The Food and Drug Administration asked a federal judge to grant a 120-day delay for a deadline 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, from May 12.
The existing deadline was the product of a legal agreement in federal court, after regulators, public-health groups and vaping companies fought over the timing for years.
The agency said its priorities hadn’t changed, but 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,”
The new coronavirus has closed laboratories in the U.S. and shuttered 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. Tobacco giant
Tony Abboud, executive director of the Vapor Technology Association, called the move “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,” he said in a statement.
FDA spokeswoman Alison Hunt said in a statement that the coronavirus is affecting all FDA-regulated industries, including tobacco manufacturers, causing the agency to request the change.
(Updates with comment from vaping industry group in eighth paragraph)
To contact the reporter on this story:
To contact the editors responsible for this story:
© 2020 Bloomberg L.P. All rights reserved. Used with permission.