Supreme Court Declines Review of First Circuit Decision on Lactai

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Supreme Court Declines to Review FDA Labeling Preemption for State Claims

by: Food and Drug Law at Keller and Heckman of Keller and Heckman LLP - The Daily Intake

Thursday, April 18, 2024

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The Supreme Court declined to review a First Circuit decision affirming dismissal of false advertising and consumer protection claims alleging that McNeil Nutritionals LLC misbranded Lactaid drug products as a dietary supplement. The lower court found that the FDA’s sole authority to enforce the Food, Drug, and Cosmetic Act (FDCA) preempts the state law claims.
Petitioners in the proposed class action claimed that Lactaid was labeled as a treatment for lactose intolerance in violation of federal regulations for labeling dietary supplements. According to the petition, the circuit court decision has “upset the delicate balance of federalism by failing to follow controlling Supreme Court precedents.” The petition referenced Medtronic, Inc. v. Lohr and Buckman Co. v. Plaintiffs’ Legal Comm., stating that those cases articulate that “’somewhat delicate balance’ between state sovereignty and the federal statutory scheme that Congress and this Court have so carefully established.”
The circuit decision employed a test in which a “complaint is preempted unless the conduct it pleads: (1) violates FDCA labeling requirements and (2) would also violate [state law claims] even if the FDCA did not exist.” The petition challenged this test as “illogical” and said that the case “presents this court with an opportunity to return the law of implied FDCA preemption to the land of sanity and certainty.”
The First Circuit held that “[b]ecause the FDCA doesn’t provide a private right of action, state law claims hinging on a theory that the targeted products violate the act are preempted.”