Tobacco Regulatory Research Priorities

TRSP supports research applications that will inform the FDA in regulation 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 in the following scientific domains. Only applications with research aims that are within FDA Center for Tobacco Products’ regulatory authority will be considered for TRSP funding opportunities.

The FDA also recommends research studies 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 comorbid mental health conditions and/or substance use disorders, military/veteran populations, pregnant women or women of reproductive age, and sexual and gender minorities.

The term "characteristic" encompasses materials, ingredients (including additives 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 of the below topics
 

Chemistry and Engineering

Understanding the chemical constituents in tobacco products and the methods for measuring them across products with diverse characteristics.

Priorities:

  • Determination of smoking or vaping regimen to be used for measuring harmful and potentially harmful constituents (HPHCs) in smoke and aerosols.
  • Identities, quantities, and origins of the chemical constituents of electronic nicotine delivery systems (ENDS) aerosols.
  • Determination of relationship between the temperature of the heating source/wicking material/air flow of ENDS devices and the constituent levels in the aerosol.
  • Development of methods to evaluate nicotine release across different smokeless tobacco products (e.g., snuff/dip, snus, chew).

Toxicity

Understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality in both users and secondary exposure; including animal and cell culture models as well as novel alternative toxicology approaches that test the toxicity of tobacco smoke, aerosols, or specific constituents in tobacco.

Priorities

  • Toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class including ENDS, cigars, waterpipes, and smokeless tobacco.
  • 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 non-cigarette tobacco products, including ENDS.
  • Toxicological impact of nicotine, flavors, and other constituents across different routes of exposure.

Addiction

Understanding the effect of tobacco product characteristics on addiction and abuse liability across populations.

Priorities

  • Impact of changes in tobacco product characteristics (such as flavors, product design, and nicotine formulation) on dependence.
  • Differences in dependence and tobacco use patterns with use of low nicotine content cigarettes in context with other tobacco products.
  • The amounts of nicotine delivered to ENDS users during experimentation, regular ENDS use, dual use of ENDS and cigarettes, and cigarette smoking quit attempts.
  • Correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamic effects of nicotine and other HPHCs delivered by ENDS.
  • The relationship between specific flavor categories in combusted tobacco products and adult users’ interest in cessation as well as quit attempts, reduced use, and/or switching to potentially less harmful tobacco products.

Health Effects

Understanding the short- and long-term health effects of tobacco products across populations of special relevance, as appropriate. Highest priority areas include cardiovascular or respiratory health effects, including inflammation. Other health effects including cancer, oral, or reproductive health may be included within projects but must not be the primary focus of the application.

Priorities

  • Impact of changes in tobacco product characteristics (such as flavors, product design, ENDS liquid nicotine concentration, nicotine formulation) on human health.
  • Association between exclusive non-cigarette tobacco-related exposures and disease risk; association between dual/poly use of cigarette and non-cigarette and disease risk.
  • Biomarkers to assess short- and long-term effects of non-cigarette tobacco products.
  • Clinical evaluations to distinguish changes in cell/tissue function/physiology specific to tobacco exposure (e.g., ENDS aerosol exposure) known to indicate longer term disease development and progression.

Behavior

Understanding the knowledge, attitudes, and behaviors related to tobacco product use and changes in tobacco product characteristics across populations, as appropriate.

Priorities

  • The impact of changes in tobacco product characteristics (such as flavors, product design, packaging, very low nicotine cigarette, nicotine formulations) on tobacco use behaviors including experimentation, initiation, progression, dual/poly use, transition to non-flavored products, and cessation-related behaviors.
  • Innovative methods and measures to assess tobacco use behaviors.
  • Measures, methods, or study designs to assess the likely impact of ENDS and heated tobacco products, and/or potential modified risk tobacco products on tobacco use behavior, including perceptions, susceptibility, experimentation, initiation, adoption, switching, and use (including dual use) and cessation-related behaviors;
  • Measures (e.g., attitudes, perceptions, intentions) to best predict future behaviors of non-cigarette tobacco product use, including among current and established users of cigars, waterpipe, and ENDS.

Communications

Understanding how to effectively communicate to the public regarding the health effects of tobacco products and nicotine (including addiction), through media campaigns, and digital media.

Priorities

  • Identifying effective messages, message components and communication channels to prevent initiation and countering uptake of ENDS by youth.
  • Messages to effectively communicate about risks associated with nicotine use and the potential harms of non-cigarette tobacco product use.
  • Methods and messages for communicating complex scientific concepts to the general public, including risk and harms of tobacco use taking into account unintended consequences.
  • Effectiveness of text and graphic warnings for tobacco products other than cigarettes.
  • Effective messages and communication for educating consumers about the health effects of cigars and waterpipe.

Marketing Influences

Understanding the impact of marketing on susceptibility to using tobacco products (both classes of products and products within classes) and transitions between experimentation, initiation to regular use, and dual use among different populations. Topics may include tobacco industry marketing such as advertising, digital media, and promotions.

Priorities

  • 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, including marketing of novel and/or potential modified risk tobacco products.
  • What components of ENDS marketing have the greatest impact on youth ENDS use.
  • How labeling, marketing, and advertising impact abuse liability of different tobacco products.
  • Impact of potential marketing restrictions on youth experimentation, initiation, use and cessation.

Impact Analysis

Understanding the potential impact of FDA regulatory actions.

Priorities

  • Evaluation of policies at the state and community level that fall within FDA CTP regulatory authorities (e.g., flavor bans, specific constituent changes or bans).
  • Methods and measures (e.g., behavioral economics, population modeling) 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 such as ban on flavored cigars, ban on menthol in cigarettes and cigars, and ban on flavors that appeal to youth in any tobacco product).
  • Impact of heightened age verification and age restricted in-person locations on youth use of ENDS.
  • Evaluations of the differential impact and/or possible unintended consequences of tobacco regulatory actions among specific populations, as appropriate, addressing how such actions may increase or decrease tobacco-related health disparities.