FDA Requests PMTA Extension

The U.S. Food and Drug Administration (FDA) has requested a 120-day extension to the May 12 premarket tobacco product application (PMTA) deadline due to complications associated with the coronavirus.

The FDA submitted a letter to the Maryland District Court requesting that Judge Grimm, the judge who ordered the original deadline, postpone the court-ordered May 12 PMTA deadline to Sept. 9.

The FDA cited lab and research organization closures; travel restrictions creating limits on information gathering; factory closures; the reallocation of some Center for Tobacco Products employees to the U.S. Public Health Service; and FDA employees working remotely, making it difficult to review applications.

The FDA’s request follows an earlier request from Altria to extend the PMTA deadline and letters from more than 15 manufacturers requesting extensions.

As of February 2020, the FDA has received 30 PMTAs for e-cigarettes and 28 substantial equivalence applications for cigars.