ALF Urges Supreme Court To Uphold FDA Enforcement Exclusivity
The Federal Food, Drug, and Cosmetic Act (“FDCA”) explicitly vests the Food & Drug Admninstration (FDA) with exclusive authority to enforce or restrain violations of its nutrition-related food labeling standards. See 21 U.S.C. § 337(a). To achieve and maintain nationally uniform nutrition labeling, the statute expressly preempts a State from establishing “any requirement for nutrition labeling of food” that is “not identical” to FDA’s requirements. See 21 U.S.C. § 343-1. California’s “Sherman Law,” the State’s analog to the FDCA, adopts on a wholesale basis all of FDA’s nutrition-related food labeling standards. See Cal. Health and Safety Code § 110100(a). The certiorari petition in Sprout Foods, Inc. v. Davidson, No. 24-737, presents the question of whether a private party can circumvent the FDCA’s enforcement exclusivity provision by alleging violations of the Sherman Law’s nutrition labeling standards even though they incorporate by reference, and thus are identical to, FDA’s standards.
ALF has filed an amicus brief urging the Supreme Court to review this question and hold that the FDCA’s enforcement exclusivity provision impliedly preempts such state-law claims. The brief was authored by Sarah Elizabeth Spencer of Spencer Willson, PLLC.
Whether the Federal Food, Drug, and Cosmetic Act’s bar against private enforcement, 21 U.S.C. § 337(a), preempts a private action seeking to enforce FDA food labeling regulations by invoking a California statute that incorporates those regulations by reference.
Additional Background:
The plaintiffs filed in California federal district court a putative class action alleging, inter alia, that Sprout Foods engaged in unlawful conduct under California’s Unfair Competition Law because it manufacturered baby food pouches whose labeling allegedly violated California’s Sherman Law, which incorporates by reference FDA’s food labeling standards. The district court dismissed this claim on the ground that it is impliedly preempted by 21 U.S.C. § 337(a), which vests the federal government with exclusive authority to enforce the FDA’s food labeling standards.
In a split decision, a Ninth Circuit panel reversed, holding that “the FDCA does not preempt private enforcement of the Sherman Law.” According to the panel majority, the FDCA does not limit enforcement of parallel state food labeling standards, and thus, the plaintiffs’ Sherman Act claims are not preempted. Dissenting, the panel’s third member argued that “a private claim based on state law that has no substantive content other than a parasitic copying of the FDCA’s requirements is impliedly preempted.”
ALF’s Amicus Brief:
ALF’s amicus brief urges the Supreme Court to grant review and hold that the FDCA impliedly preempts private actions based on alleged violations of FDCA food-labeling standards incorporated by reference in state statutes such as California’s Sherman Law.
The brief discusses the importance of the national food labeling uniformity established by the FDCA, 21 U.S.C. § 343-1. The statute’s enforcement exlcusivity provision, 21 U.S.C. § 337(a), helps to implement and maintain national labeling uniformity by centralizing and vesting soley in the federal government the authority and discretion to enforce violations of FDA’s food labeling standards. Congress intended the FDA, an agency with decades of regulatory experience and scientific expertise—not a patchwork of individual court decisions around the United States—to establish, interpret, and enforce national food labeling standards.
The FDCA impliedly preempts private litigants such as the plaintiffs in the Sprout Foods case from circumventing federal enforcement exclusivity by invoking a state law, such as the Sherman Law, that adopts “state” labeling standards identical to the federal standards. Any such enforcement of FDA’s standards by private litigants not only conflicts with the FDCA, and undermines national labeling uniformity, but also would encourage frivolous lawsuits and impose unnecessary costs on consumers, taxpayers, and product manufacturers.
Status:
The petition for a writ of certiorari is pending.
Contact:
Email ALF Executive Vice President & General Counsel Lawrence Ebner.
