The Ohio State University Tobacco Center of Regulatory Science (OSU-TCORS)

俄亥俄州立大学烟草监管科学中心 (OSU-TCORS)

• 批准号: 10666066
• 负责人: Peter G. Shields
• 金额: $ 399.25万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-14 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10666066
• 关键词: 3-Dimensional; Address; Adult; Advocate; Affect; Behavior; Biological Availability; Characteristics; Chemicals; Cigarette; Communication; Congresses; Data; Decision Making; Dermal; Dimensions; Drug Kinetics; Electronic cigarette; Environment; Evaluation; Faculty; Flavoring; Fostering; Goals; Health; Human; Industry; Intervention Studies; Isomerism; Laboratory Study; Marketing; Metabolism; Modeling; Monitor; Nicotine; Nicotine Withdrawal; Observational Study; Occupational activity of managing finances; Ohio; Oral; Pattern; Persons; Population; Postdoctoral Fellow; Public Health; Regulation; Research Personnel; Research Project Grants; Rewards; Risk; Sales; Science; Sensory; Signal Transduction; Smoke; Smokeless Tobacco; Smoker; Testing; Time; Tobacco; Tobacco Industry; Tobacco Surveillance; Tobacco use; Toxic effect; Toxicology; United States Food and Drug Administration; Universities; Withdrawal Symptom; Youth; absorption; abuse liability; addiction; addiction liability; career; demographics; design; electronic cigarette use; electronic liquid; experience; improved; nicotine craving; nicotine use; population health; prevent; psychologic; response; risk perception; satisfaction; smokeless tobacco use; smokeless tobacco user; student training; tobacco products; tobacco regulatory science; tobacco user; tool; uptake

OVERALL PROJECT SUMMARY Nicotine is the most important driver of tobacco use. The tobacco industry's manipulation of nicotine in cigarettes and smokeless tobacco led to products that were more addictive, abused, and deadly. With “starter” products for young people and nicotine-naïve users and “mature” products for established tobacco users, the industry has historically manipulated the “levers” of nicotine concentration and form to increase tobacco use across all demographics. E-cigarettes (ECs) and more recently oral nicotine pouches (ONPs) vary these nicotine dimensions signaling that the industry is again following this profit-driven strategy. Recent advancements in nicotine synthesis also makes nicotine isomer a new product lever that the industry can adjust to drive consumer uptake through changes in pharmacokinetics and misleading marketing claims. While the US Congress and FDA have imposed important regulations to dissuade tobacco use among young people, we argue that the regulation of nicotine itself may be the most effective strategy to achieve optimal population health. Like the tobacco industry, the FDA can pull these same levers via product standards and marketing regulations to adjust the appeal and addiction potential of ECs and ONPs. Through our integrative theme, “Flipping the Script”: Using the Industry's Nicotine Playbook to Maximize Public Health, the Ohio State University Tobacco Center of Regulatory Science (OSU-TCORS) will be guided by the industry's Consumer Response Model to understand how nicotine in ECs and ONPs are impacting product appeal, addictiveness, use patterns, and toxicity. We posit that regulation of nicotine's three dimensions can dissuade young people, including non-users, from using ECs and ONPs but still provide a satisfying and less harmful alternative for adult tobacco users for complete switching. Project 1 (P1) and P2 will examine the influence of EC and ONP nicotine manipulations on product appeal, abuse liability, use, and toxicity; P3, using ONPs as an exemplar product, will examine the influence of nicotine marketing claims on appeal and product trial; and P4 will examine how young people, including priority populations, respond to both nicotine product marketing and design characteristics in the natural environment. The projects are supported by the Market Monitoring Core that will provide critical real-time marketing and purchasing of products by venue and the Product Evaluation and Manipulation Core that studies products varied by nicotine dimensions with chemical and toxicological analysis. They also will be supported by the Administrative Core. The Career Enhancement Core will foster the training of students, postdoctoral fellows, and early career investigators in tobacco regulatory science. Together, the OSU-TCORS addresses the FDA priority scientific domains of Product Composition and Design, Toxicity, Addiction, Health Effects, Behavior, and Marketing Influences. The projects are highly integrated and will provide the FDA with critical, first-of-its-kind data by conducting complementary interventional and observational studies to inform the Consumer Response Model as a tool to protect public health.

总体项目摘要 尼古丁是烟草使用最重要的驱动因素。烟草业操纵香烟中的尼古丁 无烟烟草导致了更容易上瘾、滥用和致命的产品。用“启动器”产品 为年轻人和尼古丁初体验者提供的产品和为已建立的烟草使用者提供的“成熟”产品，烟草业 历史上操纵尼古丁浓度和形式的“杠杆”，以增加所有人的烟草使用。 人口统计学电子烟（EC）和最近的口服尼古丁袋（ONP）改变了这些尼古丁 这表明该行业再次遵循这种利润驱动的战略。的最新进展 尼古丁合成也使尼古丁异构体成为一种新的产品杠杆，该行业可以调整以推动消费者 通过药代动力学变化和误导性营销声明的吸收。虽然美国国会和FDA 已经实施了重要的法规来劝阻年轻人吸烟，我们认为， 尼古丁本身可能是实现最佳人群健康的最有效策略。比如烟草 行业，FDA可以通过产品标准和营销法规来调整这些杠杆， 吸引力和成瘾潜力的EC和ONP。通过我们的综合主题，“翻转脚本”：使用 该行业的尼古丁剧本，以最大限度地提高公众健康，俄亥俄州州立大学烟草中心的 监管科学（OSU-TCORS）将由行业的消费者响应模型指导，以了解 EC和ONP中的尼古丁如何影响产品吸引力、成瘾性、使用模式和毒性。我们断定 对尼古丁的三个方面进行监管可以劝阻年轻人，包括非使用者，使用EC 和ONP，但仍然为成年烟草使用者提供了令人满意且危害较小的替代品，以便完全转换。 项目1（P1）和P2将检查EC和ONP尼古丁操作对产品吸引力的影响， 滥用倾向，使用和毒性; P3，使用ONP作为示例产品，将检查尼古丁的影响 P4将研究年轻人，包括优先权， 在自然环境中，尼古丁产品的营销和设计特征都对人群产生了影响。 这些项目得到了市场监测核心的支持，该核心将提供关键的实时营销， 按地点购买产品以及研究产品的产品评估和操作核心 不同的尼古丁尺寸与化学和毒理学分析。他们还将得到 行政核心。职业提升核心将促进学生，博士后研究员， 和烟草监管科学的早期职业调查员。OSU-TCORS共同解决了FDA 优先科学领域的产品组成和设计，毒性，成瘾，健康影响，行为， 营销影响。这些项目是高度集成的，将为FDA提供关键的， 通过进行补充性干预和观察性研究来获取数据，以告知消费者的反应 作为保护公众健康的工具。