Timetable Speeds Up for Graphic Cigarette Warnings

Federal judge orders FDA to submit proposed rule on package labels, ads by the summer
Photograph: Shutterstock

WASHINGTON  A federal judge has hastened the future of graphic cigarette warning labels by stepping up the timetable by which the U.S. Food and Drug Administration (FDA) must submit its proposed and final rules on the matter, according to the Winston-Salem Journal.

The warning labels—with visuals ranging from smoke coming from a hole in a person’s trachea to cancerous lungs—have been in litigation since 2012.

In March, Judge Indira Talwani for the U.S. District Court for the District of Massachusetts ordered the FDA to come up with its final ruling by March 2020; the agency had said it could originally do so by May 2021. The judge ordered the agency to finish its study on the labels by April 15, 2019, and submit a proposed rule by Aug. 15, 2019.

The Family Smoking Prevention and Tobacco Control Act of 2009 required such graphic warnings on the top half of the front and back of cigarette packs and be 20% of cigarette advertising, with the FDA having until 2011 to issue its final rules to require the labels, the Journal reported.

But industry litigation enjoined the FDA efforts in 2012, which led to additional court battles. In 2016, the FDA responded to lawsuits by proposing the 2021 deadline for the rule.

“The court finds no reason for further delay,” Talwani wrote. “Defendant shall take all steps necessary ... and shall complete the study by April 15.”

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