Overview

In order to stay on the market, vaping and other electronic nicotine delivery system (ENDS) product manufacturers must submit a PMTA by Wednesday, September 9. Panelists will provide multiple perspectives on the PMTA process, including whether it is an appropriate safeguard of public health or creates a barrier to entry that stifles competition. Panelists will also discuss FDA’s pending review of these applications, including how it may use its enforcement discretion after September 9, how it will apply the public health standard in light of youth and population-wide risks, and what is needed to make the process appropriately efficient and transparent.

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Speakers

Stacey Gagosian, Managing Director, Public Policy, Truth Initiative
Moira Gilchrist, Vice President, Scientific and Public Communications, Phillip Morris International
Matt Holman, Director, Office of Science, Center for Tobacco Products, FDA
Moderated by Stacy Ehrlich, Partner, Kleinfeld, Kaplan & Becker LLP

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