The Family Smoking Prevention and Tobacco Control Act (TCA) gives the Food and Drug Administration (FDA) broad authority to regulate tobacco product manufacturing, distribution, and marketing. Although a vast and sound science base exists with regard to numerous areas of the TCA, new research will provide scientific evidence in several areas. Consistent with the Center's mission, CTP encourages research that addresses the below Scientific Domains. CTP encourages research studies to include, where appropriate to the research question, populations of special relevance, including (but not limited to): youth, socioeconomically disadvantaged populations, racial/ethnic minorities, underserved rural populations, people with co-morbid mental health conditions and/or substance use disorders, military/veteran populations, pregnant women or women of reproductive age, and sexual and gender minorities.
Product Composition and Design – Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics*. Priorities include:
- Determination of smoking, heat-generating, or aerosol-generating regimen to be used for measuring harmful and potentially harmful constituents (HPHC) in smoke (e.g., cigarettes, pipes) and aerosols (e.g., ENDS, heated tobacco products);
- Identification, quantification, and determination of the formation of the chemical constituents of novel tobacco products including ENDS aerosols or other aerosol-generating tobacco products;
- Determination of relationship between the nonadjustable or user adjustable design parameters of heating element temperature/wicking material/air flow of ENDS devices or other aerosol-generating tobacco products and constituent yields/particle size in the aerosol;
- Determination of the relationship between waterpipe materials/design of waterpipe devices and constituent yields in the waterpipe smoke;
- Development of internationally recognized analytical methods applicable to various tobacco types;
- Development of methods to evaluate nicotine release across different smokeless tobacco products (e.g., snuff/dip, snus, chew);
- Characterization of the antimicrobial activity of propylene glycol (PG), vegetable glycerin (VG), and flavor ingredients;
- Determination of relationship between humectant concentration or type and water activity of waterpipe, pipe, and cigar tobacco;
- Characterization of the relationship between intrinsic/extrinsic factors (e.g., battery design; environmental conditions, use conditions [e.g., changing battery, charging]) and ENDS battery overheating, fire, or explosion incidents.
Toxicity – Understanding how tobacco products and changes to tobacco product characteristics* affect their potential to cause morbidity and mortality in users and nonusers through secondary exposure; including animal (in vivo) and cell culture (in vitro) models, as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke (other than cigarette), aerosols, or specific constituents in tobacco and the tobacco product. Priorities include:
- Evaluation of toxicity from exposures to complex mixtures of tobacco-related constituents in ENDS aerosol, waterpipe smoke, cigar smoke, and smokeless tobacco using toxicological assays such as in vivo, in silico, as well as in vitro models that are more physiologically relevant to humans;
- How product design characteristics* (variation(s) in those characteristics*) impact constituent exposure and toxicity from tobacco products;
- Biomarkers to assess exposure, as well as biomarkers to assess harm or toxicity of products other than conventional cigarettes, including ENDS and waterpipes; and toxicological impact of nicotine, flavors, and other constituents across different concentrations, patterns of use behavior (dual/poly use, product switching) and routes of exposure.
Addiction – Understanding the effect of tobacco product characteristics* on addiction and abuse liability across populations. Priorities include:
- Impact of changes in tobacco product characteristics* (such as flavors, product design, and nicotine formulation) on dependence and use behaviors;
- Correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other HPHCs delivered by ENDS; and the relationship between specific flavor categories in ENDS (including, but not limited to, tobacco, menthol, fruit, and sweet/dessert) and adult users’ interest in cessation as well as quit attempts, reduced cigarette use and/or switching to potentially less harmful tobacco products;
- ENDS users’ biomarkers of exposure during ENDS experimentation, regular ENDS use, and dual use of ENDS and cigarettes (with reduced cigarettes per day and maintaining cigarettes per day).
- Impact of synthetic coolants in ENDS and cigarettes on product abuse liability (e.g., nicotine pharmacokinetics, product subjective effects), dependence, and use behaviors (such as progression to regular product use, switching, and cessation).
Health Effects – Understanding the short- and long-term health effects of tobacco products (excluding conventional cigarettes) with priority on longitudinal data. Areas of interest include cardiovascular, cancer, neurological (e.g., seizures), oral, reproductive, and respiratory health effects (including inflammation and lung disorders (e.g., asthma, COPD)). Priorities include:
- Impact of tobacco product characteristics* (such as e-liquid non-tobacco flavors, product design, e-liquid nicotine concentration, nicotine formulation) on human health;
- Impact of novel product use (e.g., ENDS, heated tobacco products) on biomarkers of exposure and biomarkers of potential harm;
- Association between exclusive products other than conventional cigarette-related exposures and disease risk; association between dual/poly use of tobacco products and disease risk;
- Identifying biomarkers of potential harm to assess short- and long-term health effects of tobacco products, with a focus on products other than conventional cigarettes, including deemed products or other novel products;
- Association between cigar sub-types use and disease risk;
- Association between waterpipe and waterpipe materials use and disease risk.
