Executive Summary

STRUCTURE/FUNCTION "IMPLIED" CLAIMS PROPOSED BAN ALTERS STATUTE, the Nutritional Health Alliance says in July 8 comments on FDA's April 29 proposed rule regarding structure/function claims ("The Tan Sheet" May 4, pp. 1-7). By proposing that labeled "reference to a characteristic set of signs or symptoms, even in the absence of the name of the disease, can be understood as a reference to the disease itself," NHA says "the agency is attempting to legislate by ignoring the language" of the Dietary Supplement Health & Education Act and "creating a whole new set of rules which alter and restrict the statutory mandate."