41 F.4th 427
5th Cir.2022Background:
- In 2016 FDA "deemed" e-cigarettes (including e-liquids) to be "tobacco products," so new products required PMTAs under the TCA; FDA must apply the APPH (appropriate for the protection of the public health) standard.
- Triton and Vapetasia submitted PMTAs for flavored, nicotine-containing e-liquids (open‑system) on the September 9, 2020 deadline.
- In Sept. 2021 FDA issued Marketing Denial Orders (MDOs), finding Petitioners failed to provide "robust and reliable" evidence (e.g., RCTs or longitudinal cohorts) showing adult benefits (cessation/switching) sufficient to outweigh youth addiction risks; accompanying Technical Project Lead (TPL) reports explained the reasoning.
- Petitioners challenged the MDOs arguing FDA lacked authority to impose a comparative‑cessation requirement and acted arbitrarily and capriciously ("surprise switcheroo," failure to consider marketing plans and reliance interests, and improper treatment of submitted evidence).
- The Fifth Circuit held (majority) FDA had statutory authority (express and implied) to consider comparative cessation evidence and did not act arbitrarily and capriciously; petitions for review denied. Judge Jones dissented, arguing FDA changed rules without notice, ignored reliance interests, and failed to meaningfully consider marketing plans.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Authority to consider comparative cessation/efficacy evidence | FDA lacks statutory authority to require or consider comparative evidence that flavored ENDS promote cessation more than tobacco‑flavored ENDS | TCA (§387j) expressly requires reports on health risks and whether product presents less risk than others; FDA may also consider other information and commission investigations | Court: FDA has express and implied authority to consider comparative cessation evidence under §387j(b) and (c) |
| Arbitrary & capricious / "surprise switcheroo" (notice & reliance) | FDA previously said long‑term/clinical studies were not expected; denying PMTAs for lack of such studies after the deadline surprised applicants and violated reliance interests | FDA’s public statements used conditional language; agency did not adopt a hard study requirement and retained discretion to demand more robust product‑specific evidence where submitted evidence is weak | Court: No unlawful switcheroo; FDA’s conditional guidance and later review are not arbitrary and capricious on this record |
| Sufficiency of submitted evidence (surveys, literature) | Petitioners’ surveys and literature showed adult benefit (e.g., self‑reported cessation) and should satisfy APPH | Submitted studies were methodologically weak, not product‑specific, self‑selected, small, or cross‑sectional and therefore insufficient to demonstrate benefit over time | Court: FDA reasonably found the evidence inadequate; denial not arbitrary |
| Consideration of marketing plans | FDA promised to evaluate marketing restrictions; refusing to review Petitioners’ marketing plans was arbitrary and prejudicial | FDA reasonably declined detailed marketing‑plan review at denial stage because prior experience showed conventional marketing restrictions failed to prevent youth access; any error was harmless and plans were not shown to be unique | Court: FDA permissibly declined further marketing‑plan review and any failure to evaluate was not reversible error |
Key Cases Cited
- FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) (Congress must delegate authority to FDA to regulate tobacco; background for TCA)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (APA arbitrary and capricious standard)
- Nicopure Labs, LLC v. FDA, 944 F.3d 267 (D.C. Cir. 2019) (FDA may accept literature reviews or other evidence in appropriate circumstances)
- Breeze Smoke, LLC v. FDA, 18 F.4th 499 (6th Cir. 2021) (denying stay; court found no "surprise switcheroo")
- Big Time Vapes, Inc. v. FDA, 963 F.3d 436 (5th Cir. 2020) (discussing TCA purpose and youth‑protection focus)
- DHS v. Regents of the Univ. of Cal., 140 S. Ct. 1891 (2020) (agency may not rely on post hoc rationalizations; must defend actions on reasons given when acting)
- Michigan v. EPA, 576 U.S. 743 (2015) (agency must consider important aspects of the problem and explain decisions)