U.S. FDA funds $3.9 million for research on flavored vaping devices

Recently, the U.S. Food and Drug Administration (FDA) awarded $3.9 million to the Tobacco Center of Regulatory Science at The Ohio State University Comprehensive Cancer Center to study how e-cigarette flavors affect the smoking behavior of current adult cigarette users.

The study will be co-led by Theodore Wagener, director of Ohio State’s Tobacco Center of Regulatory Science, and Tracy Smith of the Hollings Cancer Center at the Medical University of South Carolina.

Wagener said, “The FDA must decide how to balance its goals of protecting minors while also providing adults with access to harm-reduction products. This new trial will generate critical data to help the FDA make more informed public health decisions with lasting impact.”

Wagener added, “Although some survey-based studies suggest that flavored e-cigarettes may be more helpful for cigarette users switching to e-cigarettes, those studies are not rigorous enough to support FDA regulatory decisions. Our study will be the first to provide the FDA with clear information on whether e-cigarette flavors offer benefits to adult smokers, and if so, what those benefits are.”

This nationwide randomized controlled trial will recruit up to 1,500 cigarette users from across the United States. Researchers will measure how e-cigarette flavors affect product uptake and appeal, cigarette cravings, symptoms, dependence, and smoking behavior. Combination nicotine replacement therapy will be used as the control arm to determine the potential added benefit of e-cigarettes compared with nicotine replacement therapy.

“If our study shows that flavored e-cigarettes do not significantly improve outcomes for cigarette users switching away from smoking, then continued sales of these flavored e-cigarette products may be difficult to justify. On the other hand, if the improvement is significant, these findings will provide important trade-off considerations for current FDA regulations and help inform future decisions,” Wagener said.