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Food and Drug Administration and Compliance Issues
Thursday, April 23, 2020
Coronavirus (COVID-19) Update: Court Grants FDA’s Request for Extension of Premarket Review Submission Deadline for Certain Tobacco Products Because of Impacts from COVID-19 The following is attributed to FDA commissioner Stephen M. Hahn, M.D.
On July 12, 2019, the United States District Court for the District of Maryland ordered the FDA to require manufacturers of e-cigarettes, cigars and other deemed new tobacco products that were on the market as of Aug. 8, 2016 to submit applications for premarket review by May 12, 2020. We have steadily been working toward that deadline, but the coronavirus pandemic has drastically impaired the ability to adhere to this timeline. 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 ...