BOSTON (CN) - A federal judge in Massachusetts ordered the U.S. Food and Drug Administration on Wednesday to stop delaying the implementation of graphic warning labels on cigarette packs.
The FDA was required to develop new graphic warning labels in 2009 after the passage of the Family Smoking Prevention and Tobacco Control Act. After the first attempt to develop labels was stymied by lawsuits from tobacco companies in 2012, the FDA did not design new proposed labels.
“This court concludes that because the FDA has both ‘unlawfully withheld’ and ‘unreasonably delayed’ agency action, the court must compel agency action,” U.S. District Judge Indira Talwani wrote in a 15-page opinion.
The 2016 lawsuit to force FDA action 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, Truth Initiative and several individual pediatricians.
The plaintiffs are represented by Boston law firm Anderson & Krieger LLP.
The American Academy of Pediatrics said in an unsigned statement that it urges the FDA “to quickly issue, finalize and implement a rule requiring graphic cigarette warnings,” in accordance with Judge Talwani’s order.
“The current U.S. cigarette warnings, which are printed on the side of cigarette packs and haven’t been updated since 1984, are stale, unnoticed and a major impediment to greater progress in reducing cigarette smoking,” the group said.
The 2009 Family Smoking Prevention and Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and 20 percent of cigarette advertising and gave the FDA until June 22, 2011, to issue a final rule requiring such warnings. While the FDA met that deadline, the specific graphic warnings were challenged by five tobacco companies that claimed that requiring the labels infringed on their freedom of speech.
Ultimately, the challenged graphic warnings were struck down in August 2012 by the D.C. Circuit. The ruling only applied to the specific images proposed by the FDA and did not address the law’s underlying requirement.
In a separate case in March 2012, the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that provision did not violate the First Amendment. The U.S. Supreme Court declined to hear a tobacco industry appeal of the ruling.
That left the FDA to come up with new warnings, which never happened.
Judge Talwani set a Sept. 26 deadline for the FDA to give an expedited schedule to the court for the publication of new proposed graphic warnings.
A spokesperson from the FDA did not respond Thursday to an email request for comment.
Subscribe to Closing Arguments
Sign up for new weekly newsletter Closing Arguments to get the latest about ongoing trials, major litigation and hot cases and rulings in courthouses around the U.S. and the world.
