Antitobacco groups have decided to file a lawsuit against the U.S. Food and Drug Administration (FDA) over the agency’s delay in issuing a final rule about graphic health warnings on cigarette packs and ads. 
The legal action was launched October 4 in federal court in Boston by the following groups, as well as several pediatricians:
- American Cancer Society
- American Academy of Pediatrics
- Massachusetts Chapter of the American Academy of Pediatrics
- American Cancer Society Cancer Action Network
- American Heart Association
- American Lung Association
- Campaign for Tobacco-Free Kids
- Truth Initiative
A 2009 federal law mandated that the FDA issue a final rule on graphic (read: scary) cigarette warnings covering the top half of the front and back of cigarette packs, and 20% of cigarette advertising, by June 22, 2011.
Technically, the agency met the deadline for the proposed color warnings, which were to include images such as diseased lungs or a body on an autopsy table with words such as “smoking can kill you.” 
Livid tobacco companies sued, and the labels were ultimately struck down in federal appeals court in August 2012 on First Amendment grounds. However, that ruling only applied to certain images proposed by the health watchdog and did not affect the underlying requirement of the 2009 law.
In March 2012, a second appeals court upheld the law’s requirement for graphic warnings and the U.S. Supreme Court rejected a tobacco industry appeal of that ruling.
That means the FDA is still legally obligated to require explicit warnings on cigarette packs and ads. 
Jump ahead a year to March 2013. The agency then promised it would issue a new rule on those warnings, but that has yet to happen, despite heavy pressure from the antitobacco groups, the Campaign for Tobacco-Free Kids said in a statement.
The groups in the lawsuit allege that the FDA’s failure to issue a new rule is “agency action unlawfully withheld” and seeks a court order requiring the agency to issue a new rule. 
The lawsuit additionally states:
“The FDA has been in violation [of the 2009 law] 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.”
First Amendment Excuses
U.S. tobacco companies have been successful at dodging similar packaging requirements and graphic warnings by leaning on First Amendment protections of free speech.
In its 2012 ruling against the graphic labels that the FDA had proposed the previous year, the U.S. Court of Appeals for the District of Columbia said the government had failed to justify limits on commercial speech by showing the labels would bring down smoking rates. 
Dozens of countries have employed graphic warnings to try and reduce smoking rates. In Canada, for example, cigarette packs are adorned with a photo of a child in an oxygen mask, or a pair of hands cupping a diseased human heart. Warnings about the effects of secondhand smoke and heart disease are printed in bold text. 
Australian smokers have to look at a gangrenous foot while opening a pack of smokes.
In the United States, cigarette packs have only the surgeon general’s warning, dating back to 1984.
What’s the Holdup?
According to FDA spokesman Michael Felberbaum, the agency is conducting research to reinforce new rules that would meet the definition of the law. He said the regulator is “committed to reducing the death and disease from tobacco use.”
Dr. Michael C. Fiore, director of the University of Wisconsin’s Center for Tobacco Research and Intervention, said graphic ads would shake up even longtime smokers who are already well aware of the risks involved.
Fiore added that such ads are needed to counteract the billions of dollars that the tobacco industry spends in advertising each year, and that research clearly shows that explicit images indeed have an impact on behavior.
After Canada mandated graphic warnings on cigarette packs, smoking rates dropped 3 to 5 percentage points, according to research. That same study estimated that if the U.S. 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.”
 The Boston Globe