Beginning September 2012, U.S. Food and Drug Administration (FDA) will require larger, more prominent cigarette health warnings on all cigarette packaging, cartons and advertisements in the United States.

Earlier today the FDA unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

Bold measure
This bold measure which marks the first change in cigarette warnings in more than 25 years and are a significant advancement in communicating the dangers of smoking will help prevent children from smoking, encourage adults who do to quit, and ensure every American understands the dangers of smoking. These large new graphic warning labels will appear on the top 50% of the front and back of all cigarette packs ? replacing the 25 year-old warnings that are ineffective and hidden on the side of packages.

Powerful depictions
?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. ?President Obama wants to make tobacco-related death and disease part of the nation?s past, and not our future.?

Medical cost and loss of productivity
Tobacco use is the leading cause of premature and preventable death in the United States, responsible for 443,000 deaths each year, according to the Centers for Disease Control and Prevention (CDC), and costs our economy nearly $200 billion every year in medical costs and lost productivity. These warnings, which were proposed in November 2010, were required under the Family Smoking Prevention and Tobacco Control Act which was passed with broad bipartisan support in Congress and signed into law by president Obama on June 22, 2009.

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The FDA selected nine images from the originally proposed 36 after reviewing the relevant scientific literature, analyzing the results from an 18,000 person study and considering more than 1,700 comments from a variety of groups, including the tobacco industry, retailers, health professionals, public health and other advocacy groups, academics, state and local public health agencies, medical organizations and individual consumers.

Each warning is accompanied by a smoking cessation phone number, 1-800-QUIT-NOW, which will allow it to be seen at the time it is most relevant to smokers, increasing the likelihood that smokers who want to quit will be successful. When implemented in September 2012, all cigarettes manufactured for sale or distribution in the United States will need to include the new graphic health warnings on their packages.

Public health
The introduction of these warnings is expected to have a significant public health impact by decreasing the number of smokers, resulting in lives saved, increased life expectancy, and improved health status. ?The Tobacco Control Act requires FDA to provide current and potential smokers with clear and truthful information about the risks of smoking ? these warnings do that,? said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

The FDA action is part of a broad Obama Administration strategy previously announced by HHS Assistant Secretary for Health Howard K. Koh, M.D., M.P.H. ?Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan? outlines specific, evidence-based actions that will help create a society free of tobacco-related death and disease.

American Lung Association
In a reaction, the American Lung Association said it is extremely pleased that FDA heeded the recommendations of the Lung Association and so many public health organizations.

Smoking cessation
Quitting smoking is the single most important step an individual can take to improve their health. According to the American Lung Association, investing in smoking cessation, one of the three most effective prevention services, must be a priority to prevent disease, save lives and curb health costs.

Disturbing images
This new FDA regulation is the result of a very thorough and comprehensive scientific evaluation. While the graphic images displayed on the new warning labels may be disturbing to some, the World Health Organization (WHO) has concluded that “health warnings on tobacco packages increase smokers’ awareness of their risk. Use of pictures with graphic depictions of disease and other negative images has greater impact than words alone.” Studies have also found graphic images to be effective at deterring children from smoking ? the tobacco industry’s prime target when seeking new customers for their addictive product.

Ongoing development
As part of the new regulation, the FDA will esure that the graphic images are regularly rotated to prevent overexposure. Furthermore, as part of the program, the FDA will continue surveillance and develop new images when the existing images begin to lose their effectiveness.

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