Brief history: In 1985, the FDA originally classified benzoyl peroxide as Category I, or GRASE (Generally Recognized As Safe and Effective). Then in 1991, they reclassified benzoyl peroxide as Category III, which means “more data needed,” based on safety concerns that arose at that time. However, as of last month, the FDA decided to return benzoyl peroxide to its original Category I generally recognized as safe and effective classification because, “After reviewing the data, we now conclude that benzoyl peroxide can be adequately labeled to minimize the risks associated with benzoyl peroxide while delivering effective acne treatment.”
The official Final Rule states: “We, the Food and Drug Administration (FDA), are issuing this final rule to include benzoyl peroxide as a generally recognized as safe and effective (GRASE) active ingredient in over-the-counter (OTC) topical acne drug products.”
Summary: In short, some questions arose around benzoyl peroxide’s safety in the early 90s with animal (mice) studies. These studies were inadequate to draw any conclusions, so the FDA decided they needed more data. In the meantime, they reclassified benzoyl peroxide as Category III so until they could see more data. Several studies on benzoyl peroxide’s tumor promotion potential, mutogenicity (can it cause genetic mutations?), carcinogenicity (does it cause cancer?), and photocarcinogenicity (does it cause cancer when exposed to the sun?) were since performed. The data was in. After reviewing the findings from these studies, the FDA decided that benzoyl peroxide should again be considered GRASE (Generally Recognized As Safe and Effective).
Sunburn: Interestingly, they also found that benzoyl peroxide can decrease the skin’s tolerance to UV radiation (i.e., increase sunburn) after repeated applications, and so they are now also requiring an added warning on benzoyl peroxide labels which states, “If going outside, apply sunscreen after using this product.” Manufacturers have a year to add this warning. I will add this to our labels at our next printing.
The Federal Register reclassification of benzoyl peroxide, where the above information is taken, is actually an interesting read. I am particularly struck by both how thorough the FDA research process seems to be, and how concerned the FDA is to the health and financial concerns of both big and small business. Feel free to check it out and add your comments.