Grant Number:	5U54CA287392-02 Interpret this number
Primary Investigator:	Wagener, Theodore
Organization:	Ohio State University
Project Title:	The Ohio State University Tobacco Center of Regulatory Science (Osu-Tcors)
Fiscal Year:	2024

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.




E-cigarette market share by nicotine claims.
Authors: Ma S. , Brinkman M.C. , Berman M. , Wagener T. , Shang C. .
Source: Medrxiv : The Preprint Server For Health Sciences, 2024-08-17 00:00:00.0; , .
EPub date: 2024-08-17 00:00:00.0.
PMID: 39185515
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An observational human laboratory assessment of nicotine delivery, vaping topography and subjective effects of usual brand electronic cigarette use among young adults.
Authors: Keller-Hamilton B. , Sloan R. , Mehta T. , Hinton A. , Tackett A.P. , Roberts M.E. , Brinkman M.C. , Wagener T.L. .
Source: Addiction (abingdon, England), 2024-05-27 00:00:00.0; , .
EPub date: 2024-05-27 00:00:00.0.
PMID: 38800982
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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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Evaluating the Role of Nicotine Stereoisomer on Nicotine Pouch Abuse Liability: A Randomized Crossover Trial.
Authors: Keller-Hamilton B. , Curran H. , Alalwan M. , Hinton A. , Brinkman M.C. , El-Hellani A. , Wagener T.L. , Chrzan K. , Atkinson L. , Suraapaneni S. , et al. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2024-05-07 00:00:00.0; , .
EPub date: 2024-05-07 00:00:00.0.
PMID: 38713545
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Oral nicotine pouch manufacturer's reduced exposure claims require evidence and regulatory oversight.
Authors: Alalwan M.A. , Mays D. , Berman M.L. , El-Hellani A. , Keller-Hamilton B.L. , Brinkman M.C. , Wagener T.L. , Tackett A.P. .
Source: Tobacco Control, 2024-05-03 00:00:00.0; , .
EPub date: 2024-05-03 00:00:00.0.
PMID: 38702185
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Examining the predictive utility of behavioral economic demand indices and subjective effects on the actualized reinforcing value of menthol cigarettes and potential alternatives.
Authors: Erath T.G. , Schulz J.A. , Hinton A. , Mehta T. , Reed D.D. , Tidey J.W. , Wagener T.L. , Villanti A.C. .
Source: Nicotine & Tobacco Research : Official Journal Of The Society For Research On Nicotine And Tobacco, 2024-04-15 00:00:00.0; , .
EPub date: 2024-04-15 00:00:00.0.
PMID: 38616654
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Spree Bar, a vaping system delivering a synthetic nicotine analogue, marketed in the USA as 'PMTA exempt'.
Authors: Jordt S.E. , Jabba S.V. , Zettler P.J. , Berman M.L. .
Source: Tobacco Control, 2024-03-18 00:00:00.0; , .
EPub date: 2024-03-18 00:00:00.0.
PMID: 38499343
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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.
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Authors: El-Hellani A. , Adeniji A. , Erythropel H.C. , Wang Q. , Lamb T. , Mikheev V.B. , Rahman I. , Stepanov I. , Strongin R.M. , Wagener T.L. , et al. .
Source: Tobacco Induced Diseases, 2024; 22, .
EPub date: 2024-03-30 00:00:00.0.
PMID: 38560551
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An electronic cigarette pod system delivering 6-methyl nicotine, a synthetic nicotine analog, marketed in the United States as "PMTA exempt".
Authors: Jordt S.E. , Jabba S.V. , Silinski P. , Berman M.L. .
Source: Medrxiv : The Preprint Server For Health Sciences, 2023-11-22 00:00:00.0; , .
EPub date: 2023-11-22 00:00:00.0.
PMID: 38045384
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Authors: Balzer G. , Landrus A. , Ovestrud I. , Singer J.M. , Lu B. , Wagner D.D. , Klein E.G. , Wold L.E. , Wilson C. , Tackett A.P. , et al. .
Source: Tobacco Control, 2023-11-16 00:00:00.0; , .
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Source: Addiction (abingdon, England), 2023-11-14 00:00:00.0; , .
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The sweet spot study-Developing e-liquid product standards for nicotine form and concentration to improve public health: Protocol for a randomized, double-blinded, crossover study.
Authors: Cho Y.J. , Brinkman M.C. , Hinton A. , Nshimiyimana J.D. , Mehta T. , Adeniji A. , Norton K. , El Hellani A. , Wagener T.L. .
Source: Plos One, 2023; 18(9), p. e0291522.
EPub date: 2023-09-12 00:00:00.0.
PMID: 37699050
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Synthetic Nicotine: Science, Global Legal Landscape, and Regulatory Considerations.
Authors: Berman M.L. , Zettler P.J. , Jordt S.E. .
Source: World Health Organization Technical Report Series, 2023; 1047, p. 35-60.
EPub date: 2023-08-23 00:00:00.0.
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