Supreme Court Decides Food and Drug Administration v. Wages and White Lion Investments, LLC

On April 2, 2025, the U.S. Supreme Court decided Food and Drug Administration v. Wages and White Lion Investments, LLC, No. 23-1038, holding that FDA’s denial of the respondents’ application to market certain flavored e-cigarette products did not violate the change-in-position doctrine and that the Fifth Circuit had erred in its application of the Court’s harmless-error precedents. The Supreme Court clarified the applicable harmless-error analysis and remanded for the Fifth Circuit to apply that standard in the first instance.

Respondents are manufacturers of flavored e-cigarette products. Pursuant to the Family Smoking Prevention and Tobacco Control Act of 2009, which governs the marketing of new tobacco products, the respondents submitted premarket tobacco product applications to the FDA. Before the applications were submitted, the FDA had issued guidance regarding what those applications should contain, including scientific evidence, comparative efficacy, information about device type, and marketing plans; and the respondents’ applications included those categories of information. The FDA denied respondents’ applications, concluding that the respondents had not provided sufficient evidence and stating that the FDA did not consider the marketing plans.

Respondents petitioned for review in the Fifth Circuit. The Fifth Circuit, en banc, concluded that the FDA had acted arbitrarily and capriciously in denying the applications due to the alleged changes in the FDA’s requirements for premarket tobacco product applications between the time of its guidance and its denials of the respondents’ applications. The Fifth Circuit granted the petitions for review and remanded to the FDA.

The Supreme Court disagreed and vacated and remanded for the Fifth Circuit to reconsider its decision in light of the Supreme Court’s clarification of the harmless-error standard.

The Court first rejected respondents’ argument that the FDA’s decision was arbitrary and capricious based on its alleged changes in position between its guidance documents and its denials of respondents’ applications. Applying its existing change-in-position jurisprudence, the Court held for the first three alleged changes in the FDA’s position — FDA’s considerations in reviewing scientific evidence, comparative efficacy, and device type proffered in the applications — that FDA’s denial orders were sufficiently consistent with FDA’s prior guidance documents and therefore were not arbitrary and capricious.

On the fourth alleged change — FDA’s failure to consider the marketing plans in its denial of the applications — the FDA did not seek review of the Fifth Circuit’s finding of error but rather sought clarification on the harmless-error rule. The Supreme Court concluded that the Fifth Circuit applied its precedent in Calcutt v. FDIC, 498 U.S. 623 (2023), too broadly, and remanded for the Court of Appeals to apply a version of the harmless-error rule that was more consistent with the articulation applicable in traditional civil litigation.

The Court accordingly vacated the Fifth Circuit’s decision and remanded for the Fifth Circuit to decide whether the respondents met their burden of showing that the error was not harmless.

Justice Alito delivered the opinion of a unanimous Court. Justice Sotomayor filed a concurring opinion.