Fifth Circuit Upholds Delay of FDA's Graphic Cigarette Warning Rule

Hughes Hubbard achieved a favorable ruling for Liggett Group in the U.S. Court of Appeals for the Fifth Circuit, which upheld a district court order delaying implementation of the U.S. Food and Drug Administration's graphic cigarette warning rule.

In a published opinion, a three-judge panel held that the district court did not abuse its discretion in finding that Liggett Group and other tobacco manufacturers were likely to succeed on claims that the FDA violated the Administrative Procedure Act. The court found that, while Congress prescribed nine warning labels in the Family Smoking Prevention and Tobacco Control Act, the FDA's rule required 11 graphic warnings.

The Fifth Circuit further held that the FDA likely exceeded the limited authority granted to it under the Tobacco Control Act when it expanded the congressionally prescribed list of warning labels. The court therefore affirmed the district court's order postponing the rule's effective date.

The dispute arose from a March 2020 FDA rule requiring graphic warnings addressing smoking-related health risks on cigarette packaging and advertisements. Tobacco manufacturers challenged the rule in April 2020, and the FDA subsequently appealed a January 2025 decision by a Texas district court postponing the rule's effective date.

Law360 reported on the Fifth Circuit’s ruling.

David Woods leads the Hughes Hubbard team representing Liggett Group.