A lawsuit filed Tuesday in federal District Court in Boston aims to force the Food and Drug Administration to require cigarette packages to display images starkly depicting what tobacco can do to the human body.
Dozens of countries already require such graphic warnings. In Canada, a smoker can’t open a pack without seeing an arresting picture, such as a sad-eyed child with an oxygen mask, or a pair of hands holding a diseased human heart, each with bold text about the risk of secondhand smoke and heart disease. In Australia, smokers have to stare down a photo of a gangrenous foot.
In the United States, cigarette packages merely display the brief surgeon general’s warning, a small text unchanged since 1984.
But a 2009 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.
Tuesday’s lawsuit — brought by eight groups representing pediatricians, cancer and heart specialists, and anti-tobacco activists, along with three Massachusetts pediatricians — asks the court to order the FDA to carry out that law.
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. After legal challenges from the tobacco industry, the agency has been barred from using those images, but the law requiring pictorial warnings remains in force. The FDA, however, has failed to write the regulations to carry out that mandate.
Since then, Tuesday’s suit states, “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.”
FDA spokesman Michael Felberbaum said in an e-mail the agency is conducting research to bolster a set of rules that would meet the law’s terms and that it is “committed to reducing the death and disease from tobacco use.” He declined to comment on the litigation.
Dr. Michael C. Fiore, director of the University of Wisconsin’s Center for Tobacco Research and Intervention, said even those familiar with the hazards of smoking will be affected by powerful images at the moment they are about to smoke. Such messages are needed to counteract the billions of dollars in tobacco industry advertising, and research clearly shows that striking pictures influence behavior, he said.
A study published in 2013 found that after Canada mandated graphic warnings, smoking rates declined 3 to 5 percentage points. The study estimated that if the United States had adopted the warnings in 2012, within a year 5.3 million to 8.6 million fewer people would be smoking.
“Graphic warning labels will help to prevent kids from starting to smoke and discourage those already addicted from continuing to smoke,” Fiore said.
Richard A. Daynard, law professor and president of the Public Health Advocacy Institute at Northeastern University, said President Obama’s administration has been “inexplicably resistant” to carrying out the graphic warnings law.
“I have been totally puzzled, frustrated, and outraged” by the FDA’s inaction, he said. Daynard is not involved with Tuesday’s suit but has led other antitobacco litigation.
The groups filing the suit have written to the FDA urging action, said Dennis A. Henigan, lawyer for one of them, the Campaign for Tobacco-Free Kids. “We’ve received some responses,” Henigan said, “but nothing that gives us any reason to believe they’re moving forward in developing a new rule.”
According to the Campaign for Tobacco-Free Kids, more than 90 nations require graphic warnings on cigarette packs.
The United States’ effort to do the same initially was stymied by tobacco industry suits. A three-judge panel of the Washington, D.C., Court of Appeals rejected the specific images the FDA proposed, but did not address the requirement to display images. In a separate suit, the Sixth Circuit Court of Appeals in Cincinnati upheld the law’s requirement for graphic warnings. Both decisions came in 2012, and the Supreme Court declined to hear a tobacco industry appeal.
In March 2013, the FDA said it would develop new warnings.
Tuesday’s lawsuit was filed by the American Academy of Pediatrics, the Massachusetts Chapter of the American Academy of Pediatrics, the American Cancer Society, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association, the Campaign for Tobacco-Free Kids, the Truth Initiative, Dr. Ted M. Kremer of Holden, Dr. Jonathan Winickoff of Brookline, and Dr. Lynda Young of Worcester.
A spokesman for Reynolds American, parent of R. J. Reynolds and the Santa Fe Natural Tobacco Companies, which had sought to block the graphic warnings, declined comment Tuesday.
Henigan said the plaintiffs filed the suit in Boston because last year a judge in that court ordered another federal agency to adhere to a deadline and statute in a matter unrelated to tobacco. “There’s a very strong precedent in that court for the kind of order we are seeking for this case,” he said.
Felice J. Freyer can be reached at firstname.lastname@example.org.