FDA cosmetics adverse reaction hotline

Executive Summary

FDA is seeking clearance from the Office of Management & Budget by Dec. 2 to establish a cosmetic adverse reaction hotline program designed "to enable the public to report directly to FDA" any adverse events associated with the use of a cosmetic product, according to a Nov. 10 Federal Register notice. Based on data obtained from the hotline, FDA plans to notify cosmetics firms which products have above-normal adverse reaction rates. FDA expects the toll-free national hotline to be operational on Dec. 7