Valisure’s Benzene Testing Challenged By PCPC; FDA Focus Should Be Raw Materials, Trade Group Says
On roughly the 1-year anniversary of Valisure’s citizen petition to the FDA regarding benzene detected in body sprays, the Personal Care Products Council weighs in on the matter.
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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.
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Valisure found 70% of 148 tested dry shampoo batches contained ‘quantifiable’ benzene. The US FDA advises a strict 2ppm limit when benzene’s use is unavoidable to produce a drug product with a “significant therapeutic advance.” In dry shampoos, “any significant detection of benzene could be deemed unacceptable,” Valisure suggests in its 31 October citizen petition to the agency.