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 the evidence 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 TPSAC recommendations 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 the prohibition on the use of misleading claims of modified risk (e.g., “Light,” “Low,” and “Mild”). 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.
An FDA FAQ on the topic is available here:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/TobaccoProductsScientificAdvisoryCommittee/UCM247652.pdf
