Prospective Cohort Survey: Testing Population-Level Predictions 

Using a prospective cohort survey to test population-level predictions generated by Projects 1-3

Project 4’s (Project Director: Dr. Joanna Cohen) specific aims are to test population-level predictions that arise from Project 1-3’s controlled studies of product toxicity, user behavior and product abuse liability using a prospective cohort survey that includes current exclusive ECIG users and current dual users of ECIGs and tobacco cigarettes. Specifically, the study will assess the population-level effects of three potential regulatory actions: (1) limits on liquid nicotine concentration, (2) constraints on nicotine flux and (3) reduction in flavor availability.

Project 4 addresses the scientific domain of impact analysis and its instruments are informed by the Contextual Knowledge Core that will help determine how to assess self-report accurately and assess dependence reliably among ECIG users.

Overall, results will reveal the extent to which observations made under controlled conditions yield valid population-level predictions. Thus, this project is part of a center with an integrative theme of impact analysis that draws on the team’s expertise in evaluating population-level effects of tobacco regulation and will provide FDA a set of tools that can be used to guide regulation development so that, by the time a regulation goes into effect, validated methods have been used to test it, refine it and generate data that show its health-promoting effects are maximized and unintended consequences are minimized.

This research is supported by the National Institute on Drug Abuse of the National Institutes of Health and the Center for Tobacco Products of the U.S. Food and Drug Administration under Award Number U54DA036105. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or the Food and Drug Administration