“Some submitted PMTAs contain over 2 million files, with each file containing multiple pages of content for review,” the U.S. Small Business Administration states. “Reviewing all those products before the court-imposed moratorium on FDA enforcement actions ends on September 9, 2021, is a Herculean task that is most likely impossible. Indeed, the FDA itself has stated that the likelihood of it reviewing all the submitted applications by September 9, 2021, is low.”
The low chance of the FDA being able to review all of the PMTAs received by the Sept. 9, 2021 deadline is another reason the U.S. Small Business Administration is calling for a moratorium on enforcement action. If the enforcement action is kept as it is, small ENDS manufacturers are likely to be subject to FDA enforcement actions and removal orders after Sept. 9, 2021, even if they submitted a PMTA by the given deadline.
You can read the full letter from the U.S. Small Business Administration to the FDA urging for an extension of a moratorium on enforcement actions against ENDS manufacturers by clicking here.
For all the latest legislation and FDA news impacting the tobacco industry, click here.
