Rapid Response Characterization of New and Manipulated Tobacco Products

新烟草产品和改造烟草产品的快速响应表征

• 批准号: 8735104
• 负责人: PAMELA I CLARK
• 金额: $ 382.85万
• 依托单位: UNIV OF MARYLAND, COLLEGE PARK
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-18 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8735104
• 关键词: Acute; Address; Behavior; Characteristics; Chemicals; Data; Development; Dimensions; Family Smoking Prevention and Tobacco Control Act; Health; Human; Laboratories; Measures; Menthol; Nicotine; Pilot Projects; Regulation; Research; Research Priority; Risk; Science; Scientist; Smoke; System; Tobacco; Toxic effect; Training; United States National Institutes of Health; Variant; base; data management; design; interest; knowledge base; microbial; next generation; oral microbiome; physical property; response

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.

描述(由申请人提供)：建议成立烟草管理科学中心(TCORS)，从事与《家庭吸烟预防和烟草控制法案》(FSPTCA)相关的研究。拟议的中心将描述可燃和不可燃、常规、新的和操纵的尼古丁/烟草产品的特征，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和由此产生的人类使用行为和暴露，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、常规、新型和操纵烟草产品的化学组成和物理性质(项目I和核心B)。目标2.区分可燃烟草产品的吸引力和消费者的接受度，这些可燃烟草产品仅在感兴趣的单一特征(例如，薄荷醇浓度、烟雾酸碱度)上存在差异(项目II)。目的3.探索烟草微生物组成和吸烟者口腔微生物群(项目III)。目标4.支持中心的数据管理和统计需求，并为FDA CTP/NIH和选定的其他中心提供早期访问数据的机会。目标5.培训下一代跨学科的科学科学家，为烟草法规提供信息。目标6.通过开发/试点项目的快速反应系统扩大知识库。拟议的研究结果将为FDA烟草产品中心(CTP)对烟草产品的监管提供科学数据。拟建的中心将至少解决两个研究重点：1)“烟草产品的多样性--了解烟草产品的成分、添加剂和设计特征；使用行为”；2)“有害健康后果--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一个方面。这是一项在三个正交性背景下同时衡量危害的建议：毒性、消费者接受和喜爱以及细菌暴露，提供了一幅更清晰的图景，显示了产品在危害连续体中所处的位置，并为监管特定的产品设计特征提供了科学基础。