FDA has filed a motion with the United States District Court for the District of Maryland requesting a 120-day extension of the premarket application deadline (currently set for May 12, 2020) for many e-cigarettes, cigars and other tobacco products.
The extension is sought solely because of the coronavirus outbreak and the challenges posed during these extraordinary circumstances. If granted, the 120-day extension would move the deadline to Sept. 9, 2020. However, until a court decision is made, the May 12, 2020 deadline remains in effect.
EAS Consulting Group is closely monitoring these and other FDA initiatives. Please contact us with any questions or if we can be of assistance in the preparation and filing of your PMTAs.
If the court grants this extension, FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline, including continued enforcement discretion for a period of up to one year from the date an application was submitted (up to Sept. 9, 2021 if the 120-day extension is granted) or unless a negative action is taken by FDA during that time.
Thanks and take care,
Tara Lin Couch, Ph.D.
EAS Senior Director of Dietary Supplement and Tobacco Services
571-447-5510 tcouch@easconsultinggroup.com