The U.S. Food and Drug Administration (FDA) has awarded a $3.9 million grant to the Center for Tobacco Research at the Ohio State University Comprehensive Cancer Center to study the impact of e-cigarette flavors on smoking behavior among current adult cigarette users.

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

"The FDA must decide how to balance its goal of protecting minors with the choice of harm-reduction products for adults," Wagner said. "This new trial will produce critical data that will help the FDA make better-informed public health decisions with more lasting impact."

Wagner said, "While there are some investigative studies that suggest flavored e-cigarettes may be more helpful for cigarette users to switch to e-cigarettes, these studies are not rigorous enough for the FDA to make a regulatory decision." Our study will be the first to provide the FDA with clear information about the benefits, if any, of e-cigarette flavors for adult smokers."

The nationwide randomized controlled trial will enroll up to 1,500 cigarette users from across the country, and researchers will measure the impact of e-cigarette flavors on product absorption and attraction, cigarette cravings, symptoms, dependence, and smoking behavior. Combined nicotine replacement therapy will be used as a controlled experiment to determine the potential increased benefits of e-cigarettes relative to nicotine replacement therapy.

"If our study shows that there is no significant improvement in cigarette users switching to flavored e-cigarettes, then continuing to sell these flavored e-cigarette products may be untenable, and conversely, if the improvement is significant, these findings will provide important trade-offs for current FDA regulations and will help inform future decision-making," Wagner said.