Keller and Heckman LLP Files Citizen Petition Requesting 180-day Extension of PMTA Deadline for Small Open-System Vape Companies Due to COVID-19


On August 24, 2020, Keller and Heckman LLP filed a citizen petition (here) with the U.S. Food and Drug Administration (FDA) on behalf of a group of small vapor product manufacturers, retailers, and trade associations requesting that the agency seek a 180-day extension of the September 9, 2020 deadline (until March 8, 2021) for filing Premarket Tobacco Product Applications (“PMTAs”) due to continuing delays experienced by manufacturers in preparing the applications caused by the COVID-19 pandemic.

The current PMTA deadline was set by a federal district court in Maryland as part of a lawsuit filed by anti-vaping groups challenging an earlier August 2022 deadline established by FDA through guidance issued in 2017. Attached to the petition were 20 declarations demonstrating that many small vapor companies, without an extension, will either have to file incomplete PMTAs or not submit applications at all, thus forcing them to layoff thousands of employees, close their doors permanently, and remove from the market less risky vapor products that addicted adult smokers rely on to move away from cigarettes.

The petition specifically asks FDA to request from the district court an extension on the court-imposed deadline that would apply only to small manufacturers that demonstrate to the agency that they have been working in good faith to complete PMTAs by the September 9, 2020 cutoff and have otherwise taken steps to ensure that their products will not contribute to underage use. In particular, each manufacturer would need to show that it:

Read full article here.

Azim Chowdhury & Eric Gotting – The Continuum of Risk – September 3, 2020

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