In a recent report, the independent laboratory Valisure raised alarm bells, stating that high levels of benzene, a known carcinogen, can form in acne treatment products containing benzoyl peroxide. According to Valisure’s findings, benzene could form at levels exceeding 800 times the “conditionally restricted” concentration limit set by the US Food and Drug Administration (FDA), both in prescription and over-the-counter products.
Tests conducted by the lab involved dozens of these products, revealing that storage or handling at elevated temperatures, such as leaving them in a hot car exceeding 150°F for at least 14 days, could lead to the generation of high levels of benzene. One such test involved a ProActiv acne product stored at 158°F for nearly 17 hours, resulting in benzene levels within the product and its surrounding airspace reaching alarming levels, as per the lab’s findings.
While other acne treatment products containing ingredients like salicyclic acid or adapalene did not exhibit the same issue of benzene formation, products with benzoyl peroxide were consistently implicated. Benzene, listed among the 20 most commonly used chemicals in the US, poses significant health risks, mainly through inhalation of air containing the chemical, as outlined by the American Cancer Society.
The chemical, which can be formed through natural and human-made processes, evaporates rapidly into the air, with various industrial applications ranging from plastics and synthetic fibers to lubricants and drugs. Valisure’s report prompted the submission of a citizen petition to the FDA, urging recalls and the suspension of sales for products containing benzoyl peroxide.
In response, an FDA spokesperson acknowledged receipt of the petition, emphasizing the need for accurate and reproducible data before regulatory decisions can be made. The FDA has previously alerted drug manufacturers about benzene contamination risks in products such as hand sanitizers and aerosol drug products, underscoring benzene’s status as a known human carcinogen.
Regarding Clearasil products under the brand Reckitt Benckiser, the company expressed confidence in their safety when used as directed, dismissing Valisure’s findings as reflective of unrealistic scenarios. Valisure, alongside other companies, has previously sought patent applications for formulations or techniques aimed at reducing benzene formation in products, although no patents have been granted thus far. The implications of Valisure’s findings reverberate across the skincare industry, demanding heightened regulatory scrutiny and proactive measures to safeguard consumer health and well-being.
This recent discovery concerning benzoyl peroxide’s inherent instability and benzene formation differs significantly from previous findings in sunscreens and hand sanitizers, according to Valisure’s co-founder David Light, emphasizing the urgent need for action. “This means the problem broadly affects benzoyl peroxide products, both prescription and over-the-counter, and necessitates urgent action,” Light stated.
