Is Benzoyl Peroxide a carcinogen? Valisure Files Petition With FDA to recall acne-treatment products containing cancer-inducing chemicals

Benzoyl peroxide (BPO) is a chemical found in many acne treatment products and is not a carcinogen. However, its breaking down can result in the formation of benzene, a known carcinogen. On Tuesday, March 5, Independent Laboratory Valisure filed a petition with the FDA calling for the recall of acne-treatment products that contain BPO.

A report released on Wednesday, March 6, from Valisure, claimed that acne-treatment products containing BPO could lead to the formation of "unacceptably high levels" of benzene due to such products being "fundamentally unstable." Higher levels of benzene begin to form in the products when they are stored or even handled at higher temperatures.

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Benzoyl peroxide can break down into benzene, a known carcinogen that can cause leukemia

Valisure filed a petition with the FDA calling for the complete recall of acne-treating products that contain the chemical compound Benzoyl peroxide (BPO). According to Valisure, this is a drug product that the FDA regulates. According to Valisure, when combined with other chemicals in these products, BPO decomposes into benzene.

Benzene is a known carcinogen. The U.S. Centers for Disease Control and Prevention stated that prolonged high-level exposure to benzene can cause leukemia. The CDC also said that Benzene decreases red blood cells, leading to anemia, harms the bone marrow, harms the immune system, causes excessive bleeding, and increases susceptibility to infections.

According to Valisure, Benzene toxicity in human beings has been established for over 120 years. Benzene is a colorless liquid that can also appear light-yellow at room temperature. The FDA lists Benzene as a 'Class 1 Solvent'. It can be traced in paint strippers, gasoline, tobacco, adhesives, and other cleaning products.

The benzene's conditionally restricted FDA concentration limit is two parts per million (ppm). Still, various tests from Valisure reportedly showcased that some of these on-market benzoyl peroxide products can have up to 800 times the established limit of benzene. These levels were detected inside these specific products and in the air around these items.

This showed that the chemical can even leak from the packaging and pose a further risk of inhalation. Valisure tests reportedly concluded that these over-the-counter benzoyl peroxide products were "fundamentally unstable." When customers handle and store these products at higher temperatures, they generate "unacceptably high levels" of benzene.

After Valisure identified traces of benzene in hand sanitizers and other products like sunscreens, the FDA formulated a new guidance in December 2023 for manufacturers to reformulate their products containing carbomer, a gelling agent that Valisure pointed out as having a high risk for benzene contamination.

However, the current case of BPO products is quite different from that of sanitizers. Valisure’s Co-Founder and President, David Light, stated,

"The benzene we found in sunscreens and other consumer products were impurities that came from contaminated ingredients; however, the benzene in benzoyl peroxide products is coming from the benzoyl peroxide itself, sometimes at hundreds of times the conditional FDA limit."

He added,

"This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action."

According to a breakdown of the Valisure petition by the Dermatology Times, Valisure tests showed that Proactiv's 2.5% BPO cream housed 1761 ppm of Benzene, Clinique 2.5% BPO cream by Estee Lauder had a 401 ppm, and Up & Up 2.5% BPO cream by Target had 1598 ppm of benzene.

The 10% benzoyl peroxide creams by Clearasil and Walgreens contained 308 ppm and 114 ppm of benzene, respectively. Some of the other acne creams and lotion brands with detectable benzene levels were PanOxyl, Sandra Lee MD, Oxy, La Roche-Posay, and more.