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U.S. Department of Health and Human Services

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FDA Remarks on the Report and Recommendation on the Public Health Impact of Menthol Cigarettes

Remarks on the Report and Recommendations to FDA Regarding the Public Health Impact of Menthol Cigarettes.

Remarks by Dr. Lawrence R. Deyton, M.D., M.S.P.H., Director, Center for Tobacco Products, Food and Drug Administration. March 18, 2011

Today, FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) discussed and finalized its report content and recommendations related to its first charge – evaluation of the available scientific evidence on the impact of the use of menthol in cigarettes on the public health.

As required by the Family Smoking Prevention and Tobacco Control Act, the TPSAC will deliver its final report and recommendations to FDA by March 23, 2011.  Submission of the final report and recommendations comes approximately one year after the establishment of the TPSAC, a panel of leading public health, scientific experts and representatives of various parts of the tobacco industry, charged with providing advice, information, and recommendations to FDA on health issues related to tobacco products and other issues relating to the regulation of tobacco products. 

The TPSAC’s recommendation of “removal of menthol cigarettes from the marketplace would benefit public health in the United States” is simply that – a Committee recommendation based on its review of current, prevailing science on the topic of menthol as an ingredient in cigarettes.  The TPSAC report will undergo a thorough review by experts within the FDA Center for Tobacco Products.  These experts will analyze this report and will continue to review all of the available science regarding the impact of the use of menthol in cigarettes on the public health.  The Tobacco Control Act requires that this analysis take into account the tobacco product standard’s risks and benefits to the population as a whole (including users and non-users), effects on overall smoking initiation and cessation rates, technical achievability, and countervailing effects such as the creation of a demand for contraband.  With a thorough review of the report and recommendations pending, it is important to note that FDA’s receipt of the final report does not have a direct or immediate effect on the availability of menthol products in the marketplace. 
Although there is no required deadline or timeline for FDA to act on the issue of menthol in cigarettes, we recognize the strong interest in this issue among all stakeholders and will continue to communicate the steps the FDA is taking as it determines what future regulatory actions, if any, are warranted.  FDA intends to provide its first progress report on the review of the science in approximately 90 days.

Regardless of any action on the topics discussed in the TPSAC report on menthol, a top priority for FDA is to protect the public health from the harmful effects of tobacco use by preventing youth from starting to use tobacco products and encouraging current users to stop.  Thus we continue to develop and enforce legal requirements in order to do that.  For example, FDA is acting to enforce provisions of the law that make it illegal to sell certain tobacco products to minors. In addition, FDA has issued proposed regulations requiring the use of new graphic health warnings on cigarette packages.

I’d like to thank each member of TPSAC for all the time they have put into this important process over the past year. I’d also like to thank members of the public who attended the meetings and/or provided valuable comments. Eight TPSAC meetings were held and countless hours were spent researching information, compiling and evaluating data, and writing the actual report.  And now the work continues for the FDA.


The FDA Center for Tobacco Products' mission is to protect public health by issuing and enforcing tobacco product regulations and educating the public about the dangers of tobacco product use. Tobacco is the leading cause of preventable disease, disability, and death in the United States. Tobacco products are responsible for approximately 443,000 deaths and $193 billion on medical expenditures and lost productivity each year in the United States. The Center's priorities are to prevent youth from using tobacco, help those who use to quit, provide accurate information about tobacco, enhance the science base for tobacco product regulation, and use regulatory tools to reduce the public health burden of tobacco in the United States. Visit www.fda.gov/tobacco for more information.