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U.S. Department of Health and Human Services

Tobacco Products

Tobacco Registration and Product Listing Module (TRLM) Step-by-Step Instructions


Tobacco Registration and Product Listing Module (TRLM)

Step-by-Step Instructions


Table of Contents

  1. Enter New Tobacco Registration and Product Listing
  2. View or Update Registration Information
  3. View or Update Product Listing Information


New Registration and Product Listing

Step-by-Step Instructions

Table of Contents

  1. Log into Tobacco Registration and Product Listing
  2. Navigation
  3. Section I - Identification
  4. Section IIA - Registration (Owner Information)
  5. Section IIB - Registration (Owner Business Structure)
  6. Section IIIA - Registration (Operator Information)
  7. Section IIIB - Registration (Operator Business Structure)
  8. Section IV - Establishment Information
  9. Section V - Product Listing
  10. Registration Review Page
  11. Section VI – Confirmation Statement
  12. Complete Draft Registration and Product Listing


1. Log into Tobacco Registration and Product Listing

After logging into the FDA Unified Registration Listing Systems, users can select "Tobacco Registration and Product Listing" from the list of systems available on the FURLS Home Page as shown in Figure 1 below.

Figure 1: FDA Industry Systems Page

A picture of an example of the computer screen when a user is logged into FURLS.

Once users have selected "Tobacco Registration and Product Listing," users will navigate to the Tobacco Registration and Product Listing (TRLM) Main Menu page as shown in Figure 2 below.

Figure 2: TRLM Main Menu

A picture of the TRLM Main Menu Page for a new registration.

To begin the registration process, users can select "New Registration and Product Listing" from the list of options. The "View/Update Registration Information" and "View/Update Product Listing Information" options are currently grayed out, and will be enabled once users have submitted registration and product listing information.

Once users have selected the "New Registration and Product Listing" option from the main menu, users will navigate to Section I – IDENTIFICATION as shown in Figure 3 below.



2. Navigation

Navigation buttons, as shown in Figure 2A below, are found at the top and bottom of every page.

Figure 2A: General Navigation

A picture of the navigation buttons while entering the new registration and product listing information.

  • Back without Saving – This option navigates users to the previous page without saving the information entered on the current page.
  • Continue – This option temporarily saves the information entered on the current page and navigates users to the next page. Note that information will not be submitted to FDA until the user clicks "Submit" and completes a Confirmation Page.
  • Cancel and Back to Main Menu – Selecting this option will display a warning message; WARNING: Data entered during this session will not be saved. Press OK to continue to the Main Menu without saving or press Cancel to remain on this page.
    If users select the 'OK' button, they will be navigated to the Main Menu without any saved information which has been entered during the session. If users select the 'Cancel' button users will remain on the current page and their information will be temporarily saved.
  • Save Draft and Exit – This option will save the partially completed information which has been entered up to this point. The system will provide users with the date by which they must complete the registration. After 14 calendar days from the date users first saved the registration, the draft will be deleted from the system.

Figure 2B: Navigation Bar

This is a picture of the navigation bar for the TRLM system.

The "FURLS Home" link, located at the top right corner of each page, will take users to the FURLS Home Page (Refer to Figure 1 above). The "TRLM Home" link, located below the "FURLS Home" link, will take users to the TRLM Main Menu Page (Refer to Figure 2 above). To log out of the system, select "FURLS Home" and click on "Logout" at the top right hand corner of the page.

A "Get Help" icon, located at the top right of each page, will provide page specific help. For an overview of all help files available, please refer to the FDA Industry Systems Index of Help Pages at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm189539.htm



3. Section I – Identification

When creating a new registration, users will need to first select the submitter type from the following options:

  • Owner registering alone
  • Owner registering on behalf of operator
  • Owner who is also operator of all establishments
  • Operator registering alone
  • Operator registering on behalf of owner

Figure 3: Section I – Identification

A picture of Section I - IDENTIFICATION page that displays the following submitter types: Owner registering alone, Owner registering on behalf of operator, Owner who is also operator of all establishments, Operator registering alone, Operator registering on behalf of owner


  • If users select "Owner registering alone," the system will not display Section IIIA – Registration (Operator Information) and Section IIIB – Registration (Operator Business Structure) pages. For any other submitter type users select, Sections IIIA and IIIB will be displayed.
  • If users select "Operator registering alone," the system will not display Section IIA – Registration (Owner Information) and Section IIB – Registration (Owner Business Structure) pages. For any other submitter type users select, Sections IIIA and IIIB will be displayed.
  • If users select "Owner who is also operator of all establishments," Section IIIA – Registration (Operator Information) will be automatically populated with the owner's information from Section IIA. The data automatically populated in Section IIIA is read-only and cannot be edited.
  • If users select "Owner who is also operator of all establishments," Section IIIB – Registration (Operator Business Structure) will be automatically populated with the owner's business structure information from Section IIB. The data automatically populated in Section IIIB is read-only and cannot be edited.


4. Section IIA – Registration (Owner Information)

This page will display the Owner Information and Owner Point of Contact sections.

Figure 4: Section IIA – REGISTRATION (Owner Information)

A picture of Section IIA – REGISTRATION (Owner Information). This page also includes the Owner Point of Contact information.

On this page users will provide details for the Owner and the Owner Point of Contact. Fields marked with an asterisk (*) are mandatory. Users can enter the information or select the "Autofill from Account Information" button. The 'Autofill from Account Information' option will fill in the relevant information from users' FURLS Account Information.

NOTE: The following fields in Section IIA are required:

  • Owner Name
  • Country
  • Address Line 1
  • ZIP or Postal Code
  • City
  • State, Province or Territory

Once users have completed this section, click on the "Continue" button. See Figures 5 and 6 below:

Address Validation

The system will perform an address validation. If the address entered is found to be valid, no action is taken and the system continues to the next page, to Section IIB, as displayed in Figure 7. If there are minor differences to the requestor address, the system will display the validated address as shown in Figure 5. If the address entered cannot be verified, the system will display a warning message as shown in Figure 6.

Figure 5: Address Valid with Changes

A picture of the address validation screen when there are minor differences to the entered address for the owner.

The system will display the validated address if there are minor differences to the requestor address. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Accept validated address and continue" button to proceed to Section IIB. See Figure 7 below.

Figure 6: Address Invalid

A picture of the address validation screen when the system cannot verfiy the address provided by the requestor.

