Rutgers Center of Excellence in Rapid Surveillance of Tobacco

摘要 2009年《烟草控制法案》(TCA)授权FDA监管烟草产品以保护公众 健康，但最初只扩展到香烟。到#年其他产品被认为受FDA授权时 2016年，烟草格局发生了翻天覆地的变化，使现代烟草监控日益增多 很复杂。不幸的是，美国以香烟为中心的烟草监控系统在 应对这些变化。即使在正式呼吁改善无烟烟草和雪茄之后 20多年前的测量，对这些产品的标准化测量仍然很稀少 还不够。此外，尽管发出了许多预警信号，但有关JUUL的问题并未出现在重大新闻发布会上 全国性的调查，如全国青年烟草调查，直到2019年，也就是它成为榜首整整两年后- 在市场上销售终端品牌和终端在青年中的使用已经达到了令人担忧的水平。的确，速度很快 对烟草市场变化的评估和反应对于告知和评估FDA的 当前和即将采取的监管行动，包括拟议的产品标准(例如，禁止薄荷醇)，有待采取 电子烟的销售授权，以及经修改的风险烟草产品(MRTP)途径。因此， 由一个概念框架提供信息，该框架借鉴了传统的公共卫生监测视角，如 除了FDA的哨兵倡议，这项U01提案还组装了一个大型协作网络，其中包括 由六个哨兵州组成的网络，对多个数据源进行三角测量，以建立快速中心 烟草监测(CRST)。CRST的目标是对以下烟草产品进行快速监测：1) 营销，以产生感兴趣的信号；2)烟草产品市场，以产生和提炼信号 感兴趣；以及3)烟草产品使用行为的变化，以生成、提炼和评估 利息。我们将实施优化的烟草快速监测系统，以加强FDA的监管 使用一系列方法和主题专家快速评估有意义的烟草产品 烟草营销、烟草市场和烟草使用的变化。集结的队伍已经很深了 在烟草监管科学、监测和这些数据分析方面的经验。我们还有大量的 与联邦合作伙伴协作监督多站点项目的经验，以支持我们的 阐述了科研院所的行政管理问题。我们与FDA CTP、联邦合作伙伴以及 Casel和对FDA监管权力和流程的深入了解确保我们不仅会进行 快速监控，但通过早期信号检测预测市场变化，并提供有意义的数据 为FDA的活动提供信息，并支持重大的公共卫生影响。通过这样做，我们将建立一个新的 烟草监测范例，作为监测方法和措施的资源，支持 传统监测措施的演变，并有意义地推进烟草监管领域 科学。

ABSTRACT The 2009 Tobacco Control Act (TCA) gave the FDA authority to regulate tobacco products to protect public health but initially extended only to cigarettes. By the time other products were deemed under FDA authority in 2016, the tobacco landscape had changed dramatically, making modern tobacco surveillance increasingly complex. Unfortunately, the cigarette-centric tobacco surveillance systems in the US have been slow to respond to these changes. Even after formal calls for improvements in smokeless tobacco and cigar measurement more than 20 years ago, standardized measures of these products remain sparse and insufficient. Moreover, despite numerous early warning signals, questions about JUUL did not appear on major national surveys such as National Youth Tobacco Survey until 2019, two full years after it became the top- selling ENDS brand on the market and ENDS use among youth had reached concerning levels. Indeed, rapid assessment and response to changes in the tobacco market are essential to informing and evaluating FDA’s current and pending regulatory actions, including proposed product standards (e.g., banning menthol), pending marketing authorizations for e-cigarettes, and the modified risk tobacco products (MRTPs) pathway. Therefore, informed by a conceptual framework which draws upon a traditional public health surveillance perspective as well as FDA’s Sentinel Initiative, this U01 proposal assembles a large collaborative network, which includes a network of six sentinel states that triangulates multiple data sources to establish the Center for Rapid Surveillance of Tobacco (CRST). The CRST aims to perform rapid surveillance of: 1) tobacco product marketing, to generate signals of interest; 2) the tobacco product marketplace, to generate and refine signals of interest; and 3) changes in tobacco product use behaviors, to generate, refine, and evaluate signals of interest. We will implement an optimal rapid surveillance system of tobacco that will enhance FDA’s regulation of tobacco products using a range of methods and subject matter experts to rapidly assess meaningful changes in tobacco marketing, the tobacco marketplace, and tobacco use. The team assembled has deep experience with tobacco regulatory science, surveillance and analyses of these data. We also have extensive experience overseeing multi-site projects in collaboration with federal partners that support our ability to carry out the administrative aspects of CRST. Our ongoing engagement with FDA CTP, federal partners, and CASEL and deep knowledge of FDA’s regulatory authority and processes ensure that we will not only conduct rapid surveillance, but anticipate changes in the market via early signal detection, and deliver meaningful data to inform FDA’s activities and support a substantial public health impact. In doing so, we will establish a new paradigm of tobacco surveillance, serve as a resource on surveillance methods and measures, support evolutions in traditional surveillance measures, and meaningfully advance the field of tobacco regulatory science.