WebMD Medical News
Laura J. Martin, MD
June 21, 2011 -- Graphic images such as lifeless bodies, surgical scars, and diseased lungs are among nine new warning labels unveiled by the FDA that the agency says must appear on all cigarette packaging and advertisements by September 2012.
The FDA says in a statement on its web site that the warnings, a new effort to get people to quit smoking, represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements.
The agency says all Americans understand the dangers of smoking and the new labels are intended to prevent children from starting and induce smokers to quit.
One image shows a dead man with a surgical wound on his chest. Another picture shows a close-up of a person's mouth full of brown, rotting teeth and a lip with an open sore. Still another picture depicts a man with a breathing apparatus over his mouth and nose. And another image shows a sick baby, crying in an incubator.
Each grim image is accompanied by written warnings such as "cigarettes cause cancer," "smoking during pregnancy can harm your baby," "cigarettes are addictive," and "tobacco smoke can harm your children."
The warnings, first proposed in November 2010, were required under the Family Smoking Prevention and Tobacco Control Act that was passed in Congress and signed into law by President Obama on June 22, 2009.
The FDA chose the nine images to be used from 36 that were originally proposed.
Come September 2012, all cigarettes manufactured for sale or distribution in the U.S. must include the new graphic images and warnings on packaging.
The FDA says the warnings are expected to have a significant impact on public health by decreasing the number of smokers, which it says will result in lives saved, increased life expectancy, and better health.
"President Obama is committed to protecting our nation's children and the American people from the dangers of tobacco use," U.S. Health and Human Services Secretary Kathleen Sebelius says in the FDA news release. "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."
She says the president "wants to make tobacco-related death and disease part of the nation's past and not our future."
Tobacco use is the leading cause of premature and preventable death in the U.S. and is responsible for 443,000 deaths annually, the FDA says. And smoking costs the U.S. economy $200 billion in medical costs and lost productivity annually, according to the FDA.
Each warning will be accompanied by a smoking-cessation hotline, 800-QUIT-NOW, which may increase the likelihood that smokers who want to give up the habit will be successful.
FDA Commissioner Margaret A. Hamburg, MD, says in the news release that the agency is required to provide current and potential smokers with "clear and truthful information" about smoking risks and adds that the new "warnings do that."
Nancy Brown, CEO of the American Heart Association, says in a news release that the new labels will provide "the momentum needed to eradicate tobacco use in our nation."
The warnings will be more effective than those in the past because of their graphic, frightening nature, she suggests. She also says about a third of smoking-related deaths in the U.S. are linked to heart disease and stroke, and that secondhand smoke kills 49,000 people a year.
The American Lung Association says in its news release that the graphic labels "will appear on the top 50% of the front and back" of all cigarette packs.
"While the graphic images displayed on the new warning labels may be disturbing to some, the World Health Organization has concluded that health warnings on tobacco packages increase smokers' awareness of their risk."
The American Lung Association says the use of graphic depictions of disease "has greater impact than words alone."
The FDA action comes at a time when federal authorities say the percentage of Americans who smoke has dropped to 20% from nearly 40% since 1970. The FDA predicts the new labels will reduce the number of smokers by 213,000 in 2013.
The new images can be viewed on the FDA web site.
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SOURCES:News release, FDA.News release, American Lung Association.News release, American Heart Association.
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