FDA 3741 (New) Registration and Listing for Owners and Operators

Tobacco Product Establishment Registration and Submission of Certain Health Information

NEW_ Form_FDA_3741

Establishment Registration (Initial), the initial registration of a tobacco product establishment

OMB: 0910-0650

Document [pdf]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

REGISTRATION AND PRODUCT LISTING
OF TOBACCO PRODUCT MANUFACTURING
ESTABLISHMENTS

Form Approved: OMB No. 0910-0650
Expiration Date: xx/xx/20xx

Paperwork Reduction Act Statement: The Paperwork Reduction Act of 1995
provides that an agency may not conduct or sponsor, and a person is not
required to respond to a collection of information unless it displays a valid OMB
control number. The valid OMB control number for this information collection is
0910-0650. Initial submissions are estimated to take 100 minutes on average
per response. Update submissions are estimated to take 20 minutes on
average per response. Send comments regarding this burden estimate or any
other aspects of this collection of information, including suggestions for reducing
burden to PRAStaff@fda.hhs.gov.

The registration of tobacco product manufacturing establishments and/or the listing of tobacco products, either through
mailing this form to FDA’s Document Control Center (DCC) or electronically submitting via FDA’s Tobacco Registration and
Product Listing Module Next Generation (TRLM-NG) system does not denote FDA authorization for the marketing of
tobacco products in the United States (U.S.). FDA does not consider listed products to be authorized for the legal sale and
distribution in the U.S. unless they have an FDA marketing authorization order in effect.
Marketing a new tobacco product without an FDA marketing authorization order in effect is illegal and may be
subject to enforcement.
TABLE OF CONTENTS
Section I – Submission Type ................................................................................................................................................................ 2
Section II – Form FDA 3741 Navigation Guide and Submission Checklist....................................................................................... 3
Part A: Form FDA 3741 Navigation Guide................................................................................................................................................ 3
Part B: Submission Checklist ................................................................................................................................................................... 4
Part C: Acknowledgement ........................................................................................................................................................................ 4
Section III – Registration Information for Initial Submission ............................................................................................................. 5
Part A: Registrant Information for Initial Submission ................................................................................................................................ 5
Part B: TRLM-NG Secondary User Information for Initial Submission ..................................................................................................... 5
Section IV – Establishment Information for Initial Submission ......................................................................................................... 6
Part A: Establishment Information for Initial Submission .......................................................................................................................... 6
Part B: Establishment Owner Information for Initial Submission ............................................................................................................ 10
Part C: Establishment Operator Information for Initial Submission ........................................................................................................ 12
Section V – Product List Information for Initial Submission............................................................................................................ 14
Section VI – Material File Information for Initial Submission ........................................................................................................... 18
Section VII – Updates to Registration Information............................................................................................................................ 19
Part A: Updates to Registrant Information .............................................................................................................................................. 19
Part B: Updates to Secondary TRLM-NG User Information ................................................................................................................... 20
Section VIII – Updates to Establishment Information ....................................................................................................................... 22
Part A: Updates to Establishment Information........................................................................................................................................ 22
Part B: Updates to Establishment Owner Information ............................................................................................................................ 32
Part C: Updates to Establishment Operator Information ........................................................................................................................ 34
Section IX – Updates to Product List Information............................................................................................................................. 37
Section X – Updates to Material File Information .............................................................................................................................. 41
Section XI – Certification Statement................................................................................................................................................... 42
Section XII – Appendices..................................................................................................................................................................... 43
Appendix A – Terminology ...................................................................................................................................................................... 43
Appendix B – Statutory Requirements ................................................................................................................................................... 44
Appendix C – Additional Resources ....................................................................................................................................................... 45

FORM FDA 3741 (XX/25)

Page 1 of 45

NOTICE
Please type your responses to all questions.
An item followed by an asterisk (*) denotes a required field.
Submissions will be considered incomplete if required information is not provided.
FDA strongly encourages you to submit your establishment registration and product list online using FDA’s free TRLMNG module. To create an Industry Account, please visit: https://trlm-ng-industry.fda.gov/login.
This system greatly streamlines the data entry process for registration and product listing and facilitates efficient (and
timely) submissions to FDA and efficient processing, review, and archiving of the submission once at FDA. TRLM-NG
provides an interactive template form to report establishment registration and product listing data and an automatic
acknowledgement of FDA receipt. It also allows registrants to attach and track large numbers of material files for
labeling, advertising, and consumer information submissions.
If you are unable to submit your establishment registration and product list online using TRLM-NG, Form FDA 3741 and
FDA 3741b can be printed and mailed or saved to a USB flash drive or DVD, along with any material files, and mailed
to FDA’s Document Control Center, at the address below. Please note that should you require additional space for any
section, please print out additional pages of the applicable section or part and attach them to the form package.
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
SECTION I – SUBMISSION TYPE
Instructions for Section I – Submission Type

Section I identifies the form submission type. Options include an initial submission of the form or an update to a previously
submitted form.

Submission Type
1. Indicate submission type (select one)*:

□ Initial Establishment Registration and Product List and Material File Submission

(per sections 905(c) and 905(i)(1) of the FD&C Act) (Intended for initial registration and product list submissions)

□ Update Only to Previously Submitted Establishment Registration Submission

(per section 905(b) of the FD&C Act) (Intended for submitters who have previously created a registration but need to make
updates to the establishment information)

□ Update Only to Previously Submitted Product List and/or Material File Submission

(per section 905(i)(3) of the FD&C Act) (Intended for submitters who have previously created a product list but need to make
updates to the product list and/or associated material files)

□ Update to Both Previously Submitted Establishment Registration and Previously Submitted Product

List and/or Material File Submission (per sections 905(b) and 905(i)(3) of the FD&C Act) (Intended for submitters
who need to update the establishment information and the product list and/or associated material files)

2. Provide the TRLM-NG Registration ID that FDA previously assigned*: RG______________
(Skip if this is an initial establishment registration and product list submission)

FORM FDA 3741 (XX/25)

Page 2 of 45

Section I – Submission Type

SECTION II – FORM FDA 3741 NAVIGATION GUIDE AND SUBMISSION CHECKLIST
Instructions for Section II – Form FDA 3741 Navigation Guide and Submission Checklist
The Form Navigation Guide provides a section-by-section breakdown of the content of this form and shows all
required sections and parts as applicable depending on submission type. After reviewing the Form Navigation Guide,
please fill out and complete the Submission Checklist and Acknowledgement.

Part A: Form FDA 3741 Navigation Guide
Instructions for Part A – Form FDA 3741 Navigation Guide

Please review the Form Navigation Guide. This Navigation Guide is intended to provide the registrant with an overview of which
sections (marked with an “X”) need to be filled out depending on submission type.

Form FDA 3741 Section Content

Initial
Establishment
Registration and
Product List and
Material File
Submission

Update Only to
Previously
Submitted
Establishment
Registration
Submission

Update Only
to Previously
Submitted
Product List and/
or Material File
Submission

Update to Both a
Previously Submitted
Establishment
Registration and Previously
Submitted Product List and/
or Material File Submission

Submission Type

II.A.

Form FDA 3741 Navigation Guide

II.B.

Submission Checklist

II.C.

Acknowledgement

III.A.

Registrant Information for Initial Submission

III.B.

TRLM-NG Secondary User Information
for Initial Submission

IV.A. Establishment Information for Initial Submission

Owner Information
IV.B. Establishment
for Initial Submission

Operator Information
IV.C. Establishment
for Initial Submission

Product List Information for Initial Submission

VI.

Material File Information for Initial Submission

VII.A. Updates to Registrant Information

X (if applicable)

VII.B. Updates to TRLM-NG Secondary User Information

X (if applicable)

VIII.A. Updates to Establishment Information

X (if applicable)

VIII.B. Updates to Establishment Owner Information

X (if applicable)

VIII.C. Updates to Establishment Operator Information

X (if applicable)

Updates to Product List Information

X (if applicable)

Updates to Material File Information

X (if applicable)

XI.

Certification Statement

FORM FDA 3741 (XX/25)

Page 3 of 45

Section II – Navigation Guide and
Submission Checklist

Part B: Submission Checklist
Instructions for Part B – Submission Checklist

Please fill out the table below (as demonstrated in the Form Navigation Guide) to indicate the content you intend to provide or
update for this form.

Form FDA 3741 Section Content

Initial
Establishment
Registration and
Product List and
Material File
Submission

Update Only to
Previously
Submitted
Establishment
Registration
Submission

Update Only
to Previously
Submitted
Product List and/
or Material File
Submission

Update to Both a
Previously Submitted
Establishment
Registration and Previously
Submitted Product List and/
or Material File Submission

Submission Type

II.A.

Form FDA 3741 Navigation Guide

II.B.

Submission Checklist

II.C.

Acknowledgement

III.A.

Registrant Information for Initial Submission

III.B.

TRLM-NG Secondary User Information
for Initial Submission

IV.A. Establishment Information for Initial Submission
Owner Information
IV.B. Establishment
for Initial Submission
Operator Information
IV.C. Establishment
for Initial Submission
V.

Product List Information for Initial Submission

VI.

Material File Information for Initial Submission

VII.A. Updates to Registrant Information
VII.B. Updates to TRLM-NG Secondary User Information
VIII.A. Updates to Establishment Information
VIII.B. Updates to Establishment Owner Information
VIII.C. Updates to Establishment Operator Information
IX

Updates to Product List Information

Updates to Material File Information

XI.

Certification Statement

Part C: Acknowledgement
1.

□ Acknowledgement*: I acknowledge I have reviewed the FDA Form 3741 Navigation Guide, completed the

Submission Checklist to reflect the type of information being provided or updated in this submission, and will submit
the requested information in the sections relevant to my submission type.*

FORM FDA 3741 (XX/25)

Page 4 of 45

Section II – Navigation Guide and
Submission Checklist

SECTION III – REGISTRATION INFORMATION FOR INITIAL SUBMISSION
Instructions for Section III – Registration Information for Initial Submission

Section III includes identifying the registrant (e.g., person registering a tobacco product manufacturing facility and submitting a
product list for that establishment’s commercially distributed tobacco products).

