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U.S. Department of Health and Human Services

Tobacco Products

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Overview: Cigarette Health Warnings

Beginning September 2012*, FDA will require larger, more prominent cigarette health warnings on all cigarette packaging and advertisements in the United States.  These warnings mark the first change in cigarette warnings in more than 25 years and are a significant advancement in communicating the dangers of smoking.  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 lower medical costs.
      

Public Health Impact

Tobacco use is the leading cause of premature and preventable death in the United States, and claims almost half a million lives each year.  Requiring larger, more prominent warnings on cigarette packaging and advertisements is part of a broader strategy to help tobacco users quit and prevent young people from starting.  The new warnings serve as reminder of the negative health consequences of smoking every time someone picks up a pack of cigarettes or views a cigarette advertisement.

Watch this video to learn more about the more prominent cigarette health warnings that will be required on all cigarette packaging and advertisements in the United States.
 


  

High Resolution Image Formats**

The zipped folder contains all of the cigarette health warnings. If you do not already have WinZip, you can download WinZipdisclaimer icon a file compression program.


The PDF contains a composite of all of the images. If you do not already have Adobe Acrobat, you can download Acrobat Reader for freedisclaimer icon.


The zipped folder contains all of the cigarette health warnings. If you do not already have WinZip, you can download WinZipdisclaimer icon a file compression program.

 

Placement of New Warnings on Cigarette Packages and Advertisements

Starting in September 2012*, the new cigarette health warnings will appear

  • on the top 50 percent of both the front and rear panels of each cigarette package.
  • in the upper portion of each cigarette advertisement, occupying at least 20 percent of the area of the advertisement.  

 

Timeline: Key Dates for Implementing Health Warnings
  • November 12, 2010 – FDA released 36 proposed color graphic images and a proposed rule for public comment
  • June 21, 2011 – FDA announced its selection of nine new cigarette health warnings
  • 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
     

Selection Process for Health Warnings

FDA selected the final nine cigarette health warnings based on their ability to effectively communicate the health risks of smoking to the public.  In making selections, FDA considered its review of relevant scientific literature, more than 1,700 public comments, and results from its 18,000 person study.

 

FDA’s Authority to Issue Required Warnings

The Family Smoking Prevention and Tobacco Control Act requires nine new larger and more noticeable textual warning statements to appear 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.

  

Industry-Only Formats**

Authorized industry professionals, like tobacco manufacturers, importers, distributors, and retailers, can obtain graphic vector electronic files for all of the required warnings and the instructions for their use by:

        The Center for Tobacco Products, Food and Drug Administration
        Office of Health Communication and Education
        ATTN:  Cigarette Warning File Requests
        9200 Corporate Blvd., Rockville, MD 20850

  • Contacting the Center at 1-877-CTP-1373

 

*The implementation date is uncertain, due to ongoing proceedings in the case of R.J. Reynolds Tobacco Co. v. U.S. Food and Drug Administration, No. 11-1482 (D.D.C.), on appeal, No. 11-5332 (D.C. Cir.).

**The United States government owns all rights in the required warnings, which may not be used, reproduced, displayed, modified, or distributed except for purposes of displaying them on cigarette packaging (including cartons) and in cigarette advertising as required by 21 CFR part 1141 or with the express written permission of FDA or as permitted under the Copyright Act.