While dietary supplements are regulated by the FDA as foods, they are regulated differently from other foods and medications. Whether a product is classified as a dietary supplement, conventional food, or medication depends on the intended use. Most of the time, classification as a dietary supplement is determined by the information that the manufacturer provides on the product label or in the attached bibliography, although many food and dietary supplement labels do not include this information. The Federal Trade Commission (FTC) regulates advertising, including infomercials, of dietary supplements.
A soft drink that used the term diet as part of its brand before October 25, 1989 and whose use of that term complied with § 105.66 of this chapter as that regulation appeared in the Code of Federal Regulations on that date, may continue to use that term as part of its brand, provided that the use of the term is not false or misleading under section 403 (a) of the law. It also regulates the safety and effectiveness of medical devices, pharmaceutical products, and natural health products, funds health research and some information technology systems, and manages several public health functions nationwide. I) A statement describing the percentage of a vitamin or mineral in the food, including foods specifically intended for infants and children under 2 years of age, may be included in a statement describing the percentage of a vitamin or mineral in the food, including foods specifically intended for infants and children under 2 years of age, in relation to the reference daily intake (RDI) as defined in § 101.9 without a regulation authorizing such statement of a specific vitamin or mineral, unless such statement is expressly prohibited by the regulation under section 403 (r) (A) (vi) of the Act. 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.
B) When such products carry nutrition labels, either on a voluntary basis or because nutrition claims or other nutritional information are provided, all required information must be in a size not less than 6 points or in capital letters of 1 to 16 inches in minimum height, except that individual serving-sized packages of food served with meals in restaurants, institutions and on board passenger carriers, and not intended for retail sale, may comply with § 101.2 (c) (. Iv) Any vitamin or mineral listed in paragraph (c) (iv) of this section are added voluntarily to foods as nutritional supplements. Companies that make food claims based on this reasonably based criterion must provide relevant regulatory officials, upon request, with the specific information on which their determination is based and a reasonable assurance that the operations comply with the preparation methods or other reasons for the claim; and. The requirements of this section apply to the labeling or labeling of dietary supplements, when the dietary supplement bears a declaration provided for in section 403 (r) () () of the Federal Food, Drug and Cosmetic Act (the Act), and the manufacturer, packer or distributor wishes to take advantage of the exemption to section 201 (g) (C) of the law that is established pursuant to section 403 (r) (of the Act).
If the label or labeling of a product marketed as a dietary supplement includes a statement about the disease as defined in paragraph (g) of this section, the product will be subject to regulation as a drug, unless the statement is an authorized health claim for which the product qualifies. Finally, dietary supplements, like conventional foods, may include other statements on the label that are not defined by law or regulation (p. Statements about the content of nutrients that have not been defined by the regulation and that appear on the brand of a specific food product that was the brand that was used on that food before October 25, 1989 may continue to be used as part of that brand for that product, provided that they are not false or misleading under section 403 (a) of the Federal Food, Drug and Cosmetic Act (the Act). 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.
What's new in dietary supplements Links to updates on components, press releases and other measures taken in relation to dietary supplements and products that are marketed as dietary supplements, including warning letters and recalls. .
