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Grant Details

Grant Number: 5U01CA278695-02 Interpret this number
Primary Investigator: Delnevo, Cristine
Organization: Rutgers Biomedical And Health Sciences
Project Title: Rutgers Center of Excellence in Rapid Surveillance of Tobacco
Fiscal Year: 2024


Abstract

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.



Publications

Features of disposable e-cigarettes and their association with pricing and consumer preference: Evidence from web data of US online stores.
Authors: Ma S. , Ahn S. , Kaareen A. , Yang Q. , Qiu Z. , Chen J. , Berman M. , Wagener T. , Shang C. .
Source: Addiction (abingdon, England), 2024-12-23 00:00:00.0; , .
EPub date: 2024-12-23 00:00:00.0.
PMID: 39711153
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Lessons Learned From E-Cigarettes Should Affect FDA Regulation of Nicotine Pouches.
Authors: Delnevo C.D. , Hrywna M. .
Source: Jama, 2024-12-09 00:00:00.0; , .
EPub date: 2024-12-09 00:00:00.0.
PMID: 39652337
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Marketing for Sensa: A novel "zero nicotine vapor product" from a major tobacco company.
Authors: Robichaud M.O. , Talbot E.M. , Ganz O. , Mercincavage M. , Erythropel H.C. , Zimmerman J.B. , Jabba S.V. , Jordt S.E. , Delnevo C.D. .
Source: Research Square, 2024-10-22 00:00:00.0; , .
EPub date: 2024-10-22 00:00:00.0.
PMID: 39502773
Related Citations

The Rutgers Omnibus Study: Protocol for Quarterly Web-Based Surveys to Promote Rapid Tobacco Research.
Authors: Bover Manderski M.T. , Young W.J. , Ganz O. , Delnevo C.D. .
Source: Jmir Research Protocols, 2024-10-16 00:00:00.0; 13, p. e58203.
EPub date: 2024-10-16 00:00:00.0.
PMID: 39413372
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Marketing ZYN: examining branded and unbranded content.
Authors: Ganz O. , Barnwell P.V. , Hrywna M. , Donaldson S.I. , Allem J.P. , Delnevo C.D. .
Source: Tobacco Control, 2024-07-04 00:00:00.0; , .
EPub date: 2024-07-04 00:00:00.0.
PMID: 38964857
Related Citations

Relationship Between Product Features and the Prices of e-Cigarette Devices Sold in Web-Based Vape Shops: Comparison Study Using a Linear Regression Model.
Authors: He Y. , Yang Q. , Alish Y. , Ma S. , Qiu Z. , Chen J. , Wagener T. , Shang C. .
Source: Jmir Formative Research, 2024-05-09 00:00:00.0; 8, p. e49276.
EPub date: 2024-05-09 00:00:00.0.
PMID: 38723251
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National Trends in Sales and Price for Commercial Tobacco and Nicotine Products, 2018-2022.
Authors: Ganz O. , LaVake M. , Hrywna M. , King Jensen J.L. , Delnevo C.D. .
Source: Jama Network Open, 2024-03-04 00:00:00.0; 7(3), p. e241384.
EPub date: 2024-03-04 00:00:00.0.
PMID: 38451527
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How to Identify e-Cigarette Brands Available in the United States During 2020-2022: Development and Usability Study.
Authors: Ma S. , Kaareen A. , Park H. , He Y. , Jiang S. , Qiu Z. , Xie Z. , Li D. , Chen J. , O'Connor R.J. , et al. .
Source: Jmir Formative Research, 2024-02-28 00:00:00.0; 8, p. e47570.
EPub date: 2024-02-28 00:00:00.0.
PMID: 38416562
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Patterns of blunt and cigar use in the United States, 2015-2019.
Authors: Jensen J.K. , Ganz O. , Tomaino M. , Glasser A.M. , Sterling K. , Delnevo C.D. , Bover Manderski M.T. .
Source: Medrxiv : The Preprint Server For Health Sciences, 2024-02-27 00:00:00.0; , .
EPub date: 2024-02-27 00:00:00.0.
PMID: 38464228
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Prioritizing common terminology and measures to advance research on oral nicotine product use.
Authors: Hrywna M. , Ozga J.E. , Stanton C.A. , Chaffee B.W. , Delnevo C.D. , Fucito L.M. , Jabba S.V. , Morean M.E. , Tackett A.P. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2023-10-17 00:00:00.0; , .
EPub date: 2023-10-17 00:00:00.0.
PMID: 37846819
Related Citations

Dramatic Reductions in Cigarette Smoking Prevalence among High School Youth from 1991 to 2022 Unlikely to Have Been Undermined by E-Cigarettes.
Authors: Delnevo C.D. , Villanti A.C. .
Source: International Journal Of Environmental Research And Public Health, 2023-09-30 00:00:00.0; 20(19), .
EPub date: 2023-09-30 00:00:00.0.
PMID: 37835136
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