Lotus Vaping Technologies, LLC v. Food and Drug Administration

Petitioner is an Idaho-based small business that makes bottled “e-liquid”—a liquid that contains nicotine for use in electronic nicotine delivery systems (also known as “ENDS” and “e-cigarettes”). Petitioner’s case presents a circuit split on whether the Food and Drug Administration’s denial of hundreds of thousands of marketing applications for ENDS products, including Petitioner’s applications, was arbitrary and capricious under the Administrative Procedure Act. FDA denied the applications, all of which were for “flavored” products (i.e., flavored to taste like something other than tobacco) solely because the applications did not include certain types of studies showing that flavored ENDS are more effective than tobacco-flavored ENDS in helping cigarette smokers quit or reduce smoking. But FDA, despite providing extensive guidance on the recommended contents of these applications, had not previously informed Petitioner (or the public) that such studies were required. Moreover, for the “sake of efficiency,” FDA ignored other evidence in Petitioner’s applications—detailed plans to limit youth exposure and access to the products—that FDA previously said would be “critical” for its marketing authorization determinations. Although the court below (and several other circuits) have found FDA’s actions were not arbitrary and capricious, the Fifth Circuit (en banc) and the Eleventh Circuit have found FDA’s actions were arbitrary and capricious. The question presented is: Whether FDA’s denial of Petitioner’s marketing applications for flavored ENDS was arbitrary and