The 'Bold' But Not the Beautiful

FDA unveils final cigarette warning labels; must be on all packs, cartons, ads by Sept. 2012

Linda Abu-Shalback Zid, Senior Editor

WASHINGTON -- The U.S. Food & Drug Administration (FDA) on Tuesday unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement. The warnings represent the most significant changes to cigarette labels in more than 25 years and will affect everything from packaging to advertisements and are required to be placed on all cigarette packs, cartons and ads no later than September 2012.

Following the unveiling of the warnings the FDA held a teleconference for industry stakeholders. "The [image-nocss] final images and nine required text warnings are bold, powerful and varied, with the intention of reaching many different audiences," Lawrence Deyton, director of the FDA's Center for Tobacco Products (CTP), told participants.

These warnings, which were proposed in November 2010, were required under the Family Smoking Prevention & Tobacco Control Act, which was passed in Congress and was signed into law by President Obama on June 22, 2009.

(Click here for previous CSP Daily News coverage.)

Click hereto view the labels and for more information.

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.

Each warning is also accompanied by one of 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. 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.

The new cigarette health warnings will appear on the top 50% 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.

The majority of approximately 150 voters (58%) in a CSP Daily News Poll earlier this week said they did not think cigarette sales would be affected by the graphic images. Voters were asked, "What will adding graphic warning labels on cigarette packages mean to cigarette sales?" About 37% said there will be a small decline in sales; more than 2% said sales will "drop like a stone" and nearly 3% said they expect sales to rise.

The FDA and HHS expect the introduction of these warnings 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 statement said.

"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 & Human Services Secretary Kathleen Sebelius.

Commissioner of food and drugs Margaret A. Hamburg said, "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."

The FDA action is part of a broad Obama Administration strategy previously announced by HHS Assistant Secretary for Health Howard K. Koh to "help create a society free of tobacco-related death and disease."

During the teleconference, Deyton also said that the FDA will be holding webinars and providing other communications to ensure understanding of the regulations. "We always want to engage as much as we can to talk through the implementation issues to make sure we are as clear as possible, and that we're giving as good a direction as we can."

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. During the teleconference, however, the FDA CTP clarified that that retailers will be able to sell-through merchandise that was put into the "streams of commerce," similar to the situation with products with "light" and "mild" descriptors.

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