The system will display a warning message when the address entered cannot be verified. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Keep your address and continue" button to proceed to Section IIB. See Figure 7 below.



5. Section IIB – Registration (Owner Business Structure)

This page will display the Owner's Business Structure Information.

Figure 7: Section IIB – REGISTRATION (Owner Business Structure)

A picture of Section IIB which displays the owner's business structure information. On this page you will select the owner's type of business structure from the options below and provide the indicated information: Sole Proprietorship, Partnership, Corporation

On this page users will select the owner business structure from the following options and provide the indicated information:

  • Sole Proprietorship
  • Partnership
  • Corporation

Figure 8: Section IIB – Sole Proprietorship

A picture of the data entry fields when you select the owner's type of business structure as 'Sole Proprietorship'

If users selected "Sole Proprietorship", users will need to enter the owner name. If the owner does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Figure 9: Section IIB – Partnership

A picture of the data entry fields when you select the owner's type of business structure as 'Partnership'.

If users selected "Partnership", they will be required to enter at least two partner names. If there are more than two partners users can list all the partner names by clicking the "Add Another Partner" button. If the owner does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Figure 10: Section IIB – Corporation

A picture of the data entry fields when you select the owner's type of business structure as 'Corporation'.

If users selected Corporation, they will need to enter the name of each corporate officer and director in the field labeled "Enter Name of the Individual." If there are additional corporate officers and/or directors, users can enter the name of the each corporate officer and director by clicking the "Add Corporate Officer & Director" button. If the owner does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Once users have completed this section they can click on the "Continue" button to navigate to Section IIIA. See Figure 11 below.



6. Section IIIA – REGISTRATION (Operator Information)

This page will display the Operator information and the Operator Point of Contact sections. This page will not be displayed if users select the submitter type in Section I: Identification as "Owner registering alone."

Figure 11: Section IIIA – REGISTRATION (Operator Information)

A picture of Section IIIA – REGISTRATION (Operator Information). This page also includes the Operator Point of Contact information.

On this page users will provide details for the Operator and the Operator Point of Contact. Fields marked with an asterisk (*) are mandatory. Users can enter the information themselves or select the "Autofill from Account Information" button. The 'Autofill from Account Information' option will fill in the relevant information from users' FURLS Account Information.

NOTE: The following fields in Section IIIA are required:

  1. Operator Name
  2. Country
  3. Address Line 1
  4. ZIP or Postal Code
  5. City
  6. State, Province or Territory

Once users have completed this section, they can click on the "Continue" button. See Figure 12 and 13 below:

Address Validation

The system will perform an address validation. If the address entered is found to be valid, no action is taken and the system continues to Section IIIB as displayed in Figure 14. If there are minor differences to the requestor address, the system will display the validated address as shown in Figure 12. If the address entered cannot be verified, the system will display a warning message as shown in Figure 13.

Figure 12: Address Valid with Changes

A picture of the address validation screen when there are minor differences to the entered address for the operator.

The system will display the validated address if there are minor differences to the requestor address. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Accept validated address and continue" button to proceed to Section IIIB. See Figure 14 below.

Figure 13: Address Invalid

A picture of the address validation screen when the system cannot verfiy the address provided by the requestor.

The system will display a warning message when the address entered cannot be verified. Users can make changes to the address entered by selecting the "Make Changes" option. Otherwise, users can select the "Keep your address and continue" button to proceed to Section IIIB. See Figure 14 below.



7. Section IIIB - Registration (Operator Business Structure)

This page will display the Operator Business Structure Information. Please note that this section will not display if users select the submitter type in Section I: Identification, as "Owner registering alone."

Figure 14: Section IIIB – REGISTRATION (Operator Business Structure)

A picture of Section IIIB which displays the operator's business structure information. On this page you will select the operator's type of business structure from the options below and provide the indicated information: Sole Proprietorship, Partnership, Corporation

On this page users will need to select the operator business structure from the following options and provide the indicated information:

  • Sole Proprietorship
  • Partnership
  • Corporation

Figure 15: Section IIIB – Sole Proprietorship

A picture of the data entry fields when you select the operator's type of business structure as 'Sole Proprietorship'

If users selected Sole Proprietorship, users will need to enter the Operator name. If the Operator does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Figure 16: Section IIIB – Partnership

A picture of the data entry fields when you select the operator's type of business structure as 'Partnership'.

If users selected Partnership, users will be required to enter at least two partner names. If there are more than two partners users can list all the partner names by clicking the "Add Another Partner" button. If the operator does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Figure 17: Section IIIB – Corporation

A picture of the data entry fields when you select the operator's type of business structure as 'Corporation'.

If users selected Corporation, users will need to enter the name of each corporate officer and director in the field labeled "Enter Name of the Individual." If there are additional corporate officers and/or directors, users can enter the name of the each corporate officer and director by clicking the "Add Corporate Officer & Director" button. If the operator does business by any other name, users can list all such names by clicking the "Add Another Business Name" button.

Once users have completed this section they can click on the "Continue" button to navigate to Section IIIA&B: Operator Information & Operator Business Structure. See Figure 18 below.

Figure 18: Section IIIA&B – Operator Information and Operator Business Structure

A picture of Section IIIA&B – Operator Information and Operator Business Structure. On this page you can add another operator or edit an existing operators information.

Please note that this page shall not be displayed when the submitter type in Section I: Identification is selected as "Owner who is also operator of all establishments." This page will display the Operator Name, Address and Business Structure of each operator entered in the registration. Users can edit a specific operator's information by clicking the "Edit icon" icon in the last column. Users can delete a specific operator by clicking the "Delete icon" icon in the last column. Users can add multiple operators to the registration by clicking the "Add Another Operator" button.

Once users have completed editing the operator's information or adding operators to the registration they can click on the "Continue" button to navigate to Section IV: Establishment Information. See Figure 19 below.



8. Section IV - Establishment Information

This page will display the Establishment Information and Establishment Point of Contact information.

Figure 19: Section IV - Establishment Information

A picture of Section IV - Establishment Information page which displays the data entry fields for the Establishment Information and Establishment Point of Contact information.

In Section IV users enter information about establishment(s). Fields marked with an asterisk (*) are mandatory. Users can enter the establishment and point of contact information themselves or select the "Autofill from Operator Information" button. The "Autofill from Operator Information" option will fill in the relevant information from Section IIIA and Section IIIB. The prefilled information may be edited as required.

