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FDA Launches Web-Based Tobacco Premarket Application Forms to Enhance Submission Process

Agency Also Posts Updated PDF Forms for Applicants Who Do Not Wish to Use Web-Based Forms; Requires Use by Jan. 2, 2026

Today, FDA launched web versions of four forms in CTP Portal Next Generation (CTP Portal NextGen) for applicants submitting and amending premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. FDA transitioned from CTP Portal to CTP Portal NextGen—a new, improved web portal for submitting tobacco product applications electronically—in early 2025. The web forms allow applicants to create, validate, and submit PMTA and SE Report submissions directly through CTP Portal NextGen, further enhancing the application submission process by making it a more integrated and efficient experience.

FDA encourages applicants to use the web versions in CTP Portal NextGen. Features include:  

  • Step-by-step instructions on completing the forms
  • A more user-friendly interface that helps guide applicants through the submission process
  • The ability for multiple users to work on a submission at the same time and easily save drafts  
  • Real-time, automatic validation, ensuring all required fields are completed before submission  

The web-based forms include Forms FDA 4057, 4057a, 3965, and 3965a. Industry stakeholders with active CTP Portal accounts had the option to test and provide feedback on the new web functionality of the forms during online development. Creating these web-based forms is part of FDA’s work to promote efficiency, effectiveness, and transparency to improve its tobacco product application review process.  

PDF PMTA and SE Report Forms Remain Available

For those who do not wish to use the web-based forms, PDF versions of the PMTA and SE Report forms are still available online. At this time, applicants can continue to download the PDF version of the forms and send electronic submissions to FDA via CTP’s Document Control Center or use eSubmitter to upload completed PMTA and SE Report forms to the portal.  

Updated PDF Versions Available  

FDA published updated PDF versions of Forms FDA 4057, 4057a, 3965, and 3965a on the agency’s website. Since posting them in June 2025, FDA corrected minor technical issues. Starting Jan. 2, 2026, applicants who use the PDF versions of the forms must use the latest version of the 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. When preparing to submit an application, FDA recommends applicants check the agency’s website prior to submission to ensure they are using the current version of the form.  

Other Types of Submissions

For submission types other than PMTAs and SE Reports—such as Exemption Requests, Harmful and Potentially Harmful Constituents reports, and Tobacco Product Ingredient Listings—the existing process of using the FDA’s eSubmitter tool will continue. FDA developed the PMTA and SE Report web-based forms first as they are some of the most commonly used forms. However, the agency will introduce additional web forms for other submission types in future phases.  

If applicants have questions about the web-based forms, please email AskCTP@fda.hhs.gov or call 1-877-287-1373 between 9 a.m. and 4 p.m. ET. FDA intends to provide additional information and trainings on the web forms and will provide more details when available.  

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