Since 1968 the University of Kentucky has provided reference tobacco products (including the most recent 1R6F reference cigarette) as standards for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. The University of Kentucky, Center for Tobacco Reference Products (CTRP) is committed to supply certified standards for tobacco product research and to work with the FDA to develop new certified reference products as necessary. This project will produce and characterize smokeless tobacco reference products representative of loose leaf chewing tobacco, moist snuff, and pouched snus. These new certified reference products will be manufactured in one manufacturing run each, to ensure product uniformity, and will have certified physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, and for method validation and investigational purposes. A process for the design, analysis, and approval is included to ensure input from stakeholders and that the new reference smokeless tobacco products meet the specified goals. Quality control and sample testing parameters are defined and substantial chemical analyses will be conducted to allow for certification of product characteristics and constituent levels. The CTRP will advance efforts to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science, commercial product testing laboratories, tobacco product manufacturers, and academic researchers. This proposal outlines significant improvements to current smokeless tobacco reference products in terms of product design and certification, product distribution, product storage, planning for new reference tobacco products, establishing research capability and providing new services that will benefit the tobacco research community. A web- based interface for ordering reference tobacco products and for the secure transmission and storage of collaborative data is under development and will be enhanced to include the smokeless reference products. As an academic institution our proposal to coordinate and administer inter- laboratory comparison studies on tobacco reference products and mechanisms to provide various tobacco reference products as a service to the entire tobacco research community is an improvement over current programs. The development of high-quality smokeless tobacco reference products and providing those through the CTRP will strengthen the FDAs effort to develop the science of tobacco regulation and provide a necessary resource for tobacco product research and regulation.

Public Health Relevance

Reference tobacco products are a necessary tool for measuring and reporting harmful and potentially harmful constituents in tobacco products as required under the Family Smoking Prevention and Tobacco Control Act. Four new certified reference products representative of loose leaf chewing tobacco, moist snuff, and pouched snus will be manufactured in one manufacturing run each to ensure product uniformity, and will have certified characteristics to allow for a proficiency testing program, instrument calibration, employee/student training, method validation and investigational purposes. The current University of Kentucky Center for Tobacco Reference Products (CTRP) will expand our program for tobacco analysis and reference tobacco products to support collaborative studies, improved constituent analysis, storage and stability research and the manufacture and distribution of smokeless tobacco reference products with significant proposed improvements and development in all of these areas.

Agency
National Institute of Health (NIH)
Institute
Food and Drug Administration (FDA)
Type
High Impact Research and Research Infrastructure Cooperative Agreement Programs (UC2)
Project #
5UC2FD005671-02
Application #
9213308
Study Section
Special Emphasis Panel (ZFD1-SRC (99))
Project Start
2016-03-01
Project End
2021-02-28
Budget Start
2017-03-01
Budget End
2018-02-28
Support Year
2
Fiscal Year
2017
Total Cost
$1,999,693
Indirect Cost
Name
University of Kentucky
Department
Social Sciences
Type
Schools of Earth Sciences/Natur
DUNS #
939017877
City
Lexington
State
KY
Country
United States
Zip Code
40506