FDA Unveils Public Health Warnings

Nine graphic images to appear by September 2012

WASHINGTON -- The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.

According to a press release from the U.S. Department of Health and Human Services (HHS), the warnings represent the most significant changes to cigarette labels in more than 25 years. They are required to be placed on all cigarette packs, cartons and advertisements.

Starting in September 2012, the new cigarette health warnings will appear on the top 50% [image-nocss] of both the front and rear panels of each cigarette package, and in the upper portion of each cigarette advertisement, occupying at least 20% of the area of the advertisement.

"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." The release states, "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, 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. 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, and nine textual warning statements: WARNING: Cigarettes are addictive. WARNING: Tobacco smoke can harm your children. WARNING: Cigarettes cause fatal lung disease. WARNING: Cigarettes cause cancer. WARNING: Cigarettes cause strokes and heart disease. WARNING: Smoking during pregnancy can harm your baby. WARNING: Smoking can kill you. WARNING: Tobacco smoke causes fatal lung disease in nonsmokers. WARNING: Quitting smoking now greatly reduces serious risks to your 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. The FDA action is part of a broad Obama Administration strategy previously announced by HHS Assistant Secretary for Health Howard K. Koh. "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, according to the statement.

Upcoming Dates for Graphic Image Requirements
June 22, 2011. FDA's final rule, "Required Warnings for Cigarette Packages and Advertisements," publishes in the Federal Register.

September 22, 2012. Cigarettes for sale or distribution in the United States can no longer be manufactured or advertised without the new cigarette health warnings.

October 22, 2012. Cigarette manufacturers can no longer distribute cigarettes for sale in the United States unless they display the new cigarette health warnings.

For more information on graphic warning labels and high-resolution images, please click here.

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