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US judge blocks FDA graphic warning label requirement for cigarettes
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US judge blocks FDA graphic warning label requirement for cigarettes
Jan 14, 2025 10:08 AM

Jan 14 (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 ( BTI ) and had sued in 2020 alongside Imperial

Brands' ( IMBBF ) 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.

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