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Federal judge in Boston sets timeline for FDA to produce graphic cigarette warnings

A federal judge in Boston has ordered the US Food and Drug Administration to create mandated colorful graphic health warnings on cigarette packs and advertising products by mid-March of next year.

US District Judge Indira Talwani on Tuesday gave the agency three key dates to make the congressionally mandated label warnings a reality.

By April 15, the agency must complete the final qualitative study of nine graphic warnings and an analysis of that study. The FDA has until Aug. 15 to submit a proposed rule mandating the color graphic warnings for publication in the federal register.

The final rule requiring the graphic warnings is due by March 15, 2020, according to court papers.


The order is the latest development in a lawsuit filed in US District Court in Boston in 2016 that aimed to force the FDA to require cigarette packages to display images starkly depicting what tobacco can do to the human body. The suit was brought by eight public health and medical groups and several individual pediatricians.

Last September, Talwani ruled that the FDA “unreasonably” delayed compliance with a 2009 law that required the graphic warnings.

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

In response to the September ruling, the FDA proposed issuing the final graphic warnings rule by May 2021, but the order this week pushes up that deadline.

Current US cigarette warnings are printed on the side of the packs and haven’t been updated in more than 30 years, according to advocates.

A message left with the FDA Wednesday night was not returned.

Previous Globe coverage was used in this report. Danny McDonald can be reached at daniel.mcdonald@globe.com. Follow him on Twitter @Danny__McDonald.