Analytical laboratory Valisure submits Citizen’s Application to FDA requesting ‘a recall and suspension of sale of products containing benzoyl peroxide’



Valisure submits Citizen s Application to FDA requesting a recall and suspension of sale of products containing benzoyl

Last week, independent laboratory Valisure submitted a formal Citizen’s Application​ to the FDA “to request the Commissioner of Food and Drugs to issue a regulation, revise industry guidance, and request a recall and suspend sales of benzoyl peroxide from the US market” following the results of recent testing which revealed “that benzene, a known human carcinogen, can form at high levels in Benzoyl Peroxide (“BPO”) acne treatment products,” the company confirmed.

In a company press release, Valisure asserted that the laboratory’s testing “on dozens of prescriptions and over-the-counter benzoyl peroxide products suggest that currently formulated BPO medications are fundamentally unstable and can generate unacceptably high levels of benzene when handled or stored at higher temperatures that the products may be exposed to during handling by consumers.”

The company’s Citizen’s Application to the FDA, which was submitted on March 5 of this year, outlines the historical research into benzene’s classification as a known carcinogen, a summary of Valisure’s testing and results analysis, and the actions to be undertaken by the FDA to address the risk of potential benzene exposure to consumers via benzoyl peroxide acne products.  

Benzene and BPO

As noted in Valisure’s Citizen’s Application to the FDA, “benzene has long been directly associated with cancer in humans by epidemiological studies with persistent exposure as low as 0.8 ppm.”

Historical research into benzene’s carcinogenic properties dates back over a century, the application further said, citing “a study from 1939 on benzene [which] stated that ‘exposure over a long period of time to any concentration of benzene greater than zero is not safe,’ which is a comment reiterated in a 2010 review of benzene research specifically stating, ‘There is probably no safe level of exposure to benzene, and all exposures constitute some risk in a linear if not supralinear, and additive fashion.’”



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