Benzene, a known carcinogen that has been the subject of lawsuits against Unilever, J&J, Olaplex and L'Oréal, was recently identified in commercial acne treatment products, according to research from Valisure. However, in a press statement responding to these findings, the Personal Care Products Council (PCPC) called to question Valisure's test methods, referring to them as unrealistic.
Related: Benzene, Methanol and Lead Headline Recent Class Actions and FDA Alerts
The Studies
Per Valisure, initial GC-MS analysis of 99 benzoyl peroxide (BPO)-containing products detected benzene in 94 of the 99 products without any elevated temperature incubation. (Editor's note: actual benzene levels detected were not reported). Benzene is prohibited by the European Commission, per safecosmetics, and is restricted to a concentration of 2 parts per million (ppm) by the U.S. Food and Drug Administration (FDA), per Valisure. China’s National Medical Products Administration also limits benzene to 2 mg/kg for cosmetics, per ChemLinked.
Following the initial 99-product study, five products were tested at 37°C, 50°C and 70°C, which found that "dozens" of ppm of benzene could form within "a few weeks" at 37°C and "hundreds" of ppm at 50°C. At 70°C, the apparent degradation of BPO led the packaging to burst, per Valisure. As such, 50°C was used for a broader study of 66 BPO-containing products and in 18 days, more than 1,500 ppm of benzene was produced in two products; 100+ ppm in 17 products; and 10+ ppm in 42 products. Thus, Valisure found that BPO products could form more than 800 times the conditional regulatory limit for benzene in two weeks at a temperature of 50°C.
Valisure also noted that high levels of benzene were not only detected within BPO products, but in the air around incubated BPO products, showing that benzene could "leak out of some product packages and pose a potential inhalation risk." The company replicated a product being left in a car by incubating a Proactiv brand product at 70°C and, using a technology platform designed to analyze benzene in the air, referred to as selected-ion flow-tube mass spectrometry (SIFT-MS), identified benzene levels in a compact car’s volume of air that were ~1,270 times the Environmental Protection Agency's calculated threshold for increased cancer risk by long-term inhalation exposure to benzene.
PCPC Responds
The PCPC responded, "... The findings in the most recent Valisure petition are based on unproven, questionable methods applying unrealistic conditions which are inconsistent with the way the product would be stored normally."
The council added that in a December 2022 letter, the U.S. Food and Drug Administration (FDA) highlighted multiple deficiencies in Valisure’s analytical methods, stating that the lab should follow the same testing methods that drug manufacturers are required to use.
See related: FDA, Unilever and GSK Challenge Valisure's Benzene Findings, Test Methods
Furthermore, the PCPC noted, "Over-the-counter (OTC) drug products such as anti-acne treatments are highly regulated by the U.S. Food & Drug Administration (FDA), which has reviewed and determined benzoyl peroxide is a safe and effective anti-acne ingredient. Consumers have safely used anti-acne products for decades."
Valisure has submitted an FDA citizen petition and is requesting an investigation and market withdrawal of BPO-containing products.