Part A: Registrant Information for Initial Submission
Instructions for Part A – Registrant Information for Initial Submission

The registrant is the entity seeking to register an establishment that it owns, operates, or is authorized to represent, which
engages in the manufacture, preparation, compounding, or processing of tobacco products. The term “manufacture, preparation,
compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any tobacco
product package in furtherance of the distribution of the tobacco product from the original place of manufacture to the person who
makes final delivery or sale to the ultimate consumer or end user.
The registrant is considered the primary TRLM-NG user and shall serve as FDA’s primary point of contact (POC) for all information
contained within the registration and its product list and associated material files. The registrant shall serve as the TRLM-NG
account manager and ensure all establishment registration, product list, and associated material file information is current and
accurate in the TRLM-NG database. The registrant may add additional TRLM-NG secondary users to the registration (see Section
III.B – TRLM-NG Secondary User Information) to assist with reviewing and updating registration and product list information.

Registrant's Point of Contact Information
1. First Name*

4. Generational Suffix

2. Middle Initial

5. Professional Suffix

6. Position Title*

7. Business or Tribe Name*

9. Phone Number (Work)*

3. Last Name*

8. Fax Number

10. Phone Number (Mobile)*

11. Email Address*

Registrant’s Association to Registered Establishment
12. What is the registrant’s association to the establishment(s) being registered in this submission? (select all that apply)*

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.

Part B: TRLM-NG Secondary User Information for Initial Submission
Instructions for Part B – TRLM-NG Secondary User Information for Initial Submission

The TRLM-NG secondary user(s) is/are designated by the registrant as additional individuals who will need access to review and/
or update the registration and product list. In instances where the registrant is nonresponsive, FDA may contact the TRLM-NG
secondary user for CTP registration and listing issues. Please provide all indicated information (* is required) for each TRLM-NG
secondary user being added to the registration. If more than one TRLM-NG secondary user needs to be added, submit additional
sections for each additional user as needed.

1. Will additional individuals (other than the registrant) need access to review and update the registration in TRLM-NG?*

□ Yes (provide requested information on secondary user(s) below)
□ No (proceed to Section IV.A – Establishment Information for Initial Submission)

FORM FDA 3741 (XX/25)

Page 5 of 45

Section III – Registration Information
for Initial Submission

Designated TRLM-NG Secondary User's Point of Contact Information
2. First Name*

3. Middle Initial

5. Generational Suffix

6. Professional Suffix

7. Position Title*

8. Business or Tribe Name*

10. Phone Number (Work)*

4. Last Name*

9. Fax Number

11. Phone Number (Mobile)* 12. Email Address*

TRLM-NG Secondary User’s Association to Registered Establishment
13. What is the TRLM-NG Secondary User’s association to the establishment(s) being registered in this submission?*
(select all that apply)

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.

14. Specify level of access the secondary user will need for the registration in TRLM-NG (select one)*

□ Read only: Can only view registration materials, but cannot make changes, certify, or submit establishment
registration and product list information.

□ Review and edit: Has full access, can fill in for primary TRLM-NG account manager and edit, certify, and submit
establishment registration and product list information.

SECTION IV – ESTABLISHMENT INFORMATION FOR INITIAL SUBMISSION
Instructions for Section IV – Establishment Information for Initial Submission

Section IV includes identifying the tobacco product establishment(s) and providing key information on their operations and a
designated point of contact. Please complete this section for each establishment that engages in the manufacture, preparation,
compounding, or processing of tobacco products.

Part A: Establishment Information for Initial Submission
Establishment Identification
1. Establishment Name (Legal Name)*

2. Does the establishment go by any other name?*

□ Yes, provide alternate business name(s),

tradename(s), doing business as (dba) name(s): ____________________

□ No

3. Establishment FDA-Assigned Facility Establishment
Identifier (FEI) Number (if applicable)

4. Establishment D&B DUNS® Number (if applicable)

5. Establishment Business's Web Address or URL*

FORM FDA 3741 (XX/25)

Page 6 of 45

Section III – Registration Information
for Initial Submission

6. Date Establishment Began Manufacturing Tobacco Products for Commercial Distribution* (mm/dd/yyyy)

Establishment Physical Address
7. Street Address Line 1*

9. City*

13.

8. Street Address Line 2 (Apartment, Suite, Building Number)

10. State, Province, or Territory*

11. Country*

12. ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Establishment Point of Contact Information.

Establishment Business Mailing Address
14. Street Address Line 1*

16. City*

15. Street Address Line 2 (Apartment, Suite, Building Number)

17. State, Province, or Territory*

18. Country*

19. ZIP or Postal Code*

Designated Establishment Point of Contact
20. Establishment Point of Contact (select all that apply)*

□ Is the same as the registrant (provide first and last name, then proceed to establishment details)
□ Is the same as the TRLM-NG Secondary User, (provide first and last name, then proceed to establishment details)
□ Is not otherwise listed in previous sections (provide information below)

21. First Name*

24. Generational Suffix

22. Middle Initial

25. Professional Suffix

27. Business or Tribe Name*

29. Phone Number (Work)*

23. Last Name*

26. Position Title*

28. Fax Number

30. Phone Number (Mobile)*

31. Email Address*

Establishment Details
32. Is the establishment an Electronic Nicotine Delivery System (ENDS) retailer which performs manufacturing activities
(such as e-liquid mixing, bottling, packaging, labeling, and/or coil or device repairs) onsite? (select one)*

□ Yes □ No

33. Is the establishment located in a personal residence? (select one)*

□ Yes □ No

34. Is English the primary language spoken at the establishment? (select one)*

□ Yes □ No, primary language spoken: ____________________

FORM FDA 3741 (XX/25)

Page 7 of 45

Section IV – Establishment Information
for Initial Submission

35. Is the establishment located on Tribal lands or otherwise owned or operated by a Tribe?* (select all that apply)

□ Located on Tribal lands (proceed below)
□ Owned and/or operated by a Tribe or members of a Tribe (proceed below)
□ Privately owned/operated (skip Tribal Authority Point of Contact and proceed to Establishment Operations)
□ Not located on Tribal lands (skip Tribal Authority Point of Contact and proceed to Establishment Operations)

Designated Tribal Authority Point of Contact
36. Tribal Authority Point of Contact (select all that apply)*

□ Is the same as the registrant (provide first and last name, then proceed to establishment operations)
□ Is the same as the TRLM-NG Secondary User
(provide first and last name, then proceed to establishment operations)

□ Is the same as the establishment point of contact

(provide first and last name, then proceed to establishment operations)

□ Is not otherwise listed in previous sections (provide information below)
37. First Name*

40. Generational Suffix

38. Middle Initial

41. Professional Suffix

43. Tribe Name*

45. Phone Number (Work)*

39. Last Name*

42. Position Title*

44. Fax Number

46. Phone Number (Mobile)*

47. Email Address*

Establishment Operations
48. Select whether the establishment manufacturers finished tobacco products or products for further manufacturing use
(select one)*

□ Manufacturing of Finished Tobacco Products
□ Manufacturing of Tobacco Products for Use in Further Manufacturing

☐ Manufacturing Both Finished Tobacco Products and Products for Use in Further Manufacturing
49. Select all operations in which the establishment engages*
General Operations

□ Assembling, Modifying, or Repairing Tobacco Products
□ Labeling/Re-Labeling Tobacco Products
□ Packaging/Re-Packaging Tobacco Products
□ Contract Manufacturing Tobacco Products
□ Co-Packing (third party packaging/labeling) Tobacco Products
Product Specific Operations

□ Blending, Casing, Processing, Mixing or Reconstituting Tobacco
□ E-Liquid Production (mixing/blending nicotine, flavorings, PG/VG or other ingredients)
□ E-Liquid Filling/Packaging (bottling or pod filling)
FORM FDA 3741 (XX/25)

Page 8 of 45

Section IV – Establishment Information
for Initial Submission

□ Artisanal Pipe Making
□ Slitting, Rolling, Printing, Perforating, Cutting (for RYO products)
Additional Operations

□ Distributing Tobacco Products (specify types of tobacco products distributed)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (Specify) ________________
□ Importing Tobacco Products (specify types of tobacco products imported)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (Specify) ________________
□ Retailing Tobacco Products (specify types of tobacco products sold)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (Specify) ________________
□ Storing Tobacco Products
□ Testing Tobacco Products
□ Advertising
□ Other (specify) ________________
FORM FDA 3741 (XX/25)

Page 9 of 45

Section IV – Establishment Information
for Initial Submission

Part B: Establishment Owner Information for Initial Submission
Instructions for Part B – Establishment Owner Information for Initial Submission
Provide details on who has an ownership interest in the establishment being registered.

Owner’s Business Identification
1. Business Name (Legal Name)*

2. Does the business entity go by any other name?*

□ Yes, provide alternate business name(s), tradename(s),
doing business as (dba) name(s): _____________________

□ No

3. Owner Business Headquarter's FDA-Assigned Facility
Establishment Identifier (FEI) Number (if applicable)

4. Owner's Business Headquarter's D&B DUNS® Number
(if applicable)

Owner’s Business Physical Address
5. Street Address Line 1*

7. City*

11.

6. Street Address Line 2 (Apartment, Suite, Building Number)

8. State, Province, or Territory*

9. Country*

10. ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Owner's Point of Contact Information.

Owner’s Business Mailing Address
12. Street Address Line 1*
14. City*

13. Street Address Line 2 (Apartment, Suite, Building Number)
15. State, Province, or Territory*

16. Country*

17. ZIP or Postal Code*

Owner’s Designated Point of Contact Information
18. Owner's Designated Point of Contact (select all that apply)*

□ Is the same as the designated point of contact for the registrant.

(provide first and last name and then proceed to owner’s business structure)

□ Is the same as the designated point of contact for the TRLM-NG secondary user
(provide first and last name and then proceed to owner’s business structure)

□ Is the same as the designated point of contact for the establishment.

(provide first and last name and then proceed to owner’s business structure)

□ Is not otherwise listed in previous sections (provide information below)

19. First Name*

22. Generational Suffix

20. Middle Initial

23. Professional Suffix

25. Business or Tribe Name*

FORM FDA 3741 (XX/25)

21. Last Name*

24. Position Title*

26. Fax Number

Page 10 of 45

Section IV – Establishment Information
for Initial Submission

27. Phone Number (Work)*

28. Phone Number (Mobile)*

29. Email Address*

Owner's Business Structure
30. Select the type of business structure most applicable to the owner’s business (select one)*

□ Sole Proprietorship (provide information for the individual owner)
□ Partnership (provide information on each partner)
□ Corporation (including limited liability) (enter information on each corporate officer and director)
□ Tribe (enter information on each Tribal Leader/Councilperson)

31. Provide the indicated information for each key official within the owner’s business structure
Key Business Official #1
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #2
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #3
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #4
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #5
First Name*

Generational Suffix

FORM FDA 3741 (XX/25)

Middle Initial

Professional Suffix

Position Title*

Page 11 of 45

Last Name*

Business or Tribe Name*

Section IV – Establishment Information
for Initial Submission

Location of Formation of Legal Business Entity
32. State of Formation (if in U.S.) (optional)

33. Territory and Country if outside U.S. (optional)

Part C: Establishment Operator Information for Initial Submission
Instructions for Part C – Establishment Operator Information for Initial Submission
Provide details on who has management authority of the establishment being registered.

