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.Continue Reading It’s About Time – FDA Calls Foul on Valisure