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FDA Releases PMTA Updates

FDA Releases PMTA Updates

 

On February 16, 2021, the FDA released an update about how the PMTA approval process is going on their end. In addition to highlighting a page that is supposed to be updated bimonthly with PMTA statistics, they have also released a page with more explanation of the approval process and where applications are in the approval process.

The FDA’s article covers three applications: the PMTA applications, the SE (Substantial Equivalence) applications, and the EX REQ (Substantial Equivalence Request) applications. As there are no vape products that companies could file equivalence applications for, most vaping-related applications were PMTA applications.

There were PMTA applications for 4.8 million products. The FDA says that they are still processing applications at this stage. This stage would be the stage where the FDA confirms that your application has been submitted.

The next stage is the acceptance stage. This is the stage where the FDA makes sure the application has the information required. 84,000 products have been accepted, and 3,100 products have been rejected. That means 87,100 PMTA product applications have finished this stage.

After acceptance is the filing phase, in which teams are assigned to applications and begin to assess the applications. 29,000 products have been filed, and 1650 products were refused filing. 30,650 products have gone through the filing phase total.

As for the longest phase, the review phase, there are no solid numbers listed for the PMTA category. The FDA has finished SE and EX REQ applications, but for PMTA applications, only state that they “have also commenced substantive review on hundreds of products submitted through the PMTA pathway.”

This means, nearly halfway through the PMTA grace period, only hundreds of products have reached the final stage out of the 4.8 million products submitted. The FDA itself states “the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low.”

Although the SE and EX REQ applications were prioritized through randomness, the FDA is choosing to prioritize products with a larger share in the current market for PMTA applications. This approach makes sense for an organization that wants to take popular, problematic products off the market as fast as possible. However, this means smaller companies are more likely to be stuck waiting for a PMTA update for a product that is no longer allowed on the market.

Additionally, the FDA has been unable to provide a list of vapor products that can be sold during the grace period due to the sheer number of PMTA applications. Despite the lack of information, the FDA is still sending out warnings to shops selling products that have not submitted PMTA applications.

And there we are - nearly half a year after the PMTA deadline. Shops need to personally research which products are legal to sell, vapor products cannot be shipped through the USPS, and the FDA is nowhere near finishing PMTA applications. Unfortunately, the main thing to do is wait and see what the FDA plans to do with the large amount of work they’ve given themselves.

References:

https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/deemed-new-tobacco-product-applications-list

https://www.fda.gov/tobacco-products/ctp-newsroom/perspective-fdas-progress-review-tobacco-product-applications-submitted-sept-9-2020-deadline

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters



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