• Deanna Clark-Esposito

Survival Planning for the FDA's PMTA Deadline in 9 Months



On August 7, 2019, Brent Stafford, of Regulator Watch (https://regulatorwatch.com), interviewed me describing how to survive the accelerated timeline for the submission of the PreMarket Tobacco Application (PMTA) which is required of manufacturers of Electronic Nicotine Delivery Systems (ENDS), including e-liquids and e-cigarettes, now due on May 12, 2020. The US Food and Drug Administration defines a Tobacco Product Manufacturer as follows:


Tobacco Product Manufacturer: Any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes or labels a tobacco product OR who imports a finished tobacco product for sale or distribution in the US.


As described by Regulator Watch, “in this 20 min. episode we present a practical guide to FDA’s onerous Premarket Tobacco Application process which—thanks to a recent court ruling—is now due in less than 10-months. It seems that time for the U.S. vaping industry could be coming to an end. Is it possible to survive the PMTA process? Find out! Only on RegWatch, by RegulatorWatch.com.”


You can watch the interview at http://bit.ly/RegWatch_FDA_PMTA


Have questions about the PMTA process? Connect with us using the Contact form on the Home page or call us today at (917) 546-6997.

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