The "Autofill from Operator Information" button will not be displayed when the registration has more than one operator. When the registration has more than one operator, users will need to select at least one operator from the "Select operator(s) for this establishment" multiple-select list box as displayed in Figure 20 below. If required users may select multiple operators to be associated with the establishment.

Figure 20: Section IV - Establishment Information When Registration Has Multiple Operators

A picture of Section IV - Establishment Information when the registration has more than one Operator. The user needs to select one or more operators for the establishment.

NOTE: The following fields in Section IV are required:

  1. Establishment Name
  2. Address Line 1
  3. ZIP or Postal Code
  4. City
  5. State, Province or Territory
  6. Select operator(s) for this establishment (when the registration has more than one operator)

Once users have completed this section, they can click on the "Continue" button. See Figure 21 and 22 below:

Address Validation

The system will perform an address validation. If the address entered is found to be valid, no action is taken and the system continues to the next page, to Section V as displayed in Figure 23. If there are minor differences to the requestor address, the system will display the validated address as shown in Figure 21. If the address entered cannot be verified, the system will display a warning message as shown in Figure 22.

Figure 21: Address Valid with Changes

A picture of the address validation screen when there are minor differences to the entered address for the establishment.

The system will display the validated address if there are minor differences to the requestor address. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Accept validated address and continue" button to proceed to Section V.

Figure 22: Address Invalid

A picture of the address validation screen when the system cannot verfiy the address provided by the requestor.

The system will display a warning message when the address entered cannot be verified. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Keep your address and continue" button to proceed to Section V.



9. Section V – Product Listings

In Section V users enter information about products. Every active establishment must have at least one Product Listing. For each Product Listing, users can enter required product information, and including advertising, labeling, and consumer information materials.

Product Listing Information

Users can enter product listing information in two ways:

  1. Upload Product Listing Information with an Excel file; or
  2. Enter Product Listing information manually.

Option 1: Upload Product Listings

TRLM provides an Excel template for users to upload Product Listing Information. To download the TRLM upload template, users can click the "Upload Product Listing(s) from File" button on the Product Listing Information page.

Figure 23: Product Information

This is picture of the Product Information page.

When users click on the "Upload Product Listing(s) from File" button on the Product Listing Information page, the system will display the Upload Product Listing page. Click on the "Product Listing Template" link.

Figure 24: Upload Product Listing

This is a picture of the Upload Product Listing page.

When users click on the "Product Listing Template" link, the system will prompt users to open the file or save it.

To complete the template to be uploaded, users can enter information for the first Product Listing beginning in row 2 of the template and continue adding products, as needed, in subsequent rows. Do not delete row 1 or add/delete a column in the template.

The template consists of eight columns. Each column contains its own help to guide users through the process.

Figure 25: Upload Product Information Template

This is a picture of the Product Listing upload template.

Column A (required) – Product Name – Users can enter up to 120 characters.

Column B (optional) – Product Identification Number – Users can enter up to 100 characters.

Column C (required if column B completed) – Product Identification Number Type – If users entered a value in Column B, users must select a value from the pick list. Otherwise, users should leave column C blank.

Column D (required) – Use of this Product – Users must select a value from the pick list.

Column E (required) – Product Category – Users must select a value from the pick list.

Column F (required if "Other" selected in Column E) – If "Other…" product category, specify – If users selected "Other" in Column E, then users must enter a value in Column F. Otherwise, users should leave Column F blank.

Column G (optional) – Flavor – Users can select a value from the pick list.

Column H (required if "Other…" selected in Column G) – If "Other" is selected in Column G, then users must enter a value in Column H. Otherwise, users should leave Column H blank.

Users also can use their own Excel file instead of the TRLM template. The content and format must match the TRLM upload template. If users choose to use their own Excel file, they may enter any character in cell A1. Users can then begin to enter information for the first Product Listing in row 2.

When the upload file is complete, users can return to the Upload Product Listing page, browse for the file and click "Upload."

If the template upload is successful, the system will display a list of the products that were uploaded. Users must complete each Product Listing by either uploading all labeling for the product or by indicating that the product has no labeling. Users may also upload all consumer information and a representative sample of advertising for the product. Users will not be able to submit a registration until all product listings are complete.

Figure 26 shows the Product Listings that were uploaded.

Figure 26: Product Listings that were uploaded

This is a picture of the list of Products that were uploaded.

Users can click the "Edit icon" icon in the right column to complete or edit a Product Listing.


When users select a Product Listing to complete, the system will display the Product Listing Review page.

Users can click the "Edit" button to complete any section. Users must edit the Labeling section to upload all labeling or indicate the product has no labeling before users can continue the registration.

Users can click "Continue to Product Listings" to return to the list of Product Listings that were uploaded.

Figure 27: Product Listing Review

Product Listing Review

Select a completed Product Listing from the list to add it to the establishment users are registering.

After all Product Listings have been completed and at least one Product Listing was added to the establishment, the registration continues to Establishment Information.

If users add additional establishments during the registration, they will be able to select products from this list or, add new products to associate with the other establishments.

Option 2: Manually enter Product Listings

Figure 28: Product Information

This is a picture of the Product Information page.

Product Name (required) – Brand/sub-brand or other commercial name used in commercial distribution (e.g., Acme Blue 100s). Users can enter up to 120 characters for Product Name.

Product Identification Number (optional) – Users can enter up to 100 characters. Users must enter Product Identification Number if needed to uniquely identify the product. If users enter a Product Identification Number users also must enter Type of Product Identification Number.

Type of Product Identification Number (required if Product Identification Number was entered) – If users entered a Product Identification Number, users must select a Type of Product Identification Number.

Intended Use of Product (required) – Users must select either Consumer Use or Further Manufacturing Use.

Consumer Use Product Category (required if Consumer Use was selected for Intended Use of Product) – Users must select one or more Product Category. If the appropriate Product Category is not listed, users must select "Other" and enter its category in the text field.

Further Manufacturing Use Product Category (required if Further Manufacturing was selected for Intended Use of Product) – Users must select one or more uses. If the appropriate Product Category is not listed, users must select "Other" and enter its category in the text field.

Flavor (optional) – Users can select one or more flavors. If the product's flavor is not listed, users can select "Other" and enter a flavor in the text field.

When users choose to continue from the Product Information page, the system will display the Advertising Information page. See Figure 29.

Add Advertising.

Figure 29: Advertising Information

This is a picture of the Advertising Information page.

