604 U.S. 542
U.S.2025Background
- The Family Smoking Prevention and Tobacco Control Act (TCA) requires FDA authorization before marketing "new tobacco products" and directs the agency to judge whether a product "would be appropriate for the protection of the public health."
- In 2016 FDA "deemed" e-cigarettes tobacco products; most e-cigarette products therefore required premarket tobacco product applications (PMTAs).
- FDA issued extensive guidance and a proposed rule (2019) describing evidence expectations, cross-product comparisons, device-type enforcement priorities, and the importance of marketing plans; notice-and-comment rulemaking for final standards was not completed before adjudications began.
- Respondents (manufacturers of flavored e‑liquids for open‑system devices) filed PMTAs by the court-ordered Sept. 9, 2020 deadline; FDA denied their applications for failing to provide sufficiently "robust and reliable" product‑specific evidence (e.g., randomized controlled trial/longitudinal cohort or adequate alternative evidence) and—"for efficiency"—declined to evaluate submitted marketing plans.
- The Fifth Circuit (en banc) held FDA acted arbitrarily and capriciously—faulting changes from prior guidance (scientific‑evidence standards, comparative analyses, device‑type treatment, and not reviewing marketing plans)—and rejected FDA's harmless‑error defense. The Supreme Court vacated and remanded.
Issues
| Issue | Plaintiff's Argument (Respondents) | Defendant's Argument (FDA) | Held |
|---|---|---|---|
| Whether FDA unlawfully changed evidentiary standards (requiring RCTs/longitudinal cohorts) | FDA switched from flexible guidance to a de facto requirement for RCTs/cohort studies (fatal‑flaw memorandum) without notice | TCA and FDA guidance left broad discretion; predecisional documents warned literature reviews are weaker and applicants needed rigorous, product‑specific evidence | No unlawful change; denial orders were consistent with guidance and statutory discretion (change‑in‑position not shown) |
| Whether FDA improperly imposed a comparative‑efficacy requirement (must show flavored products benefit adult smokers vs. tobacco‑flavored) | FDA gave manufacturers discretion to pick comparators but later demanded specific cross‑flavor comparisons (no fair notice) | TCA requires comparative information; guidance repeatedly emphasized cross‑product comparisons and FDA’s interest in flavor’s appeal to youth | Held consistent with guidance and TCA; the comparative standard was a natural outgrowth, not an unexplained reversal |
| Whether FDA reversed course on device type (prioritizing cartridge enforcement but then denying open‑system flavored products) | FDA’s 2020 guidance suggested a safe harbor for non‑cartridge/open‑system products; denying those products was a surprise | 2020 guidance prioritized cartridge‑based products but expressly reserved enforcement against other products that promote youth use; FDA had evidence youth migrated device types | No arbitrary change; either consistent with guidance or, if changed, the FDA offered reasonable reasons based on youth‑use data |
| Whether FDA’s failure to consider marketing plans was reversible error and whether that error was harmless | FDA promised marketing plans were “critical” but did not review respondents’ plans; this procedural error prejudiced applicants | FDA concedes error but contends it was harmless because later denials reviewing similar plans reached same outcome | FDA conceded the error; Supreme Court declined to resolve harmless‑error fully, held the Fifth Circuit read Calcutt too broadly, vacated and remanded for the court of appeals to apply the proper harmless‑error/remand analysis |
Key Cases Cited
- Encino Motorcars, LLC v. Navarro, 579 U.S. 211 (2016) (agencies may change policy but must acknowledge change and consider reliance interests)
- FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) (requirements for reasoned explanation when agency changes position)
- Motor Vehicle Mfrs. Assn. v. State Farm, 463 U.S. 29 (1983) (arbitrary and capricious standard requires rational connection between facts and choice)
- SEC v. Chenery Corp., 318 U.S. 80 (1943) (Chenery I) (court may not supply agency’s absent reasons; agency must defend its own action)
- SEC v. Chenery Corp., 332 U.S. 194 (1947) (Chenery II) (agencies may set standards through adjudication absent statutory requirement for rulemaking)
- Calcutt v. FDIC, 598 U.S. 623 (2023) (per curiam) (recent articulation of remand rule and when remand may be unnecessary)
- Shinseki v. Sanders, 556 U.S. 396 (2009) (APA requires courts to take due account of prejudicial‑error/harmless‑error principles)
- Massachusetts Trustees of Eastern Gas & Fuel Assocs. v. United States, 377 U.S. 235 (1964) (remand may be unnecessary when one unsupported finding is immaterial)
- United States v. Citizens to Preserve Overton Park, 401 U.S. 402 (1971) (presumption of regularity and limits on probing executive motives)
- Camp v. Pitts, 411 U.S. 138 (1973) (review confined to administrative record)
- Biestek v. Berryhill, 587 U.S. 97 (2019) (substantial‑evidence standard for administrative findings)
- Morgan Stanley Capital Group Inc. v. Public Util. Dist. No. 1 of Snohomish Cty., 554 U.S. 527 (2008) (circumstances where agency was required to take a particular action)
- Long Island Care at Home, Ltd. v. Coke, 551 U.S. 158 (2007) (final rule must be a logical outgrowth of proposed rule)
- Florida Power & Light Co. v. Lorion, 470 U.S. 729 (1985) (remand is the ordinary course when agency decision rests on inadequate grounds)
- Department of Commerce v. New York, 588 U.S. 752 (2019) (courts generally avoid intrusive inquiry into agency motives)