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.
Dianne Murphy, M.D., is director of FDA’s Office of Pediatric Therapeutics. Dr. Murphy graduated from the Medical College of Virginia and completed her residency in pediatrics at the University of Virginia in Charlottesville. She has been with FDA since 1998.
Q: How does FDA define “children”?
A: For drugs, a child is defined as a person up to 17 years of age. For devices, 21 years of age is the upper limit.
Q: Are medications that are intended for children clinically tested on children?
“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.
In November, FDA officials posted 36 images on the Internet6 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
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.