US: Judge blocks FDA’s plan for graphic labels on cigarette packs

March 5, 2012

A federal judge has blocked the Food and Drug Administration’s attempt to introduce graphic labels covering half of a cigarette pack. The nine labels – including graphic images of a cadaver with a sewn-up chest, diseased lungs and gums, and cigarette smoke drifting around an infant – were chosen by the FDA in June.

U.S. District Judge Richard Leon ruled Wednesday that the labels violate free-speech rights under the First Amendment. The labels were slated to debut Sept. 22.

“While the line between the constitutionally permissible dissemination of factual information and the impermissible expropriation of a company’s advertising space for government advocacy can be frustratingly blurry, here the line seems quite clear,” Leon wrote.

R.J. Reynolds Tobacco Co. and Lorillard Inc. were among five tobacco manufacturers that filed a lawsuit against the FDA in August challenging the constitutionality of the mandated labels, which also had to cover the top 20 percent of any advertisement.

The FDA has claimed their attempt to change the labels would be the most significant change to cigarette packaging in 25 years.

The opinion follows a Nov. 7 decision by Leon in which he granted the manufacturers’ request for a preliminary injunction in a strongly worded rebuttal of the FDA’s initiative.

The U.S. Justice Department has appealed the preliminary injunction.

“As a matter of general policy, the FDA does not comment on possible, pending or ongoing litigation,” spokeswoman Michelle Bolek said Wednesday.

Leon wrote in November “it is abundantly clear from viewing these images that the emotional response they were crafted to induce is calculated to provoke the viewer to quit, or never to start smoking – an objective wholly apart from disseminating purely factual and uncontroversial information.”

In Wednesday’s 19-page opinion, Leon wrote “the government has failed to carry both its burden of demonstrating a compelling interest and its burden of demonstrating that the rule is narrowly tailored to achieve a constitutionally permissible form of compelled commercial speech.

“The graphic images are neither factual nor accurate.”

Leon said, as an example, the image of the cadaver “suggests that smoking leads to autopsies, but the government provides no support to show that autopsies are a common consequence of smoking. Indeed, it makes no attempt to do so.”

“Instead, it contends that the image symbolizes that smoking kills 443,000 Americans each year. The image, however, does not provide that factual information.”

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said Leon’s ruling “is again wrong on the science and the law.”

“It is incomprehensible that Judge Leon would conclude that the warnings are neither factual nor accurate when they unequivocally tell the truth about cigarette smoking – that it is addictive, harms children, causes fatal lung disease, cancer, strokes and heart disease, and can kill you,” Myers said.

“If allowed to stand, Judge Leon’s rulings would make it impossible to implement any effective warning labels.”

Reynolds said it was pleased with Leon’s ruling.

“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,” said Martin Holton III, executive vice president and general counsel for Reynolds. “However, the goal of informing the public about the risks of tobacco use can and should be accomplished consistent with the U.S. Constitution.”

Leon wrote the FDA has chosen not to use several alternatives offered by the manufacturers “that are easily less restrictive and burdensome for plaintiffs, yet would still allow the government to educate the public on the health risks of smoking without unconstitutionally compelling speech.”

Those include: the FDA increasing its own anti-smoking advertisements beyond the $600 million already committed to a multimedia campaign; and the FDA reducing the label to 20 percent of the packaging and requiring warnings on either the front or back of the packaging.

There has been considerable debate among advocates and health officials, as well as local smokers, about whether the labels would be effective.

For example, an FDA study released in October 2010 found that although the labels may stir the emotions of smokers, they might not cause smokers to quit.

President Barack Obama – who recently became tobacco-free, according to his medical checkup – has weighed in on the label issue since Leon’s ruling, saying cigarette manufacturers “don’t want to be honest about the consequences.”

In January 2010, Judge Joseph McKinley Jr. of U.S. District Court for the Western District of Kentucky ruled tobacco manufacturers could continue to use color and graphics in marketing their products. He also ruled manufacturers can claim a product is safer if it gains approval from the FDA.

But McKinley upheld the majority of the provisions in the Family Smoking Prevention and Tobacco Control Act, which became law in June 2010, including requiring large health warnings on cigarette packs.

Also joining the lawsuit were Reynolds American Inc. subsidiary Santa Fe Natural Tobacco Co. Inc., Commonwealth Brands Inc. and Liggett Group LLC.

Source: Winston-Salem Journal (March 1, 2012)