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The U.S. Supreme Court announced Monday that it would not hear a challenge to a U.S. Food and Drug Administration rule requiring graphic warnings on cigarette packaging, leaving intact a Fifth Circuit ruling that upheld the regulation. The decision represents a major victory for the FDA in its efforts to mandate stronger public health warnings about the risks of smoking.

The petition was filed by R.J. Reynolds Tobacco Co., ITG Brands LLC, Liggett Group LLC, and other tobacco retailers in August, arguing that the FDA’s 2020 rule infringed on their First Amendment rights. The justices, as is customary, did not explain their reasoning for denying the petition for certiorari.

FDA Warnings and the Legal Challenge

The contested rule, issued in March 2020, requires cigarette packaging to feature graphic images highlighting lesser-known health risks of smoking, such as diabetes, alongside text warnings. These warnings must cover 50% of the packaging and 20% of the space on cigarette advertisements. The tobacco companies challenged the rule, alleging it compelled speech and was overly burdensome.

U.S. District Judge J. Campbell Barker of Texas initially vacated the rule in December 2022. However, the Fifth Circuit reversed that decision, finding the warnings were factual and did not violate the First Amendment. The court emphasized that the graphic images served a public health purpose without being provocative.

FDA cigarettes warning rule : Divergent Circuit Opinions

The tobacco companies argued that the Fifth Circuit’s decision conflicted with rulings from the Ninth and Seventh circuits, which struck down similar but less intrusive warning requirements. They also pointed to an earlier D.C. Circuit decision invalidating a previous version of the FDA’s rule.

In response, the FDA defended the rule as a justified public health measure. It argued that the warnings conveyed factual information, much like the visuals found in medical textbooks, and did not violate free speech protections. The agency also contended that Supreme Court review was premature, noting the need for the district court to address unresolved claims under the Administrative Procedure Act.

Next Steps for Implementation

With the Supreme Court’s decision, the case will return to the U.S. District Court for the Eastern District of Texas to address administrative law claims. According to Dennis Henigan of the Campaign for Tobacco-Free Kids, the ruling clears the path for the FDA to enforce the new warning requirements, which are slated to take effect in December 2025.