Whether the FDA's creation of a new, heightened standard for evaluating already-pending PMTAs for certain ENDS products was arbitrary and capricious

QUESTIONS PRESENTED 1. Whether the Food and Drug Administration’s (“FDA”) creation of a new, heightened standard for evaluating already-pending premarket tobacco product applications (“PMTAs”) for certain electronic nicotine delivery systems (“ENDS”) products was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). 2. Whether FDA’s subsequent, retroactive extension of this heightened evidentiary standard to pending PMTAs for menthol-flavored ENDS was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” Id.