A representative sampling of advertising for the product may be required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's advertising on the Advertising Information page. Users can upload advertising or indicate that the product has no advertising by checking the "Product has no Advertising" box. If users upload advertising file(s) for the product, they also have the option to enter details about the product's advertising, including:

Type of Advertising (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. This date is the time of initial dissemination of the labeling, consumer information, or at the time of initial publication of the advertisement for the product.

When users finish entering the product's advertising, the system will display the Advertising Summary page that lists all of the product's advertising. See Figure 30. If users indicate that the product has no advertising, the system will display the Labeling Information page.

Figure 30: Advertising Summary

Advertising Summary

From the Advertising Summary page users can select an advertisement to edit or delete.

To edit advertising, users can click on the "Edit icon" icon to display the Advertising Information that was previously entered. Users can edit the Advertising information and click "Continue" to return to the Advertising Summary page.

To delete advertising, users can click on the "Delete icon" icon

Users also can add advertising from the Advertising Summary page.

To add advertising, users can click the "Add Advertising" button. The system will display a blank Advertising Information page. Users can enter the Advertising Information and click "Continue" to return to the Advertising Summary page.

When users choose to continue from the Advertising Summary page, the system will display the Labeling Information page. See Figure 31.

Figure 31: Labeling Information

This is a picture of the Labeling Information page.

Labeling for the product is required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's labeling on the Labeling Information page. Users must upload at least one labeling file or indicate that the product has no labeling by checking the "Product Has No Labeling" box for each product. If users upload labeling file(s) for the product, they also have the option to enter details about the product's labeling, including:

Product UPC code(s) (optional) – Users can enter one or more UPC codes separated by commas

Type of Labeling Material (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. This date is the time of initial dissemination of the labeling, consumer information, or at the time of initial publication of the advertisement for the product.

When users finish entering the product's labeling, the system will display the Labeling Summary page that lists all of the product's labeling. See Figure 32. If users indicate that the product has no labeling, the system will display the Consumer Information page.

Figure 32: Labeling Summary

This is a picture of the Labeling Summary page.

From the Labeling Summary page users can select a labeling to edit or delete.

To edit labeling, users can click on the "Edit icon" icon to display the Labeling Information that was previously entered. Users can edit the labeling information and click "Continue" to return to the Labeling Summary page.

To delete labeling, users can click on the "Delete icon" icon.

Users also can add labeling from the Labeling Summary page.

To add Labeling, users can click the "Add Labeling" button. The system will display a blank Labeling Information page. Users can enter the Labeling Information and click "Continue" to return to the Labeling Summary page.

When users choose to continue from the Labeling Summary page, the system will display the Consumer Information page. See Figure 33.

Figure 33: Consumer Information

This is a picture of the Consumer Information page.

Consumer information may be required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's consumer on the Consumer Information page. Users can upload consumer information or indicate that the product has no consumer information by checking the "Product has no Consumer Information" box. If users upload consumer information file(s) for the product, they also have the option to enter details about the product's consumer information, including:

Type of Consumer Information (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. This date is the time of initial dissemination of the labeling, consumer information, or at the time of initial publication of the advertisement for the product. When users finish entering the product's consumer information, the system will display the Consumer Information Summary page that lists all of the product's consumer information. See Figure 34. If users indicate that the product has no consumer information, the system will display the Product Listing Review page.

Figure 34: Consumer Information Summary

This is a picture of the Consumer Information Summary page.

From the Consumer Information Summary page users can select consumer information to edit or delete.

To edit Consumer information, users can click on the "Edit icon" icon to display the Consumer Information that was previously entered. Users can edit the Consumer Information and click "Continue" to return to the Consumer Information Summary page.

To delete Consumer Information, users can click on the "Delete icon" icon.

Users also can add consumer information from the Consumer Information Summary page.

To add Consumer Information, users can click the "Add Consumer Information" button. The system will display a blank Consumer Information page. Users can enter the Consumer Information and click "Continue" to return to the Consumer Information Summary page.

When users choose to continue from the Consumer Information Summary page, the system will display the Product Listing Summary page. See Figure 35.

Figure 35: Product Listing Summary

This is a picture of the Product Listing Summary page.

The Product Listing Summary is a list of the products that were added to the registration. From the Product Listing Summary users can select a product to edit or delete. Users also can choose to add another Product Listing.

If users select a Product Listing to edit, the system first will display the Product Listing Information page. Users can edit the Product Listing Information or choose to "Continue."

After continuing from the Product Listing Information page, the system displays the Advertising Summary page where users can add advertising, edit or delete existing advertising, or indicate that the product has no advertising.


After continuing from the Advertising Summary page, the system displays the Labeling Summary page where users can add labeling, edit or delete existing labeling, or indicate that the product has no labeling.

After continuing from the Labeling Summary page, the system displays the Consumer Information Summary page where users can add consumer information, edit or delete existing consumer information, or indicate that the product has no consumer information.

After continuing from the Consumer Information Summary page, the system returns to the Product Listing Summary page.

After all Product Listings have been added, users can click "Continue."

REGISTRATION – Establishment Information

Once users have completed entering the Product Listing information they will be navigated to the Establishment Information Summary page. See Figure 36.


Figure 36: REGISTRATION – Establishment Information

A picture of the registration's establishment information which displays all the establishments that have been entered. From this page you can add another establishment or edit an existing establishment's information.

This page will display the name and address of the establishment(s) users have entered. Users can edit a specific establishment's information by clicking the "Edit icon" icon in the last column. Users can delete an establishment by clicking the "Delete icon" icon in the last column.

Users can add another establishment by selecting the "Add Another Establishment" button or, continue to complete the registration by selecting the "Continue" button. If users choose to "Add Another Establishment," they will navigate to Section IV - REGISTRATION (Establishment Information) page, where users can enter information for the new establishment.

After Section IV has been completed for the second establishment, the system will display a list of products that were added to the registration.


Figure 37: Product Listing Summary

This is a picture of the Product Listing Summary page.

Users can select products from the list to associate with the second establishment. They also can choose to add a new product. Users must select at least one product from the list OR add a product listing.

Product Listings added while registering the second establishment will be associated with the second establishment. Users can associate a product that users added for the second establishment with other establishments by choosing to edit an establishment from the Establishment Summary page.

Once users have completed editing the establishment's information or adding establishments to the registration, they should click on the "Continue" button to navigate to the Registration Review page. See Figure 38 below.



