Commission rejects evidence summaries in supplement claims notification.
This article was originally published in The Tan Sheet
Executive Summary
SUPPLEMENT "STATEMENT OF AFFIRMATION" FOR SAFETY/EFFICACY ADVISED by the President's Commission on Dietary Supplement Labels final report issued Nov. 24 at the group's last meeting. Dietary supplement manufacturers voluntarily "should provide statements of affirmation that they have substantiation for the statement of nutritional support and that the product does not represent a significant or unreasonable risk of illness under conditions of use recommended or suggested in labeling," either in the notification letter to FDA required for all structure/function claims by the Dietary Supplement Health & Education Act or in a separate public notice, the report states.