When it comes to dietary supplements, the Food and Drug Administration (FDA) is the primary authority responsible for the claims on product labels, including packaging, leaflets, and other promotional materials. Under the Dietary Supplement Health and Education Act (DSHEA), manufacturers must ensure that their products are safe before they are marketed. The FDA also has the power to remove any unsafe dietary supplement from the market. Before DSHEA was passed in 1994, manufacturers were required to prove that their dietary ingredients had a history of safe use.
If a manufacturer wants to introduce a new dietary ingredient into the U. S. market, they must notify the FDA at least 75 days before doing so. This pre-market review period allows the FDA to review the available safety data for the new ingredient and, if necessary, request more information or deny marketing of the dietary supplement containing the new ingredient. Manufacturers must also be able to justify any claims they make on the label of a dietary supplement to ensure that they are true and not misleading.
The FDA has published a guide that outlines what type and amount of evidence is needed to support these claims. As with all products on the market, advertising of dietary supplements must be truthful and well-founded. The FDA and Federal Trade Commission (FTC) work together to regulate dietary supplement advertising. The FDA is primarily responsible for claims on product labeling, while the FTC is primarily responsible for claims in advertising, including print and television advertisements, infomercials, catalogs, and similar direct marketing materials. These two agencies collaborate to ensure consistency in regulating dietary supplement advertising.
The FTC also regulates advertising sent by mail. Nearly every aspect of manufacturing, labeling, and marketing dietary supplements is covered by extensive regulations issued and enforced by both the FDA and FTC. Claims that describe the role of a dietary supplement in promoting well-being are allowed on labels, provided that manufacturers have evidence to support these claims and notify the FDA within 30 days of marketing their product. Other statements on labels that require exemption from liability include statements about a benefit related to a classic nutrient-deficiency disease and statements about general well-being derived from consuming a dietary ingredient. Several deficiencies and potentially misleading practices in labeling supplements have been documented in literature. Advertising is an important area of compliance, as nearly two-thirds of people in the United States report being exposed to advertising for dietary supplements.
Finally, like conventional foods, dietary supplements may include other statements on their labels that are not defined by law or regulation. Scientific validation should be kept archived only for statements about structure and function, which state that a supplement maintains, supports, stimulates, regulates, or promotes good body functioning. It's questionable whether the public would be better served without the current regulatory system and false sense of security it provides. The National Organic Program (NOP) is a federal regulatory program that develops and enforces consistent national standards for organically produced agricultural products sold in the United States. DSHEA amended the Federal Food, Drug and Cosmetic Act (FD&C Act) to create a new regulatory framework for dietary supplements.
