WASHINGTON—E-cigarette and tobacco manufacturers now have until September 9, 2020, to file premarket applications for with the U.S. Food and Drug Administration after the U.S. District Court for the District of Maryland Friday granted the agency’s request for a 120-day extension of the deadline in light of the global outbreak of the novel coronavirus.
Under a July 12, 2019, court order, manufacturers had faced a May 12 deadline to submit for premarket review tobacco product applications (PMTAs) for e-cigarettes, flavored cigars, smokeless tobacco and hookah products deemed new to the market as of August 8, 2016, in order for them to remain on the market. On March 30, the FDA asked the court for a delay until September because of operational challenges caused by the pandemic.
Earlier this year, the FDA published guidance banning flavored cartridge-based e-cigarettes, with the exception of tobacco and menthol flavors, which took effect on February 6. However, flavored single-use disposable e-cigarettes and flavored e-liquids used in open-tank systems were allowed to stay on the market provided the manufacturers file PMTAs by the May deadline—now extended until September 9. Those products can then stay on the market for up to 12 months while FDA reviews the applications, and following that timeframe, the products can only be sold if the FDA approves them.
According to the FDA guidance, vape shops or other retailers that mix their own vape juice must submit PMTAs because they are, in those cases, manufacturing the product.
The cartridge-based flavored e-cigarettes products banned in February could be allowed back onto the market if their products are approved by FDA in the PMTA process.