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 evaluate the impact of e-cigarette flavors on smoking behavior in current adult smokers.
The study will be co-led by Theodore Wagener, 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 the goal of protecting young people with providing harm reduction options for adults,” Wagner said. This new trial will produce critical data to help make more informed public health decisions with lasting impact.”
Wagner said: “The FDA is currently making regulatory decisions about e-cigarette flavors based on incomplete scientific data. Existing data show that smokers also prefer flavored e-cigarettes, and although there are some investigative studies that suggest flavored e-cigarettes may be more conducive to switching to smoking, these studies are not rigorous enough for the FDA to base regulatory decisions on. Our study will provide the FDA with the first definitive information on whether e-cigarette flavors are beneficial for adult smokers.”
The nationwide randomized controlled trial will enroll up to 1,500 smokers across the country, and researchers will measure the impact of e-cigarette flavors on product acceptance and attraction, cigarette cravings, symptoms, dependence, and smoking behavior. Combined nicotine replacement therapy will be used as a comparison group to determine the potential gains of e-cigarettes compared to nicotine replacement therapy.
Wagner said: “If our study proves that flavored e-cigarettes do not significantly improve in switching to smoking, then the continued sale of these products may not be defensible; However, if the improvements are significant, these findings will provide a critical contrast to current FDA regulations and help inform future decision-making.”
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【1】FDA Grants $3.9 Million to Study Effects of Flavors