The U.S. Food and Drug Administration (FDA) cigarette graphic health warning saga continues. On August 18, 2026, the U.S. Court of Appeals for the Fifth Circuit issued a decision in R.J. Reynolds Tobacco Co. v. FDA, No. 25-40137, affirming the Eastern District of Texas’s order postponing the effective date of FDA’s 2020 cigarette graphic health warning rule pending a final decision on the merits. The decision delivers another significant setback for FDA’s long-running effort to require graphic images on cigarette packaging and advertisements — and provides clarity on the statutory limits of the agency’s authority under the Federal Food, Drug, and Cosmetic Act (FDCA) and the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by the 2009 Family Smoking Prevention and Tobacco Control Act (TCA).

Background: A Lengthy Regulatory Battle

FDA’s cigarette graphic health warning rule has had a turbulent history. Congress enacted the TCA in 2009, directing FDA to require nine new cigarette health warnings accompanied by “color graphics depicting the negative health consequences of smoking.” The TCA amended the FCLAA by transferring authority to FDA from the Federal Trade Commission (FTC), to require the new cigarette health warnings on cigarette packages and advertising. FDA’s first attempt to implement those requirements, in 2011, was vacated by the D.C. Circuit on First Amendment grounds.

The agency tried again, issuing a new proposed rule in 2019 and finalizing it in March 2020. As we previously reported, the 2020 rule would require 11 new textual health warning statements accompanied by color, photorealistic images displayed on the top 50% of the front and rear panels of cigarette packs and the top 20% of cigarette advertisements. Industry immediately challenged the rule in federal court, and the effective date was postponed numerous times.

The U.S. District Court for the Eastern District of Texas ultimately granted summary judgment to the industry plaintiffs on First Amendment grounds in December 2022, but the Fifth Circuit reversed on appeal, holding that the rule did not violate the First Amendment under the Zauderer standard for compelled commercial disclosures. Industry then petitioned the U.S. Supreme Court to review that First Amendment ruling, but certiorari was denied.

With the First Amendment challenge resolved, the case returned to the district court for consideration of the plaintiffs’ remaining Administrative Procedure Act (APA) claims. In the meantime, as we noted last fall, FDA had indicated it would begin enforcement in December 2025 — though pending litigation continued to threaten those plans.

The Fifth Circuit’s Decision

The Fifth Circuit’s decision affirms the district court’s postponement of the rule on a straightforward statutory basis: the FDA likely exceeded its authority by increasing the number of required warning statements from nine to 11.

The Statutory Text Points ‘One Way’

The court’s reasoning begins and ends with the text of § 1333(a)(1) of the FCLAA, which makes it “unlawful” for cigarette packages not to bear “one of the following labels” and then enumerates nine specific warnings. The court found this language creates a “closed set” of exactly nine warnings. As court colorfully put it: “If a restaurant menu says a customer may choose ‘one of the following sides’ followed by a list of nine choices, no ordinary diner reads that as license to order an unlisted tenth. Trendy eateries may keep a secret menu; the United States Code does not.”

FDA’s 2020 rule, however, discarded all but two of Congress’s nine statutory warnings and substituted statements of the agency’s own drafting, resulting in a total of 11 required warnings rather than nine. The court found this departure unsupported by the statutory text.

‘Adjust’ Cannot Bear the Weight FDA Places on It

FDA relied on § 1333(d)[2] of the FCLAA, which permits the agency to “adjust the format, type size, color graphics, and text of any of the label requirements” upon finding that a change would promote greater public understanding. The court rejected the argument that “adjust the . . . text” implicitly includes the power to add entirely new warnings or eliminate existing ones. “To adjust is to modify something that already exists — not to conjure something new,” the court wrote, concluding that “adjust” is “too modest a verb to bear the weight the FDA places on it.”

The Preemption Clause Is Not a Backdoor Delegation

FDA also argued that the FCLAA’s amended preemption clause, § 1334(a), independently authorizes it to require “additional or different statements.” The Fifth Circuit disagreed, holding that § 1334(a) is a preemption provision — not an independent grant of regulatory authority. Reading it as a freestanding delegation, the court explained, would “invert the statute’s structure” and “render § 1333(d)[2]’s limitations largely superfluous.” The court noted that “Congress does not bury a sweeping delegation in a preemption clause and then erect detailed conditions next door for the agency to vault over.”

Equitable Factors and Scope of Relief

The court also affirmed the district court’s findings on irreparable harm, balance of equities, and public interest. The rule would impose substantial, unrecoverable compliance costs on manufacturers, including redesigning packaging, retooling printing systems, and coordinating supply-chain changes across nationwide markets — costs that cannot be recovered from the government due to sovereign immunity.

On the scope of relief, the Fifth Circuit held that the district court’s universal postponement was proper under § 705 of the APA, which frames relief in “action-centric rather than party-centric terms.” The court also rejected FDA’s argument that Trump v. CASA, Inc. constrains rule-wide APA relief, reasoning that CASA addressed only equitable injunctions and “did not involve either of the APA’s remedies.”

Finally, the court declined to sever the rule, noting that “severance cannot manufacture authority the agency never had” and that the FDA itself had never identified which of its eleven warnings would survive.

What’s Next?

As we reported in November, the parallel challenge in the U.S. District Court for the Southern District of Georgia — Philip Morris USA Inc. v. FDA — resulted in a full vacatur of the same rule on different grounds, namely that the FDA violated the APA’s notice-and-comment requirements by failing to disclose key underlying data during the rulemaking process. That decision is now on appeal to the Eleventh Circuit.

The Fifth Circuit’s decision and the Eleventh Circuit appeal now run on parallel tracks. As a practical matter, no graphic health warnings are currently required on cigarette packaging or advertisements, and that is likely to remain the case for the foreseeable future. Even if FDA ultimately prevails in both circuits — which now appears increasingly unlikely — the original surgeon general’s health warnings required by the FCLAA prior to the TCA amendments likely remain in effect, and the TCA’s graphic warning provisions cannot take effect until 15 months after FDA issues the necessary implementing regulations.

The Fifth Circuit’s opinion is notable for its broader implications as well. Coming on the heels of Loper Bright Enterprises v. Raimondo, the decision underscores a judiciary increasingly willing to hold agencies to the precise terms of their statutory delegations. The court’s concluding observation captures the theme: “Precision in legislation leaves no room for improvisation in execution.”

We will continue to monitor developments in this ongoing litigation. Our team is happy to assist if you have questions about the implications of this decision as it pertains to your business.