# Research Project 1: Comparative Modeling of the Impact of E-cigarettes use on Smoking and Long-Term Health Outcomes

> **NIH NIH U54** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $79,756

## Abstract

PROJECT 1 Abstract
Under the Family Smoking Prevention and Tobacco Control Act, the FDA is required to show that any new rule
to regulate the marketing, sale or content of tobacco products is “appropriate for the protection of the public
health.” To provide the FDA with a framework to assess the potential health impacts of tobacco regulations,
this TCORS Project will harmonize and extend four established tobacco control simulation models to examine
the impact of different possible FDA regulatory actions on future trends in cigarette and e-cigarette use, and
associated health outcomes. The Project will focus on Impact Analysis (Aim 3, 4, and 5) and Health Effects
(Aims 2 and 3), with a secondary emphasis on Behavior (Aim 1).
Using a generalized harm reduction framework and statistical approaches to distinguish experimentation from
long-term tobacco product use, we will develop initial prevalence rates for the models; a range of plausible
future status quo transitions by age and gender for initiation and cessation for cigarettes and e-cigarettes; and
a range of plausible switching rates between cigarettes and e-cigarettes. Using literature reviews and expert
elicitation panels to develop relative risk estimates for specific health outcomes, we will extend the models from
all-cause mortality to also project tobacco-related mortality due to cardiovascular and chronic obstructive
pulmonary disease, and adverse maternal and child health outcomes. We will also extend the models to
consider the impact of specific policies related to cigarette and e-cigarette use, such as the provision of
information about health effects, using literature reviews and expert panels to develop policy effect estimates.
Upon incorporating the common initial prevalence and transition rates for cigarette and e-cigarette use, the
extensions regarding health outcomes, and the policy parameters, we will use the four models with their
different structures to examine the impact of current and projected future e-cigarette use on overall harms. We
will also project how specific potential FDA regulations individually and in combination will likely impact
cigarette and e-cigarette use rates and associated health outcomes over a 50-year future period. Comparative
analyses of the four models’ predictions will be conducted to further refine the likely best-case, worst-case, and
most likely projected scenarios and better assess regulatory impacts. In addition, the models will have the
capacity and flexibility to rapidly use new data from national surveillance cohorts and incorporate new
regulatory policy options as these emerge. Our models will also be made flexible enough to further consider
substitution into and away from other alternative nicotine delivery products, including cigars, smokeless
tobacco and heat-not-burn products.

## Key facts

- **NIH application ID:** 10270003
- **Project number:** 5U54CA229974-04
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** David Theodore Levy
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $79,756
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10270003

## Citation

> US National Institutes of Health, RePORTER application 10270003, Research Project 1: Comparative Modeling of the Impact of E-cigarettes use on Smoking and Long-Term Health Outcomes (5U54CA229974-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10270003. Licensed CC0.

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