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.