Late final yr, we mentioned the dismissal of three purported California no-injury class actions alleging that sure over-the-counter (“OTC”) pimples medicines have been contaminated with carcinogenic benzene. That submit additionally commented:
By the way in which, guess who says they discovered the benzene within the merchandise? It was that good, outdated “impartial” lab, Valisure − which proceeded to file a citizen’s petition with the FDA in search of motion towards [these] merchandise. Sound acquainted?
Final month, the FDA responded to the petition. The company was not impressed. Its personal testing – opposite to Valisure’s overblown claims in its petition (“detected excessive ranges of benzene . . . in lots of particular batches”) discovered virtually nothing to be involved about. It examined “95 pimples merchandise containing benzoyl peroxide for attainable benzene contamination,” and “greater than 90% of examined merchandise had undetectable or extraordinarily low ranges of benzene.” FDA, Assertion ¶1 (March 11, 2025). THe FDA initiated a “restricted variety of voluntary remembers” as a result of “findings present[ing] a small variety of merchandise with elevated ranges of benzene contamination.” Id. Solely six of 95 merchandise have been recalled, and even then, solely specified lot numbers. FDA Assertion ¶7.
Not solely that, the remembers weren’t even accompanied by any FDA advice to keep away from utilizing these merchandise.
It is very important observe the remembers are being carried out on the retail stage, not the buyer stage. This implies retailers are instructed to take away merchandise from retailer cabinets and on-line marketplaces however doesn’t particularly instruct shoppers to take actions relating to merchandise at present of their possession. Even with each day use of those merchandise for many years, the danger of an individual creating most cancers due to publicity to benzene present in these merchandise could be very low.
FDA Assertion ¶3 (emphasis added). FDA “intends to publish the complete outcomes of its testing.” FDA Assertion ¶8.
That’s not even one of the best of it. FDA then turned the tables utterly and criticized Valisure’s modus operandi of spot testing merchandise underneath absurdly unrealistic circumstances (Valisure’s Citizen petition “particularly” talked about “37°C (98.6°F), 50°C (122°F) and 70°C (158°F)”). Valisure’s “unvalidated” testing strategies are worse than ineffective – they mislead shoppers:
FDA has continued to lift concern that use of unvalidated testing strategies by third-party laboratories can produce inaccurate outcomes resulting in shopper confusion. Particularly, such strategies might end in a lot increased reported ranges of contaminants akin to benzene than are literally current in examined merchandise. It’s crucial that third-party laboratories reporting their outcomes to shoppers use validated strategies so their outcomes are dependable.
FDA Assertion ¶10 (emphasis added).
FDA thus reiterated its validation insurance policies, a nicely because the US Pharmacopeia’s 2023 white paper, “Unvalidated Strategies for Drugs High quality Testing Result in Deceptive Outcomes.” Id. ¶11. The USP paper additionally immediately addressed Valisure’s junk science:
Valisure inappropriately utilized USP strategies as a part of its testing. It’s the accountability of the consumer to accurately apply USP requirements and strategies for their very own high quality testing and high quality assurance functions. Altering, adapting or incorrectly making use of USP strategies disqualifies their validation and thereby forfeits any declare that USP strategies have been used. . . . [I]t can, and infrequently does, result in inaccurate outcomes.
Valisure’s strategies have been additional known as into query with the publication of peer-reviewed analysis that indicated that the medicines highlighted in Valisure’s testing claims have been incapable of being transformed to the purported carcinogens underneath circumstances simulating a traditional inhabitants and use. When laboratories, akin to within the case of Valisure, apply methodology that lacks rigorous and clear validation, they’re unable to say that they use analytical strategies which might be appropriate for the substance they’re attempting to measure and/or detect. And when third-party contract labs purport to perform as “shopper watchdogs,” the findings from these labs develop into suspect after they use these testing strategies.
USP White Paper at 3-4 (citation marks and footnotes omitted).
Given what the FDA printed final month, it appears fairly probably that the company is poised to disclaim Valisure’s citizen petition involving pimples merchandise – when that occurs, the denial ought to function the requisite “clear proof” to assist preemption of all of the litigation at present regarding them. E.g., Cerveny v. Aventis, Inc., 855 F.3d 1091, 1102 (tenth Cir. 2017); Pfaff v. Merck & Co., 627 F. Supp.3d 134, 144-145 (E.D.N.Y. 2022); In re Incretin-Primarily based Therapies Merchandise Legal responsibility Litigation, 524 F. Supp.3d 1007, 1030, 1032 (S.D. Cal. 2021), aff’d, 2022 WL 898595 (ninth Cir. March 28, 2022); Duggan v. Medtronic, Inc., 840 F. Supp.second 466, 472 (D. Mass. 2012); Bentzley v. Medtronic, Inc., 827 F. Supp.second 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. Tremendous. Lexis 14, at *22 (Cal. Tremendous. Jan. 28, 2025). However even earlier than that, the FDA’s place that Valisure’s testing is insufficient and inaccurate ought to kill these instances, largely for the explanations 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, right here and right here). You may’t have a category motion based mostly on purported check outcomes the place the overwhelming majority (84 of 95) of precise, validated testing reveals no issues in any respect. There’s merely no widespread difficulty, and possibly no standing, both.
Lastly, Valisure has been producing this type of rubbish for years. The FDA’s repudiation – and UPS’s − of it must be delivered to the eye of each courtroom to which Valisure testing has been submitted as supposed proof of “contamination” or “elevated threat.” Such “unvalidated” land “inaccurate” testing, producing “a lot increased reported ranges of contaminants . . . than are literally current” can not probably meet the reliability necessities of Rule 702, since “[i]t is crucial that third-party laboratories . . . use validated strategies so their outcomes are dependable.” FDA Assertion ¶10.
