Avail Vapor, LLC v. FDA, 55 F.4th 409

Background

The Tobacco Control Act (TCA) requires premarket authorization (PMTA) for "new" tobacco products and directs FDA to weigh population-level risks (initiation, especially youth) against benefits (cessation/switching by current smokers).
Flavored electronic nicotine delivery systems (ENDS) surged youth use; FDA issued guidance (2019 PMTA Guidance; 2020 Enforcement Guidance) prioritizing enforcement against flavored, youth-attractive products and stated PMTAs must present "valid scientific evidence."
Avail Vapor submitted PMTAs (Sept. 8, 2020) for fruit- and dessert-flavored e-liquids including behavioral studies and a marketing plan focused on age verification and non-descriptive names.
FDA denied Avail’s PMTAs (Sept. 15, 2021), concluding the record lacked robust, product-specific evidence that Avail’s flavored ENDS would provide adult benefits sufficient to outweigh the well-documented risks to youth; FDA found Avail’s studies methodologically insufficient.
FDA denied Avail’s administrative appeal after re-review; Avail petitioned the Fourth Circuit, challenging (inter alia) notice/reliance, statutory authority for a comparative-efficacy inquiry, and FDA’s refusal to rely on Avail’s marketing plan. The Fourth Circuit denied the petition.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether FDA adopted a new, undisclosed "comparative efficacy" evidentiary standard (surprise change)	Avail: FDA pulled a "switcheroo," later demanding long-term comparative trials despite earlier guidance suggesting long-term studies generally not required.	FDA: Guidance permitted different evidence types but always required "valid scientific evidence;" internal drafts were superseded; FDA warned applicants about the need to show long-term impact or adequate bridging.	Held: No surprise switch; FDA did not change standards sub silentio and provided adequate notice that robust, product-specific evidence was required.
Whether FDA exceeded statutory authority by requiring applicants to show flavored ENDS are more effective than tobacco-flavored ENDS at promoting cessation/switching	Avail: FDA unlawfully required comparative proof that flavored products outperform tobacco-flavored ones.	FDA: TCA expressly requires comparison of risks/benefits and changes in likelihood of initiation and cessation; comparative inquiry is inherent in statutory scheme.	Held: Within statutory authority; comparative analysis is required by §910 and reasonable.
Whether FDA acted arbitrarily by refusing to consider Avail’s marketing plan/age‑verification measures	Avail: FDA repeatedly said marketing plans matter; refusing to consider them was arbitrary.	FDA: Marketing plans are relevant only after product-level public-health showing; Avail failed the necessary scientific showing, and its plan relied on measures FDA has found ineffective.	Held: Not arbitrary; sequencing was reasonable and, even if error, failing to consider the plan was harmless because the plan offered no novel mitigation.
Whether FDA improperly failed to treat open-system (bottled e-liquid) products differently from closed-system (cartridge) products	Avail: FDA’s 2020 enforcement focus on cartridges signaled different treatment for open systems.	FDA: Evidence shows flavors drive youth use across device types; FDA acknowledged device differences but reasonably concluded flavor-role consistency across systems.	Held: FDA reasonably applied the evidence across systems; no arbitrary action.

Key Cases Cited

Motor Vehicle Mfrs. Ass’n of U.S. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary and capricious standard)
Shinseki v. Sanders, 556 U.S. 396 (2009) (harmless error / prejudicial error principle in administrative review)
Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019) (context on ENDS and e-cigarette regulation)
Prohibition Juice Co. v. U.S. Food & Drug Admin., 45 F.4th 8 (D.C. Cir. 2022) (upholding FDA’s evidentiary approach to PMTAs for flavored ENDS)
Liquid Labs LLC v. U.S. Food & Drug Admin., 52 F.4th 533 (3d Cir. 2022) (same)
Wages & White Lions Invs., LLC v. U.S. Food & Drug Admin., 41 F.4th 427 (5th Cir. 2022) (rejecting challenge to FDA’s PMTA review approach)
Breeze Smoke, LLC v. U.S. Food & Drug Admin., 18 F.4th 499 (6th Cir. 2021) (denying stay of marketing denial order)
Ohio Valley Env’t Coal. v. Aracoma Coal Co., 556 F.3d 177 (4th Cir. 2009) (presumption favoring agency action; explaining reasoned decisionmaking review)
Dep’t of Homeland Sec. v. Regents of the Univ. of Calif., 140 S. Ct. 1891 (2020) (agency change-of-course and reliance-interest principles)
Michigan v. EPA, 576 U.S. 743 (2015) (reviewing courts should consider the grounds the agency invoked when taking action)