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

> **NIH NIH U54** · UNIVERSITY OF MICHIGAN AT ANN ARBOR · 2021 · $435,024

## Abstract

PROJECT 2 - Abstract
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.
The Aims of the Project are: (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; (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; and (3) to
conduct policy simulation exercises on the impact of nicotine regulations on smoking prevalence and
associated mortality. We will focus on potential policy-related changes to smoking prevalence and overall
mortality; however, other health outcomes may be incorporated as they become available from Project One.
While the focus of the study will be on nicotine reduction, the models will be flexible enough to examine the
effect of other FDA regulations to alter cigarette content, such as limits on particular toxic ingredients. This
Project will focus on Impact Analysis (Aim 3) and Health Effects (Aims 2 and 3), with a secondary focus on
Addiction (Aims 1 and 2), as described in RFA-OD-17-006.

## Key facts

- **NIH application ID:** 10251104
- **Project number:** 5U54CA229974-04
- **Recipient organization:** UNIVERSITY OF MICHIGAN AT ANN ARBOR
- **Principal Investigator:** David Mendez Emilien
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $435,024
- **Award type:** 5
- **Project period:** 2018-09-14 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10251104

## Citation

> US National Institutes of Health, RePORTER application 10251104, Research Project 2: Modeling the Impact of Nicotine Regulation on Smoking and Smoking-Related Mortality (5U54CA229974-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10251104. Licensed CC0.

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