Update: Motion Granted for PMTA extension

Posted by Decent Distribution on Apr 23rd 2020

Update: Motion Granted for PMTA extension

On Mar. 30, FDA filed a motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline. The motion has been GRANTED - giving manufacturers more time to prepare for the lengthy application process. The Agency stated that it was seeking the extension solely because of the coronavirus outbreak and would not do so but for these highly unusual circumstances.

We are still waiting for news regarding the “streamlined approval” for small companies. Alex Azar, the US Secretary of Health and Human Services told in an interview:

"We’re working with small businesses and the vaping association to actually create pathways that would streamline approval for the open-tank small vape shop-based products..."

“What we’re focused on are the cartridges in the systems with kid-attractive flavors, not the…open-tank vaping systems, and as to all products we’re committed to working with all actors in the system to get them through the regulatory process that Congress set up as expeditiously as possible. That regulatory process is not something the President created. That was created by Congress back in the Obama administration. We just have to implement it.”

More information will be provided as it becomes available.