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Frequently Asked Questions (FAQs) for the CTP Portal/Industry Account Manager (IAM) Request

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What is CTP Portal?

The CTP Portal is a web-based tool which enables regulated tobacco industry, including manufacturers, importers, and distributors, to send tobacco product submissions that have been packaged by eSubmitter to FDA electronically. The CTP Portal can also be used to facilitate secure two-way messaging allowing tobacco industry users access to information regarding their submissions and contact with their FDA representative. Designating an Industry Account Manager (IAM) for your organization is the only way to create and access a CTP Portal account for your organization.

Can I submit my establishment registration and product listings through the CTP Portal?

No. CTP Portal is not used for tobacco registration and listing submissions. CTP Portal is separate from the Tobacco Registration and Listing Next Generation (TRLM NG). Tobacco Registration and Listing Module – Next Generation (TRLM NG) Instructions will show you how to submit tobacco registration and product listing information. Users must first create a TRLM NG account to submit tobacco registration and product listings.

What is an Industry Account Manager (IAM)?

The Industry Account Manager (IAM) is an individual who is designated by the authorized representative of an organization and is responsible for to creating and managing CTP Portal user accounts for that organization, including user accounts for non-employee attorneys or agents. The IAM acts as an “admin” for the organization’s CTP Portal account and has full access to all information in the organization’s CTP Portal account, including the ability to manage user accounts and upload submissions to FDA.

What does the IAM for my organization do? What information do they have access to?

The IAM is granted a “CTP Portal User Admin” role in CTP Portal. Only an individual with the “CTP Portal User Admin” privilege can perform the following actions in CTP Portal:

  • Create user accounts
  • Manage user accounts
  • Deactivate user accounts
  • Reset user accounts
  • Unlock user accounts

IAMs created by FDA will also be able to view submission-related information, view and reply to messages, and upload eSubmitter files through the CTP Portal.

Note: These permissions can be changed or revoked by other IAM user accounts that are created by the organization’s initial IAM.

Who can request an IAM for an organization?

Only an authorized representative who is an employee of the manufacturer can request an IAM account and designate an IAM for the organization.

Who can be the authorized representative?

The authorized representative is a person who is a corporate or executive officer with signatory powers, a general partner, or proprietor that has the authority to sign contracts, permits, applications, and other documents in the company's name. The IAM Request Form must be signed by an authorized representative who is a direct employee of the organization. The person who signs the IAM Request Form should be on file at FDA as an authorized representative for your organization (if you have one on file).

Can the designated IAM also be the authorized representative?

Yes, the designated IAM may be the same individual as the authorized representative. There is no requirement that they be different individuals. However, the person who signs the IAM Request Form should be on file at FDA as an authorized representative for your organization (if you have one on file).

Can an attorney or agent request an IAM account for my organization?

FDA no longer accepts IAM requests designating non-employee attorneys or agents to be the IAM. Attorneys that are direct employees of the organization may be designated as IAM. If an organization would like a non-employee attorney or agent to be an IAM for their organization, they should first designate an employee of the organization to be IAM in the IAM request submitted to FDA. That individual will then be able to create a secondary (additional) IAM account for the non-employee attorney or agent.

How do I request an IAM for my organization?

As an authorized representative, to designate a primary (initial) IAM for your organization:

  1. Visit the IAM Request Form and Rules of Behavior (ROB) homepage.
  2. On that page, select the appropriate button to access the IAM Request Form and ROB.
  3. Ensure the forms are fully completed and appropriately signed.
  4. Submit the signed forms to CTP.

FDA will notify the designated IAM via the email address provided on the IAM Request Form once the CTP Portal account is created. The email will include a link and instructions for the IAM to complete the account set-up. The IAM is responsible for monitoring the email address provided on the IAM Request Form. The link to complete account set-up in the email is only valid for 24 hours. If the IAM fails to complete account set-up within the 24-hour window, a new link will need to be requested by sending an email to the CTP Help Desk.

Note: Please do not submit another IAM Request Form if you did not complete the account set-up within the 24-hour window. This will further delay accessing your account.

What can I do if I miss the 24-hour deadline to complete account set-up?

If the IAM fails to complete account set-up within the 24-hour window, a new link will need to be requested by sending an email to the CTP Help Desk.

