FDA Plans to Launch Updated Submission Portal for New Tobacco Product Applications in 2025

The FDA’s Center for Tobacco Products (CTP) has announced its plans to unveil the CTP Portal Next Generation (“CTP Portal NG”) in 2025, an improved web portal for submitting applications for new tobacco products. Two notices issued in the Federal Register highlight the upcoming changes aimed at enhancing the application process.

Key Improvements

• Unified System: The new portal will consolidate electronic submissions for substantial equivalence (SE) reports, premarket tobacco product applications (PMTAs), amendments to previous submissions, and general correspondence into a single system.
  • From the Federal Register: “CTP Portal NG will provide web forms of FDA Forms 4057 and 4057a for PMTA applications and amendments, respectively…CTP Portal NG has a built-in process for applicants to upload Form FDA 4057b after applicants complete Form FDA 4057b and validate it using a new validator tool.”

• Enhanced Efficiency: By integrating PDF-editing software, FDA’s eSubmitter Desktop Tool, and the current CTP Portal Web application into one platform, the new system promises a more streamlined submission process, eliminating the need for multiple tools.

• Updated PMTA Forms: Form FDA 4057b has been updated to add the following columns: Brand; Subbrand; Manufacturer. This update aligns with the requirements of part 1114. Additionally, Characterizing Flavor has been included as a required field. Form FDA 4057a will undergo cosmetic changes, such as updated instructions, organization, and flow “…follow a consistent style and sequence with Form FDA 4057.” No changes have been announced for Form 4057.

Transition Details

Current users of any CTP systems will not need to take any action regarding these updates. Existing CTP Portal accounts, as well as any pending or in-process applications, will be automatically migrated to the new CTP Portal Next Generation.

Comment Period

As it is required to do, the FDA is seeking comments from the public on the input of that information. Beginning July 16, the public comment period will be open through September 14 at 11:59 p.m. EST. Drafts of the updated forms and screenshots of the new system can be viewed in the docket for these notices. The FDA will not consider late comments, and not commenting now may forfeit an ability to challenge the changes once enacted.