The Tobacco Products Center (CTP) of the US Food and Drug Administration has created two new resources to assist applicants in preparing and submitting amendments to their pre market tobacco product application (PMTA): Fact Sheet - Amendment Tips: Fill out Form FDA 4057a and Video - Use the CTP portal.

This situation manual provides a quick reminder to complete the FDA 4057a form - pre market tobacco product application amendment and general letter submission. In most cases, CTP can only accept PMTA amendments containing FDA Form 4057a for review. Generally speaking, when submitting amendments to PMTA, the FDA will first review the required FDA 4057a form. If the required content is missing from the table, the FDA may not continue to review the amendment.


This video provides an overview of the CTP portal and its usage, including how to search for application submission tracking numbers online.


Recently, CTP Director Brian King outlined several new initiatives aimed at improving center efficiency, effectiveness, and transparency. These activities include strengthening communication on scientific issues and practices. By providing these new resources, CTP aims to better support applicants in successfully completing the PMTA process.