In the first major change to warning labels in more than a quarter-century, the graphic images will include photographs of horribly damaged teeth and lungs and a man exhaling smoke through a tracheotomy opening in his neck. The Department of Health and Human Services selected nine color images among 36 proposed to accompany larger text warnings.
Health advocacy groups have praised the government plan in the hope that images would shock and deter new smokers and scare existing smokers into quitting.
The images are to cover the upper half of the front and back of cigarette packages produced after September 2012, as well as 20 percent of cigarette advertisements.
“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,” Kathleen Sebelius, the secretary of health and human services, said in a statement Tuesday.
The four leading tobacco companies were all threatening legal action, saying the images would unfairly hurt their property and free-speech rights by obscuring their brand names in retail displays, demonizing the companies and stigmatizing smokers.
The government won one case last year in a federal court in Kentucky on its overall ability to require larger warning labels with images; the specific images released on Tuesday are likely to stir further legal action.
The Kentucky case is before the United States Court of Appeals for the Sixth Circuit.
The new labels were required under landmark antismoking legislation giving the Food and Drug Administration power to regulate, but not ban, tobacco products. The Family Smoking Prevention and Tobacco Control Act required F.D.A. action on the graphic warning labels by Wednesday, the two-year anniversary of President Obama’s signing it into law.
The United States was the first nation to require a health warning on cigarette packages more than 25 years ago, but since then, at least 39 other nations including Canada and many in Europe have imposed more eye-catching warnings, including graphic photographs.
“This is a critical moment for the United States to move forward in this area,” F.D.A. Commissioner Margaret A. Hamburg said in an interview. “The trends in smoking really support the need for more action now. For four decades, there was a steady decline in smoking, but five to seven years ago we leveled off at about the 20 percent level of adult and youth smoking in this country.”
Lawrence R. Deyton, director of the F.D.A. Center for Tobacco Products, said the government estimates — based on other countries’ experience — that the new warning labels will prompt an additional 213,000 Americans to quit smoking next year.
“We are pleased with the images they picked,” said Nancy Brown, chief executive of the American Heart Association. “They strongly depict the adverse consequences of smoking. They will get people’s attention. And they will certainly be much more memorable than the current warning labels.”
Gregory N. Connolly, a professor and tobacco expert at the Harvard School of Public Health, also praised the strength of the pictorial warnings, but he said the F.D.A. needed to take tougher action against cigarettes. “What’s on the pack is important, but if you really want to cut smoking rates, you’ve got to get inside the pack and deal with ingredients like menthol and nicotine,” Dr. Connolly said.
The nine images chosen in the United States include some that are among the most graphic of the 36 draft images. But they also include some of the less vivid, including a cartoon depiction of a baby rather than a photo in the draft set that showed a mother blowing smoke at a baby.
The images to appear on cigarette packs on a rotating basis also include one of a man proudly wearing a T-shirt that says: “I QUIT.”
All of the packs will also contain a toll-free telephone number for smoking cessation services.
The F.D.A. has already proposed nine different text warnings that will be paired with the photographs, including, “Warning: Cigarettes cause cancer” and “Warning: Quitting smoking now greatly reduces serious risks to your health.”
The government surveyed 18,000 Americans of all ages to determine which of the 36 proposed labels would be most effective to deter smoking.
The F.D.A. can revise the selection of color photographs in the future.
A submission to the F.D.A. by R. J. Reynolds, Lorillard and Commonwealth Brands, the second, third and fourth largest cigarette makers, said the “nonfactual and controversial images” were “intended to elicit loathing, disgust, and repulsion” about a legal product.
Those companies and a few others filed suit in Kentucky in August 2009 over several provisions of the law. United States District Judge Joseph H. McKinley Jr. ruled that the companies could be forced to put graphic warning labels on the packages, but said they could not be forced to limit marketing materials to black text on a white background, saying that was too broad an intrusion on commercial free speech.
Gregg Perry, a spokesman for Lorillard Tobacco, said on Tuesday that the company was reviewing the graphics and would not comment at this time. A spokeswoman for R.J. Reynolds repeated its earlier opposition to thegraphic labels. Altria said it would not comment.
Altria, the parent company of Philip Morris, the only major tobacco company to support the overall F.D.A. legislation, said in a letter earlier this year that the graphic warning provision was an unconstitutional part of the law “added in a last-minute amendment.”
The rate of smoking in America has been cut roughly in half, to about 20 percent, from 42 percent in 1965, but health officials say progress has stalled. Smoking remains the leading cause of preventable death, killing 443,000 Americans a year, according to the Centers for Disease Control and Prevention.
Each day, an estimated 4,000 youths try their first cigarette and 1,000 a day will become regular smokers, the government says.
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