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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?

When must a manufacturer or distributor notify FDA about a dietary supplement it intends to market in the U.S.?

The Dietary Supplement Health and Education Act (DSHEA) requires that a manufacturer or distributor notify FDA if it intends to market a dietary supplement in the U.S. that contains a "new dietary ingredient." The manufacturer (and distributor) must demonstrate to FDA why the ingredient is reasonably expected to be safe for use in a dietary supplement, unless it has been recognized as a food substance and is present in the food supply.

There is no authoritative list of dietary ingredients that were marketed before October 15, 1994. Therefore, manufacturers and distributors are responsible for determining if a dietary ingredient is "new", and if it is not, for documenting that the dietary supplements its sells, containing the dietary ingredient, were marketed before October 15, 1994.

What information must the manufacturer disclose on the label of a dietary supplement?

FDA regulations require that certain information appear on dietary supplement labels. Information that must be on a dietary supplement label includes: a descriptive name of the product stating that it is a "supplement;" the name and place of business of the manufacturer, packer, or distributor; a complete list of ingredients; and the net contents of the product.

In addition, each dietary supplement (except for some small volume products or those produced by eligible small businesses) must have nutrition labeling in the form of a

"Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

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