In DiCroce v. McNeil Industries, 82 F. 4th 35 (1st Cir. 2023), the plaintiff brought a class action against a supplement manufacturer and its parent company, Johnson & Johnson, asserting state law deceptive trade practices and false advertising claims related to Lactaid, a supplement for individuals with lactose intolerance. The plaintiff argued Lactaid’s labeling was misleading because the product treats a disease, is therefore a drug rather than a supplement, and the label misled consumers into believing Food & Drug Administration (“FDA”) approval of the product was not required. According to plaintiff, Lactaid was a drug that was being deceptively marketed as a dietary supplement.
While the claims plaintiff asserted were state law claims, the underlying basis for the allegations was the assertion that Lactaid’s label violated the FDCA’s labeling requirements and was therefore misleading to consumers. The FDCA provides for exclusive enforcement by the FDA and has no private right of action. Where state law claims are based on allegations that the defendant violated a statute that has no private right of action and leaves enforcement to a regulatory body, the claims can be barred by the doctrine of implied preemption, meaning courts defer enforcement of FDCA violations to the FDA. That is exactly what happened in this case.
The trial court dismissed the plaintiff’s claims and the First Circuit affirmed, finding that state consumer protection claims that rise and fall on violations of the FDCA are impliedly preempted by the FDA’s exclusive statutory enforcement authority. Relying on prior decisions in the food labeling and medical devices space, the court reiterated the importance of the substance of the claims asserted rather than their form. Because the claims were impliedly preempted, the court found no merit in plaintiff’s argument that the trial court should have allowed the claims to proceed past the pleading stage. After losing at the First Circuit, the plaintiff asked the Supreme Court to weigh in on the issue. The Supreme Court refused in late April, which leaves the ruling by the First Circuit that plaintiff’s claims were impliedly preempted intact.