By Timothy S. Donahue

Top Takeaways:

• FDA loss: Fifth Circuit upheld the block on its graphic-warning rule.
• 11 vs. nine: Judges said FDA exceeded Congress’ mandate.
• Long fight: The ruling further delays warnings required since 2009.

The U.S. Food and Drug Administration cannot require cigarette companies to display its 11 graphic health warnings, a federal appeals court ruled Wednesday, handing the agency another setback in its yearslong effort to implement a mandate dating to 2009.

The Fifth U.S. Circuit Court of Appeals upheld a lower court ruling that blocked the FDA’s 2020 rule, finding that the agency exceeded its statutory authority when it issued 11 new textual warnings accompanied by graphic images.

Congress specified nine cigarette warnings when it enacted the Family Smoking Prevention and Tobacco Control Act. The FDA argued that the law also gave it authority to adjust those warnings to promote greater public understanding of smoking’s health consequences.

The Fifth Circuit disagreed. “The FDA may require the nine warnings Congress prescribed — no more,” U.S. Circuit Judge Don Willett wrote for the three-judge panel.

The ruling is significant because the Fifth Circuit had already rejected a separate First Amendment challenge to the graphic-warning requirement in 2024. This time, the tobacco companies prevailed on the more fundamental question of whether the FDA had statutory authority to impose the 11 warnings it selected.

R.J. Reynolds Tobacco Co., ITG Brands, Liggett Group, Santa Fe Natural Tobacco, and several retailers challenged the rule. Altria Group participated in the appeal as an amicus supporting the challengers.

The FDA’s rule would require cigarette packages and advertisements to display graphic images alongside warnings about health consequences, including bladder cancer, head and neck cancer, fatal lung disease, impaired fetal growth, cataracts, and Type 2 diabetes. The warnings would occupy the top 50% of the front and back of cigarette packages and at least 20% of advertisements.

The Tobacco Control Act directed the FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany cigarette warnings. The agency’s final rule, published in 2020, established 11 textual warnings and accompanying images.

But the Fifth Circuit said Congress had already made the central policy decision by specifying nine warnings in the statute.

According to court records, Willett rejected the government’s argument that Congress had given the FDA broader authority to modify the warnings, concluding that the agency could not use that authority to replace Congress’ nine-warning scheme with one of its own.

The decision continues a legal battle that has stretched back more than a decade.

The FDA first issued graphic cigarette warnings in 2011, but the effort was struck down after a First Amendment challenge. The agency returned with a new rule in 2020 after litigation to force implementation of the Tobacco Control Act’s warning provisions.

The current challenge produced an unusual split decision for the FDA. In March 2024, the Fifth Circuit held that the graphic warnings did not violate the First Amendment. The case returned to the district court, where the tobacco companies prevailed on their statutory challenge, prompting the FDA’s latest appeal.

Wednesday’s decision leaves the injunction intact.

The ruling does not prevent the FDA from requiring graphic cigarette warnings. Instead, it limits the agency to the authority the Fifth Circuit concluded Congress provided.

That distinction could leave the FDA with a path to pursue graphic warnings tied to the nine statements prescribed by Congress, rather than the 11-warning framework in its current rule.