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Grant Details

Grant Number: 1U54CA228110-01 Interpret this number
Primary Investigator: O'Connor, Richard
Organization: Roswell Park Cancer Institute Corp
Project Title: Wny Center for Research on Flavored Tobacco Products (CROFT)
Fiscal Year: 2018
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Abstract

Flavors increasingly drive the use of emerging tobacco products (cigarillos, waterpipe, electronic nicotine delivery systems (ENDS)). Effective regulation of these products requires comprehensive examination of flavors and flavorings, for which the toxicological, health, and behavioral implications are poorly understood. Many tobacco flavoring ingredients labeled `Generally Recognized as Safe (GRAS)' were intended for foods but have not been evaluated for inhalation toxicity. Flavors appear to play an important role in attracting users to these emerging tobacco products. FDA's scope of regulatory authority allows it to address flavored tobacco products in a number of ways, ranging from packaging and labeling rules, to restricting the use of specific flavorings via product standards, and as far as banning characterizing flavors in tobacco products. Data are needed to understand how consumers perceive and use flavored tobacco products and whether these have implications for health. We propose a Center for Research on Flavored Tobacco Products (CRoFT), the goal of which is to develop a novel framework and approaches for assessing the impact of tobacco product flavors and flavorings on consumer behavior, exposures, and health. Overall, the projects will generate findings to inform regulatory science in four areas of relevance to FDA: Toxicity, Behavior, Health Effects, and Communications. Our team is drawn together by a common interest in the impact of flavors in tobacco on health of individuals and the population as a whole. Project 1 will apply state-of-the art methods to assess the chronic toxicity of specific flavorings used in tobacco products using chemical reactivity, in vitro models, and in vivo research studies. Project 2 will apply consumer sensory and behavioral laboratory approaches to examine the behavioral impacts of flavors, including sensory thresholds for single and combinations of flavorings, and the impact of flavoring concentration on use patterns (topography, inhalation). Project 3 will apply longitudinal cohort and product-switching designs to examine the chronic respiratory health effects of flavorings in tobacco products among current users. Project 4 will apply qualitative, quantitative, and experimental approaches to examine the effects of information on flavor choice and flavored product use. Our ultimate goal is to develop a framework for integrative data analysis that combines multiple data streams (toxicity, behavior, health effects, communication, product chemistry, biomarkers) to estimate a flavor risk profile. Three center-named cores (Product Analysis; Biomarkers, Genomics, and Epigenomics; Biostatistics and Informatics), along with the required Administrative and Career Enhancement cores, support these projects. The focus on flavor positions our center to address a topic relevant across product types, and to be nimble in expanding the methodologies to new products. In developing CRoFT, we considered multiple approaches to ensure the proposed comprehensive suite of studies best addresses FDA's regulatory science needs by focusing on a critical attribute that is amenable to regulation and applicable across different tobacco product classes.

