Over the last several years, food and drug manufacturers have litigated countless class action lawsuits claiming that their products are misleadingly advertised.  Many of these lawsuits claim that a product’s packaging is misleading because it allegedly violates FDA labeling rules.  Last week, in DiCroce v. McNeil Nutritionals, LLC, — F.4th —, No. 22-1910, 2023 WL 6056144 (1st Cir. Sept. 18, 2023), the First Circuit found that these claims are impliedly preempted by the Federal Food, Drug, and Cosmetic Act (“FDCA”). 

The plaintiff in DiCroce alleged the defendants’ product, Lactaid, was misleadingly labeled as a dietary supplement because it claimed to treat lactose intolerance.  In the plaintiff’s view, that claim meant the product was a drug under the FDCA, and thus required labeling in compliance with the FDA’s rules for drugs, which the product did not have.  Specifically, the product’s label stated that the FDA had not approved the product.  Although that disclaimer was factually true, the plaintiff claimed that it was misleading because drug products require FDA approval and the disclaimer implied the opposite.  On the basis of this purported FDA labeling violation, the plaintiff brought state law claims for deceptive trade practices, false advertising, and unjust enrichment against the defendants.

On appeal, the First Circuit found that the plaintiff’s claims were preempted by the FDCA.  The First Circuit noted that only the FDA is permitted to enforce the FDCA, and thus to state a claim for relief based on conduct that violates the FDCA, a plaintiff must show that the product’s packaging is misleading even if the FDCA did not exist.  Because the plaintiff’s theory of deception rested entirely on an alleged FDCA violation, the First Circuit concluded that the plaintiff’s claims were impliedly preempted by the FDCA.

We have previously explained how preemption defenses are powerful tools against false labeling class actions, typically in cases involving state law claims that seek to impose labeling requirements different from FDA labeling rules.  The First Circuit’s decision in McNeil, however, demonstrates that federal preemption applies with equal force to “fraud on the FDA” claims.  Defendants facing false advertising class actions should therefore consider raising federal preemption defenses when faced with claims that rest on purported FDA labeling violations.