Operator’s Business Identification
1. Business Name (Legal Name)*

2. Does the business entity go by any other name?*

□ Yes, provide alternate business name(s), tradename(s),
doing business as (dba) name(s): _____________________

□ No

3. Operator Business Headquarter's FDA-Assigned Facility 4. Operator Business Headquarter’s D&B DUNS® Number
Establishment Identifier (FEI) Number (if applicable)
(if applicable)
Operator’s Business Physical Address
5. Street Address Line 1*

7. City*

11.

6. Street Address Line 2 (Apartment, Suite, Building Number)

8. State, Province, or Territory*

9. Country*

10. ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Operator Point of Contact Information.

Operator’s Business Mailing Address
12. Street Address Line 1*
14. City*

13. Street Address Line 2 (Apartment, Suite, Building Number)
15. State, Province, or Territory*

16. Country*

17. ZIP or Postal Code*

Operator’s Designated Point of Contact Information
18. Operator’s Designated Point of Contact (select all that apply)*

□ Is the same as the designated point of contact for the registrant.

(provide first and last name and then proceed to operator’s business structure)

□ Is the same as the designated point of contact for the TRLM-NG secondary user
(provide first and last name and then proceed to operator’s business structure)

□ Is the same as the designated point of contact for the establishment

(provide first and last name and then proceed to operator’s business structure)

□ Is the same as the owner's designated point of contact

(provide first and last name and then proceed to operator’s business structure)

□ Is not otherwise listed in previous sections (provide information below)

FORM FDA 3741 (XX/25)

Page 12 of 45

Section IV – Establishment Information
for Initial Submission

19. First Name*

22. Generational Suffix

20. Middle Initial

23. Professional Suffix

24. Position Title*

25. Business or Tribe Name*
27. Phone Number (Mobile)*

21. Last Name*

26. Phone Number (Work)*
28. Fax Number

29. Email Address*

Operator’s Business Structure
30. Select the type of business structure most applicable to the operator’s business (select one)*

31. Provide the indicated information for each key official within the operator’s business structure
Key Business Official #1
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #2
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #3
First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Last Name*

Business or Tribe Name*

Key Business Official #4
First Name*

Generational Suffix

FORM FDA 3741 (XX/25)

Middle Initial

Professional Suffix

Position Title*

Page 13 of 45

Last Name*

Business or Tribe Name*

Section IV – Establishment Information
for Initial Submission

Key Business Official #5
First Name*

Middle Initial

Generational Suffix

Professional Suffix

Last Name*

Position Title*

Business or Tribe Name*

Location of Formation of Legal Business Entity
32. State of Formation (if in U.S.) (optional)

33. Territory and Country (if outside U.S) (optional)

SECTION V – PRODUCT LIST INFORMATION FOR INITIAL SUBMISSION
Instructions for Section V – Product List Information for Initial Submission

Provide the requested product list information for every product manufactured at each establishment being registered with
FDA. Please clearly indicate which tobacco product(s) are associated with each establishment information was provided for
in Section IV. Every product listed must have a universal product code (UPC), product category and subcategory, package
type, characterizing flavor (tobacco, menthol, flavored [i.e., other than just tobacco or menthol alone] or unflavored), a way to
quantify the product amount (i.e., by providing the numeric value and units for either product quantity, product quantity mass,
portion count, or portion mass as applicable for the product subcategory), and an indication of the nicotine source (i.e., tobacco
derived nicotine, non-tobacco derived nicotine, both, or none) and nicotine concentration (where applicable). Provide additional
properties as needed to uniquely identify your product and distinguish it from other products within the same brand or product line
if the property is not otherwise included in the options below. See 3741b product list spreadsheet for the selectable options per
field for each product subcategory.
Note: You can use 3741b to organize and upload your product information and properties directly into TRLM-NG or save to USB/
DVD to mail to DCC. If you are submitting this form by mail, for each product you must also provide the Associated Establishment
Information, Manufacturing and Commercial Distribution Status, and Product Marketing Authorization information as indicated
below. If using TRLM-NG to submit, these data elements will be collected after you upload your 3741b product list spreadsheet.

Product Identifiers
1. Product Name*

2. Brand Name*

4. Universal Product Code (UPC)*

3. Sub-brand Name*

5. Alternative Industry Product Identification Number

6. Alternative Industry Product Identification Number Type (select one)

□ SKU
□ Catalog or Item #
□ Other (Specify) ______________________

FORM FDA 3741 (XX/25)

Page 14 of 45

Section V – Product List for
Initial Submission

7. Product Category and Subcategory*

□ Cigarettes
□ Filtered Cigarettes
□ Non-Filtered Cigarettes
□ Other (Specify) ________________
□ Cigars
□ Cigar Component
□ Cigar Tobacco Filler
□ Filtered, Sheet-Wrapped Cigars
□ Unfiltered, Leaf-Wrapped Cigars
□ Unfiltered, Sheet-Wrapped Cigars
□ Other (Specify) ________________
□ Electronic Nicotine Delivery Systems
(ENDS)/Vapes

□ Closed E-Cigarette
□ Closed E-Liquid
□ ENDS Component
□ Open E-Cigarette
□ Open E-Liquid
□ Other (Specify) ________________

□ Heated Tobacco Products (HTP)
□ Closed HTP
□ Open HTP
□ HTP Consumable
□ HTP Component
□ Other (Specify) ________________
□ Pipe Tobacco Products
□ Pipe
□ Pipe Component
□ Pipe Tobacco Filler
□ Other (Specify) ________________

□ Roll-Your-Own (RYO) Tobacco Products
□ RYO Filter
□ RYO Filtered Cigarette Tube
□ RYO Non-Filtered Cigarette Tube
□ RYO Paper Tip
□ RYO Tobacco Filler
□ RYO Rolling Paper
□ Other (Specify) ________________
□ Smokeless Tobacco Products
□ Dissolvable
□ Loose Chewing Tobacco
□ Loose Dry Snuff
□ Loose Moist Snuff
□ Loose Snus
□ Portioned Chewing Tobacco
□ Portioned Moist Snuff
□ Portioned Snus
□ Other (Specify) ________________
□ Waterpipe Tobacco Products
□ Waterpipe
□ Waterpipe Component
□ Waterpipe Heat Source
□ Waterpipe Tobacco Filler
□ Other (Specify) ________________
□ Oral Nicotine Products
□ Nicotine Pouch
□ Other (Specify) ________________
□ Other Products
(Specify) ________________

8. Intent of Use* (e.g., consumer use or for further manufacturing)

Product Attributes/Properties
9. Package Type*

FORM FDA 3741 (XX/25)

Page 15 of 45

Section V – Product List for
Initial Submission

Product Quantity*
10. Product Quantity (Numeric value and units)

11. Product Quantity Mass (Numeric value and units)

12. Portion Count (Numeric value and units)

13. Portion Mass (Numeric value and units)

Product Flavor
14. Characterizing Flavor* (select one)

□ Menthol

□ Tobacco □

□ Flavored (specify below)

Unflavored

15. Flavor Name (if flavored)

16. Flavor Description (if flavored)

Product Nicotine Attributes
17. Nicotine Concentration (Numeric value and units)

18. Nicotine Source*

E-Liquid Concentration (if applicable)
19. PG (Numeric value)

20. VG (Numeric value)

21. E-Liquid Volume (Numeric value and units)

Device/Battery Information (if applicable)
22. Wattage (Numeric value and units)

23. Battery Capacity (Numeric value and units)

Length (if applicable)
24. Length Description

25. Length (Numeric value and units)

Width (as applicable)
26. Width (Numeric value and units)

Diameter (as applicable)
27. Diameter Description

28. Diameter Format

29. Diameter (Numeric value and units)

Height (as applicable)
30. Height (Numeric value and units)

FORM FDA 3741 (XX/25)

Page 16 of 45

Section V – Product List for
Initial Submission

Portion Thickness (as applicable)
31. Portion Thickness (Numeric value and units)

Other (as applicable)
32. Tobacco Cut Style

33. Filter Ventilation (Percentage)

35. Source of Energy

34. Number of Hoses

36. Wrapper Material

37. Tip Type

38. Additional Properties

Associated Establishment Information
39. Manufacturing Establishment Name*

41. Street Address Line 1*

43. City*

40. Manufacturing Establishment Facility Establishment
Identifier (FEI) Number
42. Street Address Line 2 (Apartment, Suite, Building Number)

44. State, Province, or Territory*

45. Country*

46. ZIP or Postal Code*

Manufacturing and Commercial Distribution Status
47. Date Introduced for Commercial Distribution* (mm/dd/yyyy)

Product Marketing Authorization
48. FDA Submission Tracking Number (STN) and
Product Identifier (PD) Number*
50. Submitter Name

49. If No STN-PD#, Provide Reason

51. Applicant Name

52. Product Name as Appeared on Marketing Authorization or Exemption

FORM FDA 3741 (XX/25)

Page 17 of 45

Section V – Product List for
Initial Submission

SECTION VI – MATERIAL FILE INFORMATION FOR INITIAL SUBMISSION
Instructions for Section VI – Material File Information for Initial Submission
Use the fields below to provide the requested information on your labeling, consumer information, and advertising
material files associated with your listed products. Files themselves will need to be uploaded electronically via TRLMNG or mailed as a hard copy or USB/DVD to DCC.
Material File Identifiers
1. Material File Name*

