Benzoyl peroxide
This article was originally published in The Tan Sheet
Executive Summary
FDA will seek comments on a proposed label warning for products containing the anti-acne ingredient in an upcoming Federal Register notice, agency staffers say. The notice also will recap a March 1992 recommendation by FDA's Dermatologic Drugs Advisory Committee meeting that benzoyl peroxide should remain on the market, but that product labeling should include a caveat that there is a lack of information on benzoyl peroxide's safety. Benzoyl peroxide was moved from Category I to Category III in August 1991 after studies indicated that it promoted tumors in rats.