Court Requires FDA to Issue Graphic Warning Labels for Cigarette Packages

The District Court for the District of Massachusetts is requiring the FDA to develop a timeline for issuing labels after years of having “unlawfully delayed” or “unreasonably withheld” adherence to a 2011 law requiring it.

September 05, 2018 at 06:44 PM

5 minute read

In a victory for anti-smoking activists, a federal court ruled Wednesday that the U.S. Food and Drug Administration must provide a schedule for issuing a graphic-warnings rule for cigarette packaging by late September, years after being required to do such by federal law.

In her Wednesday ruling, U.S. District Judge Indira Talwani of the District of Massachusetts wrote that the FDA “unlawfully withheld” or “unreasonably delayed” the promulgation of graphic warnings and a rule for regulating their implementation after being tasked with the oversight of such with Congress' 2009 passing of the Tobacco Control Act. The FDA's most recent estimation for issuing a “final rule,” the order said, would be November 2021 “at the earliest.”

“The remaining question is the proper time frame for the agency to act. The court orders that, no later than September 26, 2018, the FDA shall provide to this court an expedited schedule,” Talwani wrote. Among her requirements for such are the publication of a “final rule” on the implementation of graphic warning labels for cigarettes as well as “the completion of outstanding studies” that the agency had cited as among the reasons for its initial delay.

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