This spring, the FDA appealed to the court to allow a 120-day delay because of challenges posed to applicants and the FDA by the coronavirus pandemic. Judge Grimm granted the delay, and the deadline date changed to Sept.9.
On September 4, the US time, VOOPOO disclosed that it had passed the first round of PMTA application from the Food and Drug Administration (FDA).
On August 25, 2020, firstunion successfully passed the first round of PMTA audit and was officially accepted by the food and Drug Administration (FDA).
The United States District Court for the District of Maryland has granted FDA’s request for an extension of the premarket review submission deadline for certain tobacco products, which FDA requested due to the COVID-19 pandemic. Applications are now required to be filed by Sept. 9, 2020 for many e-cigarettes, cigars and other deemed tobacco products.
However, in accordance with the U.S. District Court for the District of Columbia ruling issued on Aug. 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by the Sept. 9, 2020 deadline.
Some Chinese e-cigarette companies have already submited PMTA applications, and some have set deadlines for filing applications.
Simple Historical Background of Premarket Tobacco Product Applications (PMTAs)