Dietary supplements are regulated by the FDA as foods, not drugs. The FDA's Center for Food Safety and Applied Nutrition (CFSAN) is primarily responsible for the agency's oversight of these products. If a supplement company doesn't comply with FDA regulations, the FDA may prohibit them from selling their product. The FDA would like to know when you have a health problem that is believed to be related to a dietary supplement, even if you're not sure which product caused the problem and even if you don't visit a doctor or clinic.
An effective NDI notification process represents the FDA's only opportunity to evaluate the safety of a new ingredient before it is available to consumers and helps promote transparency and the allocation of resources based on risk. To learn more about the FTC's role in regulating dietary supplement advertising, visit the FTC website. This is why you might see inaccurate wording about what a supplement does: it does to comply with FDA guidelines on approved dietary supplement claims. By law, the FDA does not approve dietary supplements or their labeling, although certain types of claims that are sometimes used in the labeling of dietary supplements require pre-marketing review and authorization.
The FDA's role in the regulation of dietary supplements includes (among other things) inspecting dietary supplement manufacturing facilities, reviewing notifications of new dietary ingredients (NDI) and other regulatory filings on dietary supplements, investigating complaints, monitoring the dietary supplement market, examining dietary supplements and diet ingredients offered for import to determine if they meet the requirements of U. S. law. At least 75 days before introducing such dietary supplement into interstate commerce or delivering it for introduction into interstate commerce, the manufacturer or distributor must submit a notification to the FDA with information on the basis of which the company has concluded that the dietary supplement containing NDI is reasonably expected to be safe.
In general, the FDA is limited to enforcing the law after marketing because, unlike drugs that must be shown to be safe and effective for their intended use before they are marketed, the law does not require the FDA to approve the safety of dietary supplements before they reach consumers. If you have any general complaints or concerns about food products, including dietary supplements, you can contact the consumer complaint coordinator at the local FDA district office closest to you. 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 of the product. The FDA and FTC share responsibility for the oversight of dietary supplements and related promotion, with the FDA generally responsible for safety, quality and labeling, and FTC generally responsible for advertising.
As the dietary supplement industry develops new products and ingredients, promotes new delivery systems, and innovates in other ways, the FDA must do more to harness existing resources and authorities to evaluate these products. The FDA oversees the manufacture and labeling of supplements and periodically inspects companies to ensure that they comply with all regulations. The Dietary Supplement Health and Education Act (DSHEA) requires manufacturers or distributors to notify the FDA in advance and submit safety information if they intend to market a dietary supplement in the United States that contains a new dietary ingredient, unless it is present in food supply as an item used as food in a form in which it has not been chemically altered.
