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U.S. Department of Health and Human Services

For Consumers

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FDA Unveils New Cigarette Health Warnings

FDA Unveils New Cigarette Health Warnings - (JPG)

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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Nine Warnings

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 them
  • WARNING: 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 cancer
  • WARNING: Cigarettes cause strokes and heart disease—with an image of a man who needs an oxygen mask to breathe
  • WARNING: Smoking during pregnancy can harm your baby—with an illustration of a crying newborn in an incubator and hooked-up to a monitor
  • WARNING: 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 member
  • WARNING: 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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Expected Impact

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

*The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration. No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir.).

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