New Study From Valisure Extends Previous Research on Benzoyl Peroxide Products
A new study conducted by Valisure has raised concern about benzene contamination in benzoyl peroxide (BPO) drug products used for acne and rosacea treatment.
Among 111 tested BPO products, 34% contained benzene concentrations exceeding the FDA's conditional limit of 2 parts per million (ppm). Benzene, a well-known carcinogen, was found in these products even when stored at room temperature. The current analysis, published in the Journal of Investigative Dermatology, follows up on research from earlier this year suggesting elevated BPO levels in certain common acne and rosacea products.
The study researchers also reported that products exposed to elevated temperatures (50°C and 70°C) could produce benzene levels exceeding 1,000 ppm. Tests conducted at body temperature showed that some BPO products generated benzene levels as high as 60 ppm after four weeks of storage.
The study authors explored encapsulation as a possible method to stabilize BPO, although the encapsulated product, Epsolay, also was reported to have formed benzene when exposed to heat. The authors also highlighted a UV light exposure experiment indicated that benzene formation accelerated when BPO was exposed to sunlight, suggesting that outdoor use of these products may pose further risks.
"The results presented here suggest that a substantial portion of the BPO acne treatment market currently contains unacceptably high levels of benzene in products sitting on the shelf and that stabilization techniques like encapsulation do not appear to prevent the formation of benzene in BPO drug products," the authors wrote in the study. "In addition to elevated temperatures expected during use and transportation, UV exposure at levels expected outdoors is another concerning mechanism for the degradation of BPO drug products into benzene, and one that appears more rapid in the formation of benzene than heat. In the interest of public health, further study and regulatory and industry actions, such as recalls, are warranted."
Source: Kucera K, et al. Journal of Investigative Dermatology. 2024. Doi:10.1016/j.jid.2024.09.009