Starting next year, cigarette cartons, packs and advertising will feature these and six other graphic warnings, replacing the discreet admonitions that cigarette manufacturers have been required to offer since 1966.
The tobacco companies, several of which are challenging the new rule in court, refused to comment on the startling images that will now have to dominate half of the front and back of each carton and pack and 20 percent of each large ad.
The requirement is the most visible exercise of new powers granted to the Food and Drug Administration by Congress in 2009 to fight the nation’s leading cause of preventable death, and the first major overhaul of cigarette warnings in a quarter-century.
The color images also include a diseased lung, a mouth with mottled teeth and a disfigured lip, a weeping woman and a cartoon of a crying baby in an incubator. The graphics will include messages such as, “Warning: Cigarettes are addictive,” “Warning: Cigarettes cause cancer” and “Warning: Smoking can kill you.”
Each brand must rotate all the images randomly throughout the year. Every warning will also include “1-800-QUIT-NOW,” a hotline smokers can call for help kicking the habit.
The FDA predicts that the images, which are deliberately designed to disgust and unnerve all ages, will reduce the number of smokers by 213,000 by 2013 and save between $221 million and $630 million every year over the next 20 years.
“With these warnings, every person who picks up a pack of cigarettes will know exactly what risk they are taking,” said Health and Human Services Secretary Kathleen Sebelius at a White House briefing announcing the new mandate.
The final nine images were selected after the agency reviewed scientific literature and more than 1,700 public comments, and evaluated the 36 images proposed in November in a study involving 18,000 people.
Some of the more graphic possibilities — a man who appeared to be suffering a heart attack, one depicting a corpse in a coffin and another of a corpse in a morgue with a toe tag — were rejected in favor of a wide range of images that include arresting pictures as well as less dramatic ones, such as a photo of a mother holding a child and a man wearing a T-shirt that says “I Quit.”
“Sometimes with the most graphic images people sort of tune them out because they are so disturbing,” said Lawrence R. Deyton of the FDA’s new Center for Tobacco Products. “The images that work best are the ones that people can look at and have an emotional impact but not dismiss.”
The FDA will evaluate the warnings continually and update them periodically if research indicates people are becoming inured to their impact.
“We’ll begin the studies to make sure that we are keeping people sensitized,” Sebelius said. “What may seem quite shocking at the beginning, people get used to quite quickly.”
Some of the images, particularly the warning depicting a diseased mouth, are specifically aimed at dispelling the notion for teens that smoking is cool.
“We want kids to understand smoking is gross, not cool, and there’s really nothing pretty about having mouth cancer or, you know, making your baby sick if you smoke,” said FDA Commissioner Margaret A. Hamburg. “So some of these are very driven to dispelling the notion that somehow this is cool, and makes you cool.”
Public health authorities and anti-smoking advocates hailed the new warnings as a milestone in the battle against tobacco in the United States that began in 1964, when the surgeon general first declared cigarettes a public health threat.
Cigarettes began warning smokers that “Cigarettes May Be Hazardous to Your Health” in 1966. The warnings went through several modifications over the years but remained small text on the sides of packages and ads.
Smoking rates steadily fell for decades but stalled in recent years, with one in five adults and teens still smoking. Smoking kills an estimated 443,000 Americans each year, costing nearly $200 billion in medical bills and other costs. President Obama himself struggled for years to quit.
“These new warning labels have the potential to encourage adults to give up their deadly addiction to cigarettes and deter children from starting in the first place,” said John R. Seffrin, chief executive of the American Cancer Society.
The new warnings are being challenged in court by several major tobacco companies, including R.J. Reynolds Tobacco, Lorillard Tobacco and Commonwealth Brands. The companies referred queries about the new warnings to comments they submitted to the FDA. The comments labeled the images “ideological” because they do “not simply convey information intended to enable smokers to make informed decisions about whether to smoke cigarettes” but instead are designed to “elicit loathing, disgust, and repulsion.”
Altria, the parent company of Philip Morris, which is the only tobacco company to support the FDA’s new powers, also criticized the requirement for the new warnings. The company called the mandate a “last-minute” addition that failed to enable Congress to consider “alternative, less speech-restrictive warnings.” Philip Morris is the nation’s largest cigarette maker, producing such popular brands as Marlboro, Virginia Slims and Parliament.
At least 30 other countries already require graphic warnings, including some, such as in Brazil, that go even further than the U.S. messages.
Some studies have indicated that graphic images, paradoxically, can make smoking seem more appealing to some people. But Canada, which became the first country to require more graphic warnings in 2000, has seen a significant drop in smoking.
The warnings are part of the FDA’s broad new anti-smoking strategy using powers to regulate tobacco in a 2009 law. The agency has restricted the use of the terms “light,” “low” and “mild,” banned the use of fruit, candy and spice flavorings and is considering taking action to prevent the sale of menthol cigarettes.
“The tobacco companies continue to spend billions of dollars to play down the health risks of smoking and glamorize tobacco use,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “These new warnings will tell the truth about how deadly and unglamorous cigarette smoking truly is.”