TCORS 2.0: Center for the Assessment of Tobacco Regulations (CAsToR)

Research Project 2: Modeling the Impact of Nicotine Regulation on Smoking and Smoking-Related Mortality

Nicotine has long been known to be the primary addictive substance in tobacco. The Food and Drug Administration (FDA) has the authority to regulate the nicotine levels (without eliminating it) on all tobacco products and is required to address this issue. Before implementing any policy, the FDA must make a thorough assessment of the likely impacts of the policy on the public’s health. While lowering nicotine levels might be expected to lead to declining smoking rates, such policies could generate unintended consequences that would undermine their effectiveness. Our proposed analysis will examine how nicotine regulation may impact the public’s health, including possible unintended consequences from compensation behaviors and the emergence of a black market. The results of this project will inform the FDA as it contemplates designing, evaluating and justifying a policy aimed at reducing nicotine in tobacco products to non-addictive levels.

Aims

  • Aim 1: To modify two existing US population-based dynamic smoking prevalence and mortality models to account for the effects of policies that reduce nicotine to non-addictive levels in all combusted tobacco products
  • Aim 2: To model the number of new smokers, smoking prevalence trajectory, and smoking-related mortality in the US population from 2018-2100 in the absence of nicotine regulation
  • Aim 3: To conduct policy simulation exercises on the impact of nicotine regulations on smoking prevalence and associated mortality

Leads

  • David Mendez, PhDUniversity of Michigan
    David Mendez, PhD
    University of Michigan
    David Mendez, PhD
    University of Michigan: Associate Professor
    Positions: Core Lead, Career Enhancement Core (CEC); Project Lead, Research Project 2
    Role: Co-Investigator
    Profile: sph.umich.edu
    Dr. David Mendez is Core Lead for the Career Enhancement Core (CEC) and Project Lead for Research Project 2. He is also a member of the CAsToR Steering Committee. Dr. Mendez is an Associate Professor in the Department of Health Management and Policy at the University of Michigan. His research focuses on modeling trends of cigarette smoking cessation or switching to e-cigarettes. Dr. Mendez’s research also investigates the financial implications of these trends, with specific focus on tobacco control in the United States.
  • David Levy, PhDGeorgetown University
    David Levy, PhD
    Georgetown University
    David Levy, PhD
    Georgetown University: Professor, Georgetown University Medical Center
    Position: CAsToR Principal Investigator
    Dr. David Levy is PI for CAsToR at Georgetown University and co-Lead of Projects 1 - 3, and the Research Assessment and Input Development Core. He received his PhD in Economics from UCLA (USA), and is currently a Professor of Oncology at Georgetown University. He has published over 250 articles, in renowned journals such as the American Economic Review, BMJ, AJPH, JAMA, The Lancet, Tobacco Control, and PLOS Medicine. He has been principal investigator of grants from the CDC, WHO, the National Cancer Institute, and Bloomberg/Gates Foundation. Dr. Levy currently oversees the design and development of the SimSmoke tobacco policy simulation model, for which he has developed models for over 40 countries covering 85% of the world’s population, and has recently developed models of smokeless tobacco and e-cigarette use. In addition to being a principal investigator on the TCORS grant, he is currently a principal investor on a National Cancer Institute grant with the InternationalTobaccoControl Policy Evaluation Project (theITCProject) in which he has developed models of e-cigarette use for Canada, England and France; and is a principal investigator on the National Cancer Institute CISNET Lung Group. He has recently published articles providing a public health framework for evaluating e-cigarettes and showing the potential benefits of e-cigarettes, as well as papers on the cigarette and e-cigarette markets.
  • Rafael Meza, PhDUniversity of Michigan
    Rafael Meza, PhD
    University of Michigan
    Rafael Meza, PhD
    University of Michigan: Associate Professor, Epidemiology; Associate Professor of Global Public Health; Co-Leader, Cancer Epidemiology and Prevention Program, UM Rogel Cancer Center
    Position: CAsToR Principal Investigator
    Profile: sph.umich.edu
    Dr. Rafael Meza is PI for CAsToR at the University of Michigan and co-Lead of Projects 1 - 2, as well as the Data Analysis and Dissemination Core. He is an Associate Professor of Epidemiology at the University of Michigan, as well as Co-Lead the Cancer Epidemiology and Prevention Program at the UM Rogel Cancer Center. His research utilizes mathematical modeling to assess risk of and develop screening tools for cancer. Dr. Meza has extensive experience in tobacco simulation modeling and has developed models as Coordinating PI for the Cancer Intervention and Surveillance Modeling Network (CISNET) lung group.
  • Kenneth E. Warner, PhDUniversity of Michigan
    Kenneth E. Warner, PhD
    University of Michigan
    Kenneth E. Warner, PhD
    University of Michigan: Avedis Donabedian Distinguished University Professor Emeritus of Public Health; Professor Emeritus of Health Management & Policy; Dean Emeritus of Public Health
    Position: Co-Investigator, Research Project 2
    Role: Co-Investigator
    Profile: sph.umich.edu
    Dr. Kenneth Warner is Co-Investigator for Research Project 2 and a member of the CAsToR Steering Committee. Dr. Warner is the Avedis Donabedian Distinguished University Professor Emeritus of Public Health, Professor Emeritus of Health Management & Policy, and Dean Emeritus of Public Health at the University of Michigan. His expertise surrounds policy implications on tobacco use and cessation trends, in addition to tobacco-related health outcomes resulting from tobacco harm reduction strategies.