762 F.Supp.3d 529
E.D. Tex.2025Background
- Plaintiffs (R.J. Reynolds Tobacco Co. et al.) challenged an FDA rule requiring new graphic and textual health warnings on cigarette packaging and advertising, which expanded the number and changed the content of warnings mandated by the Tobacco Control Act.
- Plaintiffs contended the rule exceeded statutory authority, violated the First Amendment, was promulgated through arbitrary rulemaking, and failed to meet APA procedural requirements.
- The district court initially granted summary judgment for plaintiffs on First Amendment grounds; the Fifth Circuit reversed and remanded for analysis of APA-based statutory and procedural objections.
- On remand, the court considered motions for interim relief (plaintiffs) and summary judgment (defendants), with the rule's effective date imminent.
- The judge credited plaintiffs’ evidence of imminent, irreparable economic harm absent relief and found public interest and equitable factors favored postponing the rule.
- The central question became whether the FDA had statutory authority to change the number and substance of mandated warnings.
Issues
| Issue | Plaintiff’s Argument | Defendant’s Argument | Held |
|---|---|---|---|
| FDA statutory authority to increase warning number | FDA has no authority to require more than nine warnings as specified by statute | FDA has implied authority to add more than nine warnings under § 1333(d)(2) | For plaintiffs; no authority to increase number beyond statute |
| FDA authority to change warning wording | Statute only allows adjustments to presentation, not substantive changes to text | "Adjust the text" means FDA may rewrite substantively | Plaintiffs have some likelihood of success; interim relief warranted |
| Timing of FDA rulemaking under § 1333(d)(2) | FDA must first issue (d)(1) graphics before using (d)(2) authority | No sequential requirement; can proceed simultaneously | For FDA; no timing bar exists |
| Rule is arbitrary, capricious, or failed APA procedure | Methods and data used were flawed, misleading, and lacked proper notice/comment | Agency’s choices were reasonable and in legal compliance; APA procedural needs met | For FDA; no substantial likelihood of success for plaintiffs on these grounds |
Key Cases Cited
- Loper Bright Enters. v. Raimondo, 603 U.S. 369 (Supreme Court 2024) (No agency deference for statutory interpretation after Chevron is overruled)
- BNSF Ry. Co. v. Fed. R.R. Admin., 62 F.4th 905 (5th Cir. 2023) (standard for arbitrary/capricious review under the APA)
- FCC v. Prometheus Radio Project, 592 U.S. 414 (2021) (perfection in agency empirical analysis is not required for rulemaking)
- R.J. Reynolds Tobacco Co. v. FDA, 696 F.3d 1205 (D.C. Cir. 2012) (previous challenge to FDA warning graphics—scope of compelled speech under the First Amendment)
- Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983) (grounds for finding agency action arbitrary or capricious)