The FDA regulates both finished dietary supplement products and dietary ingredients. The FDA regulates dietary supplements according to a set of rules different from those governing conventional foods and pharmaceuticals. While the FDA does not approve dietary supplements, the agency has a role in regulating them. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (i.e., those sold in the United States before 1999) can be marketed without proof that they are effective or safe.
For new supplement ingredients, the DSHEA requires manufacturers to submit proof to the FDA that each new ingredient must be safe. Cohen in a commentary published today in the New England Journal of Medicine. By providing the industry with the opportunity to correct previous errors in submitting required safety information, the FDA can obtain more safety information about the dietary supplement market and better protect public health. The FDA and the FTC share responsibility for overseeing dietary supplements and related promotion.
The FDA is generally responsible for safety, quality, and labeling, and the FTC is generally responsible for advertising. The Food and Drug Administration announced the availability of draft guidelines aimed at increasing the amount of safety information available on the dietary supplement market, providing the industry with the opportunity to submit late notifications on new dietary ingredients (NDI). The FDA's role in regulating dietary supplements includes (among other things) inspecting dietary supplement manufacturing facilities, reviewing new dietary ingredient notifications (NDI) and other regulatory requests for dietary supplements, investigating complaints, monitoring the dietary supplement market, examining dietary supplements and dietary ingredients offered for import to determine if they meet the requirements of U. For example, calcium and vitamin D can help strengthen bones, and fiber can help maintain bowel regularity.
For a list of possible serious reactions to watch out for and how to report an adverse effect, see the FDA website, How to Report a Problem with Dietary Supplements. In addition, the FDA takes advertising into account when evaluating the intended use of a product labeled as a dietary supplement. If you have a general complaint or concern about food products, including dietary supplements, you can contact the consumer complaint coordinator at the nearest local FDA district office. We also investigate reports of adverse effects and complaints from consumers, healthcare professionals, other regulatory agencies and the industry.
However, by law, the FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used on dietary supplement labels require pre-market review and authorization (for example, the FDA wants to know if you have a health problem that is believed to be related to a dietary supplement, even if you are not sure which product caused the problem and even if you don't visit a doctor or clinic). The Dietary Supplement Health and Education Act (DSHEA) amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to create a new regulatory framework for dietary supplements. These three types of claims are not approved by the FDA and do not require evaluation by the FDA before using them on dietary supplement labels.
