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A Regulatory Impact Analysis of the FDA Warning Statement on Youth Preferences for Electronic Nicotine Delivery Systems

Principal Investigators: Scott R. Weaver

Funding Mechanism: National Institutes of Health - Grant

ID number: 1R03CA216834-01A1

Award Date: 9/21/2017

Institution: Georgia State University Research Foundation


Since the U.S. Food & Drug Administration announced its final Deeming Rule, electronic nicotine delivery systems (ENDS) have been deemed a tobacco product and are now subject to several regulations, including a new warning statement requirement for ENDS products and advertisements that will take effect in August 2018. The goal of this project is to inform a regulatory impact analysis by evaluating the effects of the required warning statement on the likelihood that youth and young adults will purchase ENDS, and whether this effect depends on ENDS flavor. Researchers will conduct an experiment with 900 youth and young adults aged 16-25 years to address three aims: (1) to examine the effects of the ENDS warning statement on willingness to purchase and intentions to use ENDS; (2) to determine whether the effect of the warning statement on willingness to purchase is mediated by risk perceptions of ENDS; and (3) to determine whether product flavors and individual factors (e.g., demographics, tobacco use) modify the warning statement’s effect on risk perceptions, intentions to use, and willingness to purchase. In this online experiment, researchers will randomize participants into conditions varying according to the warning statement and ENDS flavor, and will be asked to complete a hypothetical purchase task. Study findings will provide new information regarding the impact of the ENDS warning statement and flavors on ENDS use, purchase intentions, and risk perceptions.