Docket 23-1038
FDA
DecidedApr 2, 2025
9-0decision
Source: CourtListener.
Supreme Court upholds FDA's denial of flavored e-cigarette marketing applications
Impact6/10
What it does
The Court vacated the Fifth Circuit's ruling that the FDA had acted arbitrarily and capriciously, finding that the FDA's denial orders were sufficiently consistent with its earlier guidance on scientific evidence, cross-product comparisons, and device type. The Court also clarified that the Fifth Circuit applied an overly broad reading of the harmless-error rule in administrative law, and remanded for the lower court to reconsider whether the FDA's admitted failure to review manufacturers' marketing plans was harmless error under the correct legal standard.
Who benefits
The FDA and federal agencies generally, whose denial decisions in premarket authorization proceedings are upheld and whose discretion to develop regulatory standards through adjudication — rather than formal rulemaking — is preserved.
Who is affected
Manufacturers of flavored e-cigarette products (such as fruit-, candy-, and dessert-flavored e-liquids) who sought FDA marketing authorization and received denial orders, and who must now continue to operate without authorization to sell those products.
Practical impact
Flavored e-cigarette manufacturers whose applications were denied remain unable to legally market their products in the United States, and the FDA's denial orders stand. The case returns to the Fifth Circuit only on the narrow question of whether the FDA's failure to review marketing plans was harmless error — meaning manufacturers may get another opportunity to argue that issue, but the broader challenge to the FDA's standards has been rejected. Federal agencies more broadly retain flexibility to develop and apply regulatory standards through case-by-case adjudication without being bound to every statement made in predecisional guidance documents.
Majority — Alito
Joined by: Roberts, Thomas, Sotomayor, Kagan, Gorsuch, Kavanaugh, Barrett, Jackson
The Court reasoned that the FDA's predecisional guidance never made hard-and-fast commitments about exactly what scientific evidence would be required — it consistently signaled that rigorous, product-specific evidence was needed, even if it did not mandate a single type of study. The majority held that the FDA's requirement that applicants compare their flavored products to tobacco-flavored products was a natural outgrowth of prior guidance that already emphasized cross-product comparisons and the heightened youth appeal of non-tobacco flavors. On device type, the Court found that the FDA's 2020 guidance never created a "safe harbor" for non-cartridge products, and that even if the FDA's position evolved, it offered good reasons — namely, evidence that youth demand had shifted from cartridge-based to disposable flavored products, suggesting flavor rather than device type was the primary driver. Finally, the Court clarified that the Fifth Circuit read the harmless-error rule too narrowly by treating remand as mandatory in virtually all cases of agency error, and sent the marketing-plans issue back for reconsideration under the correct standard.
Constitutional question
Did the FDA act arbitrarily and capriciously under the Administrative Procedure Act when it denied premarket authorization applications for flavored e-cigarette products, given the guidance the agency had previously issued to manufacturers?
Precedent changed
The Court narrowed the Fifth Circuit's reading of Calcutt v. FDIC, 598 U.S. 623 (2023), clarifying that Calcutt does not stand for the proposition that remand is required in all agency-error cases except where the agency was legally required to take the same action — other exceptions to the remand rule exist and courts must apply a proper harmless-error analysis.