A federal judge in Texas sided with R.J. Reynolds and other tobacco companies in finding the U.S. Food and Drug Administration (FDA) went beyond its authority by requiring packaging and advertising to contain 11 specific warnings.
U.S. District Judge J. Campbell Barker, in Tyler, Texas, blocked the FDA from enforcing a looming requirement that cigarette packages and advertisements contain graphic warnings illustrating the health risks of smoking. 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 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 FDA argued it has the authority to adjust the format, type, and text of any required labels, but Barker said that power was limited, and even if the FDA was allowed to adjust the nine warnings, it could not add the extra two.
“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. It 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.