Breeze Smoke, LLC v. FDA, 18 F.4th 499

Background

Breeze Smoke, LLC petitioned for review and sought a stay of the FDA’s denial of its Premarket Tobacco Product Applications (PMTAs) for flavored ENDS products.
FDA denied the PMTAs for lack of evidence showing that marketing the flavored products would be "appropriate for the protection of the public health" (APPH), emphasizing youth appeal of flavored ENDS and absence of robust longitudinal or randomized evidence of public-health benefits for adult smokers.
Breeze Smoke relied on published literature, bridging analyses, a self‑conducted customer survey, and a marketing plan it said complied with FDA’s 2019 nonbinding guidance on “valid scientific evidence.”
FDA’s 2019 guidance said long‑term studies generally were not required and that applicants could rely on published literature and bridging with appropriate rationale and short‑term studies.
The panel held that Breeze Smoke did not make a strong showing of likely success on the merits under the APA; the FDA reasonably found the submitted evidence insufficient given the strong, well‑documented youth‑initiation risks of flavored ENDS.
The court observed the FDA likely did not adequately consider Breeze Smoke’s marketing‑plan mitigation measures, but concluded that error was not so pervasive as to require a stay or reversal.

Issues

Issue	Breeze Smoke's Argument	FDA's Argument	Held
Whether petitioner had to seek an agency stay first	Seeking an FDA stay was impracticable because the denial took effect immediately and agency review can take months	Rule 18 ordinarily requires agency first; but TCA allows direct judicial review including interim relief	Court: Agency stay requirement excused here; court may consider stay application on merits
Likelihood of success on APA arbitrary-and-capricious claim	FDA departed from its 2019 guidance and applied a de facto new, stricter standard without fair notice	FDA reasonably applied its guidance as permissive (allowed consideration of alternative evidence) and found Breeze Smoke’s evidence insufficient	Court: Breeze Smoke failed to show strong likelihood of success; FDA decision not arbitrary or capricious
Whether the FDA’s 2019 guidance provided fair notice / created reliance interests	Guidance led applicants to rely on literature, bridging, and short-term studies as sufficient	Guidance was nonbinding and merely indicated what FDA might consider; not a binding safe harbor	Court: Guidance did not deprive Breeze Smoke of fair notice; reliance claims unavailing
Whether FDA improperly ignored Breeze Smoke’s marketing/mitigation plan	FDA ignored/prematurely declined to evaluate the plan, failing to consider an important aspect of its decision	FDA said prior marketing plans had not satisfied it and considering Breeze’s plan would not change outcome	Court: FDA likely should have more thoroughly considered the marketing plan, but any omission was not so prejudicial as to warrant a stay

Key Cases Cited

Nken v. Holder, 556 U.S. 418 (stay factors; burden on movant to show stay warranted)
Hilton v. Braunskill, 481 U.S. 770 (four‑factor stay test)
Motor Vehicle Mfrs. Ass'n v. State Farm, 463 U.S. 29 (agency must consider relevant factors and cannot ignore important aspects)
Marsh v. Oregon Natural Res. Council, 490 U.S. 360 (arbitrary-and-capricious standard requires consideration of relevant factors)
FCC v. Prometheus Radio Project, 141 S. Ct. 1150 (courts ensure agency acted within a zone of reasonableness and reasonably explained decision)
Department of Homeland Security v. Regents of the University of California, 140 S. Ct. 1891 (courts review agency based on contemporaneous reasons and consider reliance when agency changes course)
Christopher v. SmithKline Beecham Corp., 567 U.S. 142 (fair‑notice limits on agency enforcement when guidance conflicts with prior expectations)
Vapor Technology Association v. FDA, 977 F.3d 496 (context on TCA deadlines and the regulatory landscape for ENDS)
ISTA Pharmaceuticals v. FDA, 898 F. Supp. 2d 227 (APA review of FDA administrative decisions)