# Modeling the Impact of Novel Tobacco Product use on Smoking and Long-Term Health Outcomes

> **NIH NIH U54** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2024 · $420,149

## Abstract

PROJECT 1 Abstract
Under the Family Smoking Prevention and Tobacco Control Act, the Food and Drug Administration (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, Project 1 will harmonize and extend well-established Center for
the Assessment of Tobacco Regulations (CAsToR) tobacco control simulation models to examine the impact
of FDA regulatory actions on future trends in cigarette, cigar, electronic nicotine delivery systems (ENDS), and
other novel tobacco product (ONPs) use and associated health outcomes. This project will focus on Behavior
(Aim 1), Impact Analysis (Aims 2 and 3) and Health Effects (Aims 2 and 3) as Scientific Domains (RFA-OD-22-
04). Project 1 has three aims. Aim 1. Characterize longitudinal patterns of use and transitions of
cigarettes, cigars, and ENDS, individually and in combination. Oral nicotine, heated tobacco products
(HTPs), and ONPs will be considered as data on their use become available. Using nationally representative
health surveys, literature reviews and transitions estimates, we will extend a previously developed framework
to examine transitions between regular cigarette and ENDS use to include cigars, HTPs and ONPs. We will
develop transition parameters to distinguish between exclusive, former, dual use and switching patterns for
each product. Aim 2. Develop simulation models of the use patterns of cigarettes, cigars, ENDS, and
other tobacco products in the US and their health implications. We will expand the CAsToR simulation
models (i.e., SimSmoke, Mendez and Warner, Microsimulation and SAVM) to incorporate product use, health
outcomes and all-cause mortality risk of cigars, HTPs, and ONPs. Population transitions in the models will be
modeled through sex- and age-specific initiation and cessation rates for each product and switching rates
between products. Each model will be calibrated and validated against prevalence rates by age and sex from
surveys for each product type. Aim 3. Model the impact of existing and potential regulations on tobacco
use patterns and all-cause mortality associated with cigarette, cigar, ENDS, and other novel tobacco
product use. For all models, we will create the capability to examine how past and future FDA policies will
impact combustible and novel nicotine product use and associated health outcomes. We will develop best
estimates and credible ranges of the policy effect on each product’s initiation, cessation, and switching rates.
We will consider variations in policy effect sizes by age, sex, race, and socioeconomic status. We will initially
focus on the relationship between cigarette and ENDS use, and then incorporate cigar use. Comparative
analyses of the four models’ predictions will be conducted to refine the likely best-case, worst-case, and most
likely projec...

## Key facts

- **NIH application ID:** 10932113
- **Project number:** 5U54CA229974-07
- **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:** 2024
- **Award amount:** $420,149
- **Award type:** 5
- **Project period:** 2018-09-14 → 2028-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10932113

## Citation

> US National Institutes of Health, RePORTER application 10932113, Modeling the Impact of Novel Tobacco Product use on Smoking and Long-Term Health Outcomes (5U54CA229974-07). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10932113. Licensed CC0.

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