Botanicals regulation as supplements, not OTCs, clarified by commission.
This article was originally published in The Tan Sheet
Executive Summary
BOTANICAL SUBSTANCE "EN MASSE" REGULATORY CONSIDERATION AS OTCs was not the intent of the President's Commission on Dietary Supplement Labels, commission Chairman Malden Nesheim, PhD, Cornell University, clarified at the group's Aug. 14-15 review of comments received on its draft report in Reston, Va. In its June 24 draft report, the commission proposed that FDA establish "an OTC review panel for botanical products that are intended for therapeutic and preventive use, with appropriate representation of experts on such products" ("The Tan Sheet" June 30, pp. 17-25).