Judge Blocks FDA’s Graphic Warning Rule
A federal judge in Texas has blocked the FDA from enforcing regulations to add graphic warnings to cigarette packaging and advertising, finding that 11 specific warnings required by the FDA exceeded its authority, and the effective date of the new rules has been delayed pending further litigation.
Background of the FDA Regulation
A federal judge in Texas has blocked the Food and Drug Administration (FDA) from implementing graphic warnings that were about to take effect in tobacco package advertising.
Court Ruling and Reasoning
U.S. District Judge J. Campbell Barker in Tyler, Texas, ruled in favor of R.J. Reynolds and other tobacco companies on Monday, arguing that the FDA exceeded its authority by requiring cigarette packaging and advertising to contain 11 specific warnings.
He noted that the warnings go beyond the nine that Congress mandated when it passed the Tobacco Control Act in 2009. The bill grants the FDA the power to control cigarette products and requires the use of graphic warnings.
Details of the Disputed Warnings
Barker, who was appointed by former President Donald Trump, stated that not only did the FDA add two additional warnings beyond what was required by law, but of the remaining nine warnings, only two used the exact text required by Congress.
The eleven graphic warnings depict health risks such as throat and neck cancer, fatal lung disease, restricted fetal development, cataracts, and type 2 diabetes.
FDA’s Argument and Judicial Response
The FDA argued that the law authorized it to adjust the format, type, and text of the required labels. However, Barker noted that this authority is limited, and even if the FDA allows the nine warnings to be rewritten, it cannot add two additional warnings.
“The court cannot infer policy decisions that are clearly expressed in an act of Congress,” Barker wrote.
Implementation Delayed Pending Further Litigation
The court delayed the rule’s effective date to prevent the FDA from implementing the rule in February 2026, pending further litigation.
Industry Challenge and Previous Ruling
The lawsuit was filed by R.J. Reynolds in 2020 along with ITG Brands, a subsidiary of Imperial Tobacco (IMB), and Liggett Group LLC, a subsidiary of Vector Group.
This is the second time Judge Barker has blocked the FDA’s warning label rule — he previously ruled in 2022 that the requirement violated corporate free speech rights under the First Amendment.
