食品药品监督管理局诉Wages and White Lion Investments, LLC案

This case concerns whether the FDA lawfully denied respondents authorization to market certain flavored e-cigarette products. Wages and White Lion Investments, LLC, doing business as Triton Distribution, submitted premarket tobacco product applications for flavored nicotine liquids. The FDA denied the applications, finding insufficient evidence that the products would be appropriate for public health protection. The Fifth Circuit, sitting en banc, held the FDA acted arbitrarily and capriciously. The Supreme Court granted certiorari, heard oral argument on December 2, 2024, and issued a unanimous decision on April 2, 2025, vacating the Fifth Circuit's ruling.

The Supreme Court unanimously vacated the Fifth Circuit's decision and remanded. Justice Alito delivered the opinion, holding that the FDA's denial orders were consistent with its predecisional guidance regarding scientific evidence, comparative efficacy, and device type. Regarding the FDA's failure to consider marketing plans, the Court clarified that the Fifth Circuit applied the harmless-error standard too broadly and remanded for reconsideration under the proper standard. Justice Sotomayor filed a concurring opinion.

The central dispute is whether the FDA's denial of respondents' applications was arbitrary and capricious under the Administrative Procedure Act. Specifically, whether the FDA violated the change-in-position doctrine by applying standards different from those articulated in its predecisional guidance regarding scientific evidence, comparative efficacy, device type, and marketing plans. Additionally, the case addressed the proper standard for harmless-error review when an agency fails to consider a required factor.

The decision affirms significant deference to FDA's regulatory authority over e-cigarettes post-Loper Bright. It upholds the FDA's mass denial of flavored e-cigarette applications, reinforcing the agency's public health mission to curb youth vaping. However, by remanding on the harmless-error question, the Court left unresolved whether marketing plan omissions alone could invalidate FDA denials. The case has substantial implications for the e-cigarette industry, youth vaping prevention, and the scope of agency discretion in tobacco regulation.