10. Registration Review Page

The system will display the entire registration broken out by section as shown in Figure 38 below. Users may modify a section by selecting the "Edit" button next to the section to be updated.

Figure 38: Registration Review Page

A picture of the Registration Review page. This page displays the entire registration broken out by sections. You may choose to modify a section by selecting the "Edit" button next to the section to be updated.

Users may print the submission by selecting the "Print Submission" button. A new browser window will open, which will allow users to print the registration. When finished, users can close the browser window in order to return to the TRLM application.

After reviewing the registration, users can click on the "Continue to Submit" button to navigate to Section VI: Confirmation Statement. See Figure 39 below.



11. Section VI – Confirmation Statement

This page will display the confirmation statement.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 39: Section VI – Confirmation Statement

This is a picture of the Confirmation Statement page.

On the Confirmation Statement page users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," they must enter the authorized agent's contact information.
  • Upon completion of this section, the registration is ready for submission. Click on the "Submit" button. The system will display a message that users' registration and product listing information has successfully been submitted as shown in Figure 40 below. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.

Figure 40: Confirmation Message

A picture of the successful submission message when your registration and product listing information is successfully submitted.

Users may print the submission by selecting the "Print Submission" button, or return to the TRLM Main Menu by selecting the "Back to Main Menu" button. If users select "Print Submission" a new browser window will open which will allow users to print the registration information. When finished, users can close the browser window in order to return to the TRLM application.



12. Complete Draft Registration and Product Listing

During the registration process, users may select the "Save Draft and Exit" option to save partially completed information users have entered up to this point. The system will display a message showing the last date to submit a registration before the draft is deleted as displayed in Figure 41.

Figure 41: Confirmation Message

A picture of the confirmation message when you save your partially completed information as a draft.

When the registration is saved as a draft, the Main Menu shall display an option to 'Complete Draft Registration and Product Listing' as displayed in Figure 42 below.

Figure 42: Main Menu - Complete Draft

A picture of the TRLM Main Menu page when the registration is saved as a draft. The Main Menu shall display an option to 'Complete Draft Registration and Product Listing'.

Users can select the "Complete Draft Registration and Product Listing" option from the Main Menu to navigate to the Draft Registration and Product Listing Review page. This is displayed in Figure 43 below.

Figure 43: Draft Registration and Product Listing Review Page

A picture of the Draft Registration and Product Listing Review page. This page displays the sections of the registration that are completed by you as well as the blank section of the registration that you require to continue from to complete the registration.

The Draft Registration and Product Listing Review page will display the information users entered previously. Users can modify a section by selecting the "Edit" button next to the section to be updated. The system will re-display the data entry screen corresponding to the chosen section.

Users may discard the draft by selecting the "Discard Draft" button. If users choose to discard the draft, the system shall display a warning as displayed in Figure 44 below. If users select "OK" to permanently discard a draft, they will be required to re-enter all registration information.

Figure 44: Warning Message

A picture of the warning message when you select the "Discard Draft" option.

Users may print the partially completed draft registration by selecting the "Print Draft Registration" button. A new browser window will open which will allow users to print the draft. When finished, users can close the browser window in order to return to the TRLM application.

Users may also save the partially completed draft and exit by selecting the "Save Draft and Exit" button. If registrations have not been submitted within 14 calendar days from the date users first saved the registration, the draft will be deleted from the system.

To complete the registration users can select the "Continue to Submit" button to navigate to Section VI: Confirmation Statement.

Section VI – Confirmation Statement

This page will display the confirmation statement.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 45: Section VI – Confirmation Statement

A picture of Section VI – Confirmation Statement Section. This page displays the confirmation statement for you to agree to. Please check the box if you agree and provide the indicated information.

On this page users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," they must enter the authorized agent's contact information.

Upon completion of this section, the registration is ready for submission. Click on the "Submit" button. The system will display a message that users' registration and product listing information has successfully been submitted as shown in Figure 46 below. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.

Figure 46: Confirmation Message

A picture of the successful submission message when your registration and product listing information is successfully submitted.

Users may print the submission by selecting the "Print Submission" button, or users may return to the TRLM main menu by selecting the "Back to Main Menu" button. If users select "Print Submission" a new browser window will open which will allow users to print the registration information. When users are finished, users must close the browser window in order to return to the TRLM application.


View/Update Registration Information Step-by-Step Instructions

Table of Contents

  1. View /Update Registration Information
  2. View/Update Existing Establishment Registration
  3. Add Establishment Registration
  4. Address Validation
  5. Add Product Listings to The Establishment
  6. Add New Product


1. View/Update Registration Information

After users have logged into the "Tobacco Registration and Product Listing" from FDA Industry Systems, they should navigate to the TRLM Main Menu page as shown in Figure 1 below.

Figure 1: TRLM Main Menu after Registration is Submitted

A picture of the TRLM Main Menu after the registration is submitted. Once the registration is submitted the TRLM Main Menu will display the following options: View/Update Registration Information View/Update Product Listing Information.

Once the registration is submitted the TRLM Main Menu will display the following options:


View Update Registration Information

To view, add and edit establishment information, users can select "View/Update Registration Information" from the TRLM Main Menu. The system will display the establishments that were added to users' registration as shown in Figure 2 below.

Figure 2: Establishment Summary

A picture of the Establishment Summary page when the user selects "View/Update Registration Information" from the main menu.

The Establishment Summary page contains a list of the establishment(s) that were added to users' registration. Users may add a new establishment to the registration or view or update an existing one.

To add new establishments to the registration users can select the "Add Establishment Registration" button. (For details about adding a new establishment, refer to Section# 3. Add Establishment Registration below)



2. View/Update Existing Establishment Registration

To view or update an existing establishment, users can select the establishment to update and click the "View/Update Selected Establishment Registration" button. Users will navigate to the Establishment Registration Review page for the selected establishment as shown in Figure 3 below.

Figure 3: Establishment Registration Review

A picture of the Establishment Registration Review page when the user selects the "View/Update Selected Establishment Registration" button

Establishment Registration Review

On the Establishment Registration Review page users can perform the following actions:


Update the status of the establishment:
Users can change the establishment registration status of an active establishment to 'Inactive' or change the establishment registration status of an inactive establishment to 'Active.'

When users change the status of an establishment, the system will prompt users to enter the date of the establishment status change as displayed in Figure 4 below. This date cannot be a date in the future.

