Grant Number:	5U54CA180905-12 Interpret this number
Primary Investigator:	Leventhal, Adam
Organization:	University Of Southern California
Project Title:	Usc Tobacco Center of Regulatory Science
Fiscal Year:	2024

SUMMARY/ABSTRACT: USC TCORS OVERALL In response to new FDA landmark policies targeting tobacco products with flavors and other youth-attracting features, the non-combustible market is evolving in ways that could perpetuate adolescent and young adult (AYA) use. Shifts to the non-combustible tobacco market include the emergence of modern oral nicotine products (ONPs; flavored nicotine pouches, non-therapeutic gums, lozenges, gummies) with rapidly increasing sales, e-cigarettes and ONPs with novel flavors and higher nicotine concentrations (e.g., concept flavors with ambiguous flavor names that are difficult for the FDA to classify but offer fruity sensations and e-cigarettes with >6% nicotine), and novel marketing platforms (TikTok and other social media that highly engage AYAs). USC TCORS responds to these challenges with a theme of “Informing regulation of the evolving market of non- combustible products to protect young people.” The overall Center specific aims are: Aim 1) Conduct four interrelated projects that will: (a) determine how modern ONPs and e-cigarettes impact AYA tobacco product use uptake, escalation, abuse liability, and poly-use patterns across populations; (b) identify product characteristics and marketing approaches that amplify these impacts; Aim 2) Augment our Center’s infrastructure with three cores that will optimize the productivity and impact of our regulatory science (Administrative Core, Measures and Materials Core, Data Processing and Analysis Core); and Aim 3) Develop the next generation of tobacco regulatory scientists via developing the careers of doctoral and post-doctoral trainees, and investigators transitioning to tobacco regulatory science (TRS). Collectively, USC TCORS will provide key evidence determining whether availability of certain non-combustible product classes (e.g., new ONPs), types (e.g., products that can be used discreetly), characteristics (e.g., e-cigarettes and ONPs in concept flavors), and marketing strategies (e.g., social media influencers) increase AYA’s risk of initiating and progressing along the tobacco use trajectory, including in key AYA subpopulations (e.g., sexual/gender minorities). This research will directly inform FDA’s responses to numerous e-cigarette, ONP, and other illegally marketed non-combustible products. It will provide rigorous actionable evidence to guide FDA decisions on pending marketing applications from tobacco product companies. The data will also inform FDA policies regarding which illegally-marketed products should be targeted as enforcement priorities. These achievements will build upon our successful USC TCORS Centers that, since 2013, has published 237 peer reviewed articles (166 of these published since 2018). Further, we have a substantial track record of: (a) providing foundational evidence informing FDA’s development of new policies; and (b) rapidly adapting our research to inform FDA revision of previous policies to keep pace with the evolving market; this is evidenced by 31 citations of TCORS research in FDA policy documents. FDA Scientific Areas: Behavior, Addiction and Marketing





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