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09/09/2021

FDA Reportedly Seeking More Time for Decision on Juul

The agency faced a Sept. 9 deadline to complete its review of premarket applications for newly deemed products.
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SILVER SPRING, Md. — Anyone waiting for a decision on whether Juul vapor products can be marketed in the United States may have to wait a little longer.

According to CNBC, the Food and Drug Administration (FDA) will reportedly seek more time before deciding whether Juul can continue to sell its products in the United States. The news outlet cited a report by The Wall Street Journal.

Reports of a delay come as the seconds count down on the agency's court-mandated timeline to complete its review of all premarket tobacco applications (PMTAs) for newly deemed products — mainly electronic cigarettes and vapor products — submitted to the FDA one year ago.

Per a court order, applications for premarket review for certain deemed new tobacco products on the market as of Aug. 8, 2016 were required to be submitted to the FDA by Sept. 9, 2020, as Convenience Store News previously reported.

In summer 2019, District Judge Paul Grimm of the U.S. District Court for the District of Maryland set a May 12, 2020 deadline for companies to submit their applications to the agency. However, in April 2020, Grimm agreed to extend the deadline to Sept. 9, 2020 as tobacco companies and the FDA weathered the challenges of the COVID-19 pandemic. 

In all, manufacturers submitted PMTAs for approximately 6.5 million products. The FDA then had 12 months to complete its review; however, it had previously said it would not be able to complete the review of all the products.