The Ohio State University Tobacco Center of Regulatory Science (OSU-TCORS)

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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.