A federal appeals court has kept the FDA’s 11 graphic cigarette warnings on hold while a Texas court decides the dispute. The ruling delays packaging and advertising changes for cigarette manufacturers, distributors and retailers.
The decision does not finally invalidate the rule or conclusively establish that the FDA exceeded its authority.
Key Facts
- Federal court: The Fifth Circuit affirmed an order postponing the rule’s effective date until the trial court enters a final judgment.
- Preliminary ruling: The panel found the challengers substantially likely to show that the FDA lacked authority to replace Congress’s nine warnings with 11.
- Practical effect: The new graphic-warning system remains blocked, but existing Surgeon General textual warnings remain in force.
What the ruling means now
For cigarette businesses, the new nationwide packaging, advertising and warning-rotation requirements do not take effect during this stage of the Texas case.
For consumers, the FDA’s new text-and-image warning system will not appear as required by the 2020 rule while the relief remains in place. Existing Surgeon General textual warnings remain on cigarette packages and advertisements.
The U.S. Court of Appeals for the Fifth Circuit issued its decision on August 18, 2026, in R.J. Reynolds Tobacco Company v. FDA.
The court affirmed temporary relief granted by the U.S. District Court for the Eastern District of Texas. That order preserves the current warning requirements until the trial court enters a final judgment.
The panel upheld the trial court’s preliminary finding that the challengers have a substantial likelihood of succeeding. It did not decide whether they ultimately will win the case.
Why the number of warnings matters
Congress placed nine cigarette-warning statements in federal law and directed that color graphics accompany them.
The law also allows the responsible federal official to adjust the warnings’ text, format, size and graphics through rulemaking after making a public-understanding finding.
The FDA’s 2020 final rule created 11 textual warnings paired with photorealistic color images.
The warnings would cover the top half of the front and back of cigarette packages and at least 20% of advertisements.
Manufacturers, distributors and retailers would also need FDA-approved plans for displaying and rotating the warnings.
The tobacco companies and retailers argued that the adjustment power did not authorize the FDA to replace Congress’s nine-warning set with 11 different warnings.
The Fifth Circuit agreed that this argument was likely to succeed, although the trial court still must resolve it at the merits stage.
What the FDA argued
The FDA argued that Congress gave it authority to adjust warning text and that the statute’s preemption provision supported additional or different warnings.
The agency also argued that any unauthorized warnings could be separated from valid parts of the rule.
The panel rejected those arguments for purposes of the request for temporary relief.
The FDA adopted the rule to promote greater public understanding of smoking’s negative health consequences.
The agency selected warnings addressing health effects that it considered serious but less widely understood.
Why the court allowed temporary relief
The challengers described packaging, printing, advertising, distribution and supply-chain costs that could not be recovered from the federal government.
The panel found that these claimed costs supported temporary relief while the legal challenge continues.
What happens next
The Eastern District of Texas must still decide the challengers’ statutory claims on the merits.
Its final judgment could resolve whether the FDA had authority to adopt the 11-warning system. The Fifth Circuit’s ruling leaves the effective date postponed until that judgment.
A separate federal case in Georgia resulted in the rule being set aside on different procedural grounds. That litigation is not the case decided by the Fifth Circuit.
