Following the FDA’s March 9 draft guidance on flavored electronic nicotine delivery systems, Keller and Heckman LLP highlighted the agency’s continued focus on youth-risk concerns while providing more clarity on the evidentiary expectations for adult-benefit claims. Keller and Heckman encouraged industry stakeholders to submit comments during the 60-day public comment period to ensure FDA considers the latest evidence on youth use and adult-benefit outcomes.
The firm emphasized that FDA’s risk-proportionate framework formalizes how the evidentiary burden rises with youth appeal, but that the guidance does not yet incorporate the 2025 National Youth Tobacco Survey (NYTS) data showing a substantial decline in youth vaping. Keller and Heckman noted that evolving data could inform public comments, particularly on whether the agency should recalibrate its comparative-efficacy requirement, given that factors beyond flavors—such as peer influence, boredom, and experimentation—also drive youth use. Keller and Heckman said the draft also opens the door to using non-clinical sensory studies to assess relative appeal and clarifies the limited role of device access restrictions in mitigating youth risk.
The firm will further address the guidance and other regulatory updates at its 2026 E-Vapor, Nicotine, and Tobacco Law Symposium on May 4–5 in Las Vegas, offering attendees practical insights into navigating the PMTA process under FDA’s clarified expectations.