UNITED STATES
FDA asks judge for PMTA delay

The FDA has asked for a 120-day delay on the deadline for premarket tobacco applications for e-cigarette manufacturers due to the coronavirus situation, according to Bloomberg Law.

Calling the current circumstances surrounding the global coronavirus outbreak “exceptional”, the Food and Drug Administration (FDA) has asked the federal judge in question move the deadline from 12 May to 9 September.
According to Bloomberg Law, the agency pointed out that although its priorities on the matter had not changed, the outbreak was making it difficult for companies to meet the current deadline. Mitch Zeller, the FDA’s Director of the Center for Tobacco Products said that the outbreak has led to laboratories and factories being closed down thus making it hard for companies to complete their applications. He went on to say that the FDA had received several letters from the industry requesting the delay.
Tony Abboud, executive director of the Vapor Technology Association, called the move “a step in the right direction” but said it likely wouldn’t go far enough. “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, reports Bloomberg Law.

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