Cigarette makers must add large, graphic warning labels depicting diseased lungs, a man exhaling smoke through a hole in his neck and other images to packaging and advertising in the U.S. by October 2012

Cigarette makers must add large, graphic warning labels depicting diseased lungs, a man exhaling smoke through a hole in his neck and other images to packaging and advertising in the U.S. by October 2012, government officials said Tuesday.



U.S. Food and Drug Administration via Associated Press
The nine graphic images—accompanying warning labels with messages such as "Smoking can kill you" and "Cigarettes cause cancer"—are the biggest change to warning labels in more than 25 years. Such warnings were required by a 2009 law that gave the Food and Drug Administration the authority to regulate tobacco products.

The supersize labels are the highest-profile part of an intensified war on tobacco by the federal government, which ranks it as the leading cause of preventable and premature death in the U.S., linked to an estimated 443,000 deaths a year. The adult smoking rate of 20.6% in 2009 has remained largely unchanged since 2004, and about 20% of high school students also smoke.

The new color labels must occupy the top half of the front and back of a cigarette pack, and 20% of an ad's space. Other images include a baby near a cloud of smoke, a dead body, and a man wearing a black t-shirt with "I Quit" written across the chest. All labels include the number of a national quit line. Current warning labels, which were put on cigarette packs in the 1980s, are contained in a small box with black and white text warning about the dangers of smoking.

The U.S. is following more than 40 countries that have already put graphic warnings on cigarettes. Many of those warnings are far more explicit than those the U.S. chose, including gangrenous limbs and drooping cigarettes warning of erectile dysfunction.

Reynolds American Inc., Lorillard Inc., Commonwealth Brands Inc. and other tobacco companies sued the FDA in 2009, arguing that the graphic-labeling rule and other marketing provisions in the new federal tobacco law violate their constitutional rights to free speech. Last year, a judge mostly ruled in the government's favor—including on the graphic-labeling rule—but the mixed verdict prompted appeals from both sides.

A spokeswoman for Commonwealth, a unit of U.K.-based tobacco company Imperial Tobacco Group PLC, declined Tuesday to discuss the FDA's nine label choices, citing the pending lawsuit. However, she said the company's views on the labels hadn't changed since last fall, when a senior executive said "the risks associated with smoking already are well known" and the labels only serve to stigmatize smokers.

A spokesman for Lorillard, maker of Newport cigarettes, said Tuesday it was reviewing the labels but had no immediate comment. A spokesman for Altria Group Inc., whose Philip Morris USA unit is the largest U.S. cigarette maker by sales, said the company was reviewing the FDA's selections, but referred a reporter to comments it made to the agency in January arguing that warnings "based on their ability to evoke negative or cognitive reactions" rather than objective health information "would not pass constitutional muster."

How effective the labels are at discouraging smoking remains to be seen. More than 25% of smokers in 13 of 14 countries in a recent survey reported that large, graphic warning labels prompted them to think about quitting, according to results published by the Centers for Disease Control and Prevention. In a 2001 survey sponsored by the Canadian Cancer Society, 44% of smokers said warning labels increased their motivation to quit. The Institute of Medicine, a U.S. federal advisory body, concluded in a 2007 report that graphic warnings would convey a better understanding of the health risks of smoking and would reduce U.S. consumption.

Government officials project the U.S. will have 213,000 fewer smokers in the first year after the new labels are introduced, said Lawrence Deyton, director of the FDA's Center for Tobacco Products—a small percentage of the nation's 46 million smokers. U.S. officials based their estimate on the impact of warning labels on smoking prevalence in Canada, Dr. Deyton said.

The federal fiscal 2012 budget request includes an additional $25 million to support quit-line services, Dr. Deyton said. Currently, the quit line is funded with about $114 million in state and federal money, the FDA said.

The FDA selected the nine labels out of 36 proposed images after reviewing scientific literature, more than 1,700 public comments, and results from a study of 18,000 consumers. Among the proposed images that didn't make the cut were a dead body with a toe tag, gravestones, and a nursing baby with a mother blowing smoke in its face. "We wanted the final nine to represent a balance that will speak to different motivations," Dr. Deyton said.