As the infamous May 12th PreMarket Tobacco Application Authorization (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 current pandemic.
To this effect, on March 30th the agency had filed a request for a 120-day extension on the deadline. As a result on April 3rd, Judge Paul Grimm of the United States District Court for the District of Maryland, agreed to the request and moved the deadline to September 9th, 2020.
Approximately 2,000 applications have been received
There are over 400 million eligible items that would need to apply in order to stay on the market.
Subsequently, the FDA has recently announced that the normally secretive process will be made public, and the agency will be publishing a list of all the products subject to the deadline which have filed applications. The announcement was made by Mitch Zeller, director of the FDA’s Center for Tobacco Products, via a blog post last month.
The FDA has already received applications for approximately 2,000 e-cigarettes and other newly regulated tobacco products. Zeller pointed out that there are over 400 million eligible items that would need to apply in order to stay on the market.
FDA to carry out “substantive scientific review” with regards to Juul’s submission
Last month, Juul Labs submitted its PMTA. The company’s submission included a “comprehensive scientific evidence for the JUUL Device and JUUL pods in Virginia Tobacco and Menthol flavors at nicotine concentrations of 5%, 3% and information on data-driven measures to address underage use of its products.”
“We will continue to follow the PMTA process and look forward to this next step as the FDA commences substantive review of the application,” said Juul Labs Chief Regulatory Officer Joe Murillo in a statement. Subsequently, the FDA has now notified the manufacturer that it will be carrying out a “substantive scientific review,” according to an announcement by Juul.
Similarly, Fontem US LLC submitted its documents last April, well ahead of the set deadline. The submissions included data from a comprehensive range of laboratory and clinical scientific studies on the myblue range, together with product analyses, behavioral data, health risk information, and information on the impact to both users and non-users of tobacco products.