FDA v. Wages and White Lion Investments, L.L.C.

Wikipedia · Justia · Docket · oyez.org

Argued on Dec 2, 2024.

Petitioner: Food and Drug Administration.
Respondent: Wages and White Lion Investments, L.L.C.

Advocates:

• Curtis E. Gannon (for the Petitioner)
• Eric N. Heyer (for the Respondents)

Facts of the case (from oyez.org)

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.

Question

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?