Prohibition Juice Co. v. FDA, 21-1201

Background

Youth e-cigarette use surged by 2020; FDA found flavors a primary driver of youth initiation and addiction.
The Tobacco Control Act requires premarket authorization for new tobacco products and a population‑level finding that marketing the product "would be appropriate for the protection of the public health."
Four e‑liquid manufacturers applied by the Sept. 9, 2020 deadline to market flavored ENDS liquids; each included marketing plans and consumer‑survey evidence.
In Sept. 2021 the FDA denied the applications, concluding petitioners failed to present sufficiently rigorous, probative evidence (e.g., RCTs, longitudinal or equivalently strong studies) that flavored liquids confer benefits over non‑flavored counterparts sufficient to outweigh heightened youth risk.
The FDA also stated it would not individually review applicants’ marketing/youth‑access plans at that stage, because prior plans had proven inadequate to prevent youth uptake.
Petitioners sought review in this Court, arguing (1) FDA lacked statutory authority to demand comparative benefits of flavored vs. non‑flavored products, and (2) the denials were arbitrary and capricious (including an unexplained change from FDA guidance and refusal to consider marketing plans). The Court denied the petitions.

Issues

Issue	Plaintiff's Argument	Defendant's Argument	Held
Statutory authority to require comparative showing (flavored v. non‑flavored)	FDA lacks authority to require applicants show flavored products provide greater cessation/substitution benefits vs non‑flavored products.	The Act expressly requires submission of information comparing health risks to other tobacco products and a population‑level benefit/risk balancing.	Held: FDA acted within statutory authority; comparisons and population‑level balancing are required.
"Surprise switch" — did FDA change evidentiary or substantive standards from 2019 Guidance	2019 Guidance indicated FDA might accept non‑long‑term studies; FDA later effectively required RCTs/longitudinal studies without notice.	Guidance said FDA would consider other evidence but only if scientifically rigorous; agency consistently required valid scientific evidence.	Held: No improper change; FDA consistently required rigorous, probative evidence and reasonably found petitioners’ data inadequate.
Failure to review individualized marketing / youth‑access plans	FDA acted arbitrarily by refusing to review applicants’ marketing plans, which are critical to youth‑risk analysis.	FDA argued prior plans had been inadequate and reviewing plans at that stage was unnecessary; even assuming error, petitioners cannot show prejudice/difference in outcome.	Held: Even if error, harmless — petitioners failed to show how individualized review would have changed denial.
Consideration of product differences (open vs closed systems) and other APA objections	Petitioners argued FDA misapplied data from closed systems to open systems and treated like cases differently.	FDA acknowledged device differences but reasonably concluded flavor appeal is consistent across device types; any disparate treatment addressed separately.	Held: FDA reasonably applied the evidence; other arbitrary‑and‑capricious claims fail.

Key Cases Cited

Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019) (background on Tobacco Control Act and deeming rule)
Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (arbitrary and capricious review standard)
SEC v. Chenery Corp., 332 U.S. 194 (1947) (courts judge agency action on the grounds the agency invoked)
Shinseki v. Sanders, 556 U.S. 396 (2009) (burden to show an agency error was prejudicial/harmless‑error rule)
Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021) (parallel circuit upholding FDA’s evidentiary approach)
Wages & White Lion Invs., LLC v. FDA, 16 F.4th 1130 (5th Cir. 2021) (stay panel opinion addressing similar challenges and agency reasoning)
FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) (agency must explain changes in position)