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 updated forms reflect public comments and are part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process. The latest versions of the forms offer new instructions and additional details on information applicants are required to include. Ultimately, these forms can help applicants submit higher quality applications to facilitate FDA’s review.

A list of the updated forms is below. Use of old versions of the forms will no longer be accepted after the 30-day notice period.

Updated PMTA forms:

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)

Updated or new SE forms:

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 (NEW) – SE Unique Identifying Information for New Tobacco Products

To assist applicants’ proper use of Form FDA 4057b and Form FDA 3965b, FDA is releasing version 2.0 of its Product Form Validator Tool. Applicants may use the tool for both forms to validate the data and confirm if a completed form is consistent with FDA ingestion requirements before submission.