Small Vape Companies Ask FDA to Postpone the PMTA Deadline for Them

[mcduffy]

From today's Nothing About Us. Without Us. thread.

Small Vape Companies Ask FDA to Postpone the PMTA Deadline - Vaping360

A group of small vaping manufacturers and trade organizations has requested that the FDA ask a federal court for permission to postpone the Sept. 9 PMTA deadline for 180 days. The companies say they have been prevented from complying with the process by the coronavirus pandemic.

The request came in the form of a “citizen petition” filed yesterday by Azim Chowdhury of Washington, D.C. law firm Keller Heckman. It included declarations provided by 20 individuals from the businesses and organizations behind the petition.

The petitioners are asking the FDA to grant the delay only for “certain small vapor product manufacturers” that have been working “in good faith” to meet the PMTA deadline. Specifically, they write, each manufacturer receiving a postponement of the deadline would have to show “through documentation and other evidence” that they:

Have fewer than 50 employees and/or less than $10 million in annual revenue
Only manufacture open-system products
Have taken steps to prohibit access by and sales to underage customers
Will only market to adults
Are otherwise in compliance with tobacco Control Act/Deeming Rule requirements
Have made progress toward completing their PMTA, but have been “materially delayed” due to COVID-19

The FDA, if it chooses to grant a postponement to small vaping businesses, will again have to request permission from the federal court. That’s because Maryland U.S. District Court Judge Paul Grimm ruled last year that the then-current PMTA deadline was improperly decided by the agency. Judge Grimm changed the deadline to May 12, 2020, and then allowed the agency to move the date to Sept. 9. Any changes the FDA makes to the PMTA process must now be approved by Judge Grimm.

 

[Izan]

Crossing my fingers, but not holding my breath...


Cheers
I