Independent laboratory Valisure filed a March 5, 2024, citizen petition (CP) asserting, based on its own testing, that a number of benzoyl peroxide products contain high levels of benzene and that benzene concentrations are increased when the products are stored above normal room temperatures. Valisure further asserts that benzoyl peroxide products expose consumers through direct dermal contact and inhalation of benzene emanating from the product container, even when unopened. Valisure asserts, as it did with ranitidine, that the contaminant is a degradation product of the compound itself and is not the result of contamination during manufacture, distribution or sale.
The CP provides substantial detail as to Valisure's analytical methods in an attempt to address the U.S. Food and Drug Administration's (FDA's) dismissal of Valisure’s results as unreliable due to invalidated analytical methodology used in prior petitions, but without more detailed consideration, it is not possible to determine if it has been successful. For example, in the CP at issue, Valisure reports using a GC-MS methodology that has the potential to lead to further degradation of benzoyl peroxide to benzene during the analytical process to artificially increase the benzene concentrations in the products. As another example, Valisure used incubation for 18 days at 37°C (98.6°F), 50°C (122°F) and 70°C (158°F) as a proxy for “reasonable” transport and storage conditions. This contention is unsupported, as Valisure misrepresents the references in the CP. While couched in terms of concern for public health, a key element of all of Valisure’s CPs has been to seek an FDA requirement that all medications be tested at independent laboratories (such as Valisure). In short, this CP mirrors others we have seen from Valisure in putting forth an extreme position based on its own unreplicated, poorly validated and largely unreliable testing.
Valisure has reportedly worked hand-in-hand with the plaintiffs’ bar to publicize its findings of allegedly high levels of carcinogens in consumer products with an eye towards drumming up product liability litigation related to over-the-counter drugs, sunscreen, dry shampoo and other products, and it may be following the same playbook with respect to certain acne products. Valisure’s tactics have proven to have flaws and limitations in its testing and its business model. Counsel with experience in aggressive third-party discovery, relationships with experts in the field, and strong scientific backgrounds can help companies targeted by Valisure’s testing to respond to any regulatory or litigation response following the filing of this CP.
