Electronic nicotine delivery systems (ENDS) use duration and cardiopulmonary outcomes: evidence to inform FDA regulation

The National Heart Lung and Blood Institute awarded the Regents of the University of Michigan $234,000 on September 1, 2026, under the Family Smoking Prevention and Tobacco Control Act Regulatory Research program (CFDA 93.077, Assistance Listing 93.077) to examine how the duration of electronic nicotine delivery systems (ENDS) use affects cardiopulmonary health outcomes among adults with current or former cigarette smoking histories.

The research leverages prospective, nationally representative data from the Population Assessment of Tobacco and Health (PATH) Study to assess the association between ENDS use duration and incidence of cardiopulmonary disease, determine whether baseline health status modifies these associations, and evaluate whether changes in cardiopulmonary symptoms among adults switching from cigarettes to ENDS differ according to ENDS use duration. Findings will inform FDA Center for Tobacco Products product assessment, regulation, and evaluation of harm reduction claims, and support targeted public health interventions and policies affecting millions of U.S. adults who currently or formerly smoked cigarettes.

Work is performed at the University of Michigan, Ann Arbor, Michigan, with a period of performance from September 1, 2026, through August 31, 2028. The award is a Project Grant, a standard assistance mechanism supporting time-limited research projects. The federal program supports regulatory research under the Family Smoking Prevention and Tobacco Control Act to provide scientific evidence guiding tobacco product regulation.

Abstract

Millions of adults in the united states who currently or formerly smoked cigarettes are turning to electronic nicotine delivery systems (ENDS) products as an alternative to combustible tobacco, yet the long-term effects of sustained ENDS use on cardiopulmonary health is poorly understood. This GAP in knowledge hinders the ability of the food and drug administration's (FDA) center for tobacco products (CTP) to accurately evaluate health risks, assess harm reduction claims, and establish effective regulations that protect public health. Leveraging prospective, nationally representative data from the population assessment of tobacco and health (PATH) study, the objective of this project is to clarify how the duration of ENDS use affects cardiopulmonary health outcomes among adults with current or former cigarette smoking histories. This study will generate robust, actionable evidence by (1) examining the association between the duration of ENDS use and the incidence of cardiopulmonary disease, (2) assessing whether baseline health status modifies these associations, and (3) evaluating whether changes in cardiopulmonary symptoms among adults switching from cigarettes to ENDS differ according to the duration of ENDS use. These findings will address key regulatory science needs and directly support the objectives of RFA-OD-25-008 by informing FDA CTP product assessment, regulation, and evaluation of harm reduction claims, while enabling targeted public health interventions and policies that impact the health of millions of adults who currently or formerly smoked cigarettes in the united states.