Food and Drug Administration v. Wages and White Lion Investments, L.L.C.
Issues
Was the Food and Drug Administration’s denial of White Lion’s application to market flavored e-cigarette products arbitrary and capricious?
This case asks the Supreme Court to decide whether the Food and Drug Administration’s (“FDA”) denial of Wages and White Lion Investments, L.L.C.’s (“White Lion”) application to market flavored e-cigarette products was arbitrary and capricious. White Lion submitted an application to the FDA to sell their flavored nicotine liquid, used in e-cigarettes, on the market. The FDA denied their application, claiming that White Lion did not include sufficient scientific study support in their application for the FDA to conclude that the benefits of the flavored nicotine liquid outweighed the risk of use by youth. White Lion claims that the FDA erroneously rejected their application for approval of their flavored nicotine liquid because they lacked a longitudinal comparative study, a requirement that White Lion claims was not communicated to the public. The FDA counters by claiming that longitudinal studies are not required and that White Lion’s application was rejected because they could not show that e-cigarette use reduced smoking. The outcome of this case has significant implications for youth e-cigarette use, public health, state budget stability, and product investment and innovation in the e-cigarette industry.
Questions as Framed for the Court by the Parties
Whether the court of appeals erred in setting aside the Food and Drug Administration’s orders denying respondents’ applications for authorization to market new e-cigarette products as arbitrary and capricious.
In 2009, the federal government passed the Family Smoking Prevention and Tobacco Control Act (“Tobacco Control Act”) which required manufacturers of tobacco products, including nicotine liquid for e-cigarettes, to receive Food and Drug Administration (“FDA”) authorization before selling such products. Food and Drug Administration v.
Additional Resources
- Greg Stohr & Tiffany Kary, FDA Efforts to Curb Flavored Vapes Draw Supreme Court Review, Bloomberg Law (July 2, 2024).
- Alison Durkee, Supreme Court Will Take On FDA’s Tough Flavored Vape Restrictions, Forbes (July 2, 2024).