Submit Documents via CTP Portal Next Generation

Please Note: FDA posted four updated forms that are required for submitting new tobacco product applications under the premarket tobacco product application (PMTA) and Substantial Equivalence (SE) pathways. Starting Jan. 2, 2026, applicants must use these 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. The following forms are available for download on FDA’s website:

Form FDA 4057 – Premarket Tobacco Product Application (PMTA) Submission
Form FDA 4057a – Premarket Tobacco Product Application Amendment and General Correspondence Submission
Form FDA 3965 – Tobacco Substantial Equivalence Report Submission
Form FDA 3965a – Tobacco Substantial Equivalence Report Amendment and General Correspondence Submission (formerly Form FDA 3964)

On this page:

What Is CTP Portal Next Generation (CTP Portal NextGen)?
What Can I Do in CTP Portal NextGen?
Managing CTP Portal NextGen User Accounts
FDA's eSubmitter Software and CTP Portal NextGen

What Is CTP Portal Next Generation (CTP Portal NextGen)?

CTP Portal NextGen is a web-based platform designed for regulated entities in the tobacco industry—such as manufacturers, importers, and distributors—to electronically send tobacco product submissions to the FDA. Users have the option to use web forms within CTP Portal NextGen for PMTA and SE submissions, while the eSubmitter tool will remain available to support all other submission types.

The PMTA and SE web forms offer a more integrated, efficient way to submit documents. Additional web forms for other submission types will be introduced in phases.

CTP Portal NextGen also allows users to view detailed information about their submissions. To access the portal, organizations must designate an Industry Account Manager (IAM), who will manage and secure access to the system.

CTP Portal NextGen

What Can I Do in CTP Portal NextGen?

CTP Portal NextGen is intended to be used by regulated tobacco industry manufacturers, importers, distributors, TPMF owners, universities, and other sponsors who send tobacco product submissions to CTP.

The CTP Portal NextGen can be used to:

Complete required PMTA and SE Report forms
Upload documents to CTP electronically and securely, seven days a week, with confirmation of receipt, if uploaded successfully, including:
- Ingredient Listing
- Reporting of Harmful and Potentially Harmful Constituents (HPHCs)
- Health Documents (not adverse experience or product problem reports)*
- Apply to Market
Respond to CTP inquiries
View a list of your submissions and FDA regulatory letters, including:
- Date CTP received your submission
- Assigned FDA tracking number for your submission

^{* For information regarding section 904(a)(4) requirements, please refer to the Final Guidance:}^{Health Document Submission Requirements for Tobacco Products}^.

Training materials to provide an overview of CTP Portal NextGen and how to use it, including how to find your application’s submission tracking number (STN) online will be available soon.

CTP Portal NextGen cannot be used for the following:

Register tobacco product manufacturing establishment(s) and list your product(s)
- CTP Portal NextGen does not replace the Tobacco Registration and Product Listing Next Gen (TRLM Next Generation) system. Refer to the TRLM Next Generation Instructions for guidance on how to submit tobacco registration and product listing information. Note: Users must first create a TRLM Next Generation account before submitting tobacco registration and product listings.
Gain access to the FDA Electronic Submissions Gateway (ESG)
Gain access to the Safety Reporting Portal (SRP) for submitting Adverse Experience (AE) and Product Problem Reports

Managing CTP Portal NextGen User Accounts

The organization is responsible for designating the Industry Account Manager (IAM), and the designated IAM is responsible for managing CTP Portal NextGen user accounts. While the IAM is the delegate authority, ultimately, the organization is responsible for the behavior of their employees and agents on the CTP Portal.

How Do I Create a New User Account in CTP Portal NextGen?

Only the organization’s IAM(s) can create a new user account.

How Do I Obtain a CTP Portal NextGen Account or Submit Help Desk Inquiries?

Before requesting a CTP Portal NextGen account, inquire within your organization whether an IAM has been designated. If your organization already has an IAM, contact them to request a user account. Otherwise, request an Industry Account Manager (IAM) for your organization.

For additional inquiries about CTP Portal NextGen accounts, contact the FDA eSub Help Desk by email at CTPeSub@fda.hhs.gov and include "CTP Portal NextGen" in the subject line or call 1-877-CTP-1373, extension 4.

When contacting the FDA eSub Help Desk to submit a ticket, please include the following information if applicable:

Name
Company
Email
Phone number
Username
STN (tracking number)
A summary of the issue including what IT application is being used, URL of the site where the issue was encountered, the web browser being used, and whether the computer is a Windows or Mac.
For Industry Account Manager (IAM) applicants, please include a tracking number and date of application.

What Responsibilities Does My Organization Have in Managing User Accounts for CTP Portal NextGen?

Your organization is responsible for creating users and managing the list of users who have access to your organization’s CTP Portal NextGen account and managing the permissions of each user. If an employee, attorney, or agent are no longer affiliated with your organization, the IAMs for your organization are responsible for deactivating that person’s CTP Portal NextGen user account to prevent further access. Alternatively, if the sole IAM is departing your organization, it is the responsibility of your organization and the departing IAM to reassign the IAM role to another individual prior to their departure. This will ensure continuity of access and permissions for your organization.

