Facts of the Case

Provided by Oyez

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, requiring FDA approval for new tobacco products, including e-cigarettes. FDA issued guidance on the application process, stating that long-term studies were not necessary and emphasizing the importance of marketing plans to prevent youth access. Manufacturers were encouraged to use existing data and observational studies. In January 2020, FDA announced it would prioritize enforcement against flavored, cartridge-based e-cigarette products due to their popularity among youth.

Wages and White Lion Investments (Triton Distribution) and Vapetasia, manufacturers of flavored nicotine liquids for refillable e-cigarette systems, submitted applications in September 2020. Their applications included existing studies on e-cigarettes generally and detailed marketing plans to restrict youth access. However, in August 2021, FDA unexpectedly announced a new requirement for randomized controlled trials or longitudinal cohort studies specific to flavored products. Shortly after, FDA denied the applications of Triton and Vapetasia, citing a lack of evidence that their flavored products would benefit adult users enough to outweigh risks to youth. The manufacturers challenged this decision, arguing that FDA had changed its requirements without notice and refused to consider their marketing plans.

Questions

  1. 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?

Conclusions

  1. The FDA did not act arbitrarily and capriciously in denying the respondents’ applications to market flavored e-cigarette products under the Family Smoking Prevention and Tobacco Control Act. Justice Samuel Alito authored the unanimous opinion of the Court.

    The FDA’s rejection of the applications complied with its legal authority under the Tobacco Control Act and was consistent with its earlier guidance. The statute allows the FDA to require either “well-controlled investigations” or other “valid scientific evidence” showing a new tobacco product is “appropriate for the protection of the public health.” In its guidance, the FDA did not mandate randomized controlled trials or longitudinal studies but made clear that, in their absence, manufacturers must submit scientifically rigorous and product-specific evidence. The respondents failed to meet that standard.

    Likewise, the FDA was justified in requiring proof that flavored products offered cessation benefits greater than tobacco-flavored products—a requirement foreshadowed in prior statements emphasizing the unique appeal of non-tobacco flavors to youth. The FDA’s approach to different e-cigarette device types also remained consistent, as its enforcement guidance never promised non-cartridge-based products immunity from review; the FDA reasonably inferred that youth demand would shift to any flavored product, regardless of format.

    Although the FDA erred by disregarding the marketing plans that it had previously described as “critical,” the Fifth Circuit incorrectly interpreted the relevant harmless-error standard too narrowly. The Administrative Procedure Act incorporates a civil litigation rule that courts must take “due account” of whether an error caused actual prejudice.

    Justice Sonia Sotomayor authored a concurring opinion.