Benzene Concerns in Benzoyl Peroxide Spark Calls for Safer Acne Treatment Standards

“I think there’s a value to zero, right? Especially when it comes to a known carcinogen like benzene. There’s no sort of safe amount of arsenic in your water. The idea is it’s zero... For a known carcinogen, ideally, that level is zero... We know any amount of it is not good for human health,” said Steve Xu, MD, MSc, in a recent interview with Dermatology Times.

Xu, assistant professor of translational dermatology research and pediatric dermatology in the department of dermatology and assistant professor at the McCormick School of Engineering at Northwestern Feinberg School of Medicine in Chicago, Illinois, discussed the latest study of benzene found in benzoyl peroxide (BPO) acne products in room temperature published in early October.¹

The latest round of benzene news follows the initial detection of high levels of benzene found in certain BPO-containing acne products announced on March 6, 2024. With the first detection of benzene, Valisure, LLC, an independent testing laboratory, filed a petition with the FDA requesting a recall of products affected by the elevated levels of benzene to allow regulators to investigate.²

The new study reports that "111 BPO drug products tested from major US retailers appear to be substantially contaminated with benzene when tested shortly after being acquired off the shelf." Results demonstrated that 34% of the products, equivalent to 38 products, contained benzene levels above the FDA's 2 parts per million (ppm) limit, with concentrations ranging from 0.16 ppm to 35.30 ppm.¹

Importance of Benzoyl Peroxide in Acne Treatment

BPO has long been a staple in acne treatment. It is readily available in drugstores, and dermatologists and patients alike have come to rely on its efficacy. Given its availability and history of use, BPO is considered a frontline treatment for mild to moderate acne. However, the new findings regarding benzene contamination challenge the safety of these products, potentially affecting the standard of care for dermatologists managing patients with acne.

Findings of Benzene Degradation

The latest study by Kucera et al used advanced analytical methods, including gas chromatography and mass spectrometry, to analyze BPO products under various conditions. Even when stored at room temperature, these BPO products showed benzene levels exceeding the limits deemed safe by the FDA. Benzene, a known human carcinogen, has been strongly linked to cancer risks, and its presence in BPO products raises health concerns, particularly given the widespread use of these products by teenagers and young adults.

In addition to temperature testing, the study included UV radiation exposure to simulate real-world conditions, such as patients applying BPO products before sun exposure. This added another layer of risk, as UV exposure could exacerbate the degradation of BPO into benzene, further increasing carcinogenic potential. These findings suggest that simply storing BPO products in cool conditions is not sufficient to eliminate the risk of benzene formation, meaning that everyday use could inadvertently expose users to unsafe benzene levels.

The Risk-Benefit Dilemma

Xu emphasized the importance of assessing the risk-benefit ratio in recommending BPO products. Although acne can severely impact patients' mental health and social well-being, mild acne typically does not warrant a high-risk intervention. The presence of a carcinogen in a product meant for a generally non-life-threatening condition calls into question the safety and ethics of continuing to recommend BPO, especially when safer alternatives are available. Xu likened the dilemma to oncologic treatments, where the severity of the condition often justifies the associated risks. For mild acne, however, this risk-benefit calculation is different, and benzene contamination might tip the scales in favor of alternative treatments.

Alternatives to Benzoyl Peroxide

In light of these findings, Xu suggests considering other acne treatments that lack the risk of benzene contamination. Options such as salicylic acid, glycolic acid, and topical or even oral antibiotics can be effective for managing acne without the benzene risk. In his clinical practice, Xu advises patients, particularly those with a history of cancer or immunosuppression, to explore these alternatives while the safety of BPO remains in question. He emphasizes open communication with patients, informing them of the potential risks of benzene exposure, so they can make an informed decision on whether to continue using BPO.

Need for Further Research and Policy Development

Xu advocates for more robust research into the clinical implications of benzene exposure from BPO products. While bench studies demonstrate elevated benzene levels, the clinical risk to patients remains unclear. Conducting long-term epidemiological studies to establish a direct link between benzene exposure from BPO and cancer incidence would be challenging and resource-intensive, according to Xu. However, he stresses that the absence of evidence does not imply safety and calls for further work to understand benzene's skin absorption and associated risks.

This benzene contamination issue also highlights gaps in cosmetic product regulation. Xu pointed out that legislative updates to the Food, Drug, and Cosmetic Act, enacted in 2022, mark progress in regulating personal care products. Nonetheless, the field needs stricter policies and updated guidelines to ensure the safety of dermatology and skincare products. With benzene contamination now added to a list of concerns that includes phthalates and formaldehyde releasers, Xu sees a pressing need for the dermatology community to drive policy reform.

Disclosure

Xu is the head of the medical advisory board at Geologie. He founded Geologie in 2018 and launched a BPO-free acne regimen in February 2024, available at Target, prior to the March 2024 Valisure report with the goal to offer gentler products for those interested.

References

1. Kucera K, Zenzola N, Hudspeth A, et al. Evaluation of benzene presence and formation in benzoyl peroxide drug products. J Invest Dermatol. October 7, 2024. https://www.jidonline.org/article/S0022-202X(24)02155-9/fulltext
2. Valisure detects benzene in benzoyl peroxide. News release. Valisure. March 6, 2024. Accessed November 4, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide