A federal appeals court has ruled that the U.S. Food and Drug Administration overstepped its authority by trying to require that cigarette packages and advertisements contain 11 graphic warnings illustrating the health risks of smoking.
A three-judge panel of the New Orleans-based 5th U.S. Circuit Court of Appeals on Tuesday sided with R.J. Reynolds and other tobacco companies by upholding a lower-court order that had prevented the warning label requirement from taking effect.
The ruling marked a setback for the FDA in its long-running efforts to implement part of the Family Smoking Prevention and Tobacco Control Act, a 2009 law that gave it the authority to regulate tobacco products and mandated the warning labels.
The 11 graphic warnings required under the FDA's rule included depictions of how smoking can cause bladder, head and neck cancer, fatal lung disease, stunted fetal growth during pregnancy, cataracts, and type 2 diabetes.
But U.S. Circuit Judge Don Willett, writing for the panel, said Congress in the law had listed nine specific warnings to appear on cigarette packages and advertising. The FDA "may require the nine warnings Congress prescribed — no more," he said.
"Precision in legislation leaves no room for improvisation in execution," he wrote for a panel comprised of only appointees of Republican presidents.
The rule was challenged by R.J. Reynolds, which is part of British American Tobacco (BATS.L) and had sued in 2020 alongside Imperial Brands' (IMB.L) subsidiary ITG Brands and Japan Tobacco's (2914.T) JTI Liggett unit.
R.J. Reynolds and the FDA did not respond to requests for comment.
The FDA has repeatedly struggled to implement the 2009 law's warning label requirement, which has been stuck in litigation for years.
Its initial attempt in 2011 was rejected by a federal appeals court in Washington, which had held that it ran afoul of the free speech protections of the U.S. Constitution's First Amendment.
After a years-long delay and litigation by health and medical groups seeking to force the agency to act, the FDA in 2019 once again moved to implement the warning requirement, leading to the current lawsuit by the tobacco companies.
U.S. District Judge J. Campbell Barker in Tyler, Texas in 2022 had concluded that the requirement violated the companies' speech rights under the First Amendment, but the 5th Circuit reversed that decision. The judge then in 2025 ruled in their favor on their non-constitutional arguments, leading to the latest appeal.
The case is R.J. Reynolds Tobacco Company v. Food and Drug Administration, 5th U.S. Circuit Court of Appeals, No. 25-40137.
For the government: Daniel Tenny of the U.S. Department of Justice
For R.J. Reynolds: Ryan Watson of Jones Day
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(This story has been refiled to change the day of the ruling from Monday to Tuesday, in paragraph 2.)