Note: Please do not submit another IAM Request Form if you did not complete the account set-up within the 24-hour window. This will further delay accessing your account.

How long will it take to process my IAM request?

With a properly completed and signed IAM Request Form and ROB, most IAM requests can be fulfilled within 5-10 business days of receipt. 

However, the processing time can vary depending on the completeness of the request and on the number of requests being processed at any given time. Incomplete or illegible requests may take longer to process for account creation. Depending on the volume of requests received, processing time can increase to 20 or more business days, especially before an FDA mandated deadline. To best ensure your organization has access to your CTP Portal account prior to an FDA mandated deadline, please submit your IAM request at least six weeks prior to the deadline.

Who can I contact to determine the status of my IAM request?

Please wait at least 10 business days from the date of mailing the IAM Request Form and ROB before contacting FDA about the status of your IAM request. FDA will contact the IAM listed on the IAM Request Form if there is an issue with the request preventing your CTP Portal account from being created. 

If the designated IAM has not received an email regarding account set-up within 10 business days of date of mailing, and FDA has not contacted the IAM regarding the request, the designated IAM or the authorized representative may send an email to the IAM Request Team requesting the status of the IAM request. Be sure to include the IAM name and the organization the request is for in the email. 

Can an organization have more than one IAM? How do I create additional IAMs?

Yes, an organization can have more than one IAM. FDA recommends that an organization maintain at least two IAMs for their CTP Portal account. However, FDA only creates the initial IAM for an organization. It is up to your organization to determine the appropriate person to designate as the first IAM. Once the initial IAM is created, that individual can create additional accounts as necessary, including IAM accounts, for other individuals within your organization. Please only submit one IAM request for your organization. FDA will only create one IAM account for each organization. 

To create a secondary (additional) IAM, an existing IAM may follow the directions below:

  1. Sign in into your CTP Portal account. If you are an IAM for your organization, you will see the “Admin” button at the top of the screen.
  2. Click the “Admin” button, then click the “Add New User” button.
  3. Fill in the user information. 
  4. Under the “Privileges” section, select the appropriate access for the individual, including “CTP Portal User Admin.” The “CTP Portal User Admin” privilege enables the user to create additional user accounts for your organization, as an IAM. 
  5. Click “Save.”

This new user will have the ability to create additional users for your organization as an IAM. 

FDA highly recommends that each organization maintains at least two IAMs for each organization and recommends that at least one of the IAMs is a direct employee of the organization. This will help maintain continuity of access if one of the IAMs leaves or is no longer affiliated with your organization. 

How do I keep my CTP Portal account active?

To protect the confidentiality of the information within your CTP Portal account, CTP Portal account passwords need to be changed every 90 days.  If you have difficulty changing your password, contact the CTP Help Desk.

What should I do if I have a CTP Portal account but cannot access it?

  • If you are not the sole IAM for your organization, contact an IAM for your organization. That individual will be able to send you an account reset. 
  • If you are the organization’s sole IAM, and you are unable to access your company’s CTP Portal account, contact the CTP Help Desk. CTP Portal account information can only be provided to the individual designated as the IAM on the IAM Request Form.

What if our only IAM has left the organization and we do not have access to CTP Portal account information? What do I do if our IAM has left the organization?

If your organization’s sole IAM is departing the organization, FDA highly recommends that they create additional users with IAM privileges for your organization prior to their departure. If this is not possible as the IAM has already departed, please contact the IAM Request Team for further instructions.

Does CTP Portal have non-IAM privileges?

The CTP Portal has the following user privileges:

  • View Submission-Related Information: this default privilege allows users to view submission-related information.
  • View Only Messages: allows users to view messages sent between FDA and your organization.
  • View/Reply Messages: allows users to view and reply to messages sent by FDA.
  • Upload: allows users to upload eSubmitter files through the CTP Portal.
  • User Admin: allows users to create and manage user accounts.

A user can be granted any of the above privileges. 

What responsibilities does my organization have in managing user accounts for CTP Portal?

Your organization is responsible for creating users and managing the list of users who have access to your organization’s CTP Portal 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 user account to prevent further access. Alternatively, if the sole IAM is departing your organization, it is the responsibility of the 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.
 

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