Implied Preemption for Dietary Supplements Is Here to Stay

On April 15, 2024, in a big win for the continued validity of implied preemption, the Supreme Court declined to hear an appeal of the First Circuit’s preemption-based dismissal of a proposed misbranding class action. The plaintiff claimed that the label of a dietary supplement called “Lactaid” should be required to meet the heightened regulatory requirements for drug products. The defendant—and the district court and First Circuit—disagreed.

The plaintiff made several arguments that are common in dietary supplement misbranding cases: (1) the product claims to treat a disease, making it a drug and not a dietary supplement; (2) because the product is a drug, the label is misleading and the product was misbranded; (3) the label further misled the plaintiff by falsely implying that the product is not subject to FDA evaluation; and (4) without the claims that the product treats the disease, the plaintiff would not have purchased this product.

The district court found these arguments lacked merit. It ultimately held that the plaintiff’s false advertising and deceptive trade practices claims failed because no reasonable consumer could find Lactaid’s product labels deceptive. The district court also found that no reasonable consumer’s purchasing decision would be impacted by the plaintiff’s proposed disclaimer that the FDA did not evaluate the product label, given that the label already included an express disclaimer that the product is not FDA-approved. The court did not consider the manufacturer’s implied preemption argument. Instead, it dismissed the proposed class complaint with prejudice.

On appeal, the First Circuit upheld the district court’s dismissal but found for the defendant on separate grounds. The First Circuit held that the plaintiff’s state law claims for unfair or deceptive trade practices, false advertising, and unjust enrichment existed “solely by virtue” of an alleged Federal Food, Drug, and Cosmetic Act (“FDCA”) infraction. Because the FDCA is within the purview of the FDA—and in fact gives the FDA the authority to oversee the safety of drugs and medical devices—the authority of the FDA preempted, justifying the dismissal of the proposed class action. Notably, the First Circuit concluded that future claims premised entirely on a belief that a label violates the FDCA will fail. Any such violation, if present, should be addressed by the FDA.

The First Circuit’s holding is consistent with past deference to the FDA’s regulation of dietary supplements and reaffirms these types of claims are preempted by the FDA’s authority. As the First Circuit aptly recognized, Congress intended that dietary supplements should “escape the regulatory gauntlet” required of pharmaceutical drugs. Congress enacted the Dietary Supplement Health and Education Act to ensure there are no federal barriers that “impede the ability of consumers to improve their nutrition through the free choice of safe dietary supplements.” See DiCroce v. McNeil Nutritionals (citing Senate Report No. 103-410 (1994)). Following the Supreme Court’s decision to deny cert in this case, Congress’s intention that the FDA have complete authority over the regulation of dietary supplements stands.