FDA Rolls out New Features in CTP Portal NextGen to Enhance Application Submission Process

July 17, 2026

As part of the U.S. Food and Drug Administration’s (FDA) ongoing work to promote efficiency and effectiveness, and to improve the overall tobacco product document submission process, FDA is announcing additional updates to the Center for Tobacco Products Portal Next Generation (CTP Portal NextGen). With the rollout of these new features, FDA is also announcing that it will phase out the use of eSubmitter forms for PMTA and SE submissions.

In 2025, FDA launched CTP Portal NextGen—a web portal for submitting tobacco product submissions electronically. The web portal allows applicants to create, validate, and submit forms directly through CTP Portal NextGen, further enhancing the document submission process by making it a more integrated and efficient experience.

Now, FDA is rolling out new features to the web forms for premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. These new features are based on user feedback and are expected to both increase efficiency and consistency during the document submission process and significantly reduce the data entry burden for applicants.

These updates include the ability to: 

• Upload folder(s) and sub-folder(s), in addition to files
• Identify and label submitted documents directly in the portal, ensuring all files are included in the submission
• Save contact information in an address book for reuse in future submissions

FDA encourages applicants to use the web-based forms directly within CTP Portal NextGen for the most user friendly and efficient application submission process. A user guide is also available within CTP Portal NextGen to help applicants navigate the system.

Use of eSubmitter

By Nov. 14, 2026, applicants should use the web-based forms in CTP Portal NextGen for PMTA and SE submissions (applicants may submit PDF versions if unable to submit online). After Nov.14, 2026, eSubmitter will no longer be available for PMTA and SE 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. The agency intends to introduce additional web forms for other submission types in future phases.

PDF Forms Remain Available

For applicants who are unable to use or choose not to use the web-based forms, PDF versions of the 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. 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. If submitting using webforms, PDF forms do not need to be included in applications.

Questions

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 training on the web forms and will provide more details when available.