The US Food and Drug Administration (FDA) has requested a 120-day extension to the deadline for premarket tobacco product applications (PMTAs) due to the challenges that the coronavirus outbreak is posing to companies.
As the current deadline of 11th May was ordered by the US District Court for the District of Maryland in July 2019 after a lawsuit was brought by a group of public health bodies, the FDA has filed a motion requesting that it is put back to 9th September.
According to the FDA’s Center for Tobacco Products (CTP): “The Agency states that it is seeking the extension solely because of the coronavirus outbreak and would not do so but for these highly unusual circumstances.”
The FDA indicated in its petition to the court that: “Defendants consulted with Plaintiffs, who indicated that they do not intend to oppose the motion but wish to express their misgivings about the extension on the record and therefore request leave to file a response”.
The extension has yet to be approved by the court and the FDA is meanwhile encouraging companies to submit their e-cigarette product applications “as soon as possible”.
Manufacturers planning to submit a large number of PMTA applications are advised to contact the agency to discuss the method of submission. The FDA was already considering delaying the current PMTA deadline after “numerous” inquiries from the industry expressing concern about getting their applications in on time due to the COVID-19 public health crisis.
‘Enforcement discretion’ for timely applicants
One of the last to request an extension was Altria, which wrote to the FDA last Wednesday asking for an eight-week extension – the length of time recommended by the US Centers for Disease Control and Prevention (CDC) for the practice of social distancing to slow the spread of the coronavirus.
The National Association of Tobacco Outlets (NATO) sent a letter this week to CTP director Mitch Zeller asking for a deadline extension.
Assuming the judge gives a green light to the extension request, the FDA will start on a revision of the application guidelines it published in January.
The agency wants to provide companies that submit timely applications “with continued enforcement discretion” for a year. If the 120-day deadline extension is approved, that discretionary period will be updated to 9th September 2021, according to official sources.
This will not be the first time that the PMTA deadline has been moved. In July 2019, the court in Maryland ruled against the FDA’s postponement of deadlines because it violated the Administrative Procedure Act (APA) by not following its requirements for comments and notice.
In its postponement announcement in 2017, the FDA had set a series of extended deadlines for different aspects of compliance with the deeming regulations, culminating in 2021 and 2022 dates for submission of PMTAs for e-cigarettes.
In a letter attached to the FDA’s petition to the court, Zeller stated: “As of February 29, 2020, 30 premarket tobacco product applications are pending for electronic cigarette products, 28 substantial equivalence applications are pending for cigars, and 17 substantial equivalence applications are pending for pipes or pipe tobacco products”.
What This Means: Until Maryland judge Paul Grimm decides whether to grant the requested four-month extension, the 11th May deadline is still in effect.
Moving that deadline back could definitely give a boost to some companies that were rushing to submit the application on time and have already requested more flexibility in the process in the light of present circumstances.
– David Palacios TobaccoIntelligence staff