NIH: Office of Disease Prevention

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Science will guide all FDA actions to reduce the public health toll from tobacco products in the United States. Science will help FDA understand tobacco and its ingredients and constituents, tobacco addiction, tobacco marketing and labeling, and childhood tobacco use.

FDA Center for Tobacco Products Research Interest Areas

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 FDA CTP mission, TRSP encourages research applications that address the following Scientific Domains:

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 include 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; and 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 include 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; and correlation of ENDS use behaviors with pharmacokinetic and pharmacodynamics effects of nicotine and other 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 include 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; and 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 include changes in tobacco product characteristics (such as flavors, product design, or packaging) impact 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); and 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 include 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 include 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; and impact of potential marketing restrictions on youth experimentation, initiation, use, and cessation.

Impact Analysis - Understanding the impact of potential FDA regulatory actions. Priorities include 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.

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 above topics.

Tobacco Regulatory Science Review Criteria

Review Criteria

As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

  • Significance: Does the project address an important issue or a critical barrier in regulatory authority over tobacco products? If the aims of the project are achieved, how will regulatory science research be informed or regulation affected? How will successful completion of the aims have affect on the concepts, methods, technologies, or regulation of tobacco products?
  • Investigator(s): Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
  • Innovation: Does the application challenge and seek to shift current research in the field of tobacco science as it relates to the manufacture, distribution, and marketing of tobacco products? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, or instrumentation proposed? Will the outcomes of the project provide new information to further develop the knowledge base that informs the manufacture, distribution, and marketing of tobacco products in order to protect public health?
  • Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?
  • Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items: Protection of Human Subjects; Inclusion of Women, Minorities, and Children; Vertebrate Animals; and Biohazards.

For information about funding opportunities and how to apply, visit the Funding Opportunities section.