FDA to Conduct a Substantive Scientific Review of Juul

Last month, Juul Labs submitted a PMTA to the Food and Drug Administration (FDA), which is a necessary process for it to continue selling its products in the United States. The documents submitted by the company include "comprehensive scientific evidence for JUUL devices and JUUL pods with tobacco leaf concentrations of 5% and 3%, as well as data-driven measures regarding underage use of its products."

 

Joe Murillo, Chief Regulatory Officer of Juul Labs, stated in a release: "As the FDA begins its substantive review of this application, we will continue to follow the PMTA process and look forward to the next steps." Subsequently, according to the company's announcement on Tuesday, the FDA has now notified manufacturers that it will conduct a "substantive scientific review."

 

Similarly, Fontem US LLC submitted its documents last April, well ahead of the scheduled deadline. The submitted materials include extensive laboratory and clinical scientific research data from the myblue series. This includes product analysis, behavioral data, health risk information, and information regarding the impact on tobacco product users and non-users.

 

Due to Covid-19, the PMTA deadline was delayed.

As the notorious May 12 PMTA deadline approached, many entities, including Altria Group and the Tobacco Association, requested the FDA to postpone the deadline due to complexities arising from the coronavirus pandemic.

 

In response, the agency requested on March 30 to extend the deadline by 120 days, and on April 3, U.S. District Judge Paul Grimm agreed to this request, changing the deadline to September 9, 2020.