The U.S. tobacco marketplace is changing fast, and regulatory science lags far behind. The FDA can alter this dynamic, but needs the tools to do so. One necessary tool is a model for evaluating all types of """"""""modified risk tobacco products"""""""" (MRTPs): novel tobacco products marketed with the claim that they reduce harm or risk associated with conventional products. There are few demonstrated models for predicting tobacco product harm or risk, which demands an understanding of MRTP constituents using analytic lab methods, toxicant exposure and abuse liability using human lab methods, longer-term effects using randomized control trial (RCT) methods, and attitudes, beliefs, and perceived effects using quantitative and qualitative methods. The overarching goal of the Center for the Study of Tobacco Products is to demonstrate empirically an integrated, iterative MRTP evaluation model that uses all of these methods to inform tobacco product regulation across all product types (combustible, oral, or vapor). The Center unites NIH-funded scientist/educators from multiple disciplines to demonstrate the transdisciplinary MRTP evaluation model. We begin with an evaluation of """"""""electronic cigarettes"""""""" (EClGs), novel tobacco products that are marketed now and increasingly popular. EClGs offer an opportunity to demonstrate how the model we propose can inform regulatory policy. To meet the Center's overarching goal we describe four integrated, multi-year projects that aim to: 1) Examine factors that influence MRTP nicotine and toxicant yield;2) Compare short-term effects of MRTPs to other products in the human lab;3) Characterize effects of real-world MRTP use in the natural environment using RCT methods;and 4) Study the influence MRTP use and misuse on user attitudes, beliefs, and perceived effects using qualitative and quantitative methods. An Administrative Core will facilitate financia and managerial processes, provide data management and biostatistical support, co-ordinate communication within and across centers, and interface with scientists and policymakers. A Training and Education Core will develop a course on transdisciplinary methods for evaluating products and will support up to 4 pre-doctoral and 4 postdoctoral appointees. Finally, a pilot research program will solicit and fund innovative projects from our Virginia-wide network of scientists and respond to emerging products of any type. The Center is thus structured to address FDA needs and operate collaboratively. Overall, this Center will provide the expertise, innovation, infrastructure, and information necessary for the sustained success of FDA's mandate to regulate novel tobacco products, including MRTPs.
This Center is designed to inform tobacco regulatory science and thereby contribute to public health. The four projects will answer important questions about electronic cigarettes while giving the Food and Drug Administration an empirical demonstration of a transdisciplinary, integrated, iterative, MRTP evaluation model. The Center thus provides FDA necessary scientific tools to ensure that only those novel tobacco products that have positive public health effects are marketed.
|Yingst, Jessica M; Veldheer, Susan; Hammett, Erin et al. (2017) Should electronic cigarette use be covered by clean indoor air laws? Tob Control 26:e16-e18|
|Hiler, Marzena; Breland, Alison; Spindle, Tory et al. (2017) Electronic cigarette user plasma nicotine concentration, puff topography, heart rate, and subjective effects: Influence of liquid nicotine concentration and user experience. Exp Clin Psychopharmacol 25:380-392|
|Soneji, Samir; Barrington-Trimis, Jessica L; Wills, Thomas A et al. (2017) Association Between Initial Use of e-Cigarettes and Subsequent Cigarette Smoking Among Adolescents and Young Adults: A Systematic Review and Meta-analysis. JAMA Pediatr 171:788-797|
|Sutfin, Erin L; Soule, Eric K; McKelvey, Karma et al. (2017) Implications and challenges for implementation of the FDA's final deeming rule for waterpipe tobacco. Tob Control :|
|Spindle, Tory R; Hiler, Marzena M; Breland, Alison B et al. (2017) The Influence of a Mouthpiece-Based Topography Measurement Device on Electronic Cigarette User's Plasma Nicotine Concentration, Heart Rate, and Subjective Effects Under Directed and Ad Libitum Use Conditions. Nicotine Tob Res 19:469-476|
|Hammett, Erin; Veldheer, Susan; Yingst, Jessica et al. (2017) Characteristics, use patterns and perceptions of electronic cigarette users who were never traditional cigarette smokers. Addict Behav 65:92-97|
|Bahelah, Raed; DiFranza, Joseph R; Ward, Kenneth D et al. (2017) Waterpipe smoking patterns and symptoms of nicotine dependence: The Waterpipe Dependence in Lebanese Youth Study. Addict Behav 74:127-133|
|Lopez, A A; Eissenberg, T; Jaafar, M et al. (2017) Now is the time to advocate for interventions designed specifically to prevent and control waterpipe tobacco smoking. Addict Behav 66:41-47|
|Ramôa, C P; Eissenberg, T; Sahingur, S E (2017) Increasing popularity of waterpipe tobacco smoking and electronic cigarette use: Implications for oral healthcare. J Periodontal Res 52:813-823|
|Barnes, Andrew J; Bono, Rose S; Lester, Rebecca C et al. (2017) Effect of Flavors and Modified Risk Messages on E-cigarette Abuse Liability. Tob Regul Sci 3:374-387|
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