When Setting Privileges in the CTP Portal NextGen, How Do I Know Which Specific Privileges Each User Has?

CTP Portal NextGen has four different privileges that can be given to each CTP Portal NextGen user by the CTP Portal NextGen Admin. The different privileges and their permissions and abilities within CTP Portal NextGen are described in the table below:

CTP Portal Next Generation "Privilege"	Associated Permission or Ability in CTP Portal Next Generation
CTP Portal NextGen "Privilege"	Associated Permission or Ability in CTP Portal NextGen
Submissions – View Only	This default privilege allows users to access the Submissions section from the global navigation menu, including all sub-sections, and view the draft, sent, and published submission-related information for their organization.
Submissions – Create/Edit/View	This privilege provides users with the same abilities as the Submissions - View Only privilege, but it also provides users with the ability to create and edit dedicated web forms for Premarket Tobacco Product Applications (PMTA), Substantial Equivalence (SE), and Tobacco General Correspondence (TC) submissions from within CTP Portal NextGen.
Submissions – Create/Edit/View/Submit	This privilege provides users with the same abilities as the Submissions - Create/Edit/View privilege, but it also provides users with the ability to submit both web form and eSubmitter submission packages to CTP via CTP Portal NextGen.
Administration – User Administration	This privilege allows users to create and manage user accounts for their organization. This privilege is granted to the Industry Account Manager (IAM) for their organization, and the IAM may grant this privilege to other user accounts in their organization as needed.

FDA's eSubmitter Software and CTP Portal NextGen

How Do I Package a Submission Using eSubmitter?

CTP recommends using CTP Portal NextGen to complete required PMTA and SE Report web forms, as it offers a more integrated, efficient way to submit documents. However, you have the option to use eSubmitter. Refer to Electronic Submissions for Tobacco Products and the eSubmission File Format Specifications for additional information on requirements. If using FDA's eSubmitter software, you need to:

Save your text documents as .pdf with optical character recognition and your data files in a data file format such as .xlsx or .xpt. FDA forms in spreadsheet format should be saved as .xlsx. Save all of your submission files to one folder location on your computer.
Download and install eSubmitter, if you have not already done so.
Note: eSubmitter is a free tool that helps you create an electronic submission, which you can upload into the CTP Portal NextGen.
Open eSubmitter.
Click "create new submission." Select the eSubmitter template for the submission type you want to create:
- CTP Tobacco Product Ingredient Listing
- CTP Reporting of Harmful and Potentially Harmful Constituents (HPHCs)
- CTP Tobacco Product Health Documents
- CTP Transmittal Form for All Other Submission Types
Follow the guided process within eSubmitter. Answer the questions and fill out the screens. You will be prompted to attach the PDF documents and data files you saved in step 1.
At the end of the process, eSubmitter packages your submission as a compressed ZIP file. Save the eSubmitter ZIP package to your computer.

How Do I Upload eSubmitter Packages to CTP Portal NextGen?

Log in to CTP Portal NextGen (https://ctpportal-ng.fda.gov/portal/) using your credentials.
Navigate to the dashboard and click on "Create New Submission" to open the Create New Submission page.
Select the "eSubmitter Upload | Submission Package" radio button.
Click Next to proceed.
Use the Browse button to locate the ZIP file you wish to upload. Please note:
1. CTP Portal NextGen only accepts eSubmitter ZIP files for upload.
2. Only one ZIP file can be uploaded at a time.
Enter a description for your submission in the provided field.
Once uploaded, a confirmation message will appear in CTP Portal NextGen, indicating a successful upload.
Important Note:
If you do not receive a confirmation message or encounter an error, the FDA has not received your submission package. In such cases, you will need to resubmit the file.
Refer to the image below for guidance on uploading your submission package.

Where Can I View Information on Prior Uploads?

To view previous uploads, navigate to the Submissions tab, select Sent, and check under the eSubmitter Upload Files section (see image below).

Where Can I View Information on Published Submissions?

To view published submissions, navigate to the Submissions tab, select Published (see image below).

What Are Some Possible Causes of Being Unable to View My Organization's Uploads?

There are several possible reasons for being unable to view your organization’s uploads, including:

The name of the organization used to set up the IAM account must be an EXACT match to the organization name submitted in the application.
There were multiple IAM accounts created for your organization by mistake (e.g., accounts created using slightly different spelling). In this case, please contact the CTP eSub Help Desk by email at CTPeSub@fda.hhs.gov (include "CTP Portal NextGen" in the subject line) or call 1-877-CTP-1373, extension 4.
Your access was removed by the IAM and you no longer have access to view these uploads.
Your account was deactivated. User account passwords need to be reset every 90 days to stay active (per FDA security protocols). If you did not reset your password in this timeframe, please contact the CTP eSub Help Desk by email at CTPeSub@fda.hhs.gov (include "CTP Portal NextGen" in the subject line) or call 1-877-CTP-1373, extension 4.
Your account was administratively closed by an Industry Account Manager (IAM). In this case, please contact the IAM Request Team by email at ctp-iam-request@fda.hhs.gov for further information.