U.S. FDA Program Invests $3.9 Million in Research Applied to Vape Vape Oil Flavors

The U.S. Food and Drug Administration (FDA) awarded a $3.9 million grant to the Ohio State University Comprehensive Cancer Center’s Center for Tobacco Research, applicable to evaluating the impact of e-cigarette flavors on the smoking behaviors of current adult smokers, according to a related NewsMedicalLifesciences report.

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

Wagener said, “The FDA must decide how to balance the goals of protecting young people and providing harm reduction options for adults. This one new trial will generate critical data to assist in making more informed public health decisions with lasting impact.”

Wagner said, “FDA is currently making regulatory decisions about e-cigarette flavors based on incomplete scientific data. It is now incomplete that smokers also prefer flavored e-cigarettes, and while there are some research studies suggesting that flavored e-cigarettes may be more conducive to switching to smoking, these studies are not rigorous enough for the FDA to make regulatory decisions based on them. Our study will provide the FDA with the first definitive information on whether e-cigarette flavors are beneficial to adult smokers.”

The nationwide randomized controlled trial will enroll up to 1,500 smokers nationwide, and researchers will measure the effects of e-cigarette flavors on product acceptance and appeal, craving for cigarettes, symptoms, dependence, and smoking behavior. Combined nicotine replacement therapy will be used as a comparison group to identify the potential gains of e-cigarettes compared to nicotine replacement therapy.

Wagner said, “If our study proves that flavored e-cigarettes do not show significant improvement in shifting to smoking, then continued marketing of these products may not be defensible; unbeknownst to us, if the improvement is significant, these findings will provide a critical comparison to current FDA regulatory requirements and aid in future decision-making.”