By Nate Raymond
(Reuters) – A federal judge in Texas has blocked the U.S. Food and Drug Administration from enforcing a looming requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking.
U.S. District Judge J. Campbell Barker in Tyler, Texas, on Monday sided with R.J. Reynolds and other tobacco companies in finding the FDA went beyond its authority by requiring packaging and advertising to contain 11 specific warnings.
He said those warnings go above and beyond the nine that Congress specified when in 2009 it passed the Tobacco Control Act, which gave the FDA the authority to regulate tobacco products and mandated adoption of the graphic warnings.
Barker, who was appointed by Republican President-elect Donald Trump during his first term in the White House, said not only did the FDA adopt two extra warnings beyond the nine the law required, but it only used the exact text Congress required for two of the remaining nine.
The 11 graphic warnings include depictions of how smoking can cause bladder, head and neck cancer; fatal lung disease; stunted fetal growth during pregnancy; cataracts; and type 2 diabetes.
The FDA argued the law gave it the authority to adjust the format, type and text of any of the required labels. But Barker said that power was limited, noting that even if the FDA was allowed to rewrite the nine warnings, it could not add two extra ones.
“Courts are not free to second-guess policy decisions expressed in the plain text of the congressional enactments,” Barker wrote.
The judge delayed the rule’s effective date pending further litigation, preventing the FDA from proceeding to enforce it starting 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.
(Reporting by Nate Raymond in Boston; Editing by Alexia Garamfalvi and Paul Simao)
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