# Clinical Pharmacology of Electronic Cigarettes

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2020 · $752,196

## Abstract

PROJECT SUMMARY/ABSTRACT
This proposal is a resubmission of a competing renewal application for our study, “Clinical Pharmacology of
Electronic Cigarettes”. The FDA has deemed electronic cigarettes (EC) to be tobacco products that are to be
regulated as such under the 2009 Family Smoking Prevention and Tobacco Control Act. Among the
characteristics that are relevant to FDA regulation are the addictiveness and potential harm of ECs, both of which
are determined in substantially by effects of nicotine. Regulations of ECs could include regulation of the device
power, nature of coils and wicks, and the composition of EC liquids. A critical unresolved regulatory issue is
whether there should be limit on the nicotine content of e-liquids.
Based on evidence of nicotine titration in EC users, we question the proposition that setting an upper limit for
nicotine content of e-liquids will benefit the health of smokers who are switching to EC to aid quitting cigarette
smoking. We hypothesize the opposite – namely that EC users will titrate their intake of nicotine such that they
will inhale similar amount of nicotine but fewer aerosol toxicants and suffer less harm to health when using higher
vs lower nicotine content e-liquids. Thus, we propose to study systemic nicotine exposure; nicotine-related
subjective, cardiovascular (CV) and hormonal effects; exposure to non-nicotine toxicants (volatile organic
compounds, such as acrolein and benzene); and biomarkers of CV disease (CVD) risk in EC users switched
from low to high nicotine content e-liquids. If our hypothesis of lower potential risk with use of high nicotine
concentration ECs is confirmed, it would suggest that federal regulation not place an upper limit on nicotine
content, and that regulators might in some cases promote the use of higher rather than lower nicotine liquids for
reasons of safety.

## Key facts

- **NIH application ID:** 9978768
- **Project number:** 5R01DA039264-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** NEAL L BENOWITZ
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $752,196
- **Award type:** 5
- **Project period:** 2015-06-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9978768

## Citation

> US National Institutes of Health, RePORTER application 9978768, Clinical Pharmacology of Electronic Cigarettes (5R01DA039264-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9978768. Licensed CC0.

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