“Solely as a result of the pandemic and these exceptional and unforeseen circumstances, we requested on March 30, and on April 22, 2020 were granted by the court, a 120-day extension of the May 12 deadline. The court order means applications for premarket review for many e-cigarettes, cigars and other new tobacco products are now required to be filed by Sept. 9, 2020. Consistent with the original court order, for companies that submit timely applications, the agency may continue to exercise enforcement discretion, meaning their products would generally continue to be marketed without being subject to FDA enforcement actions, for up to one year from the deadline (up to Sept. 9, 2021), unless a negative action is taken by the FDA on an application during that time.”
BILL TARLING — One thing to remember — even though the PMTA Deadline has been extended, most labs that are needed for processing the required testing, that must be included with the applications, are still closed or working on other priorities. We still don’t know how long things will still be in full or partial lockdown from COVID-19. Even when the processing labs re-open, it will take months for them to get back up to full speed, and to catch up with the backlog. A September deadline likely will still not be enough time to catch up for companies filing their PMTA submissions.
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