Coronavirus pushes back PMTA deadline to September

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Coronavirus pushes back PMTA deadline to September

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Vape companies have been granted an additional four months to submit their products for review.

A federal court accepted the request to push back the deadline, originally marked as May 12, to September 9, following delays caused by the coronavirus.

Azim Chowdhury, a regulation and public policy attorney who represents several vape industry clients, tweeted:

“The 120-days was critically needed for small businesses impacted by the COVID-19 pandemic, but the appeal of the unlawful May 12 deadline continues.

“We hope the 4th Circuit rules in our favor on the merits soon so that FDA can go through a formal APA rulemaking to set a new date.

The review of e-cigarettes is part of a government attempt to regulate the industry.

The FDA banned flavoured pods in February. However, the Premarket Tobacco product Application (PMTA) system will see most currently available products wiped from shelves altogether.

Health advocacy groups successfully sued the FDA last year, forcing them to speed up the review and setting the May 12th deadline in place.

FDA Commissioner Dr. Stephen Hahn said in a statement that the coronavirus has caused delays with e-cigarette research due to travel restrictions and limited laboratory access.

Hahn added that the staff who would be undertaking the reviews are assisting with the pandemic response.

Source: New York Times

Header image: Vapes.com

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