Development and Distribution of a Certified Reference Cigarette Suitable for Research Applications and Establishing a Proficiency Testing Program at the University of KY Reference Cigarette Program

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. A center of excellence in tobacco product analysis and reference tobacco products will be established to collaborate and coordinate studies with stakeholders, including Tobacco Centers for Regulatory Science (TCORS), product testing laboratories, tobacco product manufacturers and tobacco researchers. This proposal outlines significant improvements to the current established UKRCP in product design and development, research capability and new services that will benefit the tobacco research community including establishing a proficiency testing program. A web-based interface will be developed to allow for secure transmission and storage of data for the proficiency program. 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 a high-quality reference cigarette and using this to help establish the center of excellence will strengthen the CTP’s effort to develop the science of tobacco regulation and provide a much needed basic resource for tobacco product research.