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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?

Must all ingredients be declared on the label of a dietary supplement?

Yes, ingredients not listed on the "Supplement Facts" panel must be listed in the "other ingredient" statement beneath the panel. The types of ingredients listed there could include the source of dietary ingredients, if not identified in the "Supplement Facts" panel (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, starch, colors, stabilizers, preservatives, and flavors).

Are dietary supplement serving sizes standardized or are there restrictions on the amount of a nutrient that can be in one serving?

Other than the manufacturer's responsibility to ensure safety, there are no rules that limit a serving size or the amount of a nutrient in any form of dietary supplements. This decision is made by the manufacturer and does not require FDA review or approval.

Where can I get information about a specific dietary supplement?

Manufacturers and distributors do not need FDA approval to sell their dietary supplements. This means that FDA does not keep a list of manufacturers, distributors or the dietary supplement products they sell. If you want more detailed information than the label tells you about a specific product, you may contact the manufacturer of that brand directly. The name and address of the manufacturer or distributor can be found on the label of the dietary supplement.

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