2. Unique ID or Internal ID*

3. Date First Disseminated* (mm/dd/yyy)

Material File Information
4. Material File Title*

5. Material File Description*

6. Material File Category and Type*

□ Labeling
□ Advertising
□ Consumer Information
□ Product Labeling
□ Website or Banner
□ Brochure or Pamphlet
□ Carton
□ Digital
□ Instructions
□ Outer Container
□ Social Media
□ Catalog
□ Wrapper
□ Point of Sale
□ Cautions or Warnings
□ Affixed Tag
□ Magazine, Periodical, or Print □ Reviews or Feedback
□ Shipping and Packaging
□ Coupons
□ Press Release
□ Cigar Point of Sale Sign
□ Email
□ Business Card
□ Cigar Box
□ Brochure
□ Coupons, Rewards, or
Loyalty Cards
□ Other (Specify) ________________
□ Mobile App
□ Digital Information
□ Flyer or Handout
□ Point of Sale Customer
□ Large Sign
Information
□ Small Sign
□ Trade Show Material
□ Other (Specify) __________
□ Other (Specify)__________
7. URL (if digital, social media, or website)

8. Location of Labeling* (select one)

□ Top

□ Front

□ Side

□ Back

□ Bottom □ Other______________

9. Will there be a submission of a package label plan?*

□ Yes

□ No

10. What variables are captured in the product variation index?*

FORM FDA 3741 (XX/25)

Page 18 of 45

Section VI – Material File for
Initial Submission

11. Additional Material File Properties (if applicable)

Associated Product Identifiers
12. Product Name*

13. Universal Product Code (UPC)*

14. Alternative Industry Product
Identification Number

15. Alternative Industry Product Identification Number Type (select one)

□ SKU
□ Catalog or Item #
□ Other (Specify) ______________________

SECTION VII – UPDATES TO REGISTRATION INFORMATION

Part A: Updates to Registrant Information
Instructions for Part A – Updates to Registrant Information

Please note, all references to the “registrant” in this part are specifically referring to their role as the TRLM-NG account manager.
Use this section if the original registrant is no longer affiliated with the registered establishment and the previous TRLM-NG
account manager role in the system needs to be transferred to a new registrant to resume updating the registration.

1. Have there been any changes to who is serving as the registrant/TRLM-NG account manager or their information
(see Section III.A) since the last submission? (select one)*

□ Yes (provide the effective date of change and proceed below to provide the updated information)
□ No (skip to Section VII, Part B: Updates to TRLM-NG Secondary User Information)
Effective Date of Change (mm/dd/yyyy)* _________________

2. Select reason for registrant update (select one)*

□ Updating information for existing registrant
(complete fields 3-14, then proceed to VII.B – Updates to TRLM-NG Secondary User Information)
□ Transferring registrant role to another individual

(complete fields 15-26, then proceed to VII.B – Updates to TRLM-NG Secondary User Information)

Updated Registrant’s Point of Contact Information
3. First Name*

4. Middle Initial

□ No Update
6. Generational Suffix

□ No Update

7. Professional Suffix

□ No Update

5. Last Name*

□ No Update

8. Position Title*

□ No Update

9. Business or Tribe Name*

10. Fax Number

□ No Update
11. Phone Number (Work)*

□ No Update

FORM FDA 3741 (XX/25)

□ No Update

12. Phone Number (Mobile)*

□ No Update

Page 19 of 45

13. Email Address*

□ No Update

Section VII – Updates to
Registration Information

Updated Registrant’s Association to Registered Establishment
14. What is the registrant’s association to the establishment(s) being registered in this submission? (select all that apply)*

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.

New Registrant’s Designated Point of Contact for the Registration
15. First Name*

18. Generational Suffix

16. Middle Initial

19. Professional Suffix

21. Business or Tribe Name*

23. Phone Number (Work)*

17. Last Name*

20. Position Title*

22. Fax Number

24. Phone Number (Mobile)*

25. Email Address*

26. What is the registrant’s association to the establishment(s) being registered in this submission? (select all that apply)*

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.

Part B: Updates to TRLM-NG Secondary User(s) Information
Instructions for Part B – Updates to TRLM-NG Secondary User(s) Information

The TRLM-NG secondary user(s) is/are designated by the registrant as additional individuals who will need access to review and/
or update the establishment registration and product list information. In instances where the registrant is non-responsive, FDA
may contact the TRLM-NG secondary user for CTP registration and product listing issues.
Provide all indicated information (* is required) for each TRLM-NG secondary user being added to the registration. Submit
additional copies of this section as needed for each additional TRLM-NG secondary user added or whose information needs to be
updated.

1. Have there been any changes to who is serving as the TRLM-NG secondary user or their information
(see Section III.B) since the last submission (select one) *

□ Yes (provide the effective date of change and proceed below to provide the updated information)
□ No (skip to Section VIII.A – Updates to Establishment Information)
Effective Date of Change (mm/dd/yyyy)* _________________

FORM FDA 3741 (XX/25)

Page 20 of 45

Section VII – Updates to
Registration Information

2. Select reason for TRLM-NG secondary user update (select one)*

□

Updating information for existing TRLM-NG secondary user

(complete fields 3-5 to identify the TRLM-NG secondary user whose information needs to be updated and provide the
applicable updates in fields 6-18. Then proceed to VIII.A – Updates to Establishment Information)

□ Adding new TRLM-NG secondary user
(complete fields 19-30, then proceed to VIII.A – Updates to Establishment Information)
□ Replacing or removing TRLM-NG secondary user

(complete fields 3-5 to identify the TRLM-NG secondary user who needs to be removed and skip to field 18 to select “revoke
access and remove user”. If applicable, provide new TRLM-NG secondary information in fields 19-30)

□ Changing TRLM-NG secondary user access

(complete fields 3-5 to identify the TRLM-NG secondary user whose access level needs to be updated and select the
appropriate access level in fields 18. Then proceed to VIII.A – Updates to Establishment Information.)

Identification of TRLM-NG Secondary User to Update
3. First Name*

4. Last Name*

5. Email address*

Updated TRLM-NG Secondary User 's Point of Contact Information
6. First Name*

7. Middle Initial

□ No Update
9. Generational Suffix

□ No Update

10. Professional Suffix

□ No Update

8. Last Name*

□ No Update

11. Position Title*

□ No Update

12. Business or Tribe Name*

13. Fax Number

□ No Update
14. Phone Number (Work)*

□ No Update

15. Phone Number (Mobile)*

□ No Update

16. Email Address*

□ No Update

Updated TRLM-NG Secondary User’s Association to Registered Establishment
17. What is the updated TRLM-NG Secondary User’s association to the establishment(s) being registered in this
submission? (select all that apply)*

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.

Updates to TRLM-NG Secondary User’s Access
18. Specify level of access the secondary user will need for the registration in TRLM-NG (select one)*

□ Read only: Can view registration materials, but cannot make changes, certify, or submit registration and product
listing information.

□ Review and edit: Has full access, can fill in for primary account manager and edit, certify, and submit registration
and product listing information.

□ Revoke access and remove TRLM-NG secondary user: Removes the previously designated secondary user
from the registration so they can no longer view or edit the registration and product listing information.

FORM FDA 3741 (XX/25)

Page 21 of 45

Section VII – Updates to
Registration Information

New TRLM-NG Secondary User 's Point of Contact Information
19. First Name*

20. Middle Initial

22. Generational Suffix

23. Professional Suffix

24. Position Title*

25. Business or Tribe Name*

27. Phone Number (Work)*

21. Last Name*

26. Fax Number

28. Phone Number (Mobile)*

29. Email Address*

New TRLM-NG Secondary User’s Association to Registered Establishment
30. What is the updated TRLM-NG Secondary User’s association to the establishment(s) being registered in
this submission? (select all that apply)*

□ Establishment Owner

Has an ownership interest in one or more tobacco manufacturing establishments being registered.

□ Establishment Operator

Has management authority for one or more tobacco manufacturing establishments being registered.

□ Authorized Representative

Responsible official authorized to represent a tobacco product manufacturing establishment being registered.
SECTION VIII – UPDATES TO ESTABLISHMENT INFORMATION

Part A: Updates to Establishment Information
Instructions for Part A – Updates to Establishment Information

Provide all indicated information (* is required) for each establishment being updated or added to the registration. Submit additional
copies of this section as needed for each additional establishment added or for each additional establishment whose information
needs to be updated.

1. Have there been any changes to the establishment information (see Section IV.A) for any registered establishments
since the last submission? (select one) *

□ Yes (provide the effective date of change and proceed below to provide the updated information)
□ No (skip to Section VIII.B – Updates to Establishment Owner Information)
Effective Date of Change (mm/dd/yyyy)* _________________

2. Select the applicable statement for this submission*

□ Change in establishment information
□ Updated to establishment manufacturing status
□ An additional establishment needs to be added to the registration
New Establishment to Add to Registration

New Establishment’s Identification
3. Establishment Name (Legal Name)*

4. Does the establishment go by any other name?*

□ Yes, provide alternate business name(s),

tradename(s), doing business as (dba) name(s): ____________________

□ No
FORM FDA 3741 (XX/25)

Page 22 of 45

Section VIII – Updates to
Establishment Information

5. Establishment FDA-Assigned Facility Establishment
Identifier (FEI) Number (if applicable)

6. Establishment D&B DUNS® Number (if applicable)

7. Establishment Business’s Web Address or URL*
8. Date Establishment Began Manufacturing Tobacco Products for Commercial Distribution* (mm/dd/yyyy)

New Establishment Physical Address
9. Street Address Line 1*

11. City*

15.

10. Street Address Line 2 (Apartment, Suite, Building Number)

12. State, Province, or Territory*

13. Country*

14. ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Establishment Point of Contact Information.

