As the May 12th PMTA deadline was fast approaching, a number of entities including Altria Group Inc. and tobacco association NATO, had asked the FDA to push the deadline back due to the complications caused by the coronavirus pandemic. Altria asked that the FDA seek an extension from a federal judge in Maryland, to coincide with the eight-week social-distancing period recommended by the CDC.
Spokesman for the FDA, Michael Felberbaum, said that the agency had received numerous inquiries from the industry expressing concern about the impact of Covid-19 on the May 12th deadline. “The FDA is currently engaged in internal discussions to determine how to best address this issue,” said Felberbaum. “We encourage manufacturers who have concerns about meeting the May 12 deadline for any reason to contact the FDA directly.”
Deadline moved to September 9th
Judge Paul Grimm of the United States District Court for the District of Maryland agreed to the request, moving the deadline to September 9th, 2020.
Subsequently, on March 30th the agency filed a request for a 120-day extension on the deadline. On April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland agreed to the request, moving the deadline to September 9th, 2020.
“FDA remains aware of the recent surge in youth use of e-cigarettes and the public health imperative that these and other deemed new tobacco products undergo premarket review,” the FDA said in a statement released March 31. “The agency is committed to implementing and enforcing the premarket requirements in the law.”
Businesses who are able to submit earlier should do so
Meanwhile, FDA officials are strongly encouraging applicants who are able to submit applications earlier to do so as soon as possible. Additionally, they are asking companies with a large number of submissions to contact the agency in order to discuss their plans and method of submission.
Read Further: CSP
COVID-19 Lockdown and The Damage to Vape Businesses and Their Customers
Let’s block ads! (Why?)