Federal regulators unveiled nine graphic warnings that must be on cigarette packaging and advertisements by September 2012. The warning above shows healthy lungs (left) and the diseased lungs of a smoker. View the Warning Labels on Flickr.

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Consumers are getting a glimpse of warnings images that will be alternating on all cigarette packages and advertisements within 15 months—an effort by health officials to discourage smoking by bringing Americans face to face with tobacco-related disease.

The Food and Drug Administration unveiled the nine, color images—including some of  bodies ravaged by disease—at a news conference. The images, which are paired with text health warnings, are required under the 2009 Family Smoking Prevention and Tobacco Control Act. They must appear on every cigarette pack, carton, and advertisement by September 2012.

“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 encourage smokers to quit, and prevent children from smoking,” said Health and Human Services Secretary Kathleen Sebelius.

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In November, FDA officials posted 36 images on the Internet and gave the public 90 days to comment. The agency received more than 1,700 comments from the public, retailers, health professionals, advocacy groups, the tobacco industry, state and local public health agencies, and others.

Regulators used the comments, scientific literature, and the results of an 18,000-person study to narrow the images to nine. Each of the images—a mix of illustrations and photos depicting the negative health consequences of smoking—will be paired with one of these nine printed warnings:

WARNING: Cigarettes are addictive—with an image of a man smoking through a hole in his throat WARNING: Tobacco smoke can harm your children—with an image of a parent holding a baby as smoke drifts towards themWARNING: Cigarettes cause fatal lung disease—with an image of a disease-riddled lung and a healthy lung WARNING: Cigarettes cause cancer—with an image of an open sore and stained teeth on the lips and mouth of a smoker with mouth cancerWARNING: Cigarettes cause strokes and heart disease—with an image of a man who needs an oxygen mask to breatheWARNING: Smoking during pregnancy can harm your baby—with an illustration of a crying newborn in an incubator and hooked-up to a monitorWARNING: Smoking can kill you—with the image of a dead man with a surgery-scarred chest  WARNING: Tobacco smoke causes fatal lung disease in nonsmokers—with an image of a grieving family memberWARNING: Quitting smoking now greatly reduces serious risks to your health—with an image of a man wearing an “I Quit” T-shirt

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FDA Commissioner Margaret A. Hamburg, M.D., says she’s hopeful the graphic images will give smokers the incentive to quit and prevent potential smokers from ever starting. In fact, the phone number for the smoking cessation hotline—1-800-QUIT-NOW—will accompany each warning.

“The Tobacco Control Act requires FDA to provide current and potential smokers with clear and truthful information about the risks of smoking—these warnings do that,” she says. 

The bold health warnings will cover the top 50 percent of the front and rear panels of all cigarette packages and at least 20 percent of each advertisement. They are expected to decrease the number of smokers, which will save lives and increase life expectancy.

For more information, visit www.fda.gov/cigarettewarnings.

The Centers for Disease Control and Prevention says tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year. Tobacco addiction costs the U.S. economy nearly $200 billion every year in medical costs and lost productivity.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

June 21, 2011

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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.