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Mass. judge rules that FDA ‘unlawfully withheld’ action to require graphic cigarette warnings

Rich Pedroncelli/Associated Press/File 2012

A federal judge in Massachusetts ruled Wednesday that the US Food and Drug Administration has “unreasonably delayed” complying with a 2009 law requiring graphic warnings on cigarette packs.

“The court must compel agency action,” US District Judge Indira Talwani wrote in her decision.

The federal law required tobacco companies to display color images showing the hazards of tobacco use and occupying more than half of the cigarette pack and 20 percent of any advertisement.

Talwani ordered the FDA to provide an expedited schedule for the “completion of outstanding studies, the publication of the proposed graphic warnings rule for public comment, review of public comments, and issuance of a final graphic warnings rule” by Sept. 26.


Her decision came in a lawsuit filed in October 2016 in Boston by eight groups representing pediatricians, cancer and heart specialists, and antitobacco activists, along with three Massachusetts pediatricians. The suit asked the court to order the FDA to comply with the 2009 law.

In a statement, FDA spokesman Michael Felberbaum said the Trump administration is “analyzing the ruling . . . and will comply with any court order.”

In 2011, the FDA proposed a series of dramatic photos, including images of rotting teeth, curdled and blackened lungs, and a man exhaling cigarette smoke through a tracheotomy hole in his neck. But the agency was barred from using those images after legal challenges from the tobacco industry.

According to the FDA’s website, the agency has been “undertaking research related to graphic health warnings” since 2013.

On Wednesday, Campaign for Tobacco-Free Kids hailed the ruling as a “major victory in the fight against tobacco use, the nation’s number one cause of preventable death.”

“The current US cigarette warnings, which are printed on the side of cigarette packs and haven’t been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking,” the group said in a statement. “Studies around the world have shown that graphic warnings are most effective at informing consumers about the health risks of smoking, preventing children and other nonsmokers from starting to smoke, and motivating smokers to quit.”


Requiring graphic warnings “will protect kids, save lives and reduce tobacco-related health care costs, which total $170 billion a year,” the campaign said.

More than 120 countries require large, graphic warnings on packs of cigarettes, the group said. In Canada, for instance, images include a sad-eyed child with an oxygen mask and a pair of hands holding a diseased human heart, each with bold text about the risk of secondhand smoke and heart disease.

Felice J. Freyer of Globe staff contributed to this report. Danny McDonald can be reached at Follow him on Twitter @Danny__McDonald.