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  5. Validator Tool 2.0 for PMTA and SE Unique Identifying Information for New Tobacco Products Download and Installation
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Validator Tool 2.0 for PMTA and SE Unique Identifying Information for New Tobacco Products Download and Installation

Please Note: FDA posted six updated or new forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, applicants must use these forms in their PMTA and SE Report submissions. If applicants do not use the latest version of the forms or do not complete them properly, FDA generally intends to refuse to accept the application. The following updated forms are available for download on FDA’s website: 

  • Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
  • Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
  • Form FDA 4057b – PMTA Unique Identifying Information for New Tobacco Products (formerly referred to as a grouping spreadsheet)
  • Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
  • Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)
  • Form FDA 3965b – SE Unique Identifying Information for New Tobacco Products (New required form)

 

Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) Report submissions are required to include scientific data demonstrating that the marketing of a new tobacco product is appropriate for the protection of public health. This data is submitted on the latest version of Form FDA 4057b PMTA Unique Identifying Information for New Tobacco Products and Form FDA 3965b SE Unique Identifying Information for New Tobacco Products.

The Product Form Validator Tool 2.0 can help validate the data in Form FDA 4057b and Form FDA 3965b and confirm the forms have been completed consistent with FDA ingestion requirements before submitting to FDA. Applicants are not required to use the tool, but using the tool can help reduce the time applicants spend reviewing, correcting, and resubmitting the relevant form.

While the tool is designed to help applicants navigate the PMTA and SE submission process, successful validation using the tool does not guarantee that an application contains all elements required for acceptance.

System Requirements

  • Windows (64-bit system) 
  • Microsoft Excel
  • Adobe Acrobat Reader
  • Java 17
  • 100 MB of disk space

Download Software

Select the “Download Product Form Validator Tool 2.0 Software” link below to download and save Product_Form_Validator_Tool_v2.zip to your computer. For step-by-step instructions for downloading, extracting, and using the tool, refer to the user guide linked below.

Persons with disabilities having problems accessing the PDF files may call 1-877-CTP-1373 for assistance.

Using the tool 

  • Only one form can be validated at a time. 
  • After accessing the tool, locate and select the form to be validated. The form to be validated must be the latest version of Form FDA 4057b or Form FDA 3965b, which has a file extension of .xls or .xlsx.
    • If an error shows at this point, you should troubleshoot by verifying the file extension.
  • Once the data has successfully passed validation, you must save the completion certificate. This is important because the tool will remove the previous certificate when you begin validating a different Form FDA 4057b or Form FDA 3965b.
  • If the data fails validation, an Issue Report can be created to help solve inconsistencies such as incorrect or missing data. Be sure to carefully review the Issue Report to correct the data and then revalidate the data to obtain a completion certificate.
  • Remember to attach a copy of your completion certificate for each validated file when you are ready to submit your PMTA or SE.

Reporting tool problems 

  • If you identify a problem with the tool, contact our Help Desk. Using the Application Log is the best way for our Help Desk to find a solution.
    • Before contacting the Help Desk, make sure you navigate to and click the “Application Logs” text at the bottom right corner of the tool. This allows you to save a copy of the Application Log into a folder you chose.
    • Please email this log as an attachment to reach our Help Desk at ctpeSub@fda.hhs.gov.
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