FDA Issues New Cigarette Health Warning Labels

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. 

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.




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