Graphic Warning Labels on Cigarettes

June 21, 2011

Dear International Colleague:

I am writing today to invite you to participate in stakeholder teleconferences this afternoon to learn about the U.S. Food and Drug Administration’s (FDA) new requirement for the display of graphic illustrations and specific health warnings on cigarette packages and in cigarette advertisements. This new rule, which was announced this morning, implements a provision of our Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring nine new larger and more noticeable textual warning statements to appear prominently on cigarette packages and in cigarette advertisements. It also directs FDA to issue regulations requiring that color graphic images depicting the negative health consequences of smoking accompany the nine new textual warning statements.

One of these graphic health warnings will be required to appear on every pack of cigarettes sold in the United States and every cigarette advertisement. The warnings represent the most significant changes to cigarette labels in the United States in more than 25 years and will affect everything from packaging to advertisements.

The warnings, which were publicly proposed in November 2010, were required under the 2009 Family Smoking Prevention and Tobacco Control Act. 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 the special toll-free “help” number 800-QUIT-NOW cessation, which will allow it to be seen at the time it is most relevant to smokers, hopefully increasing the likelihood that smokers will attempt to quit smoking.

The graphic health warnings are required to be placed on all cigarette packs, cartons and ads no later than September 2012. 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, improved health status, and medial cost reductions.

Details of the FDA’s announcement pertaining to graphic health warnings on cigarette packages and ads will be provided during the following briefings. You and/or your staff are invited to join either or both of these teleconferences.

Public Health Stakeholder Teleconference

On Tuesday, June 21, 2011 from 3:30 – 4:00 p.m. (Washington time), FDA will hold a Public Health Stakeholder teleconference to allow healthcare professionals and other stakeholders an opportunity to ask questions and further discuss cigarette health warnings. This session will be moderated by Dr. Howard K. Koh, Assistant Secretary for Health, and Dr. Lawrence Deyton, Director, Center for Tobacco Products, FDA.

The toll-free number for this briefing for stakeholders in the United States is 888-603-8938, International stakeholders may call 1-415-228-4966. The Passcode for callers is “FDA HHS”.

Industry Stakeholder Teleconference

On Tuesday, June 21, 2011 from 4:15 – 4:45 p.m. (Washington time), FDA will hold a teleconference to allow industry stakeholders an opportunity to ask questions and further discuss cigarette health warnings. This session will be moderated Dr. Lawrence Deyton, Director, Center for Tobacco Products, FDA.

The toll-free number for this briefing for stakeholders in the United States is 800-619-7596, Passcode: “FDA”. International stakeholders may call 1-517-308-9474. The Passcode for callers is “FDA”.

Additional information about tobacco, including this announcement, will be available on the FDA Web site at www.fda.gov/tobacco.

If you have any questions or concerns about this matter, please contact me at + 1 301-796-4600 or at Murray.Lumpkin@fda.hhs.gov.

Sincerely,

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Murray M. Lumpkin, M.D., M.Sc.
Deputy Commissioner
International Programs

International Outreach to Foreign Embassies