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Judge Blocks FDA Plan for Graphic Cigarette Warnings
Date:11/8/2011

By Steven Reinberg
HealthDay Reporter

MONDAY, Nov. 7 (HealthDay News) -- The U.S. Food and Drug Administration's plans to require graphic warning labels on cigarette packs was derailed temporarily Monday when a federal judge blocked the effort, suggesting it was a violation of the tobacco industry's First Amendment free-speech rights.

Judge Richard Leon of the U.S. District Court in the District of Columbia said it was likely that the tobacco industry would succeed in a lawsuit to overturn the requirement, so he blocked the FDA initiative until the court case is resolved, which could take years, the Associated Press reported.

Leon said the nine graphic images, which were approved by the FDA and due to start appearing in September 2012, did more than simply convey facts about the health risks of smoking -- they took an advocacy stance, a key distinction in a free-speech case, the news service said.

"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," Leon wrote in his 29-page opinion.

The nine proposed images, which are designed to fill the top half of all cigarette packs, have stirred controversy since the concept first emerged in 2009.

One image shows a man's face and a lighted cigarette in his hand, with smoke escaping from a hole in his neck -- the result of a tracheotomy. The caption reads "Cigarettes are addictive." Another image shows a mother holding a baby as smoke swirls about them, with the warning: "Tobacco smoke can harm your children."

A third image depicts a distraught woman with the caption: "Warning: Smoking causes fatal lung disease in nonsmokers."

A fourth picture shows a mouth with smoked-stained teeth and an open sore on the lower lip. "Cigarettes cause cancer," the caption reads.

The labels are a part of the requirements of the Family Smoking Prevention and Tobacco Control Act, signed into law in 2009 by President Barack Obama. For the first time, the law gave the FDA significant control over tobacco products.

The FDA has said it hopes these new warnings would have a "significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and improved health status."

"President Obama is committed to protecting our nation's children and the American people from the dangers of tobacco use. These labels are frank, honest and powerful depictions of the health risks of smoking and they will help," U.S. Health and Human Services Secretary Kathleen Sebelius said in a news release issued in June. "These labels will encourage smokers to quit, and prevent children from smoking. President Obama wants to make tobacco-related death and disease part of the nation's past, and not our future."

Responding to Monday's legal decision, Legacy, the nation's largest nonprofit group devoted to tobacco use prevention and cessation, issued a news release that said:

"In his ruling, Judge Leon maintained that some of the images were 'unquestionably designed to evoke emotion,' and the images were crafted to 'provoke the viewer to quit, or never to start smoking.'

"We believe that, too, is precisely the point of these images: dying from a tobacco-related disease is never pretty, or pleasant or comfortable. The images chosen by the FDA are realistic, accurate depictions of the terrible toll tobacco use takes on the body."

"Evidence shows that more extensive, visual graphic warning labels such as those required by FDA can play an important role in educating consumers about the dangers of smoking. Research conducted in countries that have implemented graphic warnings, such as Canada and Australia, has found that many smokers credit the warnings with motivating them to quit and/or helping them to stay smoke-free."

Smoking is the leading cause of early and preventable death in the United States, resulting in some 443,000 fatalities each year, according to the U.S. Centers for Disease Control and Prevention, and costs almost $200 billion every year in medical costs and lost productivity.

Over the last decade, countries as varied as Canada, Australia, Chile, Brazil, Iran and Singapore, among others, have adopted graphic warnings on tobacco products. Some are downright disturbing: in Brazil, cigarette packages come with pictures of dead babies and a gangrened foot with blackened toes.

More information

For more on the warning labels and to see the images, visit this FDA website.

SOURCES: Nov. 7, 2011, news release, Legacy, Washington, D.C.; Associated Press


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