New Establishment Business Mailing Address
16. Street Address Line 1*

18. City*

17. Street Address Line 2 (Apartment, Suite, Building Number)

19. State, Province, or Territory*

20. Country*

21. ZIP or Postal Code*

Designated New Establishment Point of Contact
22. Establishment Point of Contact (select all that apply)*

□ Is the same as the registrant (provide first and last name, then proceed to establishment details)
□ Is the same as the TRLM-NG Secondary User (provide first and last name, then proceed to establishment details)
□ Is not otherwise listed in previous sections (provide information below)

23. First Name*

26. Generational Suffix

24. Middle Initial

27. Professional Suffix

29. Business or Tribe Name*

31. Phone Number (Work)*

25. Last Name*

28. Position Title*

30. Fax Number

32. Phone Number (Mobile)*

33. Email Address*

New Establishment Details Questions
34. Is the establishment an Electronic Nicotine Delivery System (ENDS) retailer which performs manufacturing activities
(such as e-liquid mixing, bottling, packaging, labeling, and/or coil or device repairs) onsite? (select one)*

□ Yes □ No

FORM FDA 3741 (XX/25)

Page 23 of 45

Section VIII – Updates to
Establishment Information

35. Is the establishment located in a personal residence? (select one)*

□ Yes □ No

36. Is English the primary language spoken at the establishment? (select one)*

□ Yes □ No, primary language spoken: ____________________

37. Is the establishment located on Tribal lands or otherwise owned or operated by a Tribe?* (select all that apply)

□ Located on Tribal lands (proceed below)
□ Owned and/or operated by a Tribe or members of a Tribe (proceed below)
□ Privately owned/operated (skip Tribal Authority Point of Contact, and proceed to Establishment Operations)
□ Not located on Tribal lands (skip Tribal Authority Point of Contact, and proceed to Establishment Operations)

Designated Tribal Authority Point of Contact
38. Tribal Authority Point of Contact (select all that apply)*

□ Is the same as the establishment point of contact

(provide first and last name, then proceed to establishment operations)

□ Is not otherwise listed in previous sections (provide information below)
39. First Name*

42. Generational Suffix

40. Middle Initial

43. Professional Suffix

45. Tribe Name*

47. Phone Number (Work)*

41. Last Name*

44. Position Title*

46. Fax Number

48. Phone Number (Mobile)*

49. Email Address*

New Establishment Operations
50. Select whether the establishment manufacturers finished tobacco products or products for further manufacturing use
(select one)*

□ Manufacturing of Finished Tobacco Products
□ Manufacturing of Tobacco Products for Use in Further Manufacturing

☐ Manufacturing Both Finished Tobacco Products and Products for Use in Further Manufacturing

FORM FDA 3741 (XX/25)

Page 24 of 45

Section VIII – Updates to
Establishment Information

51. Select all operations in which the establishment engages*
General Operations
Assembling, Modifying, or Repairing Tobacco Products
Labeling/Re-Labeling Tobacco Products
Packaging/Re-Packaging Tobacco Products
Contract Manufacturing Tobacco Products
Co-Packing (third party packaging/labeling) Tobacco Products

□
□
□
□
□

Product Specific Operations
Blending, Casing, Processing, Mixing, or Reconstituting Tobacco
E-Liquid Production (mixing/blending nicotine, flavorings, PG/VG or other ingredients)
E-Liquid Filling/Packaging (bottling or pod filling)
Artisanal Pipe Making
Slitting, Rolling, Printing, Perforating, Cutting (for RYO products)

□
□
□
□
□

Additional Operations

FORM FDA 3741 (XX/25)

Page 25 of 45

Section VIII – Updates to
Establishment Information

□ Retailing Tobacco Products (specify types of tobacco products sold)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (specify) ________________
□ Storing Tobacco Products
□ Testing Tobacco Products
□ Advertising
□ Other (specify) ________________

52. Effective Date of Change for when added Establishment began manufacturing tobacco products (mm/dd/yyyy)*

Updates to Establishment Information
Identification of Establishment to Update
53. Establishment Name (Legal Name)*

54. Establishment Name (DBA Name)*

□ No Update
55. Establishment FDA-Assigned Facility Establishment
Identifier (FEI) Number*

□ No Update

56. Establishment D&B DUNS® Number (if applicable)

□ No Update

57. Establishment Business’s Web Address or URL (optional)

□ No Update
58. Date Establishment Began Manufacturing Tobacco Products for Commercial Distribution* (mm/dd/yyyy)

□ No Update
Updates to Establishment Physical Address
60. Street Address Line 2 (Apartment, Suite, Building Number)

59. Street Address Line 1*

□ No Update
61. City*

62. State, Province, or Territory*

□ No Update
65.

□ No Update
63. Country*

□ No Update

64. ZIP or Postal Code*

□ No Update

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Establishment Point of Contact Information.

FORM FDA 3741 (XX/25)

□ No Update
Page 26 of 45

Section VIII – Updates to
Establishment Information

Updates to Establishment Business Mailing Address
67. Street Address Line 2 (Apartment, Suite, Building Number)

66. Street Address Line 1*

□ No Update
68. City*

□ No Update

69. State, Province, or Territory*

□ No Update

70. Country*

□ No Update

71. ZIP or Postal Code*

□ No Update

Designated Establishment Point of Contact

□ No Update

72. Establishment Point of Contact (select all that apply)*

73. First Name

74. Middle Initial

□ No Update
76. Generational Suffix

77. Professional Suffix

□ No Update

75. Last Name

□ No Update

78. Position Title*

□ No Update

79. Business or Tribe Name*

80. Fax Number

□ No Update
81. Phone Number (Work)*

□ No Update

82. Phone Number (Mobile)*

□ No Update

83. Email Address*

□ No Update

Updates to Establishment Details Questions
84. Is the establishment an Electronic Nicotine Delivery System (ENDS) retailer which performs manufacturing activities
(such as e-liquid mixing, bottling, packaging, labeling, and/or coil or device repairs) onsite? (select one)*

□ Yes □ No

□ No Update

85. Is the establishment located in a personal residence? (select one)*

□ Yes □ No

□ No Update

86. Is English the primary language spoken at the establishment? (select one)*

□ Yes □ No, primary language spoken: ____________________

87. Is the establishment located on Tribal lands or otherwise owned or operated by a Tribe?*

□ No Update
□ No Update

□ Located on Tribal lands (proceed below)
□ Owned and/or operated by a Tribe or members of a Tribe (proceed below)
□ Privately owned/operated (skip Tribal Authority Point of Contact, and proceed to Establishment Operations)
□ Not located on Tribal lands (skip Tribal Authority Point of Contact, and proceed to Establishment Operations)

FORM FDA 3741 (XX/25)

Page 27 of 45

Section VIII – Updates to
Establishment Information

Designated Tribal Authority Point of Contact
88. Tribal Authority Point of Contact (select all that apply)*

□ Is the same as the registrant (provide first and last name, then proceed to establishment operations)
□ Is the same as the TRLM-NG Secondary User

□ No Update

(provide first and last name, then proceed to establishment operations)

□ Is the same as the establishment point of contact

(provide first and last name, then proceed to establishment operations)

□ Is not otherwise listed in previous sections (provide information below)
90. Middle Initial

89. First Name*

□ No Update
92. Generational Suffix

□ No Update

93. Professional Suffix

□ No Update

91. Last Name*

□ No Update

94. Position Title*

□ No Update

95. Tribe Name*

96. Fax Number

□ No Update
97. Phone Number (Work)*

□ No Update

98. Phone Number (Mobile)*

□ No Update

99. Email Address*

□ No Update

Updated Establishment Operations
100. Select whether the establishment manufacturers finished tobacco products or products for further manufacturing
use (select one)*

□ Manufacturing of Finished Tobacco Products
□ Manufacturing of Tobacco Products for Use in Further Manufacturing

☐ Manufacturing Both Finished Tobacco Products and Products for Use in Further Manufacturing
101. Select all operations in which the establishment engages*

□ No Update
□ No Update

General Operations
Assembling, Modifying, or Repairing Tobacco Products
Labeling/Re-Labeling Tobacco Products
Packaging/Re-Packaging Tobacco Products
Contract Manufacturing Tobacco Products
Co-Packing (third party packaging/labeling) Tobacco Products

□
□
□
□
□

Product Specific Operations

□ Blending, Casing, Processing, Mixing, or Reconstituting Tobacco
□ E-Liquid Production (mixing/blending nicotine, flavorings, PG/VG or other ingredients)
□ E-Liquid Filling/Packaging (bottling or pod filling)
□ Artisanal Pipe Making
□ Slitting, Rolling, Printing, Perforating, Cutting (for RYO products)

FORM FDA 3741 (XX/25)

Page 28 of 45

Section VIII – Updates to
Establishment Information

Additional Operations
Distributing Tobacco Products (specify types of tobacco products distributed)
Cigarettes
Cigars
Electronic Nicotine Delivery Systems (ENDS)/Vapes
Heated Tobacco Products (HTP)
Pipe Tobacco Products
Roll-Your-Own Tobacco Products (RYO)
Smokeless Tobacco Products
Waterpipe Tobacco Products (Hookah)
Oral Nicotine Products
Other (specify) ________________

□

□
□
□
□
□
□
□
□
□
□

□ Importing Tobacco Products (specify types of tobacco products imported)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (specify) ________________
□ Retailing Tobacco Products (specify types of tobacco products sold)
□ Cigarettes
□ Cigars
□ Electronic Nicotine Delivery Systems (ENDS)/Vapes
□ Heated Tobacco Products (HTP)
□ Pipe Tobacco Products
□ Roll-Your-Own Tobacco Products (RYO)
□ Smokeless Tobacco Products
□ Waterpipe Tobacco Products (Hookah)
□ Oral Nicotine Products
□ Other (specify) ________________
□ Storing Tobacco Products
□ Testing Tobacco Products
□ Advertising
□ Other (specify) ________________

102. Effective Date of Change for when new Establishment began manufacturing tobacco products (mm/dd/yyyy)*

FORM FDA 3741 (XX/25)

Page 29 of 45

Section VIII – Updates to
Establishment Information

Updates to Existing Establishment’s Manufacturing Status
Manufacturing Status
Please indicate your establishment’s current manufacturing status

□ Reactivate – Establishment has resumed manufacturing

Establishment Name to be reactivated

Establishment FDA-Assigned Facility
Establishment (FEI) Number to be reactivated

Establishment D&B DUNS® Number to be reactivated

Street Address Line 1

City

Street Address Line 2 (Apartment, Suite, Building Number)

State, Province, or Territory

Country

ZIP or Postal Code

Date Resumed Manufacturing (mm/dd/yyyy)

□ Active – Establishment relocated (same establishment, new address)

Date Manufacturing Ceased at Previous Site (mm/dd/yyyy) Date Manufacturing Activites Began at New Site (mm/dd/yyyy)

□ Inactive – Establishment has ceased manufacturing (provide inactivation reason below)

Date Manufacturing Ceased (mm/dd/yyyy)

□ Inactive – Establishment has transferred operations to a different establishment (new establishment,
new address, different owner and/or operator) (provide inactivation reason below)

Date Manufacturing Ceased at Previous Site (mm/dd/yyyy) Date Manufacturing Activites Began at New Site (mm/dd/yyyy)

Provide the RG ID for the new establishment
(if manufacturing transferred to another establishment on a different registration) (if applicable)

FORM FDA 3741 (XX/25)

Page 30 of 45

Section VIII – Updates to
Establishment Information

Establishment Inactivation Reason:

□ Data Clean-up

Establishment was included on more than one registration (associated with more than one registration ID #), was erroneously
duplicated on the same registration, and/or was included on different registrations at the same address but going by a different
name (i.e., legal vs. dba name). If inactivating a duplicate establishment, please provide the registration ID # where the
establishment information will be kept up to date.

