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Massachusetts Federal Court Sets March 2020 Deadline for FDA to Submit Final Cigarette Graphic Warning Labels Rule for Publication

by Anderson & Kreiger
March 20, 2019

In a major public health victory in the fight against tobacco, the U.S. District Court for the District of Massachusetts has ordered the U.S. Food and Drug Administration (FDA) to issue a final rule requiring graphic health warnings on cigarette packs and in cigarette advertising, as mandated by a 2009 federal law, by March 15, 2020.

Many studies have shown that graphic warnings are more effective than the verbal warnings that have long been on cigarette packs and can significantly reduce the number of children who begin to smoke and help smokers to quit. More than 120 countries require graphic warnings on packs of cigarettes, but the United States has yet to do so.

In its ruling, the Court agreed with the plaintiffs, which include the Campaign for Tobacco Free Kids, American Academy of Pediatrics, American Cancer Society, American Lung Association, American Heart Association, and other public health organizations and Massachusetts pediatricians, that the FDA has “unlawfully withheld” and “unreasonably delayed” promulgating a graphic warnings rule, as mandated by Congress many years ago. The Court order FDA to complete its rulemaking and publish a final rule by March 2020.

Scott Lewis and Jessica Wall represent the plaintiffs, along with Dennis Henigan and Mark Greenwold from the Campaign for Tobacco-Free Kids.