Scope: Smokeless Tobacco Reference Product Development, Distribution and Research

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 supplying certified standards for research and to working with the FDA to develop new certified reference products as necessary. This project will produce and characterize smokeless tobacco reference products representative of loose moist snuff, pouched snus, and loose leaf chewing tobacco. 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 method validation for 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 meets 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, and establishing research capability and new services that will benefit the tobacco research community including proficiency testing for smokeless tobacco products. 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 much needed basic resource for tobacco product research and regulation.