On this page:
- What can I do in the CTP Portal?
- What can I NOT do in the CTP Portal?
- How do I obtain a CTP Portal Account or submit Help Desk inquiries?
- How do I upload documents through the CTP Portal?
The FDA’s Center for Tobacco Products (CTP) has developed the CTP Portal as an alternative to the existing FDA Electronic Submissions Gateway (ESG), WebTrader tool,* for tobacco product manufacturers. The CTP Portal provides a convenient, secure online system for electronically submitting documents and receiving messages from CTP.
- 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
- and more
- 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.
- Register tobacco product manufacturing establishment(s) and list your product(s).
- 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.
Before requesting a CTP Portal account, inquire within your organization whether an Industry Account Manager (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 the CTP Portal account, email CTPeSub@fda.hhs.gov and include "CTP Portal" in the subject line or call 1-877-CTP-1373, extension 4. When contacting the Electronic Submissions Help Desk to submit a ticket, please include the following information if applicable: name, company, email, phone number, username, STN, and a summary of the issue including what IT application 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.
You need to use both FDA's eSubmitter software and the CTP Portal:
- 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.
- 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.
- Log in to the CTP Portal.
- Click on the “Launch Upload Tool” button
- On the Launch Upload Tool page, click "Upload eSubmitter File."
- Browse your computer to locate your eSubmitter file and upload it to the site. A message will appear in CTP Portal confirming successful upload. If you do not receive confirmation of your upload or you receive an error message, FDA has not received your package, and you will need to resubmit.
* The CTP Portal provides more functionality than the ESG, and CTP recommends using the CTP Portal. However, if you already have an ESG WebTrader account, you can still use it to submit documents to CTP.