• 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.


©2021 by the Clark-Esposito Law Firm.

Per the NY State Attorney Ethics Rules we are providing the following statement:  ATTORNEY ADVERTISING.

DISCLAIMER: The content of this website has been prepared by the Clark-Esposito Law Firm, P.C. for informational purposes only and should not be construed as legal advice. The material posted on this website is not intended to create, and receipt of it does not constitute, a lawyer-client relationship, and readers should not act upon it without seeking professional legal counsel. The Clark-Esposito Law Firm, P.C., did not produce and is not responsible for the content of off-site legal resources. The materials on this site may constitute advertising under various state ethics rules.