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Publications

User Perceptions of Different Electronic Cigarette Flavors on Social Media: Observational Study.
Authors: Lu X. , Chen L. , Yuan J. , Luo J. , Luo J. , Xie Z. , Li D. .
Source: Journal of medical Internet research, 2020-06-24; 22(6), p. e17280.
EPub date: 2020-06-24.
PMID: 32579123
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Airway basal cell injury after acute diacetyl (2,3-butanedione) vapor exposure.
Authors: McGraw M.D. , Kim S.Y. , Reed C. , Hernady E. , Rahman I. , Mariani T.J. , Finkelstein J.N. .
Source: Toxicology letters, 2020-06-01; 325, p. 25-33.
EPub date: 2020-02-26.
PMID: 32112875
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An Animal Model of Inhaled Vitamin E Acetate and EVALI-like Lung Injury.
Authors: Bhat T.A. , Kalathil S.G. , Bogner P.N. , Blount B.C. , Goniewicz M.L. , Thanavala Y.M. .
Source: The New England journal of medicine, 2020-03-19; 382(12), p. 1175-1177.
EPub date: 2020-02-26.
PMID: 32101656
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Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2.
Authors: Li D. , Sundar I.K. , McIntosh S. , Ossip D.J. , Goniewicz M.L. , O'Connor R.J. , Rahman I. .
Source: Tobacco control, 2020 03; 29(2), p. 140-147.
EPub date: 2019-02-13.
PMID: 30760629
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Inflammatory biomarkers and growth factors in saliva and gingival crevicular fluid of e-cigarette users, cigarette smokers, and dual smokers: A pilot study.
Authors: Ye D. , Gajendra S. , Lawyer G. , Jadeja N. , Pishey D. , Pathagunti S. , Lyons J. , Veazie P. , Watson G. , McIntosh S. , et al. .
Source: Journal of periodontology, 2020-02-12; , .
EPub date: 2020-02-12.
PMID: 32052441
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Effect of e-cigarette flavors on nicotine delivery and puffing topography: results from a randomized clinical trial of daily smokers.
Authors: Voos N. , Smith D. , Kaiser L. , Mahoney M.C. , Bradizza C.M. , Kozlowski L.T. , Benowitz N.L. , O'Connor R.J. , Goniewicz M.L. .
Source: Psychopharmacology, 2020 Feb; 237(2), p. 491-502.
EPub date: 2019-11-26.
PMID: 31773209
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Flavor Preference and Systemic Immunoglobulin Responses in E-Cigarette Users and Waterpipe and Tobacco Smokers: A Pilot Study.
Authors: Jackson M. , Singh K.P. , Lamb T. , McIntosh S. , Rahman I. .
Source: International journal of environmental research and public health, 2020-01-19; 17(2), .
EPub date: 2020-01-19.
PMID: 31963835
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E-cigarette flavored pods induce inflammation, epithelial barrier dysfunction, and DNA damage in lung epithelial cells and monocytes.
Authors: Muthumalage T. , Lamb T. , Friedman M.R. , Rahman I. .
Source: Scientific reports, 2019-12-13; 9(1), p. 19035.
EPub date: 2019-12-13.
PMID: 31836726
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Are E-Cigarette Flavors Associated with Exposure to Nicotine and Toxicants? Findings from Wave 2 of the Population Assessment of Tobacco and Health (PATH) Study.
Authors: Smith D.M. , Schneller L.M. , O'Connor R.J. , Goniewicz M.L. .
Source: International journal of environmental research and public health, 2019-12-11; 16(24), .
EPub date: 2019-12-11.
PMID: 31835841
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What is the nicotine delivery profile of electronic cigarettes?
Authors: Voos N. , Goniewicz M.L. , Eissenberg T. .
Source: Expert opinion on drug delivery, 2019 11; 16(11), p. 1193-1203.
EPub date: 2019-09-13.
PMID: 31495244
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Cannabidiol differentially regulates basal and LPS-induced inflammatory responses in macrophages, lung epithelial cells, and fibroblasts.
Authors: Muthumalage T. , Rahman I. .
Source: Toxicology and applied pharmacology, 2019-11-01; 382, p. 114713.
EPub date: 2019-08-19.
PMID: 31437494
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Use of Flavored E-Cigarettes and the Type of E-Cigarette Devices Used among Adults and Youth in the US-Results from Wave 3 of the Population Assessment of Tobacco and Health Study (2015-2016).
Authors: Schneller L.M. , Bansal-Travers M. , Goniewicz M.L. , McIntosh S. , Ossip D. , O'Connor R.J. .
Source: International journal of environmental research and public health, 2019-08-20; 16(16), .
EPub date: 2019-08-20.
PMID: 31434229
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Pulmonary Toxicity and the Pathophysiology of Electronic Cigarette, or Vaping Product, Use Associated Lung Injury.
Authors: Chand H.S. , Muthumalage T. , Maziak W. , Rahman I. .
Source: Frontiers in pharmacology, 2019; 10, p. 1619.
EPub date: 2020-01-14.
PMID: 31992985
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Classification of flavors in cigarillos and little cigars and their variable cellular and acellular oxidative and cytotoxic responses.
Authors: Lawyer G.R. , Jackson M. , Prinz M. , Lamb T. , Wang Q. , Muthumalage T. , Rahman I. .
Source: PloS one, 2019; 14(12), p. e0226066.
EPub date: 2019-12-11.
PMID: 31825984
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