FDA disease claim criteria citing "recognizable" symptoms "ambiguous," Shaklee says.
This article was originally published in The Tan Sheet
Executive Summary
FDA DISEASE CLAIM CRITERIA CITING "RECOGNIZABLE" SYMPTOMS "AMBIGUOUS" and create a "moving target" for defining acceptable structure/function claims for dietary supplements versus unacceptable disease claims, Shaklee maintains in Aug. 18 comments to the agency. The company took issue with the agency's tentative criteria that a statement would be considered a disease claim if it "explicitly or implicitly claimed an effect (using scientific or lay terminology) on one or more signs or symptoms that are recognizable to health care professionals or consumers as being characteristic of a specific disease or a number of diseases."