There's been a 120 day extension added to the PMTA deadline

April 10, 2020 137 Comments

which a Maryland federal judge on Friday granted.   A 120 day extension has been added to the deadline for vape products and eLiquids regulatory applications, more commonly known as the Pre-Market Tobacco Application, in light of the novel coronavirus outbreak that has strained the Food and Drug Administration's resources so thin they don't have time to be told to ignore additional regulations they are currently disregarding or eliminating outright. 

Late last week, the FDA asked the Fourth Circuit to extend the current May 12 deadline in light of the coronavirus outbreak, saying that many of the laboratories and research organizations conducting the clinical trials for the regulatory applications have shut down or otherwise halted any and all in person testing.

In a very brief one page indicative ruling U.S. District Judge Paul W. Grimm said he would agree to extend the deadline for e-cigarette pre-market tobacco applications to Sept. 9.  The FDA told the Fourth Circuit on March 31 that many of their staff have been enlisted by the Public Health Service to help fight the pandemic, limiting the agency's ability to review applications, which they consider to be the lowest on their list of priorities given the circumstances. 

According to a letter sent by the agency; "Also, virtually the entire FDA staff responsible for reviewing pre-market applications will be teleworking until further notice," adding: "While the FDA has taken steps to enable work to be performed remotely as much as possible, the agency anticipates that it will take additional time for a remote workforce to receive and process applications and conduct scientific review of those applications."  

Another reason they cannot possibly go through all of the applications are the travel restrictions around the world that have limited the FDA's ability to gather information about vape manufacturers in countries including Italy, China, Honduras, the Dominican Republic, Nicaragua, Mexico and some other sources where vape tech is commonly manufactured.  

On the industry side, seeing as there are no big vape companies and the pandemic has left all of these small and medium sized businesses in the exact same shambles other non-vape related small and medium businesses are in, the FDA has said it has received 15 letters from groups representing thousands of market players requesting a 180-day deadline extension in light of these disruptions.

"At this point, we do not believe that an extension at the upper end of that range is appropriate given FDA's countervailing critical public health priority in promptly requiring submission of applications," the agency stated, though it clearly acknowledged a 120 day extension was necessary and warranted.  The vaping industry is currently challenging the FDA’s deadline in both the Fourth and Sixth Circuits. 

So that's where we are at. We've got a hard fight ahead of us all on this coronavirus business and it's hard to focus on vaping as it seems like such a peripheral issue, given the times we are in, but that fight must be fought in tandem.  Luckily we now have this extension in the books so we can continue the good fight against coronavirus and big tobacco. What do you think about all the goings on either front?  Tell us in the comments! 

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