FDA Submits Request to Court to Extend Premarket Application Deadline for Certain Deemed Products
On Mar. 30, FDA 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. In the motion, 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 Agency is seeking this extension due to the challenges posed during these extraordinary circumstances. If granted, the 120-day extension would move the deadline to Sept. 9, 2020.
FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review. The Agency is committed to implementing and enforcing the premarket requirements in the law. The Agency strongly encourages applicants who are able, to submit applications as soon as possible. The Agency also encourages applicants who plan on submitting applications for a large number of products to contact the Agency to discuss their plans and method of submission.
On July 12, 2019, the U.S. District court ordered FDA to require submission of applications for premarket review by May 12, 2020, for deemed new tobacco products on the market as of Aug. 8, 2016.
If the court grants this extension, FDA intends to revise its January 2020 enforcement priorities guidance to be consistent with the new deadline. Consistent with the original court order, the Agency would also intend to provide companies that submit timely applications with 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.
Until a court decision is made, the May 12, 2020 deadline is in effect. FDA encourages manufacturers who have concerns about meeting that deadline for any reason to contact the agency directly.