Whether FDA's denial of Petitioner's marketing applications for flavored ENDS was arbitrary and capricious

QUESTION PRESENTED 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 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 il capricious where FDA based the denial solely on a previously unannounced requirement for certain types of studies and where FDA ignored other evidence in the applications that FDA previously said was “critical” for marketing authorization.! 1 This is the same question presented in Magellan Technology, Inc. v. Food and Drug Administration, Case No. 23-799 (petition for certiorari filed on January 22, 2024; FDA’s response due on March 25, 2024). Undersigned counsel of record is also counsel of record for the petitioner in Magellan.