FDA Declares Benzoyl Peroxide Safe After a Decade-Long Wait


After two decades of debate, the Food and Drug Administration has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now GRASE (generally recognized as safe and effective). In 1991, the FDA proposed to classify the ingredient as a category III agent, which meant that it needed more study. There was data at that time suggesting that benzoyl peroxide was potentially carcinogenic in animals.

Over the years, though, new data has allayed the agency's concerns. "We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks associated with benzoyl peroxide while delivering effective acne treatment," the FDA noted in its final rule. However, the ingredient is still known to be a skin irritant and skin sensitizer, according to the agency.

The FDA is requiring new labeling on the cartons of products that contain benzoyl peroxide. The boxes will include warnings to avoid unnecessary sun exposure, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth. Consumers also will be cautioned that benzoyl peroxide can bleach hair or dye fabric. The label also will recommend that users wear a sunscreen.

Manufacturers will not have to include package inserts directed at consumers, however. The FDA believes that the warnings on the carton are sufficient to inform consumers of the potential risks.

It is unclear how many OTC acne products contain benzoyl peroxide, according to the FDA. Based on retail sales data from the Nielsen Company, approximately one-quarter of the estimated 330 products on the market have benzoyl peroxide as an active ingredient. Most of the manufacturers will have a year to relabel their products, but smaller companies will be given up to 2 years.

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