In February 2021, the FDA issued an update on how they are able to determine how the PMTA acceptance process is progressing from their side. Alongside the announcement of the page, which is expected to be regularly updated with PMTA figures, The FDA has released a website providing more information about how approval is granted and the places where applications are at the moment in an approval procedure.
The FDA’s article focuses on three types of applications: PMTA applications, SE (Substantial Equivalence) applications, and EX REQ (Substantial Equivalence) applications. EX REQ (Substantial Equivalence Request) applications. Because there aren’t any vape products for which companies can apply for equivalence, the majority of vaping-related applications comprised PMTA applications.
It was reported that there were PMTA requests for 4.8 million items. The FDA declares that they are working on applications at this point. This would be the point at which it is when the FDA confirms that the application was received.
The next step comes the stage of acceptance. This is the point at which the FDA assures the applicant contains the necessary information. Eighty-four thousand approved products have been approved, and 3,100 of them were rejected. This means that an average of 87,100 PMTA product applications have been completed in this phase.
After acceptance comes the filing stage, in which teams will be assigned the applications and begin evaluating the applications. There have been 29,000 applications filed, and 1650 of them were denied being filed. Thirty thousand six hundred fifty products have passed through the filing process in total.
In the most lengthy phase, which is the review phase, there are no concrete figures on this PMTA category. The FDA has completed SE as well as EX REQ applications. Still, regarding PMTA applications, they only say that they “have also commenced substantive review on hundreds of products submitted through the PMTA pathway.”
That means that, about halfway to this PMTA grace time, only a handful of products have made it to the final stage out of 4.8 million submitted. The FDA themselves states that “the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low.”
Even though SE and EX REQ applications were prioritized through randomness, SE, as well as the EX REQ application, were ranked due to randomness and randomness; the FDA will now prioritize those products that have a greater part of the marketplace to PMTA applications. This makes sense for an organization looking to remove popular, troublesome products from the market as quickly as it is possible. This means that smaller businesses will be more likely to get in limbo waiting for the PMTA update on products that are no longer available to be offered for sale.
In addition, there is a problem that the FDA is unable to give the list of vapors that are available for sale within the grace time because of the quantity of PMTA applications. Despite the absence of details, the FDA has continued to send warnings to retailers selling products who have not completed PMTA applications.
We’re almost half a year later, having passed the PMTA deadline. Shops must conduct their examination of which products are legal to sell. Vapor-based products are not able to be shipped via the USPS, and the FDA isn’t even close to completing PMTA applications. However, the most important decision is to sit and find out what the FDA will meet with the massive amount of work they’ve entrusted to them to complete.