PCPC Challenges 2ppm Benzene Limit Cited By Valisure, Class Action Plaintiffs

 
• By Lauren Nardella

In comments to the US FDA, PCPC provides a “highly conservative” risk assessment of benzene impurity in a dry shampoo product, showing that “even a benzene concentration of 15 ppm in a hypothetical aerosol dry shampoo product would have an acceptable level of risk for a lifetime of daily use.” The exercise was undertaken in response to Valisure’s petition for FDA regulatory action on benzene-tainted dry shampoos.

Class action complaints in US courts against benzene-tainted dry shampoo manufacturers cite the US Food and Drug Administration’s recommended 2ppm threshold for residual benzene in drug products, while maintaining that absolutely no level of detectable benzene should be acceptable in cosmetic products.

The Personal Care Products Council takes a different view on the matter in comments to the FDA regarding Valisure LLC’s October 2022 petition seeking regulatory action on benzene-containing dry shampoo

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