Whether the FDA improperly adopted a new and heightened evidentiary burden for marketing applications for electronic nicotine delivery systems (ENDS) without adequate notice and in an arbitrary and capricious manner

First, whether FDA adopted and applied a new and heightened evidentiary burden to marketing applications for ENDS without notice and without considering applicants’ reliance interests. The Third Circuit’s position on this issue is in direct conflict with that of the U.S. Court of Appeals for the Fifth Circuit. See Wages & White Lion Invs., LLC v. FDA, 90 F.4th 357 (5th Cir. 2024) (en banc). Second, whether FDA’s imposition of that new evidentiary burden on menthol-flavored ENDS, in particular, was arbitrary and capricious and contrary to this Court’s caselaw. See, e.g., Dep't of Homeland Sec. v. Regents of the Univ. of Cal., 140 S. Ct. 1891 (2020); Encino Motorcars, LLC v. Navarro, 579 U.S. 211 (2016); Christopher v. SmithKline Beecham Corp., 567 U.S. 142 (2012). Counsel for Petitioner has several overlapping deadlines that further justify a 30-day extension. Among other recent deadlines, Counsel for Petitioner had to draft and file a response brief in Hammett v. Portfolio Recovery Associates, LLC, No.232638 (8th Cir.), filed on January 30, 2024; prepare and file an emergency motion for stay pending appeal and an emergency motion to dismiss appeal and transfer venue in League of Women Voters of Wisconsin v. Wisconsin Elections Commission, No.2024AP166 (Wis. Ct. App.), filed on February 6, 2024; prepare and file an emergency motion for stay pending appeal in Rise, Inc. v. Wisconsin Elections Commission, No.2024AP165 (Wis. Ct. App.), filed on February 6, 2024; prepare and file an amicus brief in support of certiorari in City & County of San Francisco, California v. EPA, No.23-753 (U.S.), filed on February 12, 2024; and prepare and file a reply in support of an emergency motion for stay pending appeal in Rise, Inc. v. Wisconsin Elections Commission, No.2024AP165 (Wis. Ct. App.), filed on February 20, 2024. As for upcoming deadlines, Counsel for Petitioner must prepare and file a -2 motion for summary judgment in EXPO Wisconsin, Inc. v. Wisconsin Elections Commission, No.2023CV279 (Dane Cnty. Cir. Ct.), due March 1, 2024; prepare for and present oral argument in Zanetich v. WalMart Stores East, Inc., No.23-1996 (3d Cir.), to be held on March 4, 2024; prepare and file a response to the motion for summary judgment in Liebert v. Wisconsin Elections Commission, No.3:23-cv-672 (W.D. Wis.), due on March 8, 2024; and prepare and file a response brief in Evers v. Marklein, No.2023AP2020-OA (Wis.), due March 138, 2024. For the foregoing reasons, Petitioner respectfully requests that this Court grant this Application and extend Petitioner’s time to file a petition for a writ of certiorari by 30 days, up to and including Monday, April 15, 2024. Respectfully submitted, /s/ Misha Tseytlin MISHA TSEYTLIN Counsel of Record TROUTMAN PEPPER HAMILTON SANDERS LLP 227 W. Monroe St., Ste. 3900 Chicago, IL 60606 (608) 999-1240 BRYAN M. HAYNES TROUTMAN PEPPER HAMILTON SANDERS LLP 1001 Haxall Point, 15th Floor Richmond, VA 23219 Attorneys for Petitioner February 2024