November 10, 2010
F.D.A. Unveils Proposed Graphic Warning Labels for Cigarette Packs
By GARDINER HARRIS

WASHINGTON — Federal drug regulators on Wednesday unveiled 36 proposed warning labels for cigarette packages, including one showing a toe tag on a corpse and another in which a mother blows smoke on her baby.

Designed to cover half the surface area of a pack or carton of cigarettes, and a fifth of any advertisements for them, the labels are intended to spur smokers to quit by providing graphic reminders of tobacco’s dangers. The labels are required under a law passed last year that gave the Food and Drug Administration the power to regulate, but not ban, tobacco products for the first time.

Public health officials hope that the new labels will re-energize the nation’s antismoking efforts, which have stalled in recent years. About 20.6 percent of the nation’s adults, or 46.6 million people, and about 19.5 percent of high school students, or 3.4 million teenagers, are smokers.

Every day, about 1,000 children and teenagers become regular smokers, and 4,000 try smoking for the first time. About 440,000 people die every year from smoking-related health problems, and the cost to treat such problems exceeds $96 billion a year.

Some cigarette manufacturers vowed to fight the labels in federal court, saying they infringe the companies’ property and free-speech rights. A federal judge in Kentucky ruled in January in a related lawsuit that the F.D.A. could require graphic warning labels but that a proposed restriction intended to eliminate attractive coloring from cigarette packaging infringes free speech. That ruling has been appealed.

“The use of graphic warnings makes no contribution to the awareness of these risks and serves only to stigmatize smokers and denormalize smoking,” said Anthony Hemsley, a vice president at Commonwealth Brands, the maker of USA Gold cigarettes.

Among the most arresting of the proposed labels is one in which a man exhales smoke through a hole in his neck. Some smokers who suffer cancer of the larynx must breathe through a tracheotomy instead of their nose or mouth. But the proposed labels are not as gruesome as some mandated in Europe, in which ghastly photos of blackened teeth and decaying mouths give a Halloween aspect to cigarette packs.

“Today marks an important milestone in protecting our children and the health of the American public,” Kathleen Sebelius, the secretary of health and human services, said Wednesday.

The United States was the first country to require tobacco products to bear health warnings, and all cigarette packages now sold in the country have modest ones like “Surgeon General’s Warning: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.”

But 39 other countries have gone well beyond such brief warnings and now require large, graphic depictions of smoking’s effects. With Wednesday’s announcement, the United States — whose first European settlements in the 17th century helped to create and feed a global tobacco addiction — edged a step closer to joining those nations’ efforts to reduce the centuries-old epidemic of tobacco-related deaths.

“This is the most important change in cigarette health warnings in the history of the United States,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids.

Studies suggest that pictorial warnings are better at getting the attention of adolescents than ones that feature only text; make smokers more likely to skip the cigarette they had planned to smoke and more likely to quit; and make adolescents less likely to start smoking.

But health officials said there was some evidence that the most gruesome images, while memorable, are dismissed sooner by smokers. Health Canada recently backed away from a plan to introduce even more gruesome warnings, earning the government a rebuke from the Canadian Medical Association Journal.

“Sometimes images that are not as graphic may be more powerful in terms of changing behaviors,” said Dr. Lawrence R. Deyton, director of the Food and Drug Administration’s Center for Tobacco Products.

The F.D.A. has hired a company to survey 18,000 smokers to determine which labels might be most effective in getting smokers to quit and preventing adolescents from starting. Results were expected to be published within weeks and will be used along with public and expert comments to help winnow the 36 proposed labels to 9 by June.

By Oct. 22, 2012, manufacturers will no longer be allowed to distribute cigarettes for sale in the United States that do not display the graphic warnings. They will be required to allocate all nine warnings evenly.

Dr. Howard K. Koh, the assistant secretary for health, said in an interview that the new labels were part of the Obama administration’s comprehensive tobacco control plan that includes $250 million to support state and local antitobacco efforts.

“We want to not only support the new F.D.A. regulatory authority but reinvigorate the national commitment to ending the tobacco epidemic,” he said.

Tobacco retailers may face challenges displaying the new packaging because many stores show only the tops of cigarette packs, where the warnings would be shown, obscuring the brands. And high-end tobacco shops, which make much of their money from cigars and loose tobacco, may not want the warnings near their more expensive products.

“It may end up being that we stop carrying cigarettes,” said Ben Blackman, manager of Georgetown Tobacco in Washington. Such a result, of course, would delight public health officials.

Dr. Margaret Hamburg, the F.D.A. commissioner, said the agency would continue to monitor the effectiveness of the labels even after choosing its final nine. And if it decided that a different label would perform better than one already chosen, the agency would make a change, Dr. Hamburg said.

“We’re trying to reach a range of subpopulations and figure out what works best for whom,” she said. “When the rule takes effect, the health consequences of smoking will be obvious every time someone picks up a pack of cigarettes.”

Dr. Richard D. Hurt, director of the Nicotine Dependence Center at the Mayo Clinic, said he was hopeful the labels would save lives, though he said a higher federal tax and tougher workplace restrictions were also needed.

“The evidence is that graphic labels do make a difference in enticing smokers to stop smoking,” he said.

Still, Dr. Hurt predicted that cigarette makers would devise ways to blunt the labels’ effects with slip covers and other packaging. “It’ll be interesting to see what they try to do,” he said.