On April 2, 2025, in a significant decision in FDA v. Wages and White Lion Investments, LLC, the Supreme Court unanimously upheld the Food and Drug Administration's (FDA) decision denying marketing authorization for certain e-cigarette products. The Court held that the FDA's decision was not "arbitrary and capricious," finding it consistent with the agency's pre-decisional guidance and statutory mandate.
As summarized in Dykema's January 2025 edition, the case arose from applications by Triton and Vapetasia—manufacturers of dessert and candy-flavored e-liquids—seeking FDA approval to market new products. Under the Tobacco Control Act of 2009 (TCA), the FDA must assess whether new tobacco products are "appropriate for the protection of public health." The FDA denied the applications, citing insufficient evidence that the flavored e-liquids helped adult smokers transition from traditional cigarettes, and emphasizing the heightened risk of youth initiation and use.
The manufacturers contended that their marketing plans were specifically designed to mitigate youth access, and that the FDA failed to properly consider those plans. The U.S. Court of Appeals for the Fifth Circuit sided with the manufacturers, holding that the FDA's denial was arbitrary and capricious.
Writing for a unanimous Court, Justice Alito emphasized that the FDA's decision aligned with prior guidance and did not represent a departure warranting heightened scrutiny under the "change-in-position" doctrine. The Court further held that the FDA was entitled to require rigorous scientific data—such as "well-controlled investigations" or comparable valid scientific evidence—to support claims that the products advanced public health.
Additionally, the Court found it reasonable for the FDA to deny the applications for failing to compare the health risks of the flavored products to those of other tobacco-flavored alternatives, as required by the TCA. The manufacturers' argument that the FDA drew an impermissible distinction between cartridge-based and e-liquid products also fell flat; the Court noted the FDA had consistently prioritized enforcement against products most likely to appeal to minors. However, the Court remanded the case to the Fifth Circuit to assess whether the FDA's omission in considering the companies' marketing plans constituted harmless error. The justices criticized the Fifth Circuit for relying on an overly expansive interpretation of existing precedent in its review of the FDA's action.
In a brief concurring opinion, Justice Sotomayor underscored the FDA's reasonable latitude in allowing applicants to choose the form of scientific evidence presented—particularly in light of the pressing public health risks posed by flavored e-cigarette products among youth.
Takeaways
- Agency Discretion Affirmed: The decision reinforces the FDA's broad authority to establish evidentiary requirements for new tobacco products; youth usage is an especially significant concern.
- Deference to Agency Expertise Endures: Despite recent scrutiny of judicial deference to agencies in, and in the wake of, the Court's 2024 Loper Bright decision, the Court reaffirmed the "arbitrary and capricious" standard as a framework that continues to afford meaningful deference to agency expertise—particularly in scientific and technical contexts and where there is an express delegation to the agency by Congress.
- Implications for Future Applicants: E-cigarette manufacturers must be prepared to submit robust scientific evidence that directly addresses public impact and cannot rely solely on marketing restrictions to satisfy agency scrutiny.
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