PROJECT SUMMARY The overall goal of the American Heart Association (AHA) Tobacco Regulation Center (ATRAC) is to provide scientific data relevant to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP). The integrative theme of the Center is to evaluate and communicate the cardiovascular effects of tobacco products, within the scientific domains of Health Effects, Toxicity and Communications. Research within the Center will contribute to the scientific base of tobacco regulatory science by evaluating the cardiovascular effects of tobacco products and their constituents. The Center will support a multi-disciplinary research program to assess the toxicity of tobacco products and their constituents in in vitro assays and animal models (Project 1); evaluate short- and long-term cardiovascular health effects of tobacco products (Project 2) and assess the cardiovascular disease risk associated with the use of non-cigarette tobacco products in multiple large NIH-supported cardiovascular cohorts (Project 3). To communicate the knowledge generated within the Center and other Tobacco Centers of Regulatory Science (TCORS), the Center will develop and test approaches for effective communication of the cardiovascular consequences of tobacco product use (Project 4). To facilitate uniformity, and quality control, all measurements will be conducted in a centralized Bioanalytical and Biomarker Core. The research activities within the Center will be coordinated by an Administrative Core, while the Career Enhancement Core will oversee the career development of new and early stage investigators. The Administrative Core will maintain close communication with federal partners and will oversee the development, funding and progress of Rapid Response Projects. Research supported by the Center will develop new understanding of the cardiovascular effects of current, new and emerging tobacco products; aid in the development of messages for communicating the cardiovascular risk associated with the use of tobacco products; and build and deploy capacity and expertise to respond to new developments. Collectively, Center research will broaden the scientific base of tobacco regulatory science to inform FDA's regulation of tobacco manufacturing, distribution and marketing.

PROJECT NARRATIVE Cigarette smoking is the leading cause of death in the United States. Although the use of combustible cigarettes has declined, the advent of new and emerging tobacco products threatens to erode recent gains against tobacco. The Family Smoking Prevention and Control Act grants the Food and Drug Administration (FDA) the authority to regulate tobacco products. The overall goal of the American Heart Association Tobacco Regulation Center (ATRAC) is to provide FDA scientific evidence regarding the cardiovascular toxicity and health effects of tobacco products and their constituents and to develop new and effective means of communicating the cardiovascular effects of conventional, new and emerging tobacco products. Research supported by the Center will inform the regulation of manufacturing, distribution and marketing of tobacco products by the FDA.