What We Do
With the passage of the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), the FDA acquired the authority to regulate the manufacture, marketing, and distribution of tobacco products in order to protect public health. To better inform FDA’s regulatory authorities, the NIH and FDA formed an interagency partnership to foster tobacco regulatory research, capitalizing on NIH’s infrastructure to support tobacco-related research and funding from FDA. Get more information about the FDA Center for Tobacco Products (FDA/CTP) research priorities.
NIDA-TRSP Office Roles
- Function as NIDA liaison with FDA/CTP and NIH-TRSP
- Manage internal coordinating committee comprised of each NIDA division to:
- Monitor NIH-TRSP activities and progress
- Provide administrative templates for NIDA staff
- Devise Standard Operating Procedures (SOPs)
- Help solicit nominations for IC Investigator-initiated funding requests in response to periodic NIH-TRSP-based requests
- Review Nicotine Research Cigarettes (NRC) requests, as necessary
- NRC page with procedures / schematic
- NIDA’s Drug Supply Program
- Organize NIDA-TRSP-related meetings
Current Funding Mechanisms
In collaboration with the FDA Center for Tobacco Products, NIH is increasing its portfolio to support the scientific needs of the Center. There are a number of funding opportunities, which are currently accepting applications. Investigator initiated applications may also be submitted for review. Potential applicants should think about how the findings from the research they propose will inform a specific regulatory authority of FDA/CTP and fit within the FDA/CTP research priorities. For more information, please read the TRSP FAQs (PDF), contact an NIH Program Official or email NIDATRSprogram@nida.nih.gov with any questions concerning grant responsiveness.
Tobacco Centers of Regulatory Science (TCORS)
The multidisciplinary Tobacco Centers of Regulatory Science (TCORS) are a long-standing component of the Tobacco Regulatory Science Program. Made up of scientists with a broad range of expertise (e.g., epidemiology, economics, toxicology, addiction, and marketing), they generate critical research that informs the Food and Drug Administration’s (FDA) regulation of tobacco products. Collectively, the TCORS sites increase knowledge across the full spectrum of basic and applied research on tobacco and addiction. The program also provides young investigators with training opportunities to ensure the development of the next generation of tobacco regulatory scientists. Over the course of three rounds of TCORS, NIH and FDA have funded 29 centers. To date, the TCORS have produced over 1,800 publications, many of which have been cited in proposed rules by FDA.
Essential elements of the TCORS include:
- At least three theoretically grounded, strong research projects with an integrative theme
- An Administrative Core and other cores as needed
- The ability to conduct developmental/pilot research
- A program for career development
The most current round of TCORS, TCORS 3.0, includes awards to seven institutions. NIDA programmatically manages several TCORS from this cohort. Notably, TCORS 3.0 continues the legacy of previous TCORS, providing important data on the following scientific domains related to FDA’s regulatory authority for tobacco products:
- Understanding tobacco product composition and design
- Approaches that test the toxicity of non-cigarette tobacco smoke, aerosol, or specific constituents
- Effects of tobacco product characteristics on addiction and abuse liability
- Short- and long-term health effects of tobacco products
- Understanding knowledge, attitudes, and behaviors related to tobacco product use
- Understanding how to effectively communicate the health effects of tobacco products
- Influences of tobacco marketing
- Understanding the impact of potential FDA regulatory actions.
Through their career development and pilot project programs, the TCORS 3.0 help meet the continued need for investigators with the quality and breadth of experience necessary to conduct cutting-edge research related to the regulation of the manufacture, distribution, and marketing of tobacco products.
More information is available on TCORS.
Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL)
In addition to TCORS, NIDA administers the Center for Coordination of Analytics, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science. CASEL facilitate synthesis, coordination, and communication of research and career enhancement within the scientific research programs funded by the FDA Center for Tobacco Products (CTP). Through leadership, coordination, and facilitation of communication and collaborative efforts among tobacco regulatory science investigators, CASEL can accelerate the identification, integration, and advancement of research findings relevant to the Family Smoking Prevention and Tobacco Control Act. New to CASEL 3.0 is an Opportunity Fund (OF) that will support time-sensitive, rapid response projects to which extramural investigators may apply. The OF will be made available each year to support projects that address the high priority, time-sensitive research needs of the FDA CTP.
- NIH TRSP webpage - https://prevention.nih.gov/tobacco-regulatory-research
- Ending the Tobacco Epidemic: A Tobacco Control Strategic Action Plan for the HHS - https://www.hhs.gov/sites/default/files/ash/initiatives/tobacco/tobaccostrategicplan2010.pdf (PDF, 2 MB)
- Ending the Tobacco Problem: A Blueprint for the Nation - https://www.nap.edu/catalog/11795/ending-the-tobacco-problem-a-blueprint-for-the-nation
- FDA Center for Tobacco Product’s Science and Research Page - https://www.fda.gov/tobacco-products/tobacco-science-research
- FDA Center for Tobacco Products Homepage - https://www.fda.gov/tobacco-products
- FDA Use of Investigational Tobacco Products Guidance - https://www.fda.gov/downloads/tobaccoproducts/labeling/rulesregulationsguidance/ucm463953.pdf (PDF, 968KB)
- All requests/questions should be sent to NIDATRSprogram@nida.nih.gov and addressed to one of the following NIDA TRSP team:
- Mary Kautz, Program Coordinator
- Lizette Nkongho, MPH, Scientific Program Manager
- Flair Lindsey, Program Analyst
- For media inquiries specific to the NIH-FDA Tobacco Regulatory Science Program, please email the NIH TRSP office at TRSP@mail.nih.gov.