Last month, Juul Labs submitted a PMTA to the FDA, as part of the required process that would allow it to keep selling its products across the US. The company’s submission includes 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.”
Due to the hardships the industry is facing as a result of the Covid-19 outbreak, the PMTA deadline has been moved to September 9th, 2020.
“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 the company on Tuesday.
Similarly, Fontem US LLC submitted its documents last April, well ahead of the set deadline,. The submissions include data from a comprehensive range of laboratory and clinical scientific studies on the myblue range. These include product analyses, behavioral data, health risk information, and information on the impact to both users and non-users of tobacco products.
PMTA deadline delayed due to Covid-19
As the infamous 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.
To this effect, on March 30th the agency filed a request for a 120-day extension on the deadline, and 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.
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