Analytical Laboratory: Toxicity Testing

Using toxicity testing data to test hypotheses about advanced-generation ECIGs and generate population-level predictions regarding potential regulatory action

Project 1’s (Project Director: Dr. Alan Shihadeh) specific aims are to use established aerosol research methods to examine how ECIG emissions are influenced by three potential regulatory actions: (1) limits on liquid nicotine concentration, (2) constraints on nicotine flux and (3) reduction in flavor availability. This work is informed by the Contextual Knowledge Core (Core Director: Dr. Pebbles Fagan).

Project 1 will provide new data regarding the role of nicotine concentration, flux and liquid availability on ECIG toxicity, while informing predictions regarding the consequences of potential regulatory action. These predictions will then be examined at the population level within Project 4’s prospective cohort survey (Project Director: Dr. Joanna Cohen).

Thus, Project 1 is part of an integrative theme of impact analysis and draws on the team’s aerosol research expertise to provide FDA tools that can be used to guide regulation development so that, by the time a regulation goes into effect, methods predictive of population-level phenomena have tested it, refined it and generated data that show its health-promoting effects are maximized and unintended consequences are minimized.

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

WHO Collaborating Centre for Tobacco Product Testing and Research