The FDA does not approve dietary supplements. 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. 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's important to consult with a health professional before using any dietary supplement. Read these consumer updates for more information.
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 you from selling your product. FDA regulations require that dietary supplement labels include the name of the product and a statement stating that it is a dietary supplement or an equivalent term that replaces “dietary” with the name or type of dietary ingredient in the product (e.g. The following are important resources and information for you and your family about dietary supplements.
The FDA recommends that consumers consult with a health professional before deciding to take a dietary supplement. To grant the Secretary the authority to require the approval of a dietary supplement before it is marketed, reads the amended version of the bill. In addition, FDA regulations require that those who manufacture, package, or preserve dietary supplements follow current good manufacturing practices that help ensure the identity, purity, quality, concentration, and composition of dietary supplements. The types of ingredients listed there could include the sources of the dietary ingredients, if they are not listed on the supplement information panel (e.g.
Because taking supplements can also pose health risks, the FDA recommends that consumers inform themselves and talk to their doctor, pharmacist, or other health professional before deciding to buy or use a dietary supplement. More information on how to report adverse events associated with the use of dietary supplements can be found in How to Report a Problem with Dietary Supplements. The DSHEA classifies dietary supplements in a special category under the general food umbrella, unless the product meets the drug definition (e.g. No, a product that is sold as a dietary supplement and that is explicitly or implicitly represented for the treatment, prevention, or cure of a specific disease or class of diseases meets the definition of a drug and is subject to regulation as a drug.
In addition, the FDA considers advertising when evaluating the intended use of a product labeled as a dietary supplement. To file 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. Two less common types of statements on the labeling of dietary supplements defined by law are claims for a benefit related to a classic nutrient-deficiency disease (when accompanied by a statement that reveals the prevalence of nutrient-deficiency disease in the United States) and general well-being statements derived from the consumption of a nutrient or other dietary ingredient. .
