VAPE PMTA: A Pre-Market Tobacco Application Database

September 10, 2021

The Family Smoking Prevention & Tobacco Control Act requires that all tobacco products must receive a PreMarket Tobacco Application (PMTA) authorization before they can be sold across the U.S..Initially set for May 12th, as the deadline was approaching, many companies had asked the FDA to push the deadline back due to the complications caused by the Coronavirus pandemic.

The PMTA process was designed for product manufacturers who can afford the time and financial costs that come with it, leaving the smaller business in ruins.To this effect, on March 30th the agency filed a request for a 120-day extension on the deadline, and on April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland agreed to the request, moving the deadline to September 9th, 2020.

This means that as of last week, all vape brands’ applications must be submitted to the FDA for review, or else have their products withdrawn from the legal US market.

Sadly, the PMTA regulatory process was clearly only designed for product manufacturers who can afford the time and financial costs that come with it, leaving the smaller business in ruins. Approximately 14,000 small vape businesses are estimated to be forced to close down as a result, leaving over 160,000 Americans unemployed.