U.S. Judge Blocks FDA Rule on Cigarette Warnings

R.J. Reynolds succeeds in its challenge to the FDA mandate for graphic labels on packaging.

December 09, 2022

ALEXANDRIA, Va.—A U.S. judge in the U.S. District Court for the Eastern District of Texas has blocked a federal rule requiring graphic health warnings on cigarette packages slated to take effect in November  2023, reports the Winston-Salem Journal.

Judge John Campbell Barker Wednesday ruled in favor of the plaintiffs in R.J. Reynolds Tobacco Co. et al. v. U.S. Food & Drug Administration et al. His order vacates a March 2020 decision by the FDA to require graphic warning labels on cigarette packaging as part of the 2009 Family Smoking Prevention and Tobacco Control Act.

Last week, the same court issued another order to further postpone the effective date of required warnings on cigarettes.

In March 2020, the FDA issued a final rule requiring cigarette health warnings on cigarette packaging and advertisements. In October 2019, NACS filed a letter on the proposed rule on graphic warning labels on cigarette packages.

The now-vacated final rule required cigarette manufacturers to include graphic health warnings on cigarette packaging and advertisements. The “new cigarette health warnings must appear prominently on packages and in advertisements, occupying the top 50% of the area of the front and rear panels of cigarette packages and at least 20 percent of the area at the top of cigarette advertisements,” the rule states.

In addition, retailers of cigarettes would have been held responsible for ensuring those health warnings are visible to the public and unobscured. In terms of packaging requirements, retailers of cigarettes will not be in violation of the final rule if the cigarette packaging: (1) contains a warning; (2) is supplied to the retailer by a licensed manufacturer or distributor; and (3) is not altered by the retailer. However, retailers would be responsible for ensuring that the health warnings are visible on packages and unobscured by stickers, sleeves or other materials.

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