WNY Center for Research on Flavored Tobacco Products (CRoFT)

香料越来越多地推动新兴烟草产品（小雪茄、水烟、电子尼古丁）的使用 递送系统（ENDS））。对这些产品的有效监管需要全面审查 香料和调味品，其毒理学，健康和行为影响知之甚少。 许多被标记为“一般公认安全（GRAS）”的烟草调味料用于食品 但尚未评估吸入毒性。口味似乎在吸引用户方面发挥着重要作用 这些新兴的烟草产品。FDA的监管权限范围允许其处理调味烟草 从包装和标签规则，到限制特定产品的使用， 通过产品标准，并尽可能禁止烟草产品中的特征香料。数据 需要了解消费者如何感知和使用调味烟草产品，以及这些产品是否具有 对健康的影响。我们建议建立一个Flavorite烟草产品研究中心（CRoFT）， 其目标是为评估烟草制品的影响制定一个新的框架和方法 食用香料和调味品对消费者行为、暴露和健康的影响。总体而言，这些项目将产生调查结果， 在与FDA相关的四个领域为监管科学提供信息：毒性、行为、健康影响和 通讯我们的团队是由共同的兴趣吸引在一起的烟草口味的影响， 个人和整个人口的健康。项目1将采用最先进的方法来评估 使用化学反应性、体外模型和生物学方法研究烟草制品中使用的特定调味剂的慢性毒性 活体研究。项目2将应用消费者感官和行为实验室的方法， 风味的行为影响，包括单一风味和风味组合的感官阈值，以及 调味剂浓度对使用模式的影响（地形，吸入）。项目3将采用纵向 研究烟草中调味剂对慢性呼吸系统健康影响的队列和产品转换设计 现有用户中的产品。项目4将采用定性、定量和实验方法， 研究信息对风味选择和风味产品使用的影响。我们的最终目标是发展一个 综合数据分析框架，结合多个数据流（毒性，行为，健康影响， 通信、产品化学、生物标志物）来估计风味风险概况。三个中心命名的核心 （产品分析;生物标志物，基因组学和表观基因组学;生物统计学和信息学），沿着 所需的行政和职业提升核心，支持这些项目。注重风味定位 我们的中心致力于解决与产品类型相关的主题，并灵活地扩展方法论 到新产品。在开发CRoFT时，我们考虑了多种方法来确保所提出的 一套全面的研究最好地满足了FDA的监管科学需求， 这是一个符合法规并适用于不同烟草产品类别的属性。

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.