Behavior – Understanding the knowledge, attitudes, perceptions, and behaviors related to tobacco product use and the impact of tobacco product characteristics* on behaviors across populations, as appropriate. Priorities include:
- The impact of tobacco product characteristics* (such as e-liquid flavors, product design, nicotine concentration, and formulations) on tobacco use preferences and behaviors (such as intentions to use, experimentation, initiation, progression, dual/poly tobacco use, switching, and cessation-related behaviors) among youth, young adults, and adults;
- Innovative methods, measures, and study designs to assess tobacco use knowledge, attitudes, perceptions, and behaviors; including measures to best predict future use of tobacco products other than conventional cigarettes (e.g., cigars, waterpipe, heated tobacco products, ENDS);
- Innovative measures, methods, or study designs to assess the likely impact of ENDS and heated tobacco products, other novel products, and/or potential modified risk tobacco products on relevant outcomes, including precursors to tobacco use (e.g., perceptions, intentions, susceptibility), and tobacco use behaviors including experimentation, initiation, progression, dual/poly use, complete switching, and cessation-related behaviors.
- Communications - Understanding how to effectively communicate to the public regarding nicotine and the health effects of tobacco products through media campaigns and digital media. Priorities include:
- Identifying effective tobacco education messages, message components, and communication channels to prevent initiation and to counter uptake of ENDS use and other novel product use by youth and young adults;
- Developing methods to measure and track attention to tobacco education messages delivered on digital channels;
- Developing strategies to increase attention to and engagement with tobacco education messages delivered on digital channels;
- Identifying messages to effectively communicate about the risks associated with nicotine use and the potential relative harms of tobacco products other than conventional cigarettes use;
- Developing methods and messages for communicating complex scientific concepts to the general public, including information about the relative risks and harms of tobacco use (e.g., continuum of harm/harm reduction) while assessing and minimizing unintended consequences of such messages;
- Evaluating the effectiveness of text and pictorial warnings for tobacco products other than conventional cigarettes;
- Developing effective messages and communication for educating consumers about the health effects of cigars, waterpipe, heated tobacco products, ENDS, and novel tobacco products; and their relative harms as compared to cigarettes.
Marketing Influences – Understanding the impact of marketing on susceptibility to and initiation of using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation, regular use, product switching, dual use, and cessation-related behaviors among different populations. Topics may include marketing such as advertising, digital media, and promotions. Priorities include:
- Methods, measures, and study designs to best assess the impact of tobacco product marketing (advertising and promotion) restrictions on users and non-users of tobacco with attention to vulnerable populations (if appropriate), including marketing of new/novel tobacco products;
- Understanding what components of ENDS marketing have the greatest impact on youth and young adults’ ENDS knowledge, attitudes, perceptions, beliefs, and behaviors;
- Understanding how labeling, marketing and advertising impact abuse liability, appeal, perceptions, and intentions to use different tobacco products;
- Examining the impact of potential marketing restrictions of new/novel tobacco products on various initiation and use behaviors (e.g., experimentation, initiation, use, and cessation) across developmental age groups (e.g., youth, young adult, non-user), as well as on adult continued use, dual use, switching, and cessation;
- Examining the impact of exposure to digital tobacco marketing on youth tobacco initiation and sustained use, including prevalence and frequency of exposure on different digital channels and the impact of social media influencers and other marketing partners (e.g., musicians).
Impact Analysis – Understanding the potential or actual impact of FDA regulatory actions. Priorities include:
- Evaluation of local, state, federal, and international policies that are relevant to FDA CTP regulatory authorities (e.g., flavor bans, specific constituent changes or bans, minimum legal sales age, FDA-required cigarette health warnings), with a focus on effects on tobacco use/behavioral outcomes, including tobacco initiation and increasing use among youth and young adults, cigarette cessation and product switching among users, and prevalence change in vulnerable populations; as well as unintended consequences;
- Evaluation of tobacco product marketing authorizations of new/novel products (e.g., PMTA, MRTPA), such as potential impact on health outcomes and effects on tobacco use/behavioral outcomes, including patterns of use among users (e.g., dual use vs. switching) and initiation among unintended users (e.g., use by youth);
- Behavioral economics experiments and population-based modeling studies to estimate the range of potential impacts on behavior and health of potential FDA regulatory actions such as product standards addressing toxicity, appeal, and addiction (e.g., such as a ban on flavored cigars, a ban on menthol in cigarettes and cigars, lowering nicotine in combustible cigarettes, and ban on flavors that appeal to youth in any tobacco product);
- Evaluations of the differential impact and/or possible unintended consequences of tobacco regulatory actions among specific populations and, as appropriate, addressing how such actions may affect vulnerable populations;
- Health risk analysis at the population level to estimate the potential public health impacts of FDA regulatory actions such as tobacco product marketing authorizations of new/novel products (e.g., PMTA).
*The term "characteristic" encompasses materials, ingredients (including additives, nicotine formulations, and flavors), design, composition, heating source, and other features of a tobacco product, including harmful and potentially harmful constituents. Product characteristics can be incorporated into all the above topics.
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 the research priorities.