The Tobacco Regulatory Science Program (TRSP) supports research applications that will inform the Food and Drug Administration (FDA) in regulating of the manufacture, marketing, and distribution of tobacco products to reduce the public health toll from tobacco product use in the United States.
Research is encouraged on the following High-Priority Research Topics. These topics were updated in October 2024. Only applications with research aims that address one or more of the following High-Priority Research Topics, which are within FDA's Center for Tobacco Products regulatory authority, will be considered for TRSP funding opportunities.
High-Priority Research Relevant to Addiction
Understanding the effect of tobacco product characteristics* of electronic nicotine delivery systems (ENDS) and/or nicotine pouches on addiction and/or abuse liability across populations. Applications addressing addiction must (1) focus on ENDS and/or nicotine pouches AND (2) address one or more of the following High-Priority Research Topics:
- Correlation of nicotine pharmacokinetic and/or pharmacodynamics (and/or other abuse liability outcomes including liking, craving, and withdrawal symptoms) of ENDS and/or nicotine pouches with use behaviors, including cessation or substitution of combusted cigarettes
- Impact of changes in tobacco product characteristics* of ENDS and/or nicotine pouches on dependence and/or use behaviors including progression to regular use
High-Priority Research Relevant to Behavior
Understanding the knowledge, attitudes, perceptions, and/or behaviors related to the use of ENDS, heated tobacco products, nicotine pouches, and/or other emerging tobacco products and/or the impact of characteristics* of these products on use behaviors of these products across populations, when appropriate to the research question. Applications addressing behavior must address the following High-Priority Research Topic:
- The impact of ENDS, heated tobacco products, nicotine pouches, and/or other emerging tobacco products characteristics* on tobacco product use behaviors (such as experimentation, initiation, progression, dual/poly tobacco use, switching, and/or cessation-related behaviors) among youth, young adults, and/or adults
High-Priority Research Relevant to Health Effects
Understanding the health effects of ENDS in human subjects. Applications addressing health effects must address the following High-Priority Research Topic:
- Impact of ENDS use on human health, limited to cardiovascular effects, pulmonary effects, or neurological effects, including acute and/or chronic health outcomes in human subjects (i.e., not in animal models)
High-Priority Research Relevant to Product Composition and Design
Understanding the chemical and/or microbial constituents in any tobacco product and/or the methods for measuring them across products with diverse characteristics,* including impacts due to design properties. Applications addressing product composition and design must address one or more of the following High-Priority Research Topics:
- Determination of levels of characterizing flavors and/or the complexity of the individual ingredients on the sensory perception of such flavors in tobacco products, including cooling ingredients and/or other understudied ingredients
- Evaluation of the chemical, behavioral, and/or pharmacokinetic differences between products containing synthetic nicotine compared to products containing tobacco or nicotine derived from tobacco
High-Priority Research Relevant to Toxicity
Understanding how ENDS and/or changes to ENDS characteristics* affect their potential to cause morbidity and/or mortality in users through direct exposure and/or in nonusers through secondary exposure. These could include cell culture (in vitro) models, animal (in vivo) approaches, computational (in silico) methods, and/or other alternative toxicology approaches and/or studies that test the toxicity of ENDS aerosols (e.g., aldehydes, metals) or specific constituents (e.g., aldehydes, metals) in ENDS. Applications addressing toxicity must (1) focus on ENDS and/or their characteristics* AND (2) address one or more of the following High-Priority Research Topics:
- Toxicological hazard analysis (i.e., cytotoxicity, genotoxicity, mutagenicity, organ toxicity) of flavor ingredient use in ENDS and/or constituents formed during ENDS use
- Dose response of individual flavor ingredients used in ENDS and constituents formed during ENDS use and their potential interaction with metals
- Toxicological interactions (i.e., additive, synergistic, antagonistic) between aldehydes found in ENDS aerosols and comparison of their combined effects to their individual effects, including dose response
FDA encourages research studies to include, where appropriate to the research question, vulnerable populations, including (but not limited to) youth and young adults, those from lower socioeconomic backgrounds (e.g., those with lower household incomes or lower educational attainment), racial or ethnic minorities, sexual and/or gender minorities, rural populations, those pregnant or trying to become pregnant, active-duty military or veterans, those who are or have been incarcerated, and those with mental health conditions or substance use disorders.
If a vulnerable population will be included, applicants will be expected to identify the population and how the population is important to the research question, considering the impact on population health. Health disparity considerations can be incorporated into all of the High-Priority Research Topics.
* The term “characteristic” encompasses materials, ingredients (including additives, nicotine formulations, nicotine concentration, and flavors), design, composition, heating source, nicotine flux, and other features of a tobacco product, including harmful and potentially harmful constituents. Packaging is not included in this definition of characteristic. Characteristics of explicitly specified tobacco products can be incorporated into all of these High-Priority Research Topics.