The Food and Drug Administration (FDA) asked a federal judge to extend the May 12 court-ordered PMTA deadline by 120 days to Sept. 9, citing “the exceptional circumstances presented by the global coronavirus outbreak.”
The agency said that disruptions caused by the outbreak would make it difficult for companies to meet the deadline.
“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,” said Mitch Zeller, FDA Director of the Center for Tobacco Products, in a letter to Judge Paul Grimm.
COVID-19 has forced some laboratories in the U.S. to close, as well as some factories overseas, making it difficult for companies to complete their applications, Zeller said. Some of the FDA’s staff have also been pulled into the pandemic response.
Zeller said that as of March 25 he had received more than 15 letters and emails from the industry asking for a delay.
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.