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

QUESTION PRESENTED This case presents a circuit split on an important matter—whether FDA’s denial of hundreds of thousands of marketing applications for electronic nicotine delivery systems (also known as “ENDS” and “e-cigarettes”), including Petitioner’s applications, was arbitrary and _ capricious under _ the Administrative Procedure Act. FDA denied the applications, all of which were for “flavored” ENDS (i.e., ENDS flavored to taste like something other than tobacco) solely because the applications did not include certain types of studies showing that the flavored ENDS are more effective than tobaccoflavored ENDS in helping cigarette smokers quit or reduce smoking. But FDA had not previously informed Petitioner (or the public) that such studies would be required for marketing authorization. Moreover, for the “sake of efficiency,” FDA ignored other evidence in all applications for flavored ENDS—detailed plans to limit youth exposure and access to the products—that the agency had previously said would be “critical” for marketing authorization. While the court below (and some other circuits) found FDA’s actions were not arbitrary and capricious, the Fifth Circuit (sitting 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 capricious where FDA based the denial solely on a previously unannounced requirement for certain types of studies and where FDA ignored other evidence in ii the applications that FDA previously said was “critical” for marketing authorization.