Figure 4: Change Establishment Status

A snapshot of the Establishment Registration Review page when the user can change the status of the establishment.

When users change the status of an active establishment to 'Inactive' and continue from the Establishment Registration Review page, if the active product listing(s) associated with it are not associated with any other active establishment, the system shall display a warning message as shown in Figure 5 below.

Figure 5: Warning Message When The Product Listing(s) Associated with The Establishment Are Deactivated

A picture of the warning message displayed when the user changes the status of an active establishment to 'Inactive' and the active product listing(s) associated with it are not associated with any other active establishment.

If users acknowledge the warning for inactivating the associated product listings and select "Continue," users will navigate to the Marketing Status Change Date page. Users will be prompted to provide the "Date of Marketing Status Change" for each of the Product Listing(s) being inactivated as displayed in Figure 6 below. This date cannot be a future date.

Figure 6: Product Status Change Date field on the Product Listing Review Page

Product Status Change Date field on the Product Listing Review Page

When users change the status of an inactive establishment to 'Active' and continue from the Establishment Registration Review page, users will navigate to the "Add Product Listing to Establishment" page as displayed in Figure 7 below.

Figure 7: Add Product Listing(s) to The Establishment

A picture of the page where the user can add Product Listing(s) to the Establishment.

This page will display all product listing(s) that were previously submitted. Users must select the product listing(s) to be associated with the establishment being activated. Users may select existing product(s) by checking the "Add to Establishment" check box alongside the product listing. Users also may choose to add a new product by selecting the "Add New Product" button.

View or Update registration information:

Users can view or update the sections of the registration by clicking the section's "Edit" button. The system will display the previously submitted entries for the selected section. When users finish viewing or updating the section, they can click "Continue" to return to the Registration Review page.

Complete Annual Registration:

In order to complete annual registration, users may update the establishment information in Section IV – Registration (Establishment Information), by clicking the section's "Edit" button on the Establishment Registration Review page. When there are no changes to the establishment information, users may select the checkbox labeled "Please check this box if there are no changes to the establishment information in Section IV below" as displayed in Figure 8.

Figure 8: No Changes to Establishment Information

A snapshot of the Establishment Registration Review page where the user may select the checkbox labeled 'Please check this box if there are no changes to the establishment information in Section IV below'.

View/Updated Another Registration:

When there is more than one registered establishment, users may view or update another establishment by selecting the "Continue to View/Update Another Registration" button. This will navigate users to the Establishment Summary page to select another establishment to view or update. The "Continue to View/Update Another Registration" option shall only be displayed if there is more than one registered establishment for the account.

Add Another Establishment:

Users may add another establishment by selecting the "Add Another Establishment" button. Users will navigate to Section IV - REGISTRATION (Establishment Information) page, where users can enter information for the new establishment.

Print Submission:

Users may print the submission, by selecting the "Print Submission" button. A new browser window will open which will allow users to print the registration information users have entered so far. When finished, users can close the browser window to return to the TRLM application.

Continue to Submit:

Once users have reviewed the registration, users can submit updates by selecting the "Continue to Submit" button. Users will navigate to Section VI: Confirmation Statement. See Figure 9 below.

Section VI – Confirmation Statement Section

This page will display the confirmation statement.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 9: Section VI – Confirmation Statement

This is a picture of the Confirmation Statement page.

In this section users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," users must enter the authorized agent's contact information.

Upon completion of this section, the registration is ready for submission. Users can click on the "Submit" button. The system will display a message that users' registration information has successfully been submitted as shown in Figure 10 below. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.

Figure 10: Confirmation Message

A picture of the successful submission message when your establishment registration is successfully submitted.

Users may print the submission by selecting the "Print Submission" button, or users may choose to return to the TRLM main menu by selecting the "Back to Main Menu" button. If users select "Print Submission" a new browser window will open which will allow users to print the registration information. When users are finished, they should close the browser window in order to return to the TRLM application.



3. Add Establishment Registration

After users select "View/Update Registration Information" from the TRLM Main Menu, the system will display the establishments that were added to users' registration, as shown in Figure 11 below. To add a new establishment to the registration, users can select the "Add Establishment Registration" button.

Figure 11: Establishment Summary

A picture of the Establishment Summary page where you may choose to add a new establishment.

Users will navigate to Section IV – REGISTRATION (Establishment Information) page as displayed in Figure 12 below.

Figure 12: Add Establishment Registration

Add Establishment Registration

On this page users will enter information for the new establishment and the establishment point of contact. When the registration has more than one operator, users will be required to select at least one operator for the establishment from the "Select operator(s) for this establishment" multiple-select list box. If required, users may choose more than one operator to be associated with the establishment. Users may also choose to add another operator to be associated with the establishment by selecting the "Add Another Operator" button.

NOTE: The following fields in Section IV are required:

  • Establishment Name
  • Address Line 1
  • ZIP or Postal Code
  • City
  • State, Province or Territory

Users can select operator(s) for this establishment (when the registration has more than one operator).

Once users have completed entering the establishment information, they can click on the "Continue" button. See Figures 13, 14 & 15 below:



4. Address Validation

The system will perform an address validation. If the address is found to be valid, no action is taken and the system continues to the next page where users can add product listings to the establishment as shown in Figure 16. If there are minor differences to the address entered, the system will display the validated address as shown in Figure 13. If the address entered cannot be verified, the system will display a warning message as shown in Figure 14. If the establishment name and address is found to be a possible duplicate, the system will display a warning message as shown in Figure 15.

Figure 13: Address Valid with Changes

A picture of the address validation screen when there are minor differences to the entered address for the establishment.

The system will display the validated address if there are minor differences to the address entered. Users can make changes to the address entered by selecting the "Make changes" option.

Otherwise, users can select the "Accept validated address and continue" button to proceed to add product listing(s) to the establishment.

Figure 14: Address Invalid

A picture of the address validation screen when the system cannot verfiy the address provided by the requestor.

The system will display a warning message when the address cannot be verified. Users can make changes to the address by selecting the "Make changes" option.

Otherwise, users can select the "Keep your address and continue" button to proceed to add product listing(s) to the establishment.

Figure 15: Possible Duplicate Address

A picture of the address validation page when the establishment name and address entered is found to be a possible duplicate.

The system will display a warning message when the establishment name and address entered is found to be a possible duplicate. Users can make changes to the establishment by selecting the "Back to Establishment Information" option. If users verify that the establishment name and address is not a duplicate, users can select the "Continue" button to proceed to add product listing(s) to the establishment.



