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U.S. FDA Updates PMTA and SE Application Processes, Releases New Submission Forms and Validation Tools

Jun.09.2025
U.S. FDA Updates PMTA and SE Application Processes, Releases New Submission Forms and Validation Tools
The U.S. FDA has released six new forms for submitting applications for new tobacco products, covering both the Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) pathways. Starting July 6, 2025, all applicants will be required to use the updated forms, as previous versions will no longer be accepted.

Recently, the US Food and Drug Administration (FDA) released six updated or new forms for companies to use when submitting new tobacco product applications through the Pre-Market Tobacco Product Application (PMTA) and Substantial Equivalence (SE) pathways. Starting from July 6, 2025, applicants must use these new forms to submit PMTA or SE reports. Failure to use the latest version of the forms or to fill them out properly may result in the FDA rejecting the application.

 

The FDA stated that the updated form took into account public input and is one of the important measures taken by the FDA to improve the efficiency, effectiveness, and transparency of the review process. The new version of the form provides updated instructions for filling out the form and more details, clarifying the information applicants need to provide. This will help applicants submit higher quality applications, thereby speeding up the FDA's review process.

 

Here is the updated list of tables.

 

Updated PMTA form:

 

FDA Form 4057 - Pre-market Tobacco Product Application (PMTA) Submission Form

 

FDA Form 4057a - Pre-market Application Revision and General Communication Submission Form.

 

FDA Form 4057b – PMTA New Tobacco Product Unique Identifier Information (formerly known as "Grouping Form")

 

Updated or new SE form:

 

FDA Form 3965 - Tobacco Product Substantial Equivalence Report Submission Form.

 

FDA Form 3965a - Revision of the Substantive Equivalence Report and General Communication Submission Form (formerly FDA Form 3964)

 

FDA Form 3965b (new) – Unique Identifier Information Form for SE New Tobacco Products

 

To assist applicants in correctly filling out FDA forms 4057b and 3965b, the FDA has also released the Product Form Validator Tool 2.0. Applicants can use this tool to validate the data in both forms to ensure that the information provided meets FDA's acceptance criteria.

 

References:
[1] FDA Updates Tobacco Application Forms; Requires Use by July 6
Also Read:
[1] U.S. FDA Unveils AI Tool Elsa for Clinical Review, Internal Writing, and Data Processing
[2] FDA Appoints Bret Koplow as Acting Director of CTP
[3] FDA Embraces AI: Generative System to Be Fully Operational by June's End

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