Vapor Tech. Ass'n v. FDA, 977 F.3d 496

The Tobacco Control Act (TCA) and FDA "Deeming Rule" (2016) brought e-cigarettes within FDA regulation and required premarket tobacco applications (PMTAs) for products not on the market as of Feb. 15, 2007.
FDA initially set staggered compliance deadlines, extended to Aug. 8, 2018, then further guidance in Aug. 2017 (issued without notice-and-comment) altered compliance timing and was later challenged.
In AAP v. FDA (D. Md.), the district court held the Aug. 2017 guidance unlawful and, after remedial briefing in which the Government suggested a 10‑month deadline and submitted a declaration from CTP Director Mitchell Zeller, the court imposed a 10‑month filing deadline (May 12, 2020), later extended to Sept. 9, 2020 due to COVID‑19.
Vapor Stockroom sued the FDA in the E.D. Ky., alleging the Government’s remedial brief and Zeller declaration to the Maryland court unlawfully proposed/created the 10‑month deadline and sought declaratory relief and an injunction barring FDA enforcement based on that deadline.
The Kentucky district court dismissed for lack of standing, finding Vapor Stockroom’s alleged injury traceable to the Maryland court’s independent injunction (a third‑party action), not to FDA’s litigation submissions; Sixth Circuit affirmed and declined to reach merits or address the 2020 guidance challenge (not pleaded below).

Issue	Plaintiff's Argument	Defendant's Argument	Held
Standing to challenge FDA remedial brief and Zeller declaration under the APA	FDA’s proposal motivated the Maryland court to adopt the 10‑month deadline, causing Vapor Stockroom injury	Injuries stem from the Maryland court’s independent injunction, not FDA filings; therefore not traceable	No standing: injury traceable to third‑party court order, not FDA submissions
Whether FDA submissions constituted unlawful/final agency action	The remedial brief and declaration amounted to final agency action in violation of the APA and due process	The filings were litigation advocacy and, even if improper, did not cause Vapor Stockroom’s asserted injury	Not decided on merits—dismissal for lack of jurisdiction; merits not reached
Request for injunction preventing FDA enforcement based on the May deadline	Immediate irreparable harm; injunction needed to prevent enforcement tied to the deadline	No legal basis for injunctive relief because causal chain is broken and the Maryland judgment is independent	Injunction denied; concurrence emphasized lack of legal basis for relief
Challenge to FDA’s 2020 guidance	(Raised on appeal only) FDA independently selected May 12, 2020; plaintiffs suggested they would amend to challenge 2020 guidance	2020 guidance was not pleaded in the complaint below	Court declined to consider new arguments first raised on appeal; dismissal without prejudice presumed, so plaintiffs may refile

Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing requires injury fairly traceable to challenged action)
Simon v. E. Ky. Welfare Rts. Org., 426 U.S. 26 (1976) (injury must not result from independent third‑party action)
Parsons v. U.S. Dep't of Justice, 801 F.3d 701 (6th Cir. 2015) (standing can be satisfied if defendant’s conduct motivated third‑party injurious actions; distinguished here)
Am. Acad. of Pediatrics v. FDA, 379 F. Supp. 3d 461 (D. Md. 2019) (holding Aug. 2017 guidance unlawful)
Am. Acad. of Pediatrics v. FDA, 399 F. Supp. 3d 479 (D. Md. 2019) (remedy: district court imposed a 10‑month PMTA deadline)
In re Cigar Ass'n of Am., [citation="812 F. App'x 128"] (4th Cir. 2020) (appeal moot after FDA issued 2020 guidance)