Rutgers Center of Excellence in Rapid Surveillance of Tobacco

摘要 2009年《烟草控制法》（TCA）授权FDA监管烟草产品，以保护公众健康。 但最初仅限于香烟。当其他产品被认为是在FDA的授权下时， 2016年，烟草格局发生了巨大变化，使得现代烟草监控越来越多 复杂.不幸的是，美国以烟草为中心的烟草监控系统在 应对这些变化。即使在正式呼吁改进无烟烟草和雪茄之后， 20多年前，这些产品的标准化措施仍然很少， 不足此外，尽管有许多早期预警信号，但关于JUUL的问题并没有出现在主要的 国家调查，如全国青年烟草调查，直到2019年，整整两年后，它成为最重要的- 在市场上销售ENDS品牌，青少年中ENDS的使用已达到令人担忧的水平。的确， 评估和应对烟草市场的变化对于告知和评估FDA的信息至关重要 当前和待定的监管行动，包括拟议的产品标准（例如，禁止薄荷醇），待决 电子烟的营销授权，以及改良风险烟草产品（MRTPs）途径。因此，我们认为， 以一个概念框架为基础，该框架借鉴了传统的公共卫生监测观点， 除了FDA的哨兵倡议外，U 01提案还组建了一个大型合作网络，其中包括 由六个前哨国家组成的网络，对多个数据源进行三角测量， 烟草监测（CRST）。CRST旨在对以下产品进行快速监测：1）烟草产品 营销，以产生感兴趣的信号; 2）烟草产品市场，以产生和完善信号 3）烟草产品使用行为的变化，以生成、细化和评估 兴趣我们将实施最佳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烟草产品的 烟草营销、烟草市场和烟草使用的变化。集合起来的团队 烟草监管科学、监测和分析这些数据的经验。我们也有广泛的 与联邦合作伙伴合作监督多地点项目的经验，这些项目支持我们进行 #21453;的行政管理方面。我们与FDA CTP、联邦合作伙伴以及 CASEL和对FDA监管机构和流程的深入了解，确保我们不仅能够 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。为此，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.