□

• Surviving Registration ID #: ______________________________
• Surviving Establishment Name:____________________________
• Surviving Establishment FEI #: ____________________________
• Registration ID #’s where duplicate establishment(s) are being inactivated: ____________________________
Not engaged in tobacco product manufacturing activities
Establishment is still in business but is no longer engaged in tobacco manufacturing activities. This could include switching
to retail only, importing and/or distributing without packing, re-packaging, labeling, or re-labeling, and/or switching to only
manufacturing products that are neither tobacco products, nor component or parts of tobacco products.

□ Manufacturing only tobacco products that are not finished tobacco products

If all products manufactured at the Establishment are sold or distributed solely for further manufacturing of tobacco products.

□ Out of business
Establishment is no longer in existence in any capacity.
□ Other (Specify) ____________________________

If inactivating the registration, and therefore the establishments on the registration, use “Other – Registration Inactivation”.

Registration Inactivation Reason: (if inactivating last active establishment on registration, inactivate the registration)
The purpose of TRLM-NG is to serve as a record of establishments actively involved in the manufacture of tobacco products. If you
have no remaining active manufacturing establishments, please inactivate your registration. Note that you must re-activate your
registration when you resume tobacco product manufacturing activities or add a new tobacco product manufacturing establishment.)

□ Data Clean-up

If different business entities (i.e., owner vs. operator) registered the same establishment at the same address or if instead
of transferring the TRLM-NG account management role, a new registration was created to communicate updates to an
establishment’s information and product list. In the case of duplicate registrations, please indicate the registration ID # of the
duplicates and which is the surviving registration that will be kept up to date and confirm the establishments (name, address, FEI
#) that should be on the surviving registration.

•
•
•
•
•

TRLM-NG Registration ID #(s) of duplicates that will be inactivated: ______________
Surviving Registration ID # that will be kept up to date: _______________
Surviving Establishment Name(s): _____________
Surviving Establishment address(es): ____________
Surviving Establishment FEI #(s): ____________

□ Not engaged in tobacco product manufacturing activities

If the establishments on the registration are no longer manufacturing tobacco products (switched to retail, importing, distribution
without re-packaging or re-labeling) and thus the registration needs to be inactivated.

□ Manufacturing only tobacco products that are not finished tobacco products
If all products manufactured at the Establishment are sold or distributed solely for further manufacturing of tobacco products.
□ Out of business
If the establishments on the registration are no longer in existence in any capacity and the registration needs to be inactivated.
□ Other (Specify) ____________________________
If inactivating a registration for a reason not indicated above, specify.

Date of registration inactivation: (mm/dd/yyyy)

FORM FDA 3741 (XX/25)

Page 31 of 45

Section VIII – Updates to
Establishment Information

Part B: Updates to Establishment Owner Information
Instructions for Part B – Updates to Establishment Owner Information

Provide updated information if there have been changes to who has an ownership interest in the registered establishment(s). Owner
information, which includes the owner’s name, owner’s designated point of contact information, and owner’s business structure, will be needed
for each updated establishment on the registration. Submit additional sheets for each establishment owner that needs to be updated.

1. Have there been any changes to the Establishment(s) Owner Information (see Section IV, Part B) since
the last submission? (select one)*

□ Yes – (provide the effective date of change and proceed below to identify which establishment’s owner information
has changed and provide updated information)

□ No – (skip to Section VIII.C – Updates to Establishment Operator Information)
Effective Date of Change (mm/dd/yyyy)* _________________
Identify the currently registered establishment whose owner information needs to be updated.*
2. Establishment Name (Legal Name)*

3. Does the establishment go by any other name?*

□ Yes, provide alternate business name(s),

tradename(s), doing business as (dba) name(s): ____________________

□ No

4. Establishment FDA-Assigned Facility Establishment
Identifier (FEI) Number*

6. Street Address Line 1*

8. City*

5. Establishment D&B DUNS® Number (if applicable)

7. Street Address Line 2 (Apartment, Suite, Building Number)

9. State, Province, or Territory*

10. Country*

11. ZIP or Postal Code*

Update Establishment Owner Information
12. Owner’s Business Identification*

□ Update needed (proceed below)

□ No Update (skip to Owner’s Business Physical Address)

Business Name (Legal Name)*

Does the business entity go by any other name?*

□ Yes, provide alternate business name(s),

tradename(s), doing business as (dba) name(s: _____________________

□ No

Owner Business Headquarter’s FDA-Assigned Facility
Establishment Identifier (FEI) Number (if applicable)

13. Owner’s Business Physical Address*

□ Update Needed (proceed below)

Street Address Line 1*

City*

Owner’s Business Headquarter's D&B DUNS® Number
(if applicable)

□ No Update (skip to Owner’s Business Mailing Address)
Street Address Line 2 (Apartment, Suite, Building Number)

State, Province, or Territory*

Country*

ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip mailing address and proceed to
Owner’s Point of Contact Information.

FORM FDA 3741 (XX/25)

Page 32 of 45

Section VIII – Updates to
Establishment Information

14. Owner’s Business Mailing Address*

□ Update needed (proceed below)

Street Address Line 1*
City*

□ No Update (skip to Owner’s Designated Point of Contact Information)

Street Address Line 2 (Apartment, Suite, Building Number)

State, Province, or Territory*

Country*

ZIP or Postal Code*

15. Owner’s Designated Point of Contact Information*

□ Update Needed (proceed below)

□ No Update (skip to Owner’s Business Structure)

Owner’s Designated Point of Contact (select all that apply)*

□ Is the same as the designated point of contact for the registrant

(provide first and last name and then proceed to owner’s business structure)

□ Is the same as the designated point of contact for the TRLM-NG secondary user
(provide first and last name and then proceed to owner’s business structure)

□ Is the same as the designated point of contact for the establishment

(provide first and last name and then proceed to owner’s business structure)

□ Is not otherwise listed in previous sections (provide information below)

First Name*

Generational Suffix

Middle Initial

Professional Suffix

Last Name*

Position Title*

Business or Tribe Name*

Fax Number

Phone Number (Work)*

Phone Number (Mobile)*

16. Owner’s Business Structure*

□ Update Needed (proceed below)

Email Address*

□ No Update (skip to Key Business Officials)

Select the type of business structure most applicable to the owner’s business (select one)*

17. Provide the indicated information for each key official within the owner’s business structure*

□ Update Needed (proceed below)

□ No Update (skip to Location of Formation of Owner’s Business)

□ Update Needed (proceed below)

□ No Update (skip to Key Business Official #2)

Key Business Official #1
First Name*

Generational Suffix

FORM FDA 3741 (XX/25)

Middle Initial

Professional Suffix

Position Title*

Page 33 of 45

Last Name*

Business or Tribe Name*

Section VIII – Updates to
Establishment Information

Key Business Official #2

□ Update Needed (proceed below)

First Name*

Generational Suffix

□ Update Needed (proceed below)

First Name*

□ Update Needed (proceed below)

First Name*

□ Update Needed (proceed below)

First Name*

Generational Suffix

Position Title*

Middle Initial

Business or Tribe Name*

Last Name*

Position Title*

Business or Tribe Name*

□ No Update (skip to Key Business Official #5)
Middle Initial

Professional Suffix

Key Business Official #5

Last Name*

□ No Update (skip to Key Business Official #4)

Professional Suffix

Key Business Official #4

Generational Suffix

Middle Initial

Professional Suffix

Key Business Official #3

Generational Suffix

□ No Update (skip to Key Business Official #3)

Last Name*

Position Title*

Business or Tribe Name*

□ No Update (skip to Location of Formation of Owner’s Business)
Middle Initial

Professional Suffix

Last Name*

Position Title*

Business or Tribe Name*

18. Location of Formation of Legal Business Entity

□ Update Needed (proceed below)

State of Formation (if in U.S.) (Optional)

□ No Update (skip to Part C – Updates to Establishment Operator Information)
Territory and Country (if outside U.S.) (Optional)

Part C: Updates to Establishment Operator Information
Instructions for Part C – Updates to Establishment Operator Information

Provide updated information if there have been changes to who has management authority in the registered establishment(s).
Operator information, which includes the operator’s name, operator’s designated point of contact information, and operator’s business
structure, will be needed for each updated establishment on the registration. Submit additional sheets for each establishment
operator that needs to be updated.

1. Have there been any changes to the Establishment(s) Operator Information (see Section IV, Part C) since
the last submission? (select one)*

□ Yes – (proceed below to identify which establishment’s operator information has changed and provide the
updated information)

□ No – (skip to Section IX ‒ Updates to Product List Information)
FORM FDA 3741 (XX/25)

Page 34 of 45

Section VIII – Updates to
Establishment Information

Identify the currently registered establishment whose operator information needs to be updated.*
2. Establishment Name (Legal Name)*

3. Does the establishment go by any other name?*

□ Yes, provide alternate business name(s),

tradename(s), doing business as (dba) name(s): ____________________

□ No

4. Establishment FDA-Assigned Facility Establishment
Identifier (FEI) Number*

6. Street Address Line 1*

8. City*

5. Establishment D&B DUNS® Number (if applicable)

7. Street Address Line 2 (Apartment, Suite, Building Number)

9. State, Province, or Territory*

10. Country*

11. ZIP or Postal Code*

Update Establishment Operator Information
12. Operator’s Business Identification*

□ Update Needed (proceed below)

□ No Update (skip to Operator’s Business Physical Address)

Business Name (Legal Name)*

Does the business entity go by any other name?*

□ Yes, provide alternate business name(s), tradename(s),
doing business as (dba) name(s: _____________________

□ No
Operator’s Business Headquarter's FDA-Assigned Facility
Establishment Identifier (FEI) Number (if applicable)

Operator’s Business Headquarter's D&B DUNS® Number
(if applicable)

13. Operator’s Business Physical Address*

□ Update Needed (proceed below)

□ No Update (skip to Operator's Business Mailing Address)

Street Address Line 1*

City*

Street Address Line 2 (Apartment, Suite, Building Number)

State, Province, or Territory*

Country*

ZIP or Postal Code*

□ Select if mailing address is same as physical address. If the same, skip Mailing Address and proceed to
Operator’s Point of Contact Information.

