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. These domains were updated in February 2021. Only applications with research aims that are within FDA's 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 and young adults, race/ethnicity, low SES, rural populations, people with mental health or medical co-morbidities, military/veterans, the LBGTQ community, and pregnant women/women of reproductive age.

FAQs: Responsiveness to FDA’s Center for Tobacco Products Regulatory Authority

These FAQs (PDF) clarify research that is and is not within scope of the FDA’s Center for Tobacco Products (CTP) regulatory authority. Only research that is within the regulatory authority of the FDA CTP will be considered for funding.

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 (HPHCs). Product characteristics can be incorporated into all of the topics below:

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 (HPHCs) in smoke and aerosols.
  • Identities, quantities, and origins of the chemical constituents of Electronic Nicotine Delivery Systems or ENDS aerosols.
  • Determination of relationship between the temperature of the heating source/wicking material/air flow of ENDS devices, and constituent levels/particle size 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 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, aerosols, or specific constituents in tobacco and the tobacco product.

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 products other than conventional cigarettes, including ENDS; and toxicological impact of nicotine, flavors, and other constituents across different concentrations and 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.
  • ENDS users’ nicotine exposure during experimentation, regular ENDS use, dual use of ENDS and cigarettes, and cigarette smoking quit attempts; 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 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 tobacco product characteristics (such as flavors, product design, ENDS liquid nicotine concentration, nicotine formulation) on human health.
  • Association between exclusive products other than conventional cigarette-related exposures and disease risk; association between dual/poly use of tobacco products and disease risk.
  • Biomarkers to assess short- and long-term effects of tobacco products other than conventional cigarettes.
  • 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.
  • Association between cigar sub-types use and disease risk.

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 tobacco product characteristics (such as flavors, product design, nicotine concentration and, formulations) on tobacco use behaviors including experimentation, initiation, progression, dual/poly use, complete/partial switching, transition to non-flavored products, and cessation-related behaviors.
  • Innovative methods, measures, and study designs to assess tobacco use knowledge, attitudes, perceptions, and 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, intentions, susceptibility, experimentation, initiation, adoption, substitution, switching, and use (including dual use) and cessation-related behaviors;
  • Measures (e.g., attitudes, perceptions, intentions, behaviors) to best predict future use of tobacco products other than conventional cigarettes, including among current and established users of cigars, waterpipe, heated tobacco products and ENDS.
  • Relative appeal of different flavors and flavor categories and product types to youth, young adults, and adults.

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 tobacco products other than conventional cigarettes 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 pictorial warnings for tobacco products other than conventional cigarettes.
  • Effective messages and communication for educating consumers about the health effects of cigars, waterpipe and heated tobacco products.

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 to regular use, product switching, dual use and cessation related-behaviors 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/young adults’ ENDS use.
  • How labeling, marketing, and advertising impact abuse liability of different tobacco products.
  • Impact of potential marketing restrictions of newly authorized products on youth/young adult/non-user experimentation, initiation, use and cessation, as well as adult continued use and cessation.

Impact Analysis

Understanding the potential impact of FDA regulatory actions.

Priorities

  • Evaluation of local, state, and international policies that are relevant to FDA CTP regulatory authorities (e.g., flavor bans, specific constituent changes or bans), with a focus on effects on tobacco use/behavioral outcomes).
  • Evaluation of tobacco product marketing authorizations of new/novel products (e.g., PMTA, MRTP), with a focus on effects on tobacco use/behavioral outcomes (e.g., use by youth).
  • Behavioral economics and population 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 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 and young adults use of tobacco products.
  • 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.
Last updated on May 12, 2021