FDA 3741a (Current Registration and Listing for Owners and Operators of Dom

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

REGISTRATION AND LISTING FOR OWNERS
AND OPERATORS OF DOMESTIC TOBACCO
PRODUCT 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. The time required to complete
this information collection is estimated to average 10 - 96 minutes 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.

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
(the act) by, among other things, adding a new chapter granting FDA important new authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce
tobacco use by minors.
Complete the following question and answer form to register your establishment and submit your product listing to
FDA’s Center for Tobacco Products. For additional information on the legislation and guidance document, access the
web links provided on page 11.

STATUTORY REQUIREMENTS
All owners and operators must fulfill the requirements for section 905 of the act, as detailed below. In order to
reduce redundant submissions, FDA strongly encourages owners to register and submit product listing information
for themselves and on behalf of their operators.

Section 905(b) of the act requires that “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 the Secretary the name, places of business, and all such establishments of that person.”
Section 905(i)(1) of the act requires that all registrants “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 labeling.
Section 905(i)(3) of the act requires that certain changes in the product list be submitted biannually, once during
June and once during December.
DEFINITIONS
FDA intends to use the following definitions in implementing the registration and product listing requirements of
section 905 of the act.
1. Commercial Distribution: The term “commercial distribution” includes any distribution of a tobacco product to
consumers or to another person for future manufacturing through sale or otherwise. As examples, it includes
the distribution of a tobacco product as a promotional sample and the delivery of a tobacco product to another
manufacturer for further processing via contract without a change in the formal ownership of the product.
Commercial distribution does not include internal or interplant transfer of a tobacco product between registered
establishments within the same parent, subsidiary, and/or affiliate company and it does not include providing a
tobacco product for product testing in cases where such products are not made available for consumption or
resale.
2. Domestic Establishment: The term “domestic establishment” means an establishment in any State or
Territory or possession of the United States.

FORM FDA 3741a (XX/25)

General Information – Page i

3. 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.
4. Labeling: The term “labeling,” based on section 201(m) of the 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.
5. 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 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. 6.
6. Operator: The term “operator” means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)) who
has management authority over an establishment.
7. Owner: The term “owner” means a person, as defined in section 201(e) of the act (21 U.S.C. 321(e)) who has
an ownership interest in an establishment.
8. 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.
9. 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)).

FORM FDA 3741a (XX/25)

General Information – Page ii

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

REGISTRATION AND LISTING FOR
OWNERS AND OPERATORS OF DOMESTIC DEEMED
TOBACCO PRODUCT ESTABLISHMENTS

Form Approved: 0MB No. 0910-0650
Expiration Date: xx/xx/20xx
(See pa ge i for PRA Statement)

See page 14 for Instructions

Please type. An item followed by an asterisk (*) denotes a required field.

D

D

Check one of the following.*
New Submission and
Update to a Registration
For updates, FDA requests
Product Listing (per
(per 905(b)) (previously
that you also provide your
905(b) and 905(i)(1))
submitted to FDA)
FE/ number or the DUNSr---------- --------Number used in your Identification Number (if update)
original submission.

D

Update to a Product List
(per 905(i)(3)) (previously
submitted to FDA)
--------­

SECTION I - IDENTIFICATION
Please check the appropriate boxes.* (Note that owners and operators may register on behalf of the other party.)
REGISTRATION STATUS

1
2
3
4
5

D
D
D
D
D

Owner registering alone (Complete all sections EXCEPT II/A and /JIB)
Owner registering on behalf of operator (Complete all sections)
Owner who is also operator of all establishments (Complete all sections)
Operator registering alone (Complete all sections EXCEPT /IA and I/BJ
Operator registering on behalf of owner (Complete all sections)

SECTION IIA - REGISTRATION
Owner Information

Owner Name (Name of the Corporation/Partnership or Individual Owner)*
Address*

State, Province or Territory*

City*

Owner Headquarters D&B DUNS Number:

Owner Point of Contact

Title (e.g., Mr., Ms., Dr.):
First/Given Name
Position Title

ZIP or Postal Code*

Country*

I

I

Middle Name

Last Name

Email Address
Telephone (Include Country Code if applicable)

FORM FDA 3741a (xx/25)

FAX

Page1

I

SECTION 11B - REGISTRATION
Owner Business Structure

Select the type of business structure (Sole Proprietorship, Partnership, or Corporation) and provide indicated
information.* (Continuation sheets may be used if necessary.)

D

Sole Proprietorship (Enter owner name)

D

Partnership (Enter name of each partner)

1.
2.
3.
4.

5.
6.

D

Corporation (Enter the name of each corporate officer and director)

1.
2.
3.
4.
5.
6.

Identify State of incorporation.

Please describe further. (If applicable, give name of country if incorporation made
outside U.S.)

If the owner does business by any other name, please list all such names.
1.

2.

3.

4.

FORM FDA 3741a (xx/25)

Page2

SECTION IIIA - REGISTRATION
Operator Information

Multiple copies of this page may be submitted if you are registering on behalf of multiple operators.
Operator Name*

Address*
City*

I

Operator D&B DUNS Number:

Title (e.g., Mr., Ms., Dr.):
First/Given Name

Position Title

Operator Point of Contact

I

Middle Name

I

Email Address

Last Name

FAX

Telephone (Include Country Code if applicable)

FORM FDA 3741a (xx/25)

ZIP Code"
I

State•

Page3

SECTION 111B - REGISTRATION
Operator Business Structure
Select the type of business structure (Sole Proprietorship, Partnership, or Corporation) and provide indicated
information.* (Continuation sheets may be used if necessary. Multiple copies of this page may be submitted if you are

re gistering on behalf of multiple operators.)

