# Evaluating New Nicotine Standards for Cigarettes

> **NIH NIH U54** · WAKE FOREST UNIVERSITY HEALTH SCIENCES · 2022 · $2,857,780

## Abstract

OVERALL PROJECT SUMMARY
 Combusted tobacco use continues to devastate public health in the United States and worldwide. The
Tobacco Control Act provides the Food and Drug Administration with the authority to establish product
standards for the nicotine content of combusted tobacco products. In this renewal application we address a
critical question: What will be the impact of reducing nicotine in cigarettes in the context of alternative
tobacco products? If reduced nicotine product standards render combusted tobacco products less reinforcing,
smokers who choose not to quit using nicotine/tobacco completely will likely increase their use of non-
combusted products. This shift from combusted to non-combusted products could greatly reduce toxicant
exposure and reduce the harms associated with tobacco. Three Projects and 3 Cores are proposed. Project 1
(PI: Hatsukami) is a 12-week clinical trial that examines the use of very low nicotine content (VLNC) vs. normal
nicotine content (NNC) cigarettes when smokers are provided vouchers to exchange for cigarettes in an
experimental marketplace that contains a wide range of non-combusted products. Project 2 (PI: Donny) is a 7-
week clinical trial comparing VLNC and NNC cigarettes when participants have access to electronic cigarettes
that vary in nicotine concentration (high v. low) and available flavors (tobacco only v. tobacco and other flavors).
Project 3 (PIs: Colby & Tidey) is a laboratory-based study that assessed the choice to smoke, vape, or abstain
when adolescent smokers are provided cigarettes with VLNC v. NNC and e-cigarettes that vary in nicotine
concentrations and flavors. The Cores will provide the infrastructure and resources to conduct these studies.
The Administrative Core (Directors: Donny & Hatsukami) will ensure the implementation of appropriate
procedures and protocols, the integration of methods, measures, and concepts, the communication and
dissemination of information, the generation of new tobacco regulatory science through a pilot project program,
and the training of new tobacco regulatory scientists. The Biomarkers Core (Director: Hecht) will provide
analysis of biomarkers associated with exposure to nicotine and tobacco-related toxicants. The Biostatistics
and Data Management Core (Director: Le) will assist in study design, integration and monitoring of data, data
analysis, and, when appropriate, the development of novel ways to analyze data.

## Key facts

- **NIH application ID:** 10122928
- **Project number:** 5U54DA031659-10
- **Recipient organization:** WAKE FOREST UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** ERIC Christian DONNY
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,857,780
- **Award type:** 5
- **Project period:** 2011-09-15 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122928

## Citation

> US National Institutes of Health, RePORTER application 10122928, Evaluating New Nicotine Standards for Cigarettes (5U54DA031659-10). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10122928. Licensed CC0.

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