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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?

What is FDA's oversight responsibility for dietary supplements?

Because dietary supplements are under the "umbrella" of foods, FDA's Center for Food Safety and Applied Nutrition (CFSAN) is responsible for the agency's oversight of these products. FDA's efforts to monitor the marketplace for potential illegal products (that is, products that may be unsafe or make false or misleading claims) include obtaining information from inspections of dietary supplement manufacturers and distributors, the Internet, consumer and trade complaints, occaisional laboratory analyses of selected products, and adverse events associated with the use of supplements that are reported to the agency.

Does FDA routinely analyze the content of dietary supplements?

In that FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law. The remaining funds are used for routine monitoring of products pulled from store shelves or collected during inspections of manufacturing firms. The agency does not analyze dietary supplements before they are sold to consumers. The manufacturer is responsible for ensuring that the "Supplement Facts" label and ingredient list are accurate, that the dietary ingredients are safe, and that the content matches the amount declared on the label. FDA does not have resources to analyze dietary supplements sent to the agency by consumers who want to know their content. Instead, consumers may contact the manufacturer or a commercial laboratory for an analysis of the content.

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