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In this Article

• What is a dietary supplement?
• What is a "new dietary ingredient" in a dietary supplement?
• What is FDA's role in regulating dietary supplements versus the manufacturer's responsibility for marketing them?
• When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?
• What information must the manufacturer disclose on the label of a dietary supplement?
• Must all ingredients be declared on the label of a dietary supplement?
• Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?
• Where can I get information about a specific dietary supplement?
• Who has the responsibility for ensuring that a dietary supplement is safe?
• Do manufacturers or distributors of dietary supplements have to tell FDA or consumers what evidence they have about their product's safety or what evidence they have to back up the claims they are making for them?
• What is FDA's oversight responsibility for dietary supplements?
• Does FDA routinely analyze the content of dietary supplements?
• Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?
• Who validates claims and what kinds of claims can be made on dietary supplement labels?
• Why do some supplements have wording (a disclaimer) that says: "This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease"?
• How are advertisements for dietary supplements regulated?
• How do I, my health care provider, or any informed individual report a problem or illness caused by a dietary supplement to FDA?

Is it legal to market a dietary supplement product as a treatment or cure for a specific disease or condition?

No, a product sold as a dietary supplement and promoted on its label or in labelingas a treatment, prevention or cure for a specific disease or condition would be considered an unapproved--and thus illegal--drug. To maintain the product's status as a dietary supplement, the label and labeling must be consistent with the provisions in the Dietary Supplement Health and Education Act (DSHEA) of 1994.

*Labeling refers to the label as well as accompanying material that is used by a manufacturer to promote and market a specific product.

Who validates claims and what kinds of claims can be made on dietary supplement labels?

FDA receives many consumer inquiries about the validity of claims for dietary supplements, including product labels, advertisements, media, and printed materials. The responsibility for ensuring the validity of these claims rests with the manufacturer, FDA, and, in the case of advertising, with the Federal Trade Commission.

By law, manufacturers may make three types of claims for their dietary supplement products: health claims, structure/function claims, and nutrient content claims. Some of these claims describe: the link between a food substance and disease or a health-related condition; the intended benefits of using the product; or the amount of a nutrient or dietary substance in a product.

SOURCE: FDA.gov; "Overview of Dietary Supplements," May 7, 2009.