The May 12 premarket tobacco application (PMTA) deadline is just over a month away and quickly approaching. However, with the current Coronavirus outbreak, the FDA is seeking to push back this deadline.
Due to “the exceptional circumstances presented by the global coronavirus outbreak,” the FDA has asked a federal judge for a 120 day delay of the May 12 PMTA deadline. This would allow e-cigarette manufacturers more time to submit their applications and keep their products on the market.
If granted, this 120 day delay would move the PMTA deadline to September 9, 2020.
In June of 2019, 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 FDA. Any company that has not submitted a PMTA for their vapor product(s) by this deadline will no longer be legally allowed to sell them in the USA.
Companies that do submit a PMTA for their vape product will be allowed to remain on the market for a year while the FDA decides if it meets its strict requirements.
The FDA cited the COVID-19 pandemic as the sole reason for this 120 day extension request.
“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,” the FDA said. “The agency is committed to implementing and enforcing the premarket requirements in the law.”
The coronavirus pandemic has closed laboratories in the U.S. and deeply affected factories overseas which makes it difficult for companies to complete their applications. FDA staff members have also been pulled into the pandemic response.
Mitch Zeller, Director of the FDA Center for Tobacco Products, said that as of March 25 he had received more than 15 letters and emails from the industry asking for a delay. Tobacco giant Altria Group Inc. last week sent a letter seeking an extension.
Tony Abboud, executive director of the Vapor Technology Association (VTA), said the move is “a step in the right direction” but said it likely won’t go far enough. The trade group sent a letter to the FDA earlier this month requesting a 180-day extension for large manufacturers and a 270-day extension for small ones.
“Given that no one can predict the length and severity of the COVID-19 commercial shutdown, we hope that the FDA will revisit the appropriateness of a September 2020 deadline in the coming months,” Abboud said in a statement.
Until a court decision is made, the May 12, 2020 deadline remains in effect.
If the extension isn’t granted, there will be very few companies that will be able to submit a PMTA by the May 12 deadline. This would severely affect the vaping industry as a whole, as well as consumer access to life saving vapor products.