Ohio State receives $20 million TCORS grant to conduct tobacco regulation science research

The Ohio State University (OSU) has been awarded a $20 million Tobacco Center of Regulatory Science (TCORS) grant from the Food and Drug Administration's (FDA) Center for Tobacco Products and National Institutes of Health.

The OSU-TCORS grant is a collaboration of experts from the colleges of medicine, public health and law organized and implemented through the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

Ohio State is one of seven centers across the United States selected to conduct research aimed at gathering scientific evidence needed to better inform the FDA's regulation of tobacco products. TCORS grant recipients are selected based on a rigorous review of scientific and technical skills and the relevance of proposed projects to TCORS program priorities. Since the TCORS program was founded in 2013, the NIH and FDA have funded 29 centers to conduct tobacco regulation science research in the fields of epidemiology, economics, toxicology and marketing.

Maximizing public health through research

Led by Theodore Wagener, Ph.D., and Peter Shields, M.D., the OSU-TCORS research grant is organized around the theme of "Flipping the Script" and uses the tobacco industry's nicotine playbook to improve public health through four research projects:

• Informing e-cigarette nicotine regulations to promote public health
  Project leaders: Ahmad El Hellani, PhD, Environmental Health Sciences, and Wagener, who is the Leonard J. Immke, Jr. and Charlotte L. Immke Chair in Cancer Research at the College of Medicine

This project will study how manipulating the different dimensions of nicotine affect how much smokers and e-cigarette users like the products, how often they use them, and how harmful they are. It will also examine if there is a way to regulate nicotine that makes e-cigarettes unattractive to young people and non-users while still giving smokers a less harmful and satisfying alternative.

• Informing oral nicotine pouch regulations to promote public health
  Project leaders: Brittney Keller-Hamilton, Ph.D., MPH College of Medicine, and Marielle Brinkman, College of Public Health

This project will examine how the various dimensions of nicotine affect the appeal, addictiveness, and use or oral nicotine pouches. Researchers will also look at how these factors influence product switching – for example, from smokeless tobacco or combustible cigarettes to pouches. In addition, the study will look at how the use of these products impacts the microbiome of pouch users compared to cigarette and smokeless tobacco users.

• Nicotine product claims on appeal, perceptions and usage behaviors
  Leader: Darren Mays, Ph.D., MPH, assistant dean for research, College of Medicine

This project will examine how features of oral nicotine pouch packaging affect the appeal, use, and perceptions of pouches among young people and whether these features create preferences for pouches compared to e-cigarettes, cigarettes and smokeless tobacco. The ultimate goal of the project is to determine how product packages should be regulated so that they are appealing to adult tobacco users but with minimal appeal to young people.

• Naturalistic assessment of e-cigarette and oral nicotine pouch use among adolescents and young adults
  Leaders: Amy Ferketich, Ph.D., and Megan Roberts, Ph.D., both of the College of Public Health
  This project is a two-year prospective observational study of 2,000 youths and young adults from across the United States to identify marketing exposures and product design characteristics that drive continued use, product escalation and nicotine dependence. This study will give particular attention to the impact on populations historically targeted by the tobacco industry.

Training opportunities in tobacco regulatory science

The OSU-TCORS grant also provides undergraduates, predoctoral graduate students, postdoctoral trainees and early career faculty with exposure, training and experience in tobacco regulatory sciences to advance researchers toward becoming independent tobacco scientists. The career enhancement core includes:

• Mentored postdoctoral research training opportunities in tobacco regulatory science;
• Annual pilot research funding for mentored research projects that align with overarching goals of OSU-TCORS projects;
• 10-week summer undergraduate training program in tobacco regulatory science;
• Research-in-progress meetings where faculty and trainees can present research in progress for feedback, including concepts under development, preliminary findings and planned projects or proposals for funding;
• A Mary Ellen Wewers Seminar Series that will monthly feature scientists whose research cuts across interdisciplinary aspects of tobacco regulatory science.

Real-time monitoring of the tobacco industry

Historically, the tobacco industry has manipulated nicotine in combustible cigarettes and smokeless tobacco products, like chewing tobacco, to sustain dependence among existing users but also to increase their appeal and addictiveness for young people and non-users. This has resulted in products that have addicted millions of people, explained Wagener, who directs the Center for Tobacco Research at the OSUCCC – James. He says the industry is now using similar strategies to promote e-cigarette and oral nicotine pouch use, especially among young people.

"This grant allows us to conduct critical research to guide the FDA's regulation of nicotine in e-cigarettes and oral nicotine pouches. We argue that just as the industry manipulates nicotine in its products to ignite epidemic use, effective, science-based regulation of nicotine has the potential to spur major public health victories. Our ultimate goal is to determine what regulations will lead to reduced youth use of e-cigarettes and oral nicotine pouches while at the same time support smokers and smokeless tobacco users looking to switch to less harmful alternatives," said Wagener, co-principal investigator of the OSU-TCORS grant.

A marketing monitoring core will conduct real-time surveillance of the tobacco industry to collect economic-impact data on product sales in both online and brick-and-mortar stores. This team will identify product attributes such as nicotine concentrations, source (tobacco vs. synthetic) and claims on product packaging to help understand how the industry's manipulation of nicotine has impacted product appeal, usage patterns and health toxicity.

Also, a product evaluation and manipulation core will gather data about tobacco product design characteristics – including the chemical, physical and bacterial properties of nicotine components and how they affect product appeal, addictiveness and toxicity. This team will also formulate e-cigarette liquids and oral nicotine pouches for use in the studies.