14. Operator’s Business Mailing Address*

□ Update Needed (proceed below)

Street Address Line 1*
City*

FORM FDA 3741 (XX/25)

□ No Update (skip to Operator's Designated Point of Contact Information)

Street Address Line 2 (Apartment, Suite, Building Number)

State, Province, or Territory*

Country*

Page 35 of 45

ZIP or Postal Code*

Section VIII – Updates to
Establishment Information

15. Operator’s Designated Point of Contact Information*

□ Update Needed (proceed below)

□ No Update (skip to Operator’s Business Structure)

Operator's Designated Point of Contact (select all that apply)*

□ Is the same as the designated point of contact for the registrant

(provide first and last name and then proceed to operator’s business structure)

□ Is the same as the designated point of contact for the TRLM-NG secondary user
(provide first and last name and then proceed to operator’s business structure)

□ Is the same as the designated point of contact for the establishment

(provide first and last name and then proceed to operator’s business structure)

□ Is not otherwise listed in previous sections (provide information below)

First Name*

Generational Suffix

Middle Initial

Professional Suffix

Position Title*

Business or Tribe Name*

Phone Number (Work)*

Last Name*

Fax Number

Phone Number (Mobile)*

16. Operator’s Business Structure*

□ Update Needed (proceed below)

Email Address*

□ No Update (skip to Key Business Officials)

Select the type of business structure most applicable to the operator’s business (select one)*

□ Sole Proprietorship (provide information for the individual owner of the operator's business)
□ Partnership (provide information on each partner)
□ Corporation (including limited liability) (enter information on each corporate officer and director)
□ Tribe (enter information on each Tribal Leader/Councilperson)

17. Provide the indicated information for each key official within the operator’s business structure*

□ Update Needed (proceed below)

□ No Update (skip to Location of Formation of Operator's Business)

□ Update Needed (proceed below)

□ No Update (skip to Key Business Official #2)

Key Business Official #1
First Name*

Generational Suffix

Key Business Official #2

Professional Suffix

□ Update needed (proceed below)

First Name*

Generational Suffix

FORM FDA 3741 (XX/25)

Middle Initial

Position Title*

Last Name*

Business or Tribe Name*

□ No Update (skip to Key Business Official #3)
Middle Initial

Professional Suffix

Position Title*

Page 36 of 45

Last Name*

Business or Tribe Name*

Section VIII – Updates to
Establishment Information

Key Business Official #3

□ Update needed (proceed below)

First Name*

Generational Suffix

□ Update needed (proceed below)

First Name*

□ Update needed (proceed below)

First Name*

Last Name*

Position Title*

Business or Tribe Name*

□ No Update (skip to Key Business Official #5)
Middle Initial

Professional Suffix

Key Business Official #5

Generational Suffix

Middle Initial

Professional Suffix

Key Business Official #4

Generational Suffix

□ No Update (skip to Key Business Official #4)

Last Name*

Position Title*

Business or Tribe Name*

□ No Update (skip to Location of Formation of Owner's Business)
Middle Initial

Professional Suffix

Last Name*

Position Title*

Business or Tribe Name*

18. Location of Formation of Legal Business Entity

□ Update needed (proceed below)

State of Formation (if in U.S.) (Optional)

□ No Update (skip to Section IX – Updates to Product List)

Territory and Country (if outside U.S.) (Optional)

SECTION IX – UPDATES TO PRODUCT LIST INFORMATION
Instructions for Section IX

Provide information below on the type of change (i.e., adding new product, updating existing product details, updating product
marketing status, etc.).

1. Have there been any changes to the Product List since the last submission?*

□ Yes – (proceed below to identify changes and provide updated information)
□ No – (skip to Section X – Updates to Material File Information)

2. Since your last submission, are any of the following true (select all that apply)?*

□ Product name, identifiers, or attributes have changed
□ A new product was introduced into commercial distribution
□ A product was removed from commercial distribution (inactivating product)
□ A product was reintroduced into commercial distribution or manufacturing resumed of previously discontinued
product (reactivating product)

□ Product is now associated with another establishment on this same registration
□ Product is now associated with another establishment on a different registration
□ Product manufacturing has transferred to a new manufacturing site
□ Manufacturing of product has ceased, but remaining product is still being distributed by a third party
FORM FDA 3741 (XX/25)

Page 37 of 45

Section IX – Updates to Product
List Information

3. Effective Date of Change (mm/dd/yyyy)*

Fields Impacted*

Value on Last Submission

Updated Value for Current Submission

Product Identification

Product Name

□

Product Name

□

Brand Name/Sub-brand

□

Universal Product Code (UPC)

□

Alternative Industry Product Identification #

□

Product Category

□

Product Subcategory

□

Intent of Use

No Update
Brand Name/Sub-brand

No Update
Universal Product Code (UPC)

No Update
Alternative Industry Product Identification #

No Update
Product Category

No Update
Product Subcategory

No Update
Intent of Use

No Update

Product Attributes
Package Type

Product Attributes

□

Package Type

□

Product Quantity

□

Product Quantity Mass

□

Portion Count

□

Portion Mass

□

Characterizing Flavor

□

Flavor Name (if flavored)

□

Flavor Description (if flavored)

No Update
Product Quantity

No Update
Product Quantity Mass

No Update
Portion Count

No Update
Portion Mass

No Update
Characterizing Flavor

No Update
Flavor Name (if flavored)

No Update
Flavor Description (if flavored)

No Update

FORM FDA 3741 (XX/25)

Page 38 of 45

Section IX – Updates to Product
List Information

Value on Last Submission
Nicotine Concentration

Updated Value for Current Submission

□

Nicotine Concentration

□

Nicotine Source

□

%PG

□

%VG

□

E-Liquid Volume

□

Wattage

□

Battery Capacity

□

Length Description

□

Length (numeric value and units)

□

Width (numeric value and units)

□

Diameter Description

□

Diameter Format

□

Diameter (numeric value and units)

□

Height

□

Portion Thickness

□

Tobacco Cut Style

□

Filter Ventilation

□

# of Hoses

No Update
Nicotine Source

No Update
%PG

No Update
%VG

No Update
E-Liquid Volume

No Update
Wattage

No Update
Battery Capacity

No Update
Length Description

No Update
Length (numeric value and units)

No Update
Width (numeric value and units)

No Update
Diameter Description

No Update
Diameter Format

No Update
Diameter (numeric value and units)

No Update
Height

No Update
Portion Thickness

No Update
Tobacco Cut Style

No Update
Filter Ventilation

No Update
# of Hoses

No Update
FORM FDA 3741 (XX/25)

Page 39 of 45

Section IX – Updates to Product
List Information

Value on Last Submission

Updated Value for Current Submission

Source of Energy

□

Source of Energy

□

Wrapper Material

□

Tip Type

□

Additional Properties

No Update
Wrapper Material

No Update
Tip Type

No Update
Additional Properties

No Update

Associated Establishments

Associated Establishment Name

□

Associated Establishment Name

□

Associated Establishment FEI#

□

Associated Establishment Address

No Update
Associated Establishment FEI#

No Update
Associated Establishment Address

No Update

Manufacturing and Commercial Distribution Status

□

Date Introduced for Commercial Distribution (mm/dd/yyyy)

No Update

Date Introduced for Commercial Distribution
(mm/dd/yyyy)

Product Marketing Authorization

Product Marketing Authorization
Product Name as Appeared on Marketing Authorization or
Exemption

□

Product Name as Appeared on Marketing
Authorization or Exemption

□

STN-PD#

□

If No STN-PD #, Provide Reason

□

Submitter Name

□

Applicant Name

No Update

STN-PD#

No Update
If No STN-PD #, Provide Reason

No Update
Submitter Name

No Update
Applicant Name

No Update

4. Have you ceased manufacturing, but the remaining product is still being distributed by third parties? (optional)

□ Yes (provide information below)
•
•
•

Distributor Name: ____________________
Distributor FEI #: ____________________
Distributor Address: ____________________

FORM FDA 3741 (XX/25)

Page 40 of 45

□ No

Section IX – Updates to Product
List Information

SECTION X – UPDATES TO MATERIAL FILE INFORMATION
Instructions for Section X

Provide information below on the type of change (i.e., adding new material file, updating existing material file details or association,
updating date of dissemination, etc.)

1. Have there been any changes to the Material Files since the last submission?*

□ Yes – (proceed below to identify changes and provide updated information)
□ No – (skip to Section XI – Certification Statement)

2. Select the Material File updates needed (select all that are applicable)*

□ Adding new Material File to existing product
□ Updating Material File for existing product
□ Removing and/or replacing Material File for existing product
□ Adding new Material File for new product
□ Need to update Product – Material File association

3. Effective Date of Change (mm/dd/yyyy)*

Fields Impacted*

Previous Value on Last Submission

Updated Value for Current Submission

Material File Identifiers

Material File Name

□

Material File Name

□

Unique ID or Internal ID Number

□

Date Material File First Disseminated (mm/dd/yyyy)

No Update
Unique ID or Internal ID Number

No Update
Date Material File First Disseminated (mm/dd/yyyy)

No Update

Material File Information
Material File Title

Material File Information

□

Material File Title

□

Material File Description

□

Material File Category

□

Material File Type

□

URL (if digital, social media, or website)

□

Location of Labeling

No Update
Material File Description

No Update
Material File Category

No Update
Material File Type

No Update
URL (if digital, social media, or website)

No Update
Location of Labeling

No Update
FORM FDA 3741 (XX/25)

Page 41 of 45

Section X – Updates to Material
File Information

Previous Value on Last Submission

Updated Value for Current Submission

Submitting a package label plan?

☐ Yes ☐ No

□

Submitting a package label plan?

□

What variables are captured in the product
variation index?

□

Additional Material File Properties

No Update

What variables are captured in the product variation index?

