Wages and White Lion Investments, L.L.C. v. United States Food and Drug Administration, No. 21-60766 (5th Cir. 2021)Annotate this Case
The 2009 Family Smoking Prevention and Tobacco Control Act, implemented through the FDA, 21 U.S.C. 387a(b), 393(d)(2), prohibits manufacturers from selling any “new tobacco product” without authorization. The FDA’s 2016, “Deeming Rule” classified electronic nicotine delivery systems (e-cigarettes) as a “new tobacco product.” To avoid an overnight shutdown of the e-cigarette industry, the FDA delayed enforcement of the Deeming Rule then required e-cigarette makers to submit premarket tobacco applications (PMTAs). Originally, the FDA required that all PMTAs be filed by 2018. The FDA later extended the PMTA deadline to 2022 but then moved the deadline to 2020. Initially, the FDA’s guidance stated that “in general, FDA does not expect that applicants will need to conduct long-term studies to support an application” but later changed course and required long-term studies of e-cigarettes.
Triton had e-cigarette products on the market before the Deeming Rule. Triton (and others) submitted PMTAs for flavored e-cigarettes. In August 2021, the FDA announced that it would deny the PMTAs for 55,000 flavored e-cigarettes, stating it “likely” needed evidence from long-term studies." Less than a week later, Triton submitted a letter stating that it intended to conduct long-term studies of its products. About two weeks later, the FDA issued Triton a marketing denial order. The Fifth Circuit granted a temporary administrative stay and, later, a full stay, “to prevent the FDA from shutting down Triton’s business” pending disposition of Triton’s petition.