Tobacco control groups push for appeal to allow graphic cigarette labels

A federal judge had ruled that mandating warnings on packages was unconstitutional. Tobacco companies hailed the decision as a victory.

By — Posted March 12, 2012

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Health organizations are urging the Obama administration to fight a federal court decision blocking graphic warning labels from appearing on cigarette packages.

Judge Richard J. Leon of the U.S. District Court for the District of Columbia on Feb. 29 declared unconstitutional the Food and Drug Administration's rule mandating the new images, which include pictures of a man smoking through a tracheotomy hole and a dead person with a surgery-scarred chest. The images were to begin appearing on packages in September.

The American Lung Assn., the American Cancer Society and others called the ruling a threat to public health and asked that the Justice Dept. appeal the decision as soon as possible.

"We strongly disagree with [the judge's] conclusion that the new graphic warnings are 'neither factual nor accurate,' " the association said in a statement. "The facts are clear and indisputable that cigarette smoking is addictive, harms children, causes fatal lung disease, cancer, strokes and heart disease, and can kill you."

The Justice Dept. and the FDA declined to comment on the ruling or discuss the case's next step. On its website, the FDA said because of ongoing litigation, the enforcement date for the warnings is uncertain. The Dept. of Health and Human Services remained positive about the warnings' implementation.

"This administration is determined to do everything we can to warn young people about the dangers of smoking, which remains the leading cause of preventable death in America," HHS said in a statement. "We are confident that efforts to stop these important warnings from going forward will ultimately fail."

The judge correctly decided that enforcement of the images violate the First Amendment rights of tobacco manufacturers, said Martin L. Holton III, executive vice president and general counsel for R.J. Reynolds Tobacco Co., one of the plaintiffs.

"We believe governments, public health officials, tobacco manufacturers and others share a responsibility to provide tobacco consumers with accurate information about the various health risks associated with smoking," Holton said." However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the U.S. Constitution."

Warnings aimed at smoking prevention

The FDA released the text and graphic health warnings in June 2011, saying tobacco companies should prepare to place them on all cigarette packs, cartons and advertisements beginning in September 2012. The warnings were part of the Family Smoking Prevention and Tobacco Control Act, which became law in 2009. The labels were aimed at cutting the nation's tobacco use and preventing others from starting to smoke, the FDA said.

R.J. Reynolds and other tobacco companies sued the government over the images in August 2011.

The American Medical Association joined other health organizations in submitting three friend-of-the-court briefs in support of the warnings.

"Overwhelming evidence demonstrates that existing warnings have failed to inform the public adequately of the risks of tobacco use and that the industry has intentionally undermined those warnings by misrepresenting the health consequences of smoking and marketing their products to children," one of the briefs said. "Evidence also establishes that the large, graphic warnings required [by the FDA] are effective both at raising public awareness of the risks of smoking and at reducing tobacco use."

Leon temporarily blocked the warnings in November 2011. In his Feb. 29 opinion, Leon said not only did the images violate the Constitution, but the FDA also failed to convey through the images any factual information about actual health consequences of smoking.

"It is clear that the government's actual purpose is not to inform or educate, but rather to advocate a change in behavior, specifically to encourage smoking cessation and to discourage potential new smokers from starting," Leon said. "The government's reliance on the graphic images -- which were chosen based on their ability to provoke emotion, a criterion that does not address whether the graphic images affect consumers' knowledge of smoking risks -- coupled with the toll-free number, further supports the conclusion that the government's actual purpose is to convince consumers that they should 'quit now.' "

Leon's ruling conflicts with a 2010 federal court decision in a similar lawsuit. In that case, the U.S. District Court for the Western District of Kentucky said the graphic images were legal.

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Case at a glance

Can the FDA force tobacco companies to put graphic warning labels on cigarette packages?

The U.S. District Court for the District of Columbia said no. The court concluded that the mandatory graphic images violate the First Amendment by unconstitutionally compelling speech.

Impact: The FDA must halt enforcement of the warnings, which were scheduled to go into effect in September.

R.J. Reynolds Tobacco Co. v. United States Food and Drug Administration, U.S. District Court for the District of Columbia, Feb. 29

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