Scope: Smokeless Tobacco Reference Product Development, Distribution and Research

Since 1968 the University of Kentucky has provided reference cigarettes as the standard for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. The University of Kentucky Reference Cigarette Program (UKRCP) is committed to continue providing standards for tobacco product research and to work with the FDA to develop new products as necessary for regulation and analytical testing. The project will produce and characterize 50 million, high-quality research cigarettes representative of an American blended cigarette that are manufactured in one manufacturing run with physical and chemical characteristics to allow for proficiency testing, instrument calibration, employee/student training, method validation and for investigational purposes. Quality control and sample testing parameters are defined to specific requirements to meet the project goals and substantial chemical analyses will be conducted by the manufacturer, outside testing labs and at the University of Kentucky to allow for certification of product physical parameters 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.