FDA Asks Court to Delay PMTA Deadline for Vapor Products
SILVER SPRING, Md. — The Food and Drug Administration (FDA) is taking steps to push back the court-mandated date for companies to submit premarket tobacco applications (PMTAs) for recently deemed tobacco products.
Those products, under the 2016 final deeming rule, include electronic cigarettes and vapor products.
In June, 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 PMTAs to the agency, as Convenience Store News previously reported.
Now, with six weeks to the due date, the FDA asked Grimm for a 120-day delay for e-cigarette manufacturers to submit applications to keep their products on the market, according to Bloomberg Law.
The agency must approve PMTAs for the products to remain 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.
In the letter, Zeller noted that the virus has closed laboratories in the United States and factories overseas, making it difficult for companies to complete their applications. Some of the agency's staff have also been pulled into the pandemic response.
As of March 25 Zeller had received more than 15 letters and emails from the industry asking for a delay, Bloomberg Law added.
Those included Richmond, Va.-based Altria Group Inc. and the National Association of Tobacco Outlets.