WNY Center for Research on Flavored Tobacco Products (CRoFT)

WNY 调味烟草产品研究中心 (CRoFT)

• 批准号: 10248504
• 负责人: Maciej Lukasz Goniewicz
• 金额: $ 397.26万
• 依托单位: ROSWELL PARK CANCER INSTITUTE CORP
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10248504
• 关键词: Address; Area; Behavior; Behavioral; Biological Markers; Biometry; Chemicals; Chemistry; Chronic; Clinical Sciences; Communication; Communication Research; Data; Data Analyses; Data Linkages; Educational Curriculum; Electronic Nicotine Delivery Systems; Emerging Tobacco Products; Ensure; Flavoring; Food; Genomics; Goals; Grant; Health; Individual; Informatics; Inhalation; Inhalation Exposure; Inhalation Toxicology; Institutes; Label; Laboratories; Life; Longitudinal cohort; Mentors; Methodology; Methods; Names; New York; Pattern; Perception; Play; Population; Positioning Attribute; Regulation; Research; Resources; Risk; Role; Science; Sensory; Sensory Thresholds; Stream; Tobacco; Tobacco use; Toxic effect; Toxicology; Training and Education; Translational Research; Vision; authority; base; biobehavior; career; cigarillos; consumer behavior; data streams; design; epigenomics; hookah; in vitro Model; in vivo; interest; notch protein; novel; programs; research study; respiratory health; response; tobacco flavor; tobacco products; tobacco regulatory science

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.

口味越来越多地推动新兴烟草产品的使用（雪茄，水管，电子尼古丁 输送系统（末端））。对这些产品的有效调节需要全面检查 毒理学，健康和行为影响的风味和调味料对此知之甚少。 许多标记为“通常被认为是安全（gras）”的烟草调味成分用于食品 但尚未评估吸入毒性。口味似乎在吸引用户中起着重要作用 这些新兴的烟草产品。 FDA的监管机构范围使其能够解决烟草的烟草 从包装和标签规则到限制使用特定的产品，以多种方式进行产品 通过产品标准的调味料，并禁止在烟草产品中表征味道。数据是 需要了解消费者如何看待和使用风味的烟草产品，以及这些产品是否具有 对健康的影响。我们提出了一个关于调味烟草产品（Croft）的研究中心， 其目标是开发一个新颖的框架和评估烟草产品影响的方法 关于消费者行为，暴露和健康的口味和调味料。总体而言，这些项目将产生调查结果 为与FDA相关的四个领域的监管科学信息：毒性，行为，健康影响和 通讯。我们的团队因对烟草中口味的影响的共同兴趣而被吸引 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，体外模型和在 体内研究。项目2将采用消费者感觉和行为实验室方法来检查 口味的行为影响，包括单一和调味剂组合的感觉阈值，以及 调味料浓度对使用模式（地形，吸入）的影响。项目3将应用纵向 同类和产品切换设计，以检查烟草中调味剂的慢性呼吸健康影响 当前用户中的产品。项目4将应用定性，定量和实验方法 检查信息对风味选择和风味产品使用的影响。我们的最终目标是开发 集成数据分析的框架，结合了多个数据流（毒性，行为，健康效应， 沟通，产品化学，生物标志物），以估计风险风险概况。三个以中心为中心的核心 （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）以及 所需的行政和职业增强核心，支持这些项目。关注风味位置 我们的中心解决跨产品类型相关的主题，并在扩展方法方面敏捷 到新产品。在开发Croft时，我们考虑了多种方法来确保提议 全面的研究套件最能通过关注关键来满足FDA的监管科学需求 适合法规的属性，适用于不同的烟草产品类别。