Graphic images for cigarette labels put on hold

Monday, November 7, 2011

A federal judge today sided with five tobacco companies that are fighting attempts by the Food and Drug Administration to require mandatory statements and graphic images on all cigarette packages.

The companies obtained a preliminary injunction from U.S. District Judge Richard J. Leon in the District of Columbia that prevents the FDA from enforcing the new rule.

Leon said the companies were substantially likely to prevail in their arguments that the new rule unconstitutionally compels speech in violation of the First Amendment.

In 2009, Congress passed and President Barack Obama signed into law the Family Smoking Prevention and Tobacco Control Act, which gave the FDA additional authority to regulate tobacco products. With this authority, the FDA created a rule requiring nine new text warnings and graphic images for cigarette packages.

The tobacco companies sued in federal court, arguing that the implementation of the new rule violated the First Amendment and the Administrative Procedure Act. With respect to the free-speech claim, the companies claimed that forcing them to include new text warnings and graphic images violated their First Amendment rights.

Leon agreed with the tobacco companies in R.J. Reynolds Tobacco Company v. United States Food and Drug Administration. He said the rule compelled the companies to engage in speech they didn’t agree with.

The FDA argued that mandated disclaimers or disclosures in commercial-speech cases should be evaluated under a rational-basis test, deferential to government, that asks only whether the government’s requirements are rational or reasonable.

The tobacco companies contended that the FDA rule constituted pure compulsion of speech, which required the court to apply a stricter standard of review. The judge agreed, finding that the reduced standard for evaluating disclaimers of commercial speech applies only when the disclaimers are purely information and factual.

Leon wrote that “the evidence here overwhelmingly suggests that the Rule’s graphic-image requirements are not the type of purely factual and uncontroversial disclosures that are reviewable under this less stringent standard.” He said many of the mandated images were provocative and controversial, including one of a body on an autopsy table.

Leon applied strict-scrutiny analysis to the regulations. This standard requires the government to demonstrate a compelling interest in approving a regulation and to prove that its restrictions are very narrowly drawn.

The government argued that the regulation served its compelling goal of informing consumers about the dangers of tobacco use. But the judge said that the government seemed to have another purpose — advocating a change in consumer behavior.

Leon also determined that the rule — even if supported by a compelling interest — was not narrowly tailored. “[T]he sheer size and display requirements for the graphic images are anything but narrowly tailored,” he wrote.

“In short, the Government has neither carried its burden of demonstrating a compelling interest, nor demonstrated how the Rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech,” Leon concluded.

The FDA refused to comment on the ruling, according to the Associated Press.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, urged the Obama administration to appeal the ruling that he said “is wrong on the science and wrong on the law,” the AP reported. Myers said a delay would serve only the financial interests of tobacco companies that spend billions to downplay the health risks of smoking and glamorize tobacco use.

“Studies around the world and evidence presented to the FDA have repeatedly shown that large, graphic warnings, like those adopted by the FDA, are most effective at informing consumers about the health risks of smoking, discouraging children and other nonsmokers from starting to smoke, and motivating smokers to quit,” Myers said in a statement. “Because of that evidence, at least 43 other countries now require large, graphic cigarette warnings.”

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