|1U01CA278695-01 Interpret this number
|Rutgers Biomedical And Health Sciences
|Rutgers Center of Excellence in Rapid Surveillance of Tobacco
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
Prioritizing common terminology and measures to advance research on oral nicotine product use.
, Ozga J.E.
, Stanton C.A.
, Chaffee B.W.
, Delnevo C.D.
, Fucito L.M.
, Jabba S.V.
, Morean M.E.
, Tackett A.P.
Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco, 2023-10-17; , .
Dramatic Reductions in Cigarette Smoking Prevalence among High School Youth from 1991 to 2022 Unlikely to Have Been Undermined by E-Cigarettes.
, Villanti A.C.
International journal of environmental research and public health, 2023-09-30; 20(19), .