Late last year, we discussed the dismissal of three purported California no-injury class actions alleging that certain over the counter (“OTC”) acne medicines were contaminated with carcinogenic benzene. That post also commented:
By the way, guess who says they found the benzene in the products? It was that good, old “independent” lab, Valisure − which proceeded to file a citizen’s petition with the FDA seeking action against [these] products. Sound familiar?
Last month, the FDA responded to the petition. The agency was not impressed. Its own testing – contrary to Valisure’s overblown claims in its petition (“detected high levels of benzene . . . in many specific batches”) found practically nothing to be concerned about. It tested “95 acne products containing benzoyl peroxide for possible benzene contamination,” and “more than 90% of tested products had undetectable or extremely low levels of benzene.” FDA, Statement ¶1 (March 11, 2025). THe FDA initiated a “limited number of voluntary recalls” due to “findings show[ing] a small number of products with elevated levels of benzene contamination.” Id. Only six of 95 products were recalled, and even then, only specified lot numbers. FDA Statement ¶7.
Not only that, the recalls were not even accompanied by any FDA recommendation to avoid using those products.
It is important to note the recalls are being conducted at the retail level, not the consumer level. This means retailers are instructed to remove products from store shelves and online marketplaces but does not specifically instruct consumers to take actions regarding products currently in their possession. Even with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low.
FDA Statement ¶3 (emphasis added). FDA “intends to publish the full results of its testing.” FDA Statement ¶8.
That’s not even the best of it. FDA then turned the tables completely and criticized Valisure’s modus operandi of spot testing products under absurdly unrealistic conditions (Valisure’s Citizen petition “specifically” mentioned “37°C (98.6°F), 50°C (122°F) and 70°C (158°F)”). Valisure’s “unvalidated” testing methods are worse than useless – they mislead consumers:
FDA has continued to raise concern that use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion. Specifically, such methods may result in much higher...
