Rapid Response Characterization of New and Manipulated Tobacco Products

描述（由申请人提供）：拟议的是一个烟草监管科学中心（TCORS）的研究有关的家庭吸烟预防和烟草控制法案（FSPTCA）。拟议的中心将描述可燃和不可燃、传统、新的和操纵的尼古丁/烟草产品以及这些产品的变化对人类行为和暴露的影响。该中心的重点是在交叉急性实验室试验中检查的产品及其导致的人类使用行为和暴露。 目的1.描述可燃、不可燃、传统、新和加工烟草产品（项目I和核心B）的化学特征和物理特性。目标2.为了区分仅在单一感兴趣的特征上不同的可燃烟草产品的吸引力和消费者接受度（例如，薄荷醇浓度，烟气pH值）（项目II）。目标3.探索烟草微生物成分和烟草使用者的口腔微生物组（项目III）。目标4.支持中心的数据管理和统计需求，并向FDA CTP/NIH和选定的其他中心提供数据的抢先体验。目标5.培养下一代跨学科科学家，为烟草监管提供信息。目标6.通过发展/试点项目的快速反应系统扩大知识基础。 拟议研究的结果将为FDA烟草制品中心（CTP）对烟草制品的监管提供科学数据。拟建中心将至少解决两个研究重点：1）“烟草产品的多样性-了解成分，添加剂和设计特征;使用行为”; 2）“不良健康后果-了解多种烟草类型的健康风险...... " 相关性：在大多数研究中，人们只能研究烟草危害的单一方面。这是一个建议，同时测量三个正交的情况下的伤害：毒性，消费者接受和喜欢，和细菌暴露，提供了一个更清晰的图片，在一个产品的伤害是一个连续的，并为特定的产品设计功能的监管的科学依据。

DESCRIPTION (provided by applicant): Proposed is a Tobacco Center of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (FSPTCA). The proposed Center will characterize combustible and non-combustible, conventional, new and manipulated nicotine/tobacco products and the impact of variations in those products on human behavior and exposure. The focus of the Center is the products and resulting human use behaviors and exposures, examined in crossover acute laboratory trials. Objective 1. To characterize the chemical profiles and physical properties of combustible, non-combustible, conventional, new and manipulated tobacco products (Project I and Core B). Objective 2. To differentiate the appeal and consumer acceptance of combustible tobacco products that differ only on a single characteristic of interest (e.g., menthol concentration, smok pH) (Project II). Objective 3. To explore tobacco microbial constituents and the oral microbiome of tobacco users (Project III). Objective 4. To support the data management and statistical needs of the Center, and provide FDA CTP/NIH and select other Centers with early access to the data. Objective 5. To train the next generation of transdisciplinary scientists in science to inform tobacco regulation. Objective 6. To expand the knowledge base through a rapid response system of developmental/pilot projects. The results of the proposed research will provide scientific data to inform the regulation of tobacco products by the FDA Center for Tobacco Products (CTP). The proposed Center will address, at a minimum, two research priorities: 1) "Diversity of Tobacco Products - understanding the constituents, components, ingredients, additives, and design features; use behaviors"; 2)"Adverse Health Consequences - understanding health risks of multiple tobacco types..." RELEVANCE: In most studies, one can only examine a single dimension of tobacco harm. This is a proposal to simultaneously measure harm in three orthoganal contexts: toxicity, consumer accepance and liking, and bacterial exposure, providing a much clearer picture of where a product lies in a continuum of harm, and a scientific basis for regulation of particular product design features.