||5U54CA228110-02 Interpret this number
||Roswell Park Cancer Institute Corp
||Wny Center for Research on Flavored Tobacco Products (CROFT)
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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