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Policy Federal Judge Approves Delay of PMTA Deadline for Vapor Products


GREENBELT, Md. Tobacco and vapor companies have an extra four months to file their premarket tobacco applications (PMTAs) for newly deemed tobacco products with the Food and Drug Administration (FDA).

Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for newly deemed tobacco product including electronic cigarettes and vapor products to remain on the market.

This past summer, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for companies to submit the applications to the agency, as Convenience Store News previously reported.

However, on April 3, Grimm said he would agree to extend the deadline for the PMTAs to Sept. 9, according to Law360.

Grimm's decision came after the FDA asked Grimm for a 120-day delay for e-cigarette manufacturers to submit applications to keep their products on the market. Citing "the exceptional circumstances presented by the global coronavirus outbreak," the agency proposed moving the deadline to Sept. 9. The agency pointed to the COVID-19 pandemic and not changing priorities in its request, the news outlet added.

"FDA remains acutely aware of the recent surge in youth use of e-cigarettes and the public health imperative to ensure that these and other deemed new tobacco products undergo premarket review," Mitch Zeller, the director of the FDA's Center for Tobacco Products, said in a letter to Grimm filed on March 30.

FDA's letter followed a push from tobacco industry players, including Altria Group Inc. and the National Association of Tobacco Outlets.


Vapesourcing Opinion:

Filing a PMTA is an expensive and time-consuming task,due to coronavirus, it is necessary to delay the PMTA deadline. It is a good news for the e-cigarette industry. 
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