5. Add Product Listings to The Establishment

Upon completing the establishment information users will navigate to the "Add Product Listing to Establishment" page as displayed in Figure 16 below.

Figure 16: Add Product Listing to Establishment

Add Product Listing to Establishment

This page will display all the product listings users have added to the registration. Users may select existing product(s) by checking the "Add to Establishment" check box or, choose to add a new product by selecting the "Add New Product" button.



6. Add New Product

Selecting the "Add New Product" button will navigate users to Section V: Product Listing page as displayed in Figure 17 below. Users can enter the required information for the new product added.

Figure 17: Product Listing Information

This is a picture of the Product Information page.

Complete the Advertising, Labeling, and Consumer Information sections for the product listing added.

Once users have completed adding product(s) to the establishment, they should click on the "Continue" button to navigate to the Registration Review page.

Registration Review Page

The system will display the entire registration broken out by section as shown in Figure 18 below. Users may choose to modify a section by selecting the "Edit" button next to the section to be updated. The system will re-display the data entry screen corresponding to the chosen section.

Figure 18: Registration Review Page

Registration Review Page

After reviewing or updating the registration information, users can view, update, or add another establishment, or users can submit the update(s).

  • Users may add another establishment by selecting the "Add another Establishment" button. Users will navigate to Section IV - REGISTRATION (Establishment Information) data entry page, where users can enter information for the new establishment if required.
  • Users may view or update another establishment by selecting the "View/Update Establishment Registration" button. Users will navigate to the establishment summary page to select another establishment to view or update.
  • Users may print the establishment registration by selecting the "Print Submission" button. A new browser window will open which will allow users to print the registration information users have entered so far. When users are finished, they can close the browser window in order to return to the TRLM application.
  • Users may choose to submit by selecting the "Continue to Submit" button. Users will navigate to Section VI: Confirmation Statement. See Figure 19 below.

Section VI - Confirmation Statement Section

This page will display the confirmation statement.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 19: Section VI - Confirmation Statement

Section VI - Confirmation Statement

On this page users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," they must enter the authorized agent's contact information.

Upon completion of this section, the registration is ready for submission. Users can click on the "Submit" button. The system will display a message that users' registration and product listing information has successfully been submitted as shown in Figure 20 below. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.

Figure 20: Confirmation Message

A picture of the successful submission message when your registration and product listing information is successfully submitted.

Users can print the submission by selecting the "Print Submission" button or, return to the TRLM main menu by selecting the "Back to Main Menu" button. If users select "Print Submission" a new browser window will open which will allow users to print the registration information. Users should close the browser window to return to the TRLM application.

View/Update Product Listing Information

Table of Contents

  1. View/Update Product Listing Information
  2. View/Update Selected Product
  3. Add Product Listing
  4. Upload Files


1. View Update Product Listing Information

To view, add and update Product Listings for a registered establishment, users can select "View/Update Product Listing Information" from the TRLM Main Menu. The system will display a list of the Product Listings (Figure 1) that were added to the registration.

Figure 1: Product Listing Summary

This is a picture of the Product Listing Summary page.



2. View Update Selected Product

Users can select one Product Listing to update and click "View/Update Selected Product."

The system will display the Review page for the selected Product Listing.

Figure 2: Product Listing Review

This is a picture of the Product Listing Review page.

From the Product Listing Review page users can update the product's marketing status (Figure 3).

Users also can view and update the product's information, advertising, labeling, or consumer information by clicking the section's "Edit" button. The system will display the previously submitted entries for the selected section. When users finish updating the section, they can click "Continue" to return to the Product Listing Review page.

If users registered more than one establishment, they can view and update the establishments associated with the product.

After updating the product, users can view, update, and add another product listing, or users can submit the update(s). The system will display the Product Listings Summary page.

When users choose to "Continue to Submit," the system will display the Confirmation Statement.

Figure 3: Product Listing Review page - Marketing Status

This is a close-up picture of the Change Marketing Status section of the Product Listing Review page.

Users can change the marketing status of an active Product Listing to "Discontinued" or change the marketing status of an inactive Product Listing to "Reintroduced to Market." The system will prompt users for the date that the marketing status changed.

When a Product Listing is reintroduced to market and if users registered more than one establishment, they will select establishment(s) to be associated with the product from the Establishment section on the Review page.

Figure 4: Establishment Information

This is a picture of the Establishment Information page.

Users must select at least one establishment from the list to associate with the product listing.

Users can click "Continue" to return to the Product Listing Review page.

Users can click "Continue to Submit." This page will display the confirmation statement.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 5: Confirmation Statement

This is a picture of the Confirmation Statement page.

On this page users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," they must enter the authorized agent's contact information.

Upon completion of this section, the registration is ready for submission. Users can click on the "Submit" button. The system will display a message that users' registration and product listing information has successfully been submitted. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.



3. Add Product Listing

To add products for a registered establishment, users can select "View/Update Product Listing Information" from the TRLM Main Menu. The system will display a Summary of the Product Listings that were added.

Figure 6: Product Listing Summary

This is a picture of the Product Listing Summary page.

The Product Listing Summary page contains a list of the products that were added to the registration and provides the option to add a Product Listing.

Users can click "Add Product" to enter the new product's information. See Figure 7.

Figure 7: Product Information

This is a picture of the Product Information page.

Product Name (required) – Brand/sub-brand or other commercial name used in commercial distribution (e.g., Acme Blue 100s). Users can enter up to 120 characters for Product Name.

Product Identification Number (optional) – Users can enter up to 100 characters. Users must enter Product Identification Number if needed to uniquely identify the product. If users enter a Product Identification Number users also must enter Type of Product Identification Number.

Type of Product Identification Number (required if Product Identification Number was entered) – If users entered a Product Identification Number, users must select a Type of Product Identification Number.

Intended Use of Product (required) – Users must select either Consumer Use or Further Manufacturing Use.

Consumer Use Product Category (required if Consumer Use was selected for Intended Use of Product) – Users must select one or more Product Category. If the appropriate Product Category is not listed, users must select "Other" and enter its category in the text field.

Further Manufacturing Use Product Category (required if Further Manufacturing was selected for Intended Use of Product) – Users must select one or more uses. If the appropriate Product Category is not listed, users must select "Other" and enter its category in the text field.

Flavor (optional) – Users can select one or more flavors. If the product's flavor is not listed, users can select "Other" and enter a flavor in the text field.

