The latest on PMTA

Following the most recent Food and Drug Administration (FDA) presentation on the progress of Premarket Tobacco Product Application (PMTA) review, our Chief Regulatory Officer shares some of the key details along with how we think this will impact vape products in the market.

Some of the key details from our Chief Regulatory Officer, Damien Bové, include:

  • FDA have received 6,500,000 PMTA applications from 500 companies (Approximately).
  • Supported by 100 Tobacco Product Master Files (TPMFs) including ADACTs.
  • Applications are not being review on first in basis, but are being reviewed on a market risk basis. This means that companies with larger reach are being reviewed first.
  • FDA will not be able to complete the review of all PTMAs by 9th September 2021, so any products that have not had their review completed will risk enforcement action from FDA.
  • So far 320,000 products have been accepted for review, and 50,000 have been rejected so the FDA has reviewed just over 5% of PMTAs received for completeness.
  • FDA anticipates having reviewed all applications by the end of July and issues all acceptance or refuse to file letters by then.
  • The published list only contains 6,000 products and is not a comprehensive list.
  • FDA can defer enforcement on a case by case basis after the 9 September 2021.
  • Any new PMTAs will be reviewed along side 9th September 2020 submissions but will be delayed by the massive 9thSeptember 2020 review workload.
  • FDA anticipates that some PMTA authorisation orders will be given prior to 9th  September 2021.

The vast majority of the industry will be operating without authorisation after the 9th  September 2021 review deadline and will risk FDA enforcement. However we can anticipate the FDA extending periods of enforcement discretion after this time, the FDA can’t take blanket actions due to the limitation of the court case that defined FDA PMTA review timelines. It also highlights that many companies are still awaiting their acceptance or refusal to file letters, but all should receive them by the end of July 2021.

To discuss PMTA with one of our specialists, please call Adact on (786) 706-4316 or email [email protected].