Rapid Response Characterization of New and Manipulated Tobacco Products

描述（由申请人提供）：拟设立一个烟草监管科学中心（tors），用于研究《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、新型和操纵的尼古丁/烟草制品以及这些产品的变化对人类行为和暴露的影响。该中心的重点是产品及其导致的人类使用行为和暴露，并在交叉急性实验室试验中进行检查。目的1。描述可燃、不可燃、传统、新型和加工烟草制品的化学特征和物理特性（项目一和核心B）。目标2。区分可燃烟草产品的吸引力和消费者接受度，这些可燃烟草产品仅在单个感兴趣的特征上不同（例如，薄荷醇浓度、烟雾pH值）（项目二）。目标3。探索烟草微生物成分和烟草使用者口腔微生物组（项目三）。目标4。支持中心的数据管理和统计需求，并为FDA CTP/NIH和选择其他中心提供早期访问数据的机会。目标5。培训下一代跨学科科学家，为烟草管制提供科学信息。目标6。通过发展/试验项目的快速反应系统扩大知识基础。拟议的研究结果将为FDA烟草制品中心（CTP）对烟草制品的监管提供科学数据。该中心将至少解决两个研究重点：1)“烟草制品的多样性——了解其成分、成分、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……”

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.