Benzoyl Peroxide Acne Products Shown to Contain High Levels of Benzene

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There may be concerningly-high levels of the human carcinogen known as benzene within acne treatment products using benzoyl peroxide (BPO), according to findings from a new investigation by Valisure.¹

This announcement by Valisure, an autonomous quality assurance organization, was followed by a decision to file their 8th US Food and Drug Administration (FDA) Citizen Petition. The announcement noted that benzoyl peroxide acne treatment products may be fundamentally unstable and their formation of benzene is concerning, given conditional FDA limits.

"There is not a safe level of benzene that can exist in any skin care product, over the counter or prescription,” Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University, said in a statement. “The current data on BPO degrading into high levels of benzene is extremely concerning given its prominent use in skin care, and this study should serve as another wake-up call for improved manufacturing and quality control of consumer healthcare products.”

Major Findings

Benzoyl peroxide is known to be within a category of drug products that are regulated by the FDA, and certain products on the market that contain benzoyl peroxide were noted by the organization as going over the FDA's conditionally restricted limit on benzene concentrations of 2 parts per million by more than 800 times.

These increased levels of the carcinogen were identified within benzoyl peroxide products themselves and even within the air surrounding incubated products. Officials with Valisure noted that this could suggest a possible risk of inhalation and eventual cancer risk resulting from benzene leakage depending on product packaging.

The organization conducted evaluations on many different prescription and over-the-counter benzoyl peroxide products, and these assessments indicated that current formulations of benzoyl peroxide medications show inherent instabilities. Situations involving exposure to higher temperatures, as an example, may lead to the generation of unacceptably high benzene levels.

Valisure officials also expressed that benzene may be produced within a given product but could then escape into the product’s surrounding environment. The organization is now, as a result of the findings, calling for an investigation into benzene levels and a withdrawal from the market of products containing benzoyl peroxide.

A key point made in the announcement is that other acne treatment products with salicylic acid or adapalene have been tested by officials with the group and the same issue was not identified. Valisure officials’ initial assessment had looked into 175 products designed for acne treatment, with 99 having benzoyl peroxide and 76 with other ingredients.

Their findings had demonstrated no detectable benzene or values under 2 ppm within the 76 other products. However, 94 out of 99 BPO products contained benzene even without elevated temperature incubation. Subsequent studies on stability indicated that substantial levels of benzene have the potential to appear within benzoyl peroxide products within only a few weeks at elevated temperatures.

A precedent for action protecting consumers was cited by Valisure officials as well, given the organization’s 2019 Citizen Petition on the inherent instability of ranitidine and ranitidine’s formation of the probable human carcinogen N-nitrosodimethylamine. Following these findings, the FDA had made a request to withdraw all ranitidine drug products from the market.

Valisure’s new assessment highlighted the instability of benzoyl peroxide products and noted the levels of benzene far exceed any FDA regulatory guidance. The organization had implemented both traditional gas chromatography mass spectrometry and selected-ion flow-tube mass spectrometry to confirm the formation of benzene in such products and the chemical’s release into the surrounding environment.

References

1. ^{Valisure Detects Benzene in Benzoyl Peroxide. Valisure. March 6, 2024. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide. Date accessed: March 6, 2024.}