FDA Required Structure and Function Claims Notices

A Structure or Function Claim is one that characterizes the relation between a nutrient and the normal structure and function of the body. These are the standard dietary supplement claims.

The general rule is, no later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify The Secretary of Health and Human Services that it has included such a statement on the label or in the labeling of its product. The statements that are included are the Classical Deficiency Disease, General Wellness and Structure and Function Claims that nearly all nutrient supplement marketers make. The "label" is what is affixed to the bottle, "labeling" is the hang tag or other company literature (including advertising) about the product.

This procedure does NOT include Health Claims (claims that characterize the relation between a nutrient and a disease) which require prior FDA approval under a Health Claim Petition procedure.