FDA Asked to Delay PMTA Deadline Due to Coronavirus

Given the disruptions caused by the COVID-19 outbreak, Altria and tobacco retailing association NATO, have both asked the FDA to delay its May 12th deadline for tobacco manufacturers to turn in premarket tobacco applications (PMTAs).

Diane Caruana

March 31, 2020

In March 2019, the FDA issued its much-anticipated guidelines with regards to new restrictions on vaping products. Amongst other things, the document had announced that the infamous PMTA deadline which the FDA has been heavily criticised for, was to be moved a year forward from 2022 to 2021.

However, a court case which was brought about by anti-tobacco and health groups following the announcement of the initial PMTA delay (to 2022), had resulted in a ruling requiring e-cig manufacturers to submit their PMTAs by May 2020. The vaping industry had pointed out that the expedited deadline was “arbitrary” and “impossible to meet for thousands of small and mid-sized vapor businesses.”

Subsequently, as the deadline approaches, Altria Group Inc. and tobacco association NATO, have both sent letters to the FDA asking that the deadline is pushed back by eight weeks due to complications caused by the coronavirus pandemic. Altria asked that the FDA seek an extension from a federal judge in Maryland to coincide with the eight-week social-distancing period recommended by the CDC.

Currently retailers need to prioritize adapting to the COVID-19 outbreak

“Given the enormous number of products that require [PMTA] submissions, retailers would be very hard pressed to continue their critical workplace function of providing food, beverages, groceries, medications and gasoline to the public while simultaneously attempting to comply with FDA tobacco regulations.”

Similarly, executive director for NATO (National Association of Tobacco Outlets) Tom Briant, asked director of the CTP Mitch Zeller, to petition for the extension, as currently retailers are having to prioritise providing necessities to the public.

“Retail employees would need to determine whether hundreds of deemed tobacco products can remain on store shelves if [PMTAs] are submitted to the FDA by May 12, 2020, or need to be removed from stores if such applications are not submitted to the agency by that deadline,” said Briant in a letter.

The FDA is in discussions with regards to how to address the issue

Spokesman for the FDA, Michael Felberbaum, pointed out that the agency had received numerous inquiries from the industry expressing concern about the impact of Covid-19, on the May 12th deadline. “The FDA is currently engaged in internal discussions to determine how to best address this issue,” said Felberbaum. “We encourage manufacturers who have concerns about meeting the May 12 deadline for any reason to contact the FDA directly.”

Read Further: Bloomberg