Menthol Cigarette Report Tobacco Products Scientific Advisory Committee Meeting July 15, 2010 Corinne G. Husten, MD, MPH Senior Medical Advisor Center for Tobacco Products, FDA 1
Menthol Cigarette Report 907(e)(1): Immediately upon the establishment of TPSAC, the Secretary shall refer to the Committee for report and recommendation the issue of the impact of the use of menthol in cigarettes on the public health, including such use among children, African Americans, Hispanics, and other racial and ethnic minorities 2
Menthol Cigarette Report 907(e)(2): Not later than 1 year after its establishment, the TPSAC shall submit to the Secretary the required report and recommendations Menthol Report due: March 23, 2011 3
Review of the March 30-31 TPSAC Meeting Presentations of published research on Use of menthol cigarettes by demographic groups Menthol cigarettes and smoking initiation Marketing of menthol cigarettes and consumer perceptions Menthol cigarette sensory qualities, topography Menthol s effect on nicotine dependence Menthol cigarettes and smoking cessation behavior Health effects of mentholated cigarettes 4
July 15-16 TPSAC Meeting Industry presentations on five topics: Characterization of menthol in cigarettes Clinical effects of menthol cigarettes Biomarkers of disease risk for menthol cigarette smokers Marketing data on menthol cigarettes Population effects of menthol cigarettes 5
Areas of Interest Identified by the Committee Characterization of Menthol Trends in quantities of menthol present in the cigarette rod and smoke over time for various brands/subbrands of menthol and nonmenthol products as determined by the Cambridge Filter/ISO test method using standard parameters as well as the intense smoking conditions set forth in Canadian regulations Information regarding the manufacturing of menthol cigarettes, including Source and type of menthol used Presence or use of any menthol analogs* Types of manufacturing processes through which menthol is introduced into the tobacco product, as well as the considerations in selecting a particular method *FDA added this request of Industry 6
Areas of Interest Identified by the Committee Characterization of Menthol Threshold (menthol content) at which a product is identified and marketed as a menthol cigarette Rationale for adding menthol to cigarettes not marketed as menthol cigarettes, and the criteria for determining quantity of menthol to be added International brands of menthol cigarettes, the quantities of menthol in both menthol and nonmenthol cigarettes sold internationally, and the factors considered in determining the quantity of menthol to be added 7
Areas of Interest Identified by the Committee Clinical Effects of Menthol Studies of dose-response relationships for the physiologic effects of mentholated tobacco smoke Mechanistic studies of menthol effects including Chemosensory effects of menthol compounds in tobacco smoke, including effects at thermal and trigeminal receptors Effect of menthol on the neurobiology of tobacco dependence Effect of menthol on clinical and behavioral measures 8
Areas of Interest Identified by the Committee Clinical Effects of Menthol Studies addressing the dosing relationship and the metabolic interactions between nicotine and menthol, including resulting perceptions of nicotine strength and the interaction between menthol delivery and nicotine/tar levels, for both low-menthol and high-menthol products Information on correlations between menthol content and consumer perceptions regarding Taste Nicotine strength Product harm 9
Areas of Interest Identified by the Committee Biomarkers Analyses of laboratory and populations studies using biomarkers to assess the effect of menthol content on disease risk for cigarette smokers, based on cigarette consumption (e.g., cigarettes per day), including data related to menthol among population subgroups 10
Areas of Interest Identified by the Committee Marketing Data Data on consumer preferences for menthol cigarettes Consumer perception studies of advertising and packaging of menthol cigarettes Marketing strategies for various brands / subbrands of menthol cigarettes, including strategies targeted to particular demographic groups Marketing strategies for various brands / subbrands of menthol cigarettes sold internationally 11
Areas of Interest Identified by the Committee Population Effects Among cigarette smokers, rates of switching from menthol to nonmenthol cigarettes and vice versa Comparative rates of initiation by youth and young adults for menthol and nonmenthol cigarettes Comparative rates of cessation for users of menthol and nonmenthol cigarettes 12
Update on Other Information Requested by Committee Members Request for industry documents sent 05/26/10 Mandatory and voluntary submissions due to FDA 08/26/10 In progress Analysis of publicly available internal tobacco industry documents White paper on the studies presented at the first meeting References have been updated with relevant articles suggested by industry representatives and others 13
Update on Other Information Requested by Committee Members Expect contract to be awarded shortly to: Fund secondary data analyses of existing research studies on initiation, cessation, addiction and health effects of cigarette use to assess the impact of menthol cigarettes on these measures Analyze menthol cigarette sales data Develop a statistical model of menthol cigarettes effects on initiation and cessation Support for the writing of the menthol report Plan to establish a menthol report subcommittee Report will be presented to TPSAC for review and approval 14
Clarifying Questions? 15