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. Research priorities supported through the NIH-FDA Tobacco Regulatory Science Program include:
- Nicotine dependence threshold among youth and adults and impact of nicotine reduction on tobacco product use behavior (e.g., topography, compensation, switching, multiple use, initiation, cessation, relapse)
- Cigar (small, large, cigarillos) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity
- Smokeless tobacco initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence and toxicity
- E-cigarettes initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity
- Other tobacco product (e.g., hookah, pipes, dissolvables) initiation, use (including transitions to other tobacco products and multiple use), perceptions, dependence, toxicity
- The impact of tobacco product characteristics, (e.g., ingredients, constituents, components, additives such as flavors, and labeling and marketing) on initiation, especially among youth and other vulnerable populations
- Toxicity thresholds for each of the 20 harmful and potentially harmful constituents identified in the March 2012 Guidance for Industry
- Computational/mathematical modeling and simulation and/or statistical modeling of the public health impact of FDA/CTP regulation of potential modified risk tobacco products, e.g., product standards, communications regarding risks of tobacco products
- Consumer perceptions of tobacco products including the impact of labeling and marketing
- Effective communication strategies regarding harmful and potentially harmful constituents and risks of tobacco products
Vulnerable populations referenced in research questions include, but are not limited to age, gender, race, ethnicity, income, occupation, geographic location, people with mental health or medical co-morbidities, the military/veterans, the lesbian, gay, bi-sexual, transgendered, questioning (LGBTQ) community, and pregnant women/women of reproductive age.
Tobacco Regulatory Science 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 the field? If the aims of the project are achieved, how will scientific knowledge and/or technical capability be improved? How will successful completion of the aims affect the concepts, methods, and technologies related to the manufacture, distribution, and marketing 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.