Valisure Finds Benzene in Benzoyl Peroxide Acne Treatments

Benzoyl peroxide (BPO) acne treatments tested by Valisure contain benzene, a known human carcinogen. The Personal Care Products Council refuted the findings and noted:

“Over-the-counter (OTC) drug products such as anti-acne treatments are highly regulated by the Food & Drug Administration, which has reviewed and determined benzoyl peroxide is a safe and effective anti-acne ingredient. Personal care products companies do not add benzene to any OTC personal care product as some stories allege. The findings in the most recent Valisure petition are based on unproven, questionable methods applying unrealistic conditions which are inconsistent with the way the product would be stored normally. In fact, in a December 2022 letter, FDA highlighted multiple deficiencies in Valisure’s analytical methods and stated that the lab should follow the same testing methods that drug manufacturers are required to use.”

According to Valisure,  BPO products can form over 800 times the conditionally restricted FDA concentration limit of 2ppm for benzene. High levels of benzene were detected inside BPO products, as well as in the air around incubated BPO products, showing that benzene can leak out of some product packages and pose a potential inhalation risk, according to Valisure. Incubation of a Proactiv product at the temperature of a hot car (70°C) resulted in the detection of benzene in a compact car’s volume of air at ~1,270 times the EPA calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.

“This discovery of benzoyl peroxide’s fundamental instability and formation of benzene is substantially different than Valisure’s previous findings of benzene in sunscreens, hand sanitizers and other consumer products,” said Valisure Co-Founder and President David Light. “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. This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action.”

Valisure’s tests on dozens of prescription and over-the-counter benzoyl peroxide products suggest that currently formulated BPO medications are fundamentally unstable and can generate unacceptably high levels of benzene when handled or stored at higher temperatures  that the products may be exposed to during handling by consumers. Benzene can be produced in the product itself and potentially escape into the surrounding air. Therefore, Valisure is requesting an investigation and market withdrawal of BPO-containing products.

Data in the Valisure petition suggests that only BPO-containing acne treatment products have this issue of forming high levels of benzene, and that other acne treatment products tested by Valisure, such as those containing salicylic acid or adapalene, do not appear to have this problem.

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