Supplement claims citing "degrees of normality" are not disease claims, attorney suggests.
This article was originally published in The Tan Sheet
Executive Summary
DIETARY SUPPLEMENT CLAIMS CITING "DEGREES OF NORMALITY" are not necessarily disease statements, D.C. attorney Anthony Young (Piper & Marbury) suggested at a forum on dietary supplements in Washington, D.C. April 30. In commentary on FDA's April 29 proposed rule on structure/function claims, Young suggested industry focus attention on the provision that designates as inappropriate for supplements statements claiming an effect on an "abnormality" of the body, including, for example, symptoms associated with menopause.