Recently, there has been a proliferation of putative class actions targeting allegedly misleading statements (or omissions) on the FDA-approved labels for over-the-counter (“OTC”) drugs.  Last year, we explained how these types of claims are vulnerable to a strong federal preemption defense.  In short, because the Federal Food, Drug, and Cosmetic Act (“FDCA”) explicitly forbids states from imposing OTC labeling requirements that are “different from,” “in addition to,” or “otherwise not identical” with those provided under federal law, 21 U.S.C. § 379r(a), state-law claims that directly challenge or conflict with the FDA’s decision-making for OTC drug labels are expressly preempted.

In Patora v. Vi-Jon, LLC, 2023 WL 5610300 (S.D.N.Y. Aug. 30, 2023), the Southern District of New York rejected the latest in a long line of attempts to evade this clear principle.  In Patora, plaintiffs alleged that some of defendant’s laxative products—which were recalled after testing positive for bacterial contamination—were falsely labeled because they did not list bacteria as an ingredient or warn of potential bacterial contamination.  As has become typical in these types of OTC labeling cases, the Patora plaintiffs alleged that they would not have purchased the products if they were “properly” labeled as containing bacteria and sought purely economic damages.

Defendant moved to dismiss on federal preemption grounds, arguing that the FDA-approved monograph for its laxative products only required listing of active and inactive ingredients, both of which are defined in the FDCA as including components “intended” to be in the drug.  Because there was no intent to include bacteria in the product, the FDCA did not require it to be listed on the label.  And because the monograph did not require a bacteria warning, the plaintiffs could not, either.  The Court agreed, dismissing plaintiffs’ claims in full.

Defendants facing OTC labeling claims should continue to raise federal preemption defenses where plaintiffs’ allegations conflict with an FDA-approved monograph.  Although plaintiffs will undoubtedly continue to look for holes and carve-outs, the purpose of Section 379r is to prevent a “patchwork of inconsistent packaging regulations” that would inevitably result if states were permitted to enforce their own unique requirements.  See Goldstein v. Walmart, Inc., 637 F. Supp. 3d 95, 113 (S.D.N.Y. 2022).  As evidenced by Patora and other recent decisions, federal preemption continues to be a strong defense in these putative false labeling class actions.