D

Sole Proprietorship (Enter operator name)

D

Partnership (Enter name of each partner)

1.
2.
3.
4.
5.
6.

D
1.

Corporation (Enter the name of each corporate officer and director)

2.
3.
4.
5.
6.

Identify State of incorporation.

Please describe further. (If applicable, give name of country if incorporation made
outside U.S.)

If the operator does business by any other name, please list all such names.
1.

2.

3.

4.

FORM FDA 3741a (xx/25)

Page4

SECTION IV - REGISTRATION
Establishment Information

Enter contact and registration information for each establishment being registered. (Multiple copies of this page
may be submitted.)
Establishment Name*

Address*
City*

I

Establishment D&B DUNS Number:

State•

ZIP Code"
I

Is this establishment an Electronic Nicotine Delivery System (ENDS) Retail Establishment?

D

Yes

D
D
D

Blending

D

No

Operation (Check all that apply)
Manufacturing
Reconstituting

Title (e.g., Mr., Ms., Dr):
First/Given Name
Position Title

D
D
D

Packaging

D
D
D

Labeling

Saucing (or casing)

Testing

Other (Specify):

Establishment Point of Contact

I

Middle Name

I

Email Address

Page5

------------

Last Name

FAX

Telephone (Include Country Code if applicable)

FORM FDA 3741a (xx/25)

Storing

SECTION V - DEEMED TOBACCO PRODUCT LISTING
Sections V should be completed for each product listed. (Multiple copies of pages 6 through 8 may be submitted.)

1. Product Name* (i.e., brand/sub-brand or other commercial name used in commercial distibution - e.g., Acme E-Cig or
Acme Cigar)

2. Product Identification Number (Must be provided if needed to uniquely identify the product)
3. Type of Product Identification Number (Check only one)
Item/Catalog Number

□ SKU Number
□ UPC Number
D

4. Intended Use of Product (Check one)*

D

Consumer Use (Go to question 5)

D

Further Manufacturing Use (Skip to question 6)

5. Consumer Use Product Category (Check applicable, then skip to question 7)*
Cigar
D Waterpipe Tobacco Diffuser
D Cigar Tobacco
D Waterpipe Tobacco Flavor
Enhancer
Cigar

□

D Other (Specify below)

Cigar Component or Part
D Cigar Filter
D Cigar Paper

□ Cigar Tip

D Cigar Tipping Paper
D Cigar Wrapper
D Other (Specify below)

Pipe Tobacco
D Pipe Tobacco

D Pipe Tobacco Kit
D Other (Specify below)

Waterpipe Tobacco
D Waterpipe Tobacco

D Other (Specify below)

Waterpipe Tobacco Component or
Part

D Waterpipe Tobacco Base
D Waterpipe Tobacco Bowl
D Waterpipe Tobacco Cinder

FORM FDA 3741a (xx/25)

D
D
D
D
D

Waterpipe Tobacco Foil/Screen

D
D
D
D

Waterpipe Tobacco Mouthpiece

D

Other (Specify below)

Waterpipe Tobacco Gasket

Waterpipe Tobacco Grommet

Waterpipe Tobacco Hose
Waterpipe Tobacco Hose
Cooling Attachment

Waterpipe Tobacco Valve
Waterpipe Tobacco Stem

Waterpipe Tobacco Filtration
Base Additives

Electronic Nicotine Delivery
System
ENDS Open (Select from list)

ENDS Closed (Select from list)

Electronic Nicotine Delivery
System Component or Part
E-Liquid

□
□ ENDS Adapter
D

ENDS Atomizer

Page6

□ ENDS Battery
□ ENDS Bridge
□ ENDS Cartomizer
□ ENDS Cartridge
□ ENDS Charger
□ ENDS Clearomizer
□ ENDS Coil
□ ENDS Digital Display/Lights
□ ENDS Drip Tip
□ ENDS Drip Well
□ ENDS Filler Material
□ ENDS Filter
□ ENDS Mouthpiece
□ ENDS Software
□ ENDS Tank
D

Other (Specify below)

D Other (Specify below)

6. Further Manufacturing Use Product Category (Check applicable)*
Cigar
D Cigar Tobacco

□ Cigar

D Other (Specify below)
Cigar Component or Part
D Cigar Filter
D Cigar Paper

□ Cigar Tip

D Cigar Tipping Paper
D Cigar Wrapper
D Other (Specify below)
Pipe Tobacco
D Pipe Tobacco

D Pipe Tobacco Kit
D Other (Specify below)

Waterpipe Tobacco
D Waterpipe Tobacco

D Other (Specify below)

Waterpipe Tobacco Component or
Part

D Waterpipe Tobacco Base
D Waterpipe Tobacco Bowl
D Waterpipe Tobacco Cinder

D Waterpipe Tobacco Diffuser
D Waterpipe Tobacco Flavor
Enhancer

D Waterpipe Tobacco Foil/Screen
D Waterpipe Tobacco Gasket
D Waterpipe Tobacco Grommet
D Waterpipe Tobacco Hose
D Waterpipe Tobacco Hose
Cooling Attachment

D Waterpipe Tobacco Mouthpiece
D Waterpipe Tobacco Valve
D Waterpipe Tobacco Stem
D Waterpipe Tobacco Filtration
Base Additives

D Other (Specify below)
Electronic Nicotine Delivery
System
ENDS Open (Select from list)

□ ENDS Battery
□ ENDS Bridge
D ENDS Cartomizer
□ ENDS Cartridge
□ ENDS Charger
D ENDS Clearomizