FDA "disease" definition for supplements threatens structure/function claims -- CRN.
This article was originally published in The Tan Sheet
Executive Summary
FDA "DISEASE" DEFINITION FOR SUPPLEMENT CLAIMS COULD "CONSUME" STRUCTURE/FUNCTION category, the Council for Responsible Nutrition says, rendering the classification of permissible dietary supplement statements "meaningless." In Aug. 11 comments to FDA, CRN urges the agency to withdraw the revised definition of "disease" set forth in its April 29 proposed rule delineating acceptable structure/function claims. CRN maintains it is "opposed to expansion of the disease definition, and in particular, to the inclusion of the phrase `structure or function' in the definition."