The U.S. Food and Drug Administration (FDA) has provided an update on its review of the tobacco product applications that have been submitted by the Sept. 9, 2020 deadline.
Certain deemed tobacco products including e-cigarettes, hookah products and some cigars were supposed to submit a premarket application to the FDA by Sept. 9, 2020. Those companies that did submit an application by the deadline are allowed to remain on the market for up to a year pending FDA review, though they are still subject to FDA enforcement.
“We have worked several years to prepare for premarket review of a large number of deemed products,” writes Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These efforts included improving information technology systems, engaging with stakeholders, significantly increasing hiring, streamlining review procedures, and providing and promoting guidance and resources to inform industry.”
The FDA has received thousands of tobacco product submissions covering millions of products, with many of those coming in very close to the Sept. 9 deadline. The submissions also varied in the number of tobacco products contained in each submission, size, format and organization. Despite this, Zeller reports that the “intake” of the large number of submissions has gone smoothly so far. With the intake of submissions nearly complete, the FDA is now shifting its focus to the acceptance, filing, and substantive review of those applications.
So far, the FDA has completed the processing step of all exemption from Substantial Equivalence Reqeusts (EX REQ) and all Substantial Equivalence Reports that were submitted by Sept. 9, 2020. In terms of Substantial Equivalence, the FDA received applications for 6,800 products from 100 companies. The FDA received applications for 350 products from 15 companies seeking exemption requests. All of these applications have been fully processed. In terms of premarket tobacco product applications, the FDA has processed applications for 4.8 million products from 230 companies and processing of these applications is still underway.
Zeller states that the FDA had wanted to be able to share a list of products that had been submitted under all three pathways at once but this hasn’t been possible because the processing of these applications is still underway. For now, the FDA is only share the SE and EX REQ list and providing a PMTA update at this time.
