Unlike drugs, supplements do not require prior approval from the FDA before being offered for sale to the consumer. The Dietary Supplement Health and Education Act of 1994 (DSHEA) defined the role of supplements and outlined what dietary supplement companies can legally say about their products. The law states that, since supplements are not drugs, supplement companies cannot imply, insinuate, or claim 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 inaccurate wording about what a supplement does: it's made to comply with FDA guidelines on approved dietary supplement claims.

The FDA doesn't “approve” dietary supplements because it doesn't approve foods. The FDA only approves pharmaceutical drugs. The FDA monitors the manufacture 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 them from selling their product. The FDA (Center for Food Safety and Applied Nutrition) and the Federal Trade Commission (FTC) participate in this process. New drugs and biological products for people must be approved by the FDA before they are marketed in interstate commerce.

For more detailed information on the subject, see a recent report from the AMA Council on Science and Public Health that updated and modernized the AMA's dietary supplement policy. Instead, FDA experts carry out a careful evaluation of the results of clinical laboratory, animal and human tests conducted by manufacturers. The FDA is responsible for protecting public health by regulating human and biological drugs, animal drugs, medical devices, tobacco products, foods (including animal foods), cosmetics, and electronic products that emit radiation. Supplements are often marketed now without being proven to work as is claimed causing the FDA or FTC to update them once they have been distributed. Whatever their form, the DSHEA classifies dietary supplements (DS) in a special category within the general scope of food and therefore the FDA remains responsible for helping to regulate the industry albeit playing a minor role. Two members of the AMA took some time to talk about what doctors would like patients to know about vitamins and nutritional supplements. So what exactly is the FDA's role in the supplement industry and what do those two little phrases mean? Let's dive in. Companies that want to add new food additives to foods are responsible for providing the FDA with information that shows that the additives are safe.

Higher-risk (class III) devices such as mechanical heart valves and implantable infusion pumps generally require FDA approval of an application for pre-marketing approval before being marketed. This includes those used in foods (including animal foods), dietary supplements, medications, cosmetics and some medical devices. However not all of these products undergo pre-marketing approval; that is a review of safety quality and effectiveness by FDA experts and approval by the agency before a product can be sold to consumers. Nutrition (food) is important because under FD&C Act vitamins and other supplements are treated as a subset of food products and not as pharmaceutical products. While vitamins and nutritional or dietary supplements can be beneficial to health they can also pose health risks. This includes defining and enforcing types of claims that supplement companies can make about their products.

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