The 5th U.S. Circuit Court of Appeals ruled that the FDA exceeded its authority by requiring cigarette packages and advertisements to carry 11 graphic health warnings, upholding a lower-court order that blocked the rule from taking effect. The ruling, reported by Reuters, is a setback for the FDA’s long-running effort to implement the warning-label provisions of the 2009 Family Smoking Prevention and Tobacco Control Act.
Writing for the three-judge panel, U.S. Circuit Judge Don Willett said Congress authorized nine specific warnings and that the FDA could not add two additional warnings on its own. The FDA’s proposed images covered health effects including bladder, head and neck cancers, fatal lung disease, impaired fetal growth, cataracts, and Type 2 diabetes. “The FDA may require the nine warnings Congress prescribed — no more,” Willett wrote.
The case was brought by R.J. Reynolds Tobacco Co., ITG Brands, and JTI Liggett after the FDA revived the graphic-warning requirement in 2019 following years of litigation. The 5th Circuit previously rejected a First Amendment challenge to the rule in 2024, but a Texas federal judge later blocked it on separate statutory grounds. The latest ruling addresses that issue and leaves the FDA’s implementation of the 2009 warning requirement facing further legal obstacles. The case is R.J. Reynolds Tobacco Company v. Food and Drug Administration, No. 25-40137.
