The FDA cigarette warning rule requiring eleven graphic health warnings on cigarette packaging has been blocked at the preliminary stage, after the United States Court of Appeals for the Fifth Circuit affirmed a district court injunction on 18 August 2026, holding that the Food and Drug Administration (FDA) most likely exceeded its statutory authority under the Family Smoking Prevention and Tobacco Control Act (TCA).
The panel, comprising Judges Don Willett, Leslie Southwick, and James Ho, concluded that the TCA’s operative provision, section 1333(a)(1), prescribes exactly nine warning statements that cigarette manufacturers and retailers must rotate. The FDA’s 2020 rule, codified at 21 CFR Part 1141 and published at 85 FR 15708 on 18 March 2020, discarded all but two of those nine statements and substituted eleven of the agency’s own drafting.
The FDA Cigarette Warning Rule at Issue
The TCA requires warning labels to cover the top 50 per cent of the front and rear panels of cigarette packages, and at least 20 per cent of cigarette advertisements, paired with colour graphics depicting smoking-related health harms. The statute also imposes detailed placement, rotation, and formatting requirements.
The FDA’s rule retained that structural framework but replaced the congressional text. Among the graphic images the agency selected, Newsweek reported, were a depiction of smoke-damaged lungs, a woman with a large neck tumour captioned ‘WARNING: Smoking causes head and neck cancer,’ and feet blackened by impaired blood flow.
Judge Willett’s opinion disposed of the statutory question with deliberate brevity. ‘Rarely is statutory text this crisp,’ he wrote. Section 1333(a)(1) makes it unlawful to sell cigarettes whose package ‘fails to bear, in accordance with the requirements of this section, one of the following labels,’ then immediately lists nine. The opinion’s conclusion was direct: ‘Nine is not a placeholder for eleven.’
The analogy chosen by the court was equally spare. A restaurant menu offering ‘one of the following sides’ from nine choices gives no diner licence to order an unlisted tenth. ‘Trendy eateries may keep a secret menu; the United States Code does not,’ Judge Willett wrote. ‘When Congress opts for precision, agencies must respect that choice, not revise it.’
A Decade of Litigation Before the APA Challenge
The litigation stretches back to 2020 and has passed through two distinct legal phases before reaching the FDA cigarette warning rule’s statutory validity.
In the first phase, the district court on 7 December 2022 granted partial summary judgment to R.J. Reynolds on First Amendment grounds, vacating the graphic warning rule on the basis that it compelled manufacturers to carry the FDA’s own messaging, according to the Public Health Law Center’s litigation tracker.
That ruling did not survive appeal. A separate Fifth Circuit panel, on 21 March 2024, reversed and found the eleven warnings ‘factual and uncontroversial,’ satisfying First Amendment scrutiny, Reuters reported. The Supreme Court subsequently declined to hear R.J. Reynolds’ appeal of that First Amendment ruling, according to Newsweek.
The case then returned to district court on the separate question of whether the FDA had the statutory authority under the Administrative Procedure Act (APA) to substitute its own warnings for Congress’s. It is that APA challenge which the Fifth Circuit panel has now addressed.
Among the plaintiffs whose APA claims succeeded at the preliminary injunction stage was Liggett Group, alongside R.J. Reynolds and other cigarette manufacturers and retailers, according to Hughes Hubbard. Jones Day, representing the plaintiffs, fielded a team including Amelia DeGory, Christian George Vergonis, and Ryan Jeffrey Watson.
The Washington Legal Foundation filed an amicus brief supporting the injunction, arguing that the panel could also affirm on constitutional avoidance grounds, not only on the statutory text alone, though the court resolved the matter on statutory construction without reaching that alternative basis.
What Comes Next
The public health stakes of the FDA cigarette warning rule are not in dispute between the parties. Cigarette smoking kills more than 480,000 Americans a year, and roughly one in eight American adults still smokes, according to government data cited in the First Amendment phase of the proceedings. Warning labels on cigarette packages had not been updated since 1984 before the FDA’s 2020 rulemaking, CNBC reported at the time of the agency’s proposed rule.
The Fifth Circuit’s ruling is limited to the preliminary injunction stage. The district court found only that plaintiffs had shown a substantial likelihood of success on their statutory claim; the merits remain to be determined. Subject to any onward appeal, the FDA must either defend its substitution of eleven warnings against the panel’s statutory reading at full trial, or return to Congress to seek the broader rulemaking authority the TCA does not presently confer.
