Food and Drug Administration v. Wages and White Lion Investments, dba Triton Distribution
In brief
The FDA's denials of these flavored e-cigarette applications remain in place, subject to further proceedings consistent with the Court's decision.
- Where it stands
- Decided
Decided 9-0 · April 2, 2025 · Opinion by Justice Alito
- What it’s about
- The Supreme Court ruled that the FDA did not act arbitrarily or capriciously when it denied applications to market flavored e-cigarette products, finding the agency's requirement for robust scientific evidence was consistent with the Tobacco Control Act.
- Who it affects
- The decision supports the FDA's ability to require strong scientific evidence before allowing flavored e-cigarette products onto the market. Manufacturers seeking approval must show their products are appropriate for protecting public health.
Summary: written with AI from the case record.
What it's about
The Court also clarified the harmless-error standard under the Administrative Procedure Act, determining that the FDA's failure to review marketing plans did not prejudice the outcome.
The case concerns how the FDA applies the Tobacco Control Act's requirement that tobacco products be appropriate for the protection of public health.
Question presented
Was the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products arbitrary and capricious, in violation of the Administrative Procedure Act?
What the Court decided
Holding
1. As a preliminary matter, the Court declines to reach and thus expresses no view on respondents’ argument that the FDA erred in evaluating respondents’ applications under standards developed in adjudication rather than standards promulgated in notice-and-comment rulemaking. This complicated question sweeps beyond the question presented and lacks adequate briefing. 2. The Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers’ premarket tobacco product applications is vacated because the FDA’s denial orders were sufficiently consistent with its predecisional guidance—as to scientific evidence, comparative efficacy, and device type—and thus did not run afoul of the change-in-position doctrine. 3. The Fifth Circuit relied on an overly broad reading of Calcutt v. FDIC, 598 U. S. 623 ( per curiam ), to reject the FDA’s claim of harmless error regarding the agency’s change of position on marketing plans. The FDA does not contest that despite assuring manufacturers that marketing plans would be “critical” to their applications, the FDA ultimately did not consider respondents’ marketing plans. The FDA argued below that any error in this respect was harmless error because it issued denial orders to other manufacturers after reviewing marketing plans that were materially indistinguishable from respondents’. 90 F. 4th 357, vacated and remanded.
- Result
- Vacated
The vote
- Joined the judgment
- Concurred in a separate opinion
- Wrote an opinion
- Majority · 8joined the Court's opinion
- Concurring · 1agreed with the result, wrote separately
- Sotomayorwrote separately
From the opinions
“The Fifth Circuit’s conclusion that the FDA acted arbitrarily and capriciously in its adjudication of manufacturers’ premarket tobacco product applications is vacated”
What's next
The case returns to the Fifth Circuit for further proceedings. The lower court must apply the Supreme Court's ruling, including its direction to reconsider the FDA's harmless-error argument about marketing plans.
Documents
Docket activity
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More questions
- What did the Supreme Court rule in FDA v. Wages and White Lion Investments?
- The Court ruled that the FDA's denial orders were not arbitrary or capricious. It vacated the Fifth Circuit's decision.
- Who won FDA v. Wages and White Lion Investments?
- The FDA won at the Supreme Court. The Court upheld the agency's approach to scientific evidence and its evaluation of the applications.
- What does FDA v. Wages and White Lion Investments mean for e-cigarette manufacturers?
- Manufacturers seeking authorization for flavored e-cigarettes face the FDA's requirement for robust scientific evidence. They must show marketing their products protects public health.
- Is the FDA's scientific-evidence approach still the law after FDA v. Wages and White Lion Investments?
- Yes. The Court said the FDA's denial orders were sufficiently consistent with its earlier guidance on scientific evidence, comparative efficacy, and device type.
- What happens next in FDA v. Wages and White Lion Investments?
- The case goes back to the Fifth Circuit. That court must reconsider whether the FDA's failure to review marketing plans was harmless error.
Sources
Primary materials plus reporting. Best-effort analysis: this explainer relies on a mix of primary materials and trusted secondary sources. Official filings and opinions remain authoritative.