When users choose to continue from the Product Information page, the system will display the Advertising Information page. See Figure 8.

Figure 8: Advertising Information

Advertising Information

A representative sampling of advertising for the product may be required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's advertising on the Advertising Information page. Users can upload advertising or indicate that the product has no advertising by checking the "Product has no Advertising" box. If users upload advertising file(s) for the product, they also have the option to enter details about the product's advertising, including:

Type of Advertising (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. The date must be less than or equal to the current date

When users finish entering the product's advertising, the system will display the Advertising Summary page that lists all of the product's advertising. See Figure 9. If users indicated that the product has no advertising, the system will display the Labeling Information page.

Figure 9: Advertising Summary

This is a picture of the Advertising Summary page.

From the Advertising Summary page users can select an advertisement to edit, or delete.

To edit advertising, users can click on the Edit icon icon to display the Advertising Information that was previously entered. Users can edit the Advertising information and click "Continue" to return to the Advertising Summary page.

To delete advertising, users can click on the "Delete icon" icon.

Users also can add advertising from the Advertising Summary page.

To add advertising, users can click the "Add Advertising" button. The system will display a blank Advertising Information page. Users can enter the Advertising Information and click "Continue" to return to the Advertising Summary page.

When users choose to continue from the Advertising Summary page, the system will display the Labeling Information page. See Figure 10.


Figure 10: Labeling Information

This is a picture of the Labeling Information page.

Labeling for the product is required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's labeling on the Labeling Information page. Users must upload at least one labeling file or indicate that the product has no labeling by checking the "Product Has No Labeling" box for each product. If users upload labeling file(s) for the product, they also have the option to enter details about the product's labeling, including:

Product UPC code(s) (optional) – Users can enter one or more UPC codes separated by commas

Type of Labeling Material (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. The date must be less than or equal to the current date.

When users finish entering the product's labeling, the system will display the Labeling Summary page that lists all of the product's labeling. See Figure 11. If users indicate that the product has no labeling, the system will display the Consumer Information page.

Figure 11: Labeling Summary

This is a picture of the Labeling Summary page.

From the Labeling Summary page users can select a labeling to edit or delete.

To edit labeling, users can click on the Edit icon icon to display the Labeling Information that was previously entered. Users can edit the labeling information and click "Continue" to return to the Labeling Summary page.

To delete labeling, users can click on the "Delete icon" icon.

Users also can add labeling from the Labeling Summary page.

To add Labeling, users can click the "Add Labeling" button. The system will display a blank Labeling Information page. Users can enter the Labeling Information and click "Continue" to return to the Labeling Summary page.

When users choose to continue from the Labeling Summary page, the system will display the Consumer Information page. See Figure 12.


Figure 12: Consumer Information

This is a picture of the Consumer Information page.

Consumer information may be required. Users should refer to guidance document, section III.C.2, for additional details.

Users can enter information about the product's consumer on the Consumer Information page. Users can upload consumer information or indicate that the product has no consumer information by checking the "Product has No Consumer Information" box. If users upload consumer information file(s) for the product, they also have the option to enter details about the product's consumer information, including:

Type of Consumer Information (optional) – Users can enter up to 120 characters

Title (optional) – Users can enter up to 120 characters

Unique ID or Internal ID Number (optional) – Users can enter up to 40 characters

Date First Disseminated (optional) – Users can select a date from the calendar icon or enter a date. The date must be less than or equal to the current date.

When users finish entering the product's consumer information, the system will display the Consumer Information Summary page that lists all of the product's consumer information. See Figure 13. If users indicate that the product has no consumer information, and if users' registration has only one establishment, the system will display the Product Listing Review page that contains the details users entered for the product. If users' registration has multiple establishments, the system will display a list of establishments added to the registration.

Figure 13: Consumer Information Summary

This is a picture of the Consumer Information Summary page.

From the Consumer Information Summary page users can select consumer information to edit or delete.

To edit Consumer information, users can click on the Edit icon icon to display the Consumer Information that was previously entered. Users can edit the Consumer Information and click "Continue" to return to the Consumer Information Summary page.

To delete Consumer Information, users can click on the "Delete icon" icon.

Users also can add consumer information from the Consumer Information Summary page.

To add Consumer Information, users can click the "Add Consumer Information" button. The system will display a blank Consumer Information page. Users can enter the Consumer Information and click "Continue" to return to the Consumer Information Summary page.

When users choose to continue from the Consumer Information Summary page, the system will display the Product Listing Summary page (if users' registration has only one establishment).

If users' registration has more than one establishment, then when they continue from entering Consumer Information, the system will display a list of the establishments (Figure 14) that were added to the registration.

Figure 14: Establishment Information

This is a picture of the Establishment Information page.

Users must select at least one establishment from the list to associate with the product listing users are adding.

When users continue from the Establishment Information page, the system will display the Product Listing Summary page. See Figure 15.

From the Product Listing Summary page users can choose to edit a product listing, add another product listing, or continue to submit.


Figure 15: Product Listing Summary

This is a picture of the Product Listing Summary page.

Users can click "Continue to Submit."

The system will display the Confirmation Statement page. See Figure 16.

Note: Users must agree to the Confirmation Statement before submitting.

Figure 16: Confirmation Statement

This is a picture of the Confirmation Statement page.

On this page users are required to select the Identity of the Signatory. The options are: Owner, Operator, or Authorized Agent.

  • If users select "Owner," the relevant contact information fields will be pre-filled with contact information for the owner from section IIA and can be edited.
  • If users select "Operator," the relevant contact information fields will be pre-filled with contact information for the operator from section IIIA and can be edited. When the registration has more than one operator, users can select the operator from the drop-down list.
  • If users select "Authorized Agent," they must enter the authorized agent's contact information.

Upon completion of this section, the registration is ready for submission. Users can click on the "Submit" button. The system will display a message that users' registration and product listing information has successfully been submitted. In order to receive notifications, users should configure their email's Spam or Junk folders to allow messages from ctpreglist@fda.hhs.gov.



4. Upload Files

To upload a file, users can click "Browse" to find the file to upload and then

click "Upload" .

The system will display the file name and file size of the uploaded file.

File size is limited to 50MB per file.

The following file types are accepted: .pdf, .xpt, .xml, .dtd, .gif, .tif, .jpg, .sgml, .mol, .xls, .xlsx, .csv, .wmv, .avi, .zip