Background
The Family Smoking Prevention and Tobacco Control Act prescribes nine warning statements for cigarette packages and advertisements and directs the FDA to require accompanying color graphics. The FDA’s challenged rule discarded all but two of Congress’s warnings, substituted agency-drafted statements, and required rotation among eleven text-and-graphic warnings.
Cigarette manufacturers and retailers challenged the rule under the First Amendment and the Administrative Procedure Act. After the Fifth Circuit rejected their First Amendment claim in an earlier appeal, the district court found them substantially likely to succeed on APA claims concerning the FDA’s statutory authority and postponed the rule’s effective date under 5 U.S.C. § 705 pending a final merits decision. The FDA appealed that interim relief.
The Court’s Holding
The Fifth Circuit affirmed, holding that the district court did not abuse its discretion in finding the plaintiffs substantially likely to show that the FDA exceeded its statutory authority by increasing the prescribed warnings from nine to eleven. The panel read the statutory phrase “one of the following labels,” followed by nine specified warnings, as establishing a closed set. It concluded that the FDA’s authority to “adjust” warning text did not clearly authorize adding warnings and that the statute’s preemption clause was not an independent grant of regulatory power.
The court also upheld the district court’s findings on irreparable harm and the equities because compliance would require substantial, unrecoverable expenditures while existing cigarette warnings would remain in place during the postponement. It further held that § 705 permits rule-wide postponement, that the Supreme Court’s decision in Trump v. CASA concerning universal equitable injunctions did not foreclose that statutory remedy, and that the district court was not required at this preliminary stage to sever portions of the rule. The court did not finally invalidate the rule or decide the plaintiffs’ remaining APA theories.
Key Takeaways
- The decision preserves interim relief; it does not constitute a final merits judgment that the FDA’s rule is unlawful.
- The panel concluded that plaintiffs are substantially likely to establish that Congress limited the required cigarette-warning regime to nine warnings and did not authorize the FDA to expand it to eleven.
- In the Fifth Circuit, an APA § 705 postponement operates against the agency action itself and need not be restricted to the named plaintiffs.
Why It Matters
The ruling keeps the FDA’s graphic-warning rule from taking effect while the Eastern District of Texas completes its merits review, allowing manufacturers and retailers to avoid potentially unrecoverable nationwide compliance costs in the meantime.
More broadly, the opinion applies a strict textual limit to agency authority and distinguishes statutory APA relief from universal injunctions issued solely under a court’s equitable powers. Its statutory analysis also conflicts with a Georgia district court’s treatment of the FDA’s authority in separate litigation over the same rule.