By Timothy S. Donahue

Top Takeaways:

• FDA now offers fully web-based PMTA and SE Report forms through CTP Portal NextGen, enabling guided, real-time-validated online submissions.
• Updated PDF forms remain available, but beginning Jan. 2, 2026, applicants must use the latest posted versions or risk refusal to accept.
• Additional web forms for other tobacco submissions will follow as FDA continues phased upgrades to the NextGen portal.

The U.S. Food and Drug Administration has introduced web-based versions of four major regulatory forms used in premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports, representing the latest update to the agency’s CTP Portal Next Generation (CTP Portal NextGen).

The new forms—FDA 4057, 4057a, 3965, and 3965a—can now be completed, validated, and submitted entirely online, a change FDA says will simplify and modernize the application process for tobacco manufacturers and other regulated entities.

The CTP Portal NextGen replaced the original CTP Portal in early 2025, providing a redesigned interface and enhanced features for companies submitting electronic forms. The introduction of web-based forms marks a significant expansion of the platform, offering step-by-step guidance, real-time automatic validation, and support for multiple users to collaborate and save drafts at the same time.

According to FDA, these features are intended to reduce administrative burden and improve submission accuracy before applications enter scientific review.

Industry stakeholders with active CTP Portal accounts were invited to test the web-based features during development and provide feedback to the agency. FDA stated that this effort supports its broader objectives of enhancing efficiency, transparency, and the overall effectiveness of the tobacco-product review process.

PDF versions of the PMTA and SE forms will remain available. Applicants can continue to download the fillable PDFs and submit them electronically through CTP’s Document Control Center or upload them using eSubmitter. However, FDA has issued updated PDF versions of Forms 4057, 4057a, 3965, and 3965a to fix minor technical issues found since their release in June 2025.

Starting January 2, 2026, applicants who submit via PDF must use the most recent versions available on FDA’s website. The agency stated it generally plans to reject applications that use outdated forms or are filled out incorrectly.

FDA emphasized that stakeholders submitting other types of filings—such as Exemption Requests, Harmful and Potentially Harmful Constituents (HPHC) reports, and Tobacco Product Ingredient Listings—should continue using eSubmitter for those submission categories.

The agency focused on PMTA and SE Report forms during the first phase of web migration because they are some of the most frequently used regulatory filings. Additional web-based forms for other submission types will be added in later phases of the CTP Portal NextGen rollout.

Applicants with questions about the new online forms can contact FDA’s Center for Tobacco Products through AskCTP@fda.hhs.gov or by calling 1-877-287-1373 during business hours. FDA said more information and training materials will be provided as additional web form features become available.