A new $3.9 million grant from the U.S. Food and Drug Administration (FDA) will allow researchers with the Center for Tobacco Research at The Ohio State University Comprehensive Cancer Center to evaluate effects of e-cigarette flavors on the smoking behaviors of current adult smokers.
The study, co-led by Theodore Wagener, PhD, director of Ohio State's Center for Tobacco Research, and Tracy Smith, PhD, of the Medical University of South Carolina (MUSC) Hollings Cancer Center, will be the first to provide definitive information about the impact of non-tobacco e-cigarette flavors for helping adult smokers stop smoking.
Wagener says this study will provide scientific data that are urgently needed to inform the FDA's regulation of flavor use in e-cigarettes.
Youth advocates have strenuously objected to flavored e-cigarettes, arguing that, with flavors like cinnamon bun, cotton candy, bubble gum, mango, strawberry or chocolate, e-cigarettes are enticing young people to take up an addictive and harmful habit. Those flavors might also be more appealing to adults who smoke cigarettes and have been unable to quit.
The FDA is currently making regulatory decisions about e-cigarette flavors with incomplete scientific data. Existing data show that smokers also prefer flavored e-cigarettes, and while there are a few survey studies suggesting that flavored e-cigarettes may be more helpful for switching to vaping, these studies are not rigorous enough for the FDA to base its regulatory decisions on. Our study will be the first to provide the FDA with definitive information as to the benefit, if any, of e-cigarette flavors to adult smokers."
Theodore Wagener, PhD, Director of Ohio State's Center for Tobacco Research
While the National Academies of Science, Engineering and Medicine have concluded that e-cigarettes are likely to be far less harmful than combustible cigarettes, Wagener notes that more than 1 million e-cigarette products have been banned since 2020, mostly due to the significant rise in youth vaping, often with flavored e-cigarettes.
Switching to e-cigarettes, while not a completely healthy choice, is thought to be better than continuing to smoke, a concept that public health scientists refer to as "harm reduction."
Wagener says "the FDA must decide how to balance its goals of protecting young people and offering harm-reduction options to adults. This new trial will generate critical data to help make more informed public health decisions that have a lasting impact.".
New study evaluates how much flavoring impacts smoking behavior
This national, randomized, controlled trial will recruit up to 1,500 cigarette users from the across the United States.
Researchers will measure e-cigarette flavor impact on product uptake and appeal, cigarette craving, symptoms, dependence and smoking behavior, including sustained and complete switching from cigarettes to e-cigarettes. They will also utilize combination nicotine replacement therapy (NRT, patch and lozenge) as an FDA-approved comparator to determine the potential increased benefit (or not) of e-cigarettes versus nicotine replacement therapies on smoking. Smokers will be randomized to one of three groups: preferred flavor e-cigarette, tobacco flavor e-cigarette or combination nicotine replacement therapy.
Study participants will receive products at no cost for 14 weeks. Participants in the preferred flavor group will be able to change flavors throughout that time. Changes in smoking will be biochemically confirmed via remote exhaled carbon monoxide readings at 12 weeks and 26 weeks after the product switch date.
"If our study demonstrates no significant improvements in switching with flavored e-cigarette use, then the continued sale of these products is likely indefensible; however, if improvements are significant, these findings will provide a critical counterweight to the current FDA regulations and will aid future decision making," Wagener said.