Project Summary/Abstract: Since 1968 the University of Kentucky has provided reference tobacco products as standards for non-clinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. This project will produce and characterize machine made, sheet-wrapped cigar tobacco reference products representative of large cigars (processed leaf filler, non-premium), little cigars (brown cigarettes) and small cigars (cigarillos). 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 cigar reference 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 cigar 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 cigar reference products. The CTRP web-based solution and database will be migrated to a Cloud environment to scale resources to meet future demand, while reducing operational costs and increasing the effectiveness of IT processes and personnel. As an academic institution, our proposal will be a service to the entire tobacco research community and is an improvement over current efforts to coordinate and administer inter-laboratory comparison studies on tobacco reference products and mechanisms to provide various cigar tobacco reference products. The development of high-quality cigar tobacco reference products and providing those through the CTRP will strengthen the FDA’s effort to develop the science of tobacco regulation and provide a much needed basic resource for tobacco product research and regulation.

Project Narrative Reference cigar 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. Three new, machine-made, sheet-wrapped, certified cigar reference products representative of large cigars (processed leaf filler, non-premium), little cigars (brown cigarettes) and small cigars (cigarillos) 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 for investigational purposes. The 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 cigar tobacco reference products with significant proposed improvements and development in all of these areas.