Tobacco Regulatory Research Priorities

TRSP encourages research applications that address the FDA's research priorities to better understand toxicity, addiction, and appeal of tobacco products.

Research is encouraged in the following scientific domains. (Note: Only applications with research aims that are within FDA Center for Tobacco Products’ regulatory authority will be considered for TRSP funding opportunities.)

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.

Toxicity

Understanding how tobacco products and changes to tobacco product characteristics affect their potential to cause morbidity and mortality, 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. 

Given the chronic nature of the human health effects of tobacco products, the assessment of both chronic and acute tobacco product toxicity is important. Assays that can address chronic toxicity resulting from long term tobacco use are a priority and an important piece of the evaluation of the human health effects of tobacco products.

Priorities

  • Toxicological assays (in vivo and in vitro) to compare toxicity across different types of tobacco products within the same class, including electronic nicotine delivery systems (ENDS), cigars, waterpipes, and smokeless tobacco.
  • How product design characteristics (and changes 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.

Addiction

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

Priorities

  • Impact of changes in tobacco product characteristics (such as flavors or product design) 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 harmful and potentially harmful constituents (HPHCs) delivered by ENDS.

Health Effects

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

Priorities

  • Impact of changes in tobacco product characteristics (such as flavors or product design) on human health.
  • Biomarkers to assess short- and long-term effects of non-cigarette tobacco products.
  • Clinical evaluations to distinguish changes in cell 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.

Priorities

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

Communications

Understanding how to effectively communicate to the public and vulnerable populations regarding nicotine and the health effects of tobacco products, including media campaigns and digital media.

Priorities

  • Messages to effectively communicate about nicotine and the 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.

Marketing Influences

Understanding why people become susceptible to using tobacco products (both classes of products and products within classes) and to transitions between experimentation and initiation to regular use and dual use. Topics may include tobacco industry marketing such as advertising, point-of-sale, digital media, and promotions.

Priorities

  • Methods, measures, and study designs to best assess the impact of tobacco product advertising, and promotion restrictions on users and non-users of tobacco, including marketing of novel and/or potential modified risk tobacco products.
  • Impact of potential marketing restrictions on youth experimentation, initiation, use, and cessation.

Impact Analysis

Understanding the impact of potential FDA regulatory actions.

Priorities

  • Evaluation of policies at the state and community level that fall within FDA CTP regulatory authorities.
  • 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 products standards addressing toxicity, appeal, and addiction.