Anti-tobacco groups filed a lawsuit Tuesday against the Food and Drug Administration to force the agency into issuing a final rule for graphic health warnings on cigarette packs and advertising.

The lawsuit, filed in the U.S. District Court for the District of Massachusetts, alleges that the FDA’s failure to issue a federally mandated rule on new graphic warnings is unlawful and seeks a court order requiring the agency to take action.

The 2009 Family Smoking Prevention and Tobacco Control Act required graphic warnings to cover the top half of the front and back of cigarette packs and 20 percent of cigarette advertising. The Act gave the FDA until June 22, 2011, to issue a final rule requiring such warnings. The current, text-only warnings haven’t been updated since 1984.

While the FDA met that deadline, the specific images in the proposed graphic warnings were struck down in August 2012 by the U.S Court of Appeals for the D.C. Circuit.

The ruling was based, in part, on the court’s judgment that the FDA had not provided sufficient evidence that graphic warnings would reduce the number of Americans who smoke.  But anti-tobacco groups point to a  2013 study that said if the U.S. had implemented warnings in 2012 as planned, the number of adult smokers in the U.S. would have decreased by 5.3 million – 8.6 million in 2013.

Ruling separately in March 2012, the U.S. Court of Appeals for the 6th Circuit upheld the law’s graphic warnings requirement, finding that they do not violate the First Amendment. That court found the warnings “are reasonably related to the government’s interest in preventing consumer deception and are therefore constitutional.”

Big tobacco appealed, but the U.S. Supreme Court declined to hear the case.

The groups that filed the lawsuit – the American Heart Association, American Academy of Pediatrics, Massachusetts Chapter of the American Academy of Pediatrics, American Cancer Society, American Cancer Society Cancer Action Network, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative – said the two Court of Appeals’ decisions show the FDA is still legally obligated to require graphic health warnings, using different images than those struck down in 2012

The FDA said in March 2013 that it would issue a new rule, but has not done so.

“The FDA has been in violation for more than four years. During that time, over 3 million Americans, the vast majority of them minors, have begun to smoke on a regular basis. Half of them will die prematurely as a result of tobacco-related disease,” the lawsuit says.

Tobacco use is the No. 1 preventable cause of death in the United States, killing more than 480,000 Americans and costing about $170 billion in health care expenses each year.