Judge Blocks FDA’s Rule Requiring Graphic Labels on Cigarettes

A man smokes a cigarette in New York City in a file photograph. Shannon Stapleton/Reuters)

A federal judge has blocked the U.S. Food and Drug Administration (FDA) rule requiring graphic warning labels on cigarettes, finding that the requirement went beyond the FDA’s authority.

The Tobacco Control Act outlines one of nine specific warnings to be placed on cigarette packages, including “WARNING: Smoking can kill you.” In its 2019 rule, the FDA added two options and altered some of the others, including changing “Smoking during pregnancy can harm your baby” to “Smoking during pregnancy stunts fetal growth.”

Congress said in the same law that the FDA may adjust certain aspects of the warning, including the required type sizes. But lawmakers did not give the agency authority to change the number of warnings, U.S. District Judge Campbell Barker wrote in his Jan. 13 ruling.

“The first question is whether the agency has authority to increase the number of compelled warnings from nine to eleven. As the court reads the Act, Congress did not give the agency that authority,” Barker concluded.

Barker noted that the FDA had previously kept just nine warnings in previous updates to cigarette packaging requirements.

FDA officials had argued that Congress had just happened to choose nine warnings.

“The fact that Congress ‘happened’ to choose nine warnings is not dispositive, the agency says, especially since eleven warnings are not too much more burdensome than nine. But what Congress ‘happens’ to do is the law. Courts are not free to second-guess policy decisions expressed in the plain text of the congressional enactments,” the judge added later.

Barker entered a preliminary injunction blocking the rule while the case proceeds in the court system.

The FDA had planned to start enforcing the rule in February 2026.

The ruling was a victory for R.J. Reynolds, which is part of British American Tobacco and had sued in 2020 alongside Imperial Brands’ subsidiary ITG Brands and Vector Group’s Liggett Group unit.

R.J. Reynolds and the FDA declined to comment.

The decision marked the second time Barker has blocked the FDA’s warning label rule. In 2022, the judge concluded the requirement violated the companies’ speech rights under the U.S. Constitution’s First Amendment.

The New Orleans-based 5th U.S. Circuit Court of Appeals reversed that decision in March, and the U.S. Supreme Court in November declined to hear the tobacco companies’ appeal. But the companies had asserted other, non-constitutional arguments that Barker needed to rule on.

Reuters contributed to this report.