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 reported levels of contaminants such as benzene than are actually present in tested products. It is critical that third-party laboratories reporting their results to consumers use validated methods so their results are reliable.

FDA Statement ¶10 (emphasis added).

FDA thus reiterated its validation policies, a well as the US Pharmacopeia’s 2023 white paper, “Unvalidated Methods for Medicine Quality Testing Lead to Misleading Results.”  Id. ¶11.  The USP paper also directly addressed Valisure’s junk science:

Valisure inappropriately applied USP methods as part of its testing.  It is the responsibility of the user to correctly apply USP standards and methods for their own quality testing and quality assurance purposes.  Changing, adapting or incorrectly applying USP methods disqualifies their validation and thereby forfeits any claim that USP methods have been used. . . .  [I]t can, and often does, lead to inaccurate results.

Valisure’s methods were further called into question with the publication of peer-reviewed research that indicated that the medicines highlighted in Valisure’s testing claims were incapable of being converted to the purported carcinogens under conditions simulating a normal population and use.  When laboratories, such as in the case of Valisure, apply methodology that lacks rigorous and transparent validation, they are unable to claim that they use analytical techniques that are suitable for the substance they are trying to measure and/or detect. And when third-party contract labs purport to function as “consumer watchdogs,” the findings from these labs become suspect when they use these testing methods.

USP White Paper at 3-4 (quotation marks and footnotes omitted).

Given what the FDA published last month, it seems quite likely that the agency is poised to deny Valisure’s citizen petition involving acne products – when that happens, the denial should serve as the requisite “clear evidence” to support preemption of all the litigation currently concerning them.  E.g., Cerveny v. Aventis, Inc., 855 F.3d 1091, 1102 (10th Cir. 2017); Pfaff v. Merck & Co., 627 F. Supp.3d 134, 144-145 (E.D.N.Y. 2022); In re Incretin-Based Therapies Products Liability Litigation, 524 F. Supp.3d 1007, 1030, 1032 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (9th Cir. March 28, 2022); Duggan v. Medtronic, Inc., 840 F. Supp.2d 466, 472 (D. Mass. 2012); Bentzley v. Medtronic, Inc., 827 F. Supp.2d 443, 451 (E.D. Pa. 2011); State v. Purdue Pharma L.P., 2019 WL 3776653, at *2-3 (N.D. Dist. July 22, 2019); Rieger v. Medtronic MiniMed, Inc., 2025 Cal. Super. Lexis 14, at *22 (Cal. Super. Jan. 28, 2025).  But even before that, the FDA’s position that Valisure’s testing is inadequate and inaccurate should kill these cases, mostly for the reasons that the Third Circuit gave in Huertas v. Bayer US LLC, 120 F.4th 1169, 1181 (3d Cir. Nov. 7, 2024) (see our “silver lining” posts, here and here).  You can’t have a class action based on purported test results where the vast majority (84 of 95) of actual, validated testing reveals no problems at all.  There’s simply no common issue, and probably no standing, either.

Finally, Valisure has been generating this sort of garbage for years.  The FDA’s repudiation – and UPS’s − of it should be brought to the attention of every court to which Valisure testing has been submitted as supposed evidence of “contamination” or “increased risk.”  Such “unvalidated” land “inaccurate” testing, generating “much higher reported levels of contaminants . . . than are actually present” cannot possibly meet the reliability requirements of Rule 702, since “[i]t is critical that third-party laboratories . . . use validated methods so their results are reliable.”  FDA Statement ¶10.