Report: Unacceptably High Benzene Levels Detected in Numerous Acne Products Containing BPO
An independent laboratory has reported that it has detected elevated levels of benzene in a number of widely used acne products, according to a press release.
Valisure, an independent testing laboratory based in Connecticut, has filed a citizen's petition with the U.S. Food and Drug Administration requesting suspension in sales of products containing benzoyl peroxide (BPO) pending an investigation, and an update in agency guidance on the daily permissible amount and exposure limits for benzene in any drug or cosmetic product. According to Valisure, results from its testing indicated that on-market BPO products "can form over 800 times the conditionally restricted FDA concentration limit to 2 parts per million (ppm) for benzene," adding that the issue "applies broadly to BPO products current on the market." They go further, saying that the tests showed not only were elevated benzene levels detected in the products, but also in the surrounding air of incubated products, presenting an additional inhalation risk.
Valisure tested 66 products containing BPO for their analysis. The findings impact many popular over-the-counter products such as PanOxyl, Walgreens' acne bar soap, and Walmart's Equate Beauty acne cream, as well as Estee Lauder's Clinique, Target's Up & Up, Clearasil, and Proactiv, among others.
"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 approximately 1,270 times the EPA's calculated threshold for increased cancer risk by long-term inhalation exposure to benzene," Valisure said in the news release.
The findings impact dozens of prescription and over-the-counter products that contain BPO that Valisure said are now known to be unstable and which can generate unacceptably high benzene levels when handled or stored at higher temperatures.
"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, an associate professor of dermatology at Yale University and a member of the Practical Dermatology editorial board, said in the news release. "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.”
Valisure added that this FDA petition notes that only acne products containing BPO were detected to have this problem, and other acne products such as those containing salicylic acid or adapalene, do not appear to have this problem.
Source: Valisure press release. Accessed March 6, 2024.