No Update
Additional Material File Properties

☐ Yes ☐ No

No Update

Associated Product Identifiers

Product Name

□

Product Name

□

Universal Product Code (UPC)

□

Alternative Industry Product Identication Number
and Type

No Update
Universal Product Code (UPC)

No Update
Alternative Industry Product Identication Number and Type

No Update

SECTION XI – CERTIFICATION STATEMENT
Certification Statement
The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to
be true and accurate. I agree to update and report changes to this information as required under section 905 of the
Federal Food, Drug, and Cosmetic (FD&C) Act. I certify that this information and the accompanying submission are
true and correct, that no material fact has been omitted, and that I am authorized to submit this on the Registrant’s
behalf. I understand that under section 1001 of title 18 of the United States Code, anyone who knowingly and
willfully makes a materially false, fictitious, or fraudulent statement or representation in any matter within the
jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to
criminal penalties.
☐ Agree*
Warning: A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.
Identity of the Signatory*:
☐ Owner (listed in Section IV, Part B)
☐ Operator (listed in Section IV, Part C)
☐ Authorized Representative (listed in Section III, A or B)
1. Signature and Date (mm/dd/yyyy)*

2. Typed Name and Title*

FORM FDA 3741 (XX/25)

Page 42 of 45

Section XI – Certification Statement

SECTION XII – APPENDICES

Appendix A: Terminology
Terminology
In this form, FDA intends to use the following terminology in implementing the registration and product listing
requirements of section 905 of the FD&C Act.
1.

Authorized Representative: Authorized representative or Authorized agent (for a foreign applicant), who can
provide information related to registration and listing of the subject tobacco product manufacturer including the
name, address, and contact information (including email address).

Commercial Distribution: Commercial distribution means any distribution of a tobacco product, whether domestic
or imported, to consumers or to any person, but does not include interplant transfers of a tobacco product between
establishments within the same parent, subsidiary, and/or affiliate company, nor does it include providing a
tobacco product for product testing where such product is not made available for personal consumption or resale.
“Commercial distribution” does not include the handling or transfer of a tobacco product from one consumer to
another for personal consumption.

Component or part: Means any software or assembly of materials intended or reasonably expected:
(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or
(2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that
is an accessory of a tobacco product.

Contract Manufacturer: Manufactures a finished tobacco product to another establishment’s specifications.

Domestic Establishment: The term “domestic establishment” means an establishment in any State or Territory or
possession of the United States.

Electronic Nicotine Delivery System (ENDS): Refers to an electronic device that delivers e-liquid (liquid nicotine
combined with colorings, flavorings, and/or other ingredients such as propylene glycol (PG) and vegetable glycerin
(VG)) in aerosol form into the mouth and lungs when inhaled, serving as an aerosolizing apparatus. The term may
refer to vapes, vape pens, personal vaporizers, cigalikes, e-pens, e-hookahs, e-cigars, e-pipes, and e-cigarettes.

Establishment: The term “establishment” means a place of business under one ownership at one general physical
location. A single building may house more than one distinct establishment if the establishments are under separate
ownership.

Finished Tobacco Product: The term “finished tobacco product” means a tobacco product, including all
components and parts, sealed in final packaging (e.g., filters or filter tubes sold to consumers separately or as part
of kits) or in the final form in which it is intended to be sold to consumers.

Labeling: The term “labeling,” based on section 201(m) of the FD&C Act (21 U.S.C. 321(m)), means all labels and
other written, printed, or graphic matter (1) upon any tobacco product or any of its containers or wrappers, or (2)
accompanying such tobacco product.

10. Manufacturing: The term “manufacturing” means the manufacture, preparation, compounding, or processing of a
tobacco product, including repackaging or otherwise changing the container, wrapper, or labeling of any tobacco
product package (section 905(a)(1) of the FD&C Act). This term includes the activities of reconstituting and blending
tobacco leaf; testing for quality control and product release; and applying any chemical, additive, or substance to the
tobacco leaf other than potable water in the form of steam or mist. This term excludes the activities of de-stemming,
drying, or packing tobacco leaf; mechanically removing foreign material from tobacco leaves; and humidifying
tobacco leaf with nothing other than potable water in the form of steam or mist.
11. Material File: For any listed tobacco product subject to section 905(i)(1)(A) of the FD&C Act, a material file includes
a reference to the authority for the marketing of such tobacco product and a copy of all labeling for such tobacco
product. For any listed tobacco product subject to section 905(i)(1)(B) of the FD&C Act, a material file includes a
copy of all consumer information and other labeling for such tobacco product and a representative sampling of
advertisements for such tobacco product.
12. Contract Manufacturer: Manufactures a finished tobacco product to another establishment's specifications.
13. Domestic Establishment: The term “domestic establishment” means an establishment in any State or Territory or
possession of the United States.
FORM FDA 3741 (XX/25)

Page 43 of 45

Section XII – Appendices

14. Non-Tobacco Nicotine (NTN): The nicotine in the tobacco product is not made or derived from tobacco, such as
synthetic nicotine.
15. Operator: The term “operator” means a person, as defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e))
who has management authority over an establishment.
16. Owner: The term “owner” means a person, as defined in section 201(e) of the FD&C Act (21 U.S.C. 321(e)) who
has an ownership interest in an establishment.
17. Pouch: The term "pouch" means a permeable pouch, intended to be filled with pre-portioned tobacco product and
placed in the oral cavity with the tobacco product.
18. Product Identifier Number (PD #): The number FDA assigns to each product within a submission to distinguish
among the products included in that submission. PD#’s are only relevant within the context of a specific STN.
19. Registrant: FDA defines “registrant” as any person that registers a tobacco manufacturing facility and submits a
product list for tobacco products commercially marketed in the United States.
20. Retailer: The term “retailer” means any person, government, or entity who sells tobacco products to individuals for
personal consumption, or who operates a facility where self-service displays of tobacco products are permitted.
21. Submission Tracking Number (STN): The number that FDA assigns to submissions that are received from an
applicant, such as a PMTA, supplemental PMTA, SE reports, exemption requests, MRTPAs, and submissions
related to investigational tobacco products.
22. Tobacco-Derived Nicotine (TDN): The nicotine in the tobacco product is derived from tobacco.
23. Tobacco Product: The term “tobacco product” means “any product made or derived from tobacco, or containing
nicotine from any source, that is intended for human consumption, including any component, part, or accessory
of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product).” This term does not include an article that is a drug, a device, a combination
product, or a food if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine,
as defined in the act (section 201(rr) of the FD&C Act (21 U.S.C. 321 (rr); as amended by section 111(a) of the
Consolidated Appropriations Act, 2022 (Pub. L. 117-103)).

Appendix B: Statutory Requirements
FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control
Act) (Public Law 111-31) into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act
(FD&C Act) by, among other things, adding a new chapter granting the U.S. Food and Drug Administration (FDA)
authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health
generally and to reduce tobacco use by minors.
Under section 201(rr) of the FD&C Act, a tobacco product (1) means any product made or derived from tobacco,
or containing nicotine from any source, that is intended for human consumption, including any component, part, or
accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part,
or accessory of a tobacco product); and (2) does not mean an article that is a drug defined under section 201(g)(1) of
the FD&C Act, a device defined under section 201(h) of the FD&C Act, or a combination product described in section
503(g) of the FD&C Act, or a food under section 201(f) of the FD&C Act if it contains no nicotine, or no more than trace
amounts of naturally occurring nicotine.
Generally, to be legally marketed in the United States, the FD&C Act requires “new tobacco products” to have a
premarket authorization order in effect. A “new tobacco product” is any tobacco product that was not commercially
marketed in the United States as of February 15, 2007, or any modified tobacco product that was commercially
marketed after February 15, 2007 (section 910(a) of the FD&C Act). Generally, a marketing authorization order
under section 910(c)(1)(A)(i) of the FD&C Act is required for a new tobacco product unless (1) the manufacturer of
the product submitted a report under section 905(j) of the FD&C Act and FDA issues an order finding the product
substantially equivalent to a predicate tobacco product (section 910(a)(2)(A) of the FD&C Act) or (2) the manufacturer
submitted a report under section 905(j)(1)(A)(ii) of the FD&C Act and all modifications are covered by exemptions from
the requirements of substantial equivalence granted by FDA under section 905(j)(3) of the FD&C Act.
FORM FDA 3741 (XX/25)

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STATUTORY REQUIREMENTS
Section 905 of the FD&C Act describes the requirements for owners and operators of establishments
engaged in the manufacture, preparation, compounding, or processing of tobacco product(s) to register these
establishments and list their tobacco products with FDA.
•

•

Section 905(b) of the FD&C Act requires that “[o]n or before December 31st of each year, every person
who owns or operates any establishment in any State engaged in the manufacture, preparation,
compounding, or processing of a tobacco product or tobacco products shall register with [FDA] the
name, places of business, and all such establishments of that person.”
Section 905(c) of the FD&C Act requires that “[e]very person upon first engaging in the manufacture,
preparation, compounding, or processing of a tobacco product or tobacco products in any establishment
owned or operated in any State by that person shall immediately register with [FDA] that person's name,
place of business, and such establishment.”
Section 905(d) of the FD&C Act requires that “[e]very person required to register under subsection (b)
or (c) shall immediately register with the Secretary any additional establishment which that person owns
or operates in any State and in which that person begins the manufacture, preparation, compounding, or
processing of a tobacco product or tobacco products.”
Section 905(i)(1) of the FD&C Act requires that all registrants under the subsections above “shall, at
the time of registration […] file with [FDA] a list of all tobacco products which are being manufactured,
prepared, compounded, or processed by that person for commercial distribution,” along with certain
accompanying information, such as all consumer information and other labeling.
Section 905(i)(3) of the FD&C Act requires that certain changes in a product list be submitted to FDA
biannually, once during June and once during December.

Appendix C: Additional Resources
1. Family Smoking Prevention and Tobacco Control Act — Family Smoking Prevention and Tobacco
Control Act - An Overview | FDA
2. FDA Registration and Tobacco Product Listing Guidance for Industry — Registration and Product
Listing for Owners and Operators of Domestic Tobacco Product Establishments | FDA
3. Tobacco Registration and Product Listing Module Next Generation (TRLM NG) User Guide —
TRLM NG
4. CTP Guidance Document Search — Guidance Related to Tobacco Products | FDA
5. Reference for the Consolidated Appropriations Act, 2022 — Text - H.R.2471 - 117th Congress (20212022): Consolidated Appropriations Act, 2022 | Congress.gov | Library of Congress
6. Manufacturing Compliance — Manufacturing | FDA
a. See “Register your establishment and submit list of products, labeling and advertisements” section.

FORM FDA 3741 (XX/25)

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Section XII – Appendices

File Type	application/pdf
File Title	Registration and Product Listing of Tobacco Product Manufacturing Establishments
Subject	FDA, Food and Drug Administration, Department of Health and Human Services, Tobacco, Form 3741, Registration, Listing, Owners an
Author	Food and Drug Administration
File Modified	2025-09-09
File Created	2025-09-09