FDA Appeals District Court Decision on Graphic Warning Rule
This is a repost of a Cigar Rights of America story on November 21, 2025, written by Cody Carden. To see the original story click here.
On October 27th, the U.S. Food & Drug Administration (FDA) appealed the decision from the U.S. District Court for the Southern District of Georgia that struck down its 2020 rule requiring graphic health warnings on cigarette packages and advertisements. The case now moves to the Eleventh Circuit. A separate challenge to the same rule is already underway at the Fifth Circuit, meaning two federal appeals courts could soon weigh in on whether the agency’s second attempt at graphic warnings can move forward.
Background
As we reported earlier this year, Judge Lisa Wood vacated the rule in August after finding that the FDA failed to disclose the raw data behind the studies it relied on. She ruled that this lack of transparency prevented the public from meaningfully participating in the notice-and-comment process. A similar ruling came out of Texas in January, where Judge Campbell Barker blocked the rule on the grounds that the FDA likely violated the Administrative Procedures Act.
Why the Appeal Matters
By appealing, the FDA is trying to revive its graphic warning rule after more than a decade of setbacks. The outcome of the Eleventh and Fifth Circuit cases will determine whether the agency can finally implement these warnings or whether the rule will remain on hold or potentially scrapped altogether.
Broader Takeaways
Although the case directly concerns cigarette packaging, it has broader relevance for how courts assess the FDA’s regulatory authority and adherence to statutory boundaries. For the premium cigar industry, which has long argued that FDA’s regulatory approach fails to account for product distinctions, the litigation serves as another reminder of the importance of limiting agency overreach.
CRA will continue to monitor developments in this case and provide updates on what they may signal for the future of FDA tobacco regulation.
