Altria Joins NATO in Asking FDA to Extend PMTA Deadline
RICHMOND, Va. — With approximately six weeks to go until premarket tobacco applications (PMTA) for deeming products are due, there is a push for the Food and Drug Administration (FDA) to move the date back.
On March 25, Richmond-based Altria Group Inc. sent a letter to the agency asking that the May 12 PMTA deadline be pushed back eight weeks as the country continues to the deal with the COVID-19 pandemic, according to Bloomberg Law.
In June, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for companies to submit premarket tobacco applications (PMTA) to the agency.
His decision came after the FDA had previously extended the original deadline set in the 2016 final deeming rule. The FDA must approve PMTA bids for e-cigarette and vapor products to stay on the market.
However, in the letter Altria asked that the FDA seek an extension from the court to coincide with the eight-week social-distancing period recommended by the U.S. Centers for Disease Control and Prevention to slow the spread of the coronavirus, the news outlet reported.
While the tobacco company is on track to meet the PMTA deadline, many Altria employees — as well as those employed by its partners like analytical labs — are working remotely.
If the agency cannot grant an extension, Altria proposed it allow companies to submit data and product samples after the deadline if the pandemic hinders their efforts, according to Bloomberg Law.
"Although we make this request and raise these issues given these unprecedented times, we remain committed to working with the agency on these important product submissions," Altria Senior Vice President Paige Magness said in the letter.
Altria's letter followed similar request from the National Association of Tobacco Outlets (NATO). The association sent a letter to FDA Director Mitchell Zeller asking the agency's Center for Tobacco Products to consider petitioning the U.S. District Court for the District of Maryland for an extension of the current deadline.
In a news item on the letter, which was posted on Swisher International's website, NATO also cited the virus crisis in its request.
Among the key arguments in NATO's letter was the impact complying with FDA tobacco regulations would have on retailers who are currently working with a limited staff.
"That is, 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," NATO said. "Given the enormous number of products that require pre-market application 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."
In a statement obtained by Bloomberg Law, Michael Felberbaum, a spokesman for the FDA, said that the agency had received numerous inquiries from the industry expressing concern about the impact of COVID-19 on the May 12 deadline.
"The FDA is currently engaged in internal discussions to determine how to best address this issue," Felberbaum said. "We encourage manufacturers who have concerns about meeting the May 12 deadline for any reason to contact the FDA directly."