The Food and Drug Administration is seeking a 120-day extension of the deadline by which electronic cigarette manufacturers need to submit their premarket tobacco product applications.
The current May 12 deadline was imposed after a U.S. district court judge ruled the agency had shirked its responsibility by allowing e-cigs to be marketed without regulatory oversight. However, because of the "highly unusual circumstances" brought on by the coronavirus pandemic, the FDA believes the extension is warranted.
The regulator submitted its request to the same Maryland district court that originally demanded that the FDA take action. If granted, the extension would move the deadline to Sept. 9.
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E-cigarette manufacturers, including companies that make the e-liquids used in the devices, as well as cigars and other nicotine and tobacco products, need to submit applications to the FDA for review if they want to keep selling their products in the U.S.
So far only Philip Morris International (PM +2.00%) and British American Tobacco (BTI +0.35%) have submitted applications, and only Philip Morris' IQOS device has been approved.
There are questions about how many companies other than the industry giants will be able to comply with these regulations, as the applications for the two tobacco companies have run into the tens of thousands of pages and cost them millions of dollars to complete. It took the FDA over two years to approve Philip Morris's application; British American Tobacco's, which was submitted late last year, is still under review.
