Federal Judge Blocks FDA’s Graphic Warning Label Rule, Citing Overreach

In a significant decision, a federal judge in Texas has blocked the U.S. Food and Drug Administration (FDA) from enforcing its rule requiring graphic warnings on cigarette packages and advertisements, a regulation that was set to take effect in February 2026. The ruling by U.S. District Judge J. Campbell Barker is the latest development in a contentious legal battle between tobacco companies and the FDA over the extent of its regulatory authority under the Tobacco Control Act (TCA).

Judge Barker, who was appointed by President Trump, ruled that the FDA exceeded its authority by mandating 11 specific warnings, despite the TCA only requiring nine. Additionally, Barker noted that the FDA failed to adhere to the exact language specified by Congress for the required warnings, using the prescribed text for only two out of nine.

The 11 graphic warnings proposed by the FDA included visual depictions of the health risks associated with smoking, such as lung disease, cancers, fetal growth issues, and other serious conditions. The FDA argued that it was authorized to modify the format, type, and text of the labels, but Judge Barker stated that this authority did not extend to adding two additional warnings beyond what Congress explicitly mandated.

“Courts are not free to second-guess policy decisions expressed in the plain text of the congressional enactments,” Judge Barker wrote in his ruling. He delayed the rule’s implementation to allow for further litigation, effectively preventing the FDA from moving forward with enforcement for now.

Judge Barker’s ruling is his second regarding FDA’s graphic warning rule. In 2022, he ruled that the requirement violated tobacco companies’ First Amendment rights. That decision was overturned by the 5th U.S. Circuit Court of Appeals, and the Supreme Court declined to hear an appeal. However, the latest ruling focuses on non-constitutional arguments, specifically whether the FDA adhered to the authority granted by Congress.

The ruling is a victory for Big Tobacco Companies – R.J. Reynolds, ITG Brands, and Liggett Group – which sued the FDA in 2020. The tobacco companies have long argued that the FDA’s rule imposes unfair restrictions and exceeds its statutory authority.

Implications for Tobacco Regulation and Premium Cigars

Judge Barker’s decision in this case underscores ongoing concerns about the FDA’s expansive interpretation of its regulatory powers under the TCA. While the case focuses on cigarette packaging, it serves as a critical reminder of the need for clear boundaries when regulating distinct tobacco product categories.

Premium cigars, in particular, face similar risks of regulatory overreach. Cigar Rights of America (CRA) has consistently advocated for differentiated treatment of premium cigars, emphasizing their unique characteristics and minimal public health impact compared to other tobacco products. This ruling reinforces the importance of maintaining checks on the FDA’s authority to ensure that regulations remain within the scope intended by Congress.

CRA will continue to monitor this case and provide updates on how it may influence future regulatory actions affecting the premium cigar industry.