On March 4th, the FDA issued a final rule to include benzoyl peroxide as a generally recognized safe and effective active ingredient in over the counter topical acne drug products, at concentrations of from 2.5 to 10%. As part of this final rule the FDA added new warnings and directions for benzoyl peroxide, that are basically a restatement of the warnings and directions originally included for this ingredient in the '85 and '91, proposed regulations. The agency also included in this final rule, revisions to the labeling requirements for resorcinol, resorcinol monoacetate and salicylic acid and sulfur to meet OTC Drug Facts labeling content and format requirements.
In 1991 the FDA issued a proposed rule classifying benzoyl peroxide as a category III ingredient on the basis of safety concerns that suggested that benzoyl peroxide might be a tumor promoter. Despite concerns regarding the ingredient the FDA determined that the ingredient should continue to be available until further studies were completed to determine whether or not the ingredient was in fact a tumor promoter.
After study of the tests which were conducted by industry over several years, the FDA determined that the ingredient was not a tumor promoter and was safe and effective for treatment of acne.