Premarket Tobacco Application (PMTA)

Synchrogenix facilitated the first ever FDA authorization of a premarket tobacco application (PMTA). The application filed by Swedish Match North America was submitted to FDA under the PMTA pathway on March 11, 2015. FDA issued a marketing order on November 10, 2015.

To date, the FDA has yet to authorize marketing of any other new tobacco products through the PMTA pathway.

 

Impact for the Tobacco Industry

FDA’s premarket review pathway is defined by a series of staggered compliance periods, and this FDA web page provides a comprehensive list of the various requirements and their associated compliance deadlines.

The premarket review pathway culminates in the deadlines for submission of premarket applications for combustible and non-combustible products.

  • A PMTA for combustible tobacco products must be submitted by August 8, 2021.
  • A PMTA for non-combustible tobacco products (such as ENDS or e-cigarettes) must be submitted by August 8, 2022.

For a complete listing of the services we offer in support of your PMTA, please click here.

 

Tobacco Submission Project Inquiry

Please email contactus@synchrogenix.com for more information.