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Public health groups sue FDA on graphic cigarette warning labels

A group of anti-tobacco and public-health groups sued the Food and Drug Administration on Tuesday in an attempt to compel it to establish graphic warnings labels on cigarette packaging and marketing.

It’s been more than 3½ years since there’s been legal or regulatory movement on graphic warnings, particularly on what they will look like and when they will appear.

The 2009 federal Tobacco Control Act required graphic warnings covering the top half of the front and back of cigarette packs and on 20 percent of cigarette advertising.

The FDA was given until June 22, 2011, to issue a final rule requiring such warnings.

The governments of more than 90 countries require similar graphic warning labels. Australia, which was among the first to introduce the labels and has some of the most graphic images, is perhaps the most noteworthy.

The FDA chose nine labels in June 2011, which were scheduled to debut in September 2012. The labels included smoke coming out of a tracheal hole, diseased lungs and gums, and a man who appears deathly ill.

A group of tobacco manufacturers that include R.J. Reynolds Tobacco Co. and Lorillard Inc. filed a lawsuit in September 2011 against the FDA regarding the labels.

Two parallel legal cases with differing judicial opinions have put the initiative on hold.

The anti-tobacco and public health groups argue that the federal Administrative Procedure Act, which governs federal agencies, gives federal courts the power to “compel agency action unlawfully withheld or unreasonably delayed.”

“The FDA is in violation of its nondiscretionary statutory duty,” according to the plaintiffs’ lawsuit.

The plaintiffs contend that one of the legal tracks gives the FDA clearance to implement its final rule on the warning labels. Some plaintiffs argue that the lack of warning labels “makes it more difficult” for them “to educate and counsel members of the public not to smoke.”

In August 2012, a panel of the U.S. Court of Appeals for the D.C. Circuit voted 2-1 that the proposed specific warning labels violated the First Amendment. That ruling did not address the law’s underlying requirement.

The FDA said in March 2013 that it declined to further appeal the D.C. Circuit ruling and would create new warning labels.

In March 2012, the U.S. Court of Appeals for the Sixth Circuit upheld the law’s requirement for graphic warnings, finding that this provision did not violate the First Amendment. The U.S. Supreme Court declined in April 2013 to hear an appeal of the Sixth Circuit ruling.

“The FDA is undertaking research to support a new rulemaking consistent with (the Tobacco Control Act),” spokesman Michael Felberbaum said Wednesday.

While the industry and advocacy groups await the next FDA warning label proposals, several studies have been published that found mixed smoker reactions to the initial nine proposed labels.

In December 2010, an FDA study found putting graphicwarning labels on cigarette packs may stir emotions, but not lead to quitting.

UNC Chapel Hill researchers said in June that 40 percent of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34 percent with the text warning.

A February 2016 study published by University of Illinois researchers at the journal Communication Research suggests graphic images strike some people as manipulative, a reaction that could backfire on the attempt to steer individuals away from smoking.

Lawsuit plaintiffs

The 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, Truth Initiative, and several individual pediatricians.

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