“Structure/Function” Claims in Dietary Supplement Labeling

Abstract

Enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA) permitted manufacturers of dietary supplements to make structure/function' claims on labels, describing the helpful impact of the product on the structure or function of the human body. In general, there appears to be considerable confusion (perhaps within FDA as well as within the industry) about which types of structure/function' claims are subject to the requirements for notification to FDA and for use of the labeling disclaimer, and which types are not. Many structure/function' claims that have been the subjects of the more-than-2,000 company notifications to FDA could properly have been used in labeling without any notification to the agency. FDA appeas to both the voluntary submission ot the agency of unrequired notifications of structure/function claims and the unrequired use of the DSHEA disclaimer in related dietary supplement labeling. The author concludes that much of the current use of the DSHEA disclaimer in labeling is not required.