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Federal judge blocks FDA from enforcing graphic cigarette label rule

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January 14, 2025
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Federal judge blocks FDA from enforcing graphic cigarette label rule

A federal judge in Texas has temporarily blocked the Food and Drug Administration (FDA) from enforcing a requirement that cigarette packages include graphic warnings on the impacts of smoking.  

On Monday, U.S. District Judge J. Campbell Barker in Tyler, Texas, ruled in favor of R.J. Reynolds Tobacco Company and others, finding the FDA does not have the authority to require cigarette packaging and advertising to include one of 11 different warning labels.  

In the ruling, Barker wrote that the law only requires cigarette packages and advertisements to include one of nine warning labels and that the agency does not have the authority to add two more.  

He also said the agency only used the exact text required by law for two out of its 11 warning labels.  

The FDA recommended new health warnings with color images for cigarette packages and advertisements in 2019 with the stated purpose of promoting “greater public understanding” of the negative health outcomes of smoking.  

Those warnings include graphic images — like a pair of feet with multiple toe amputations and a woman with a large, protruding tumor in her neck — placed next to text.  

A year later, the agency issued a final rule requiring the new health warnings to be placed on cigarette packages and advertising. But the requirement has yet to be implemented due to legal challenges brought by tobacco companies like R.J. Reynolds arguing that the new warnings violate their right to free speech.  

R.J. Reynolds, along with Imperial Brands, sued the FDA over the new warnings in 2020. Barker ruled in favor of the tobacco companies in 2022. But R.J. Reynolds brought the case to the Supreme Court after the 5th U.S. Circuit Court of Appeals ruled the FDA’s requirement for packaging and advertisements did not violate the First Amendment.  

The Supreme Court declined to hear the challenge, allowing the lower court’s ruling to stand.  

Barker’s Monday decision temporarily blocks the FDA from enforcing the warning label requirement until a final judgment in the case is issued.  

The FDA has yet to respond to a request for comment from The Hill.

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