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Tobacco Regulatory Science Research Program at FDA S Center for Tobacco Products: Summary and Highlights FISCA YEARS 20102017

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Tobacco Regulatory Science Research Program at FDA S Center for Tobacco Products: Summary and Highlights FISCA YEARS 20102017 CENTER FOR TOBACCO PRODUCTS | OFFICE OF SCIENCE Tobacco Regulatory Science Research Program at FDA s Center for Tobacco Products: Summary and Highlights FISCA YEARS 20102017 June 2018 Dedication DAVID L. ASHLEY, PH.D. David L. Ashley, Ph.D., served as the Director of the Office of Science from July 2010 to May 2017. Throughout his tenure as the first Director of CTP-OS, he applied his valuable scientific and leadership expertise to implement a rigorous scientific program to review tobacco product applications, provide scientific input into development of regulations and guidance, improve the scientific knowledge base, and develop a tobacco regulatory research program. Dr. Ashley’s vision was for CTP-OS to be recognized nationally and internationally as the premier scientific organization for the regulation of tobacco products. There is no other tobacco regulatory organization in the world that has this responsibility and authority. Under his direction, several “firsts” were accomplished, such as preventing new tobacco products that did not meet the statutory standard from entering the market, finding new tobacco products appropriate for the protection of public health under the premarket tobacco application pathway, and launching the large, longitudinal Population Assessment of Tobacco and Health (PATH) Study. These “firsts” highlight Dr. Ashley’s contribution to public health and tobacco control through science-based policy. We dedicate this report to Dr. Ashley in honor of his many accomplishments and his unwavering dedication to and leadership of the Office of Science. Table of Contents Introduction ............................................................................................................................... ....................1 eadership Perspective: CTP’s Comprehensive Tobacco and Nicotine Regulation Plan .................3 Mitchell Zeller, J.D., Director, Center for Tobacco Products eadership Perspective: Tobacco Use and the Role of Tobacco Regulatory Science .......................4 Matthew Holman, Ph.D., Director, CTP Office of Science eadership Perspective: CTP-OS’s Research Priorities ................................................................... 5 Cathy L. Backinger, Ph.D., M.P.H., Deputy Director for Research, CTP Office of Science eadership Perspective: Science-Based Public Education Campaigns ...........................................7 Kathy Cro by, Director, CTP Office of Health Communication and Education FDA s Tobacco Product Regulation ............................................................................................................. 10 CTP-OS: Who We Are ............................................................................................................................... .... 13 OHCE s Science-Based Approach to Communicating Public Health Messages ....................................... 16 CTP s Regulatory Research Program ......................................................................................................... 18 Research Summary ......................................................................................................................... 18 CTP-Funded Projects by Research Domain .................................................................................... 19 CTP-Funded Projects by Population ................................................................................................ 20 CTP-Funded Projects by Tobacco Product ...................................................................................... 21 Tobacco Product Research Summaries ...................................................................................................... 23 Cigarettes and Cigarette Smoke ...................................................................................................... 25 E-cigarettes ............................................................................................................................... ...... 30 Cigars ............................................................................................................................... ................ 37 Smokeless Tobacco and Snus .......................................................................................................... 40 Hookah (Waterpipe) ......................................................................................................................... 46 Dissolvables ............................................................................................................................... ...... 50 ow Nicotine ............................................................................................................................... ..... 54 Flavors............................................................................................................................... ............... 57 Studies Examining Strategies and Impacts of CTP Public Education Campaigns ......................... 62 Research Partners ............................................................................................................................... ....... 68 National Institutes of Health ............................................................................................................ 68 Tobacco Regulatory Science Program .................................................................................. 68 Tobacco Centers of Regulatory Science ............................................................................... 68 Center for Evaluation and Coordination of Training and Research ..................................... 71 Other Grants ......................................................................................................................... 71 NIH Intramural Projects ....................................................................................................... 72 PhenX ............................................................................................................................... ..... 72 CENTER FOR TOBACCO PRODUCTS Table of Contents (cont’d.) Research Partners (Cont’d.) The Population Assessment of Tobacco and Health (PATH) Study ................................................. 74 Centers for Disease Control and Prevention ................................................................................... 75 Division of aboratory Science ............................................................................................. 75 Office on Smoking and Health .............................................................................................. 75 National Center for Health Statistics ................................................................................... 75 Division of Reproductive Health ............................................................................................ 75 National Center for Toxicological Research .................................................................................... 77 Other Federal Partners .................................................................................................................... 77 Contracts ............................................................................................................................... ........... 77 In-House Research .......................................................................................................................... 77 Funded Publications ............................................................................................................................... ..... 79 Training the Next Generation of Regulatory Scientists ............................................................................. 86 Looking Toward the Future ......................................................................................................................... 91 References ............................................................................................................................... .................... 93 CENTER FOR TOBACCO PRODUCTS Introduction Introduction The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), enacted on June 22, 2009, directed the U.S. Food and Drug Administration to create a Center for Tobacco Products (CTP) that works to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products, and by educating the public about tobacco products and the dangers their use poses. To carry out its regulation of tobacco products under the Federal Food, Drug, & Cosmetic Act (FD&C Act), CTP established an Office of Science (OS) to ensure that a robust science base informs the center’s actions. To meet its mission, CTP-OS assesses existing scientific evidence and supports new research to inform regulatory actions intended to protect the public health by: • Reducing the number of people who start to use tobacco products • Encouraging more people to stop using these products • Reducing the adverse health impact for those who continue to use these products Focus on Regulatory Science To make the most effective regulatory decisions, CTP must increase critical knowledge in evolving areas of regulatory science including the population health effect of the rapidly changing tobacco product market. Regulatory science research is critical to understanding the impact of manufacturing, marketing, and distribution of tobacco products on public health so that effective product review decisions can be made and other critical
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