U.S. FDA to Announce Sept. 9 PMTA Deadline
While not yet official, the deadline for submitting premarket tobacco product authorizations (PMTA) to the U.S. Food and Drug Administration (FDA) is one step closer to being delayed from May 12, 2020 to Sept. 9, 2020 due to the Covid-19 pandemic.
Judge Paul Grimm of the U.S. District Court for the District of Maryland issued an “indicative ruling” granting the FDA’s request to delay the deadline by 120 days.
The ruling is not yet final, however, due to procedural issues that are expected to be resolved expeditiously. Due to appeals filed by several organizations, including the Vapor Technology Association and the FDA itself, Grimm no longer has the authority to modify his original ruling which moved the deadline to May 2020. That power now lies with the U.S. Court of Appeals for the Fourth Circuit.
For the ruling to become valid, the Fourth Circuit must remand the case back to Grimm’s court where Grimm says he would modify the order to allow the FDA to delay the change. The FDA will then need to update its regulations to move the PMTA date to Sept. 9, 2020.