The FDA’s Center for Tobacco Products (CTP) has introduced new web-based versions of key forms used for PMTA and Substantial Equivalence (SE) Report submissions. These updated forms are now available through CTP Portal Next Generation (NextGen), the agency’s enhanced portal for electronic tobacco product application submissions.
The transition from the legacy CTP Portal to NextGen earlier this year introduced new capabilities, but FDA’s deployment of fully web-based forms marks a significant step toward improving efficiency, accuracy, and workflow integration for applicants.
Key Features of the New Web-Based Forms
CTP noted several enhancements designed to simplify the submission experience:
- Built-in step-by-step guidance to help applicants complete forms correctly
- A more intuitive, user-friendly interface
- Ability for multiple users to collaborate on a submission and save drafts
- Real-time validation to ensure all required fields are completed prior to submission
The new web versions cover Forms FDA 4057, 4057a, 3965, and 3965a, which applicants use for PMTA and SE Report submissions. Stakeholders with active CTP Portal accounts participated in testing and provided feedback during development.
PDF Forms Still Available — With Important Updates
FDA confirmed that applicants may continue using PDF versions of the forms if preferred. Submissions can still be sent via:
- CTP’s Document Control Center, or
- eSubmitter uploads into the portal
However, FDA has updated the PDF versions of Forms 4057, 4057a, 3965, and 3965a to correct technical issues identified since June 2025.
Starting January 2, 2026, applicants using the PDF route must use the latest version of each form. Failure to use the correct version—or incomplete forms—will generally result in Refuse-to-Accept (RTA).
FDA advises applicants to always download fresh copies from the agency’s website before submitting.
EAS Perspective
These updates reflect CTP’s broader push to modernize and streamline the tobacco product application process. The introduction of collaborative, validated web forms—combined with a firm RTA enforcement date—signals FDA’s expectation that applicants strengthen submission accuracy and version control.
EAS will continue monitoring CTP Portal NextGen developments and provide guidance as new features roll out.
Source: FDA Center for Tobacco Products
Date: December 3, 2025
Posted in FDA and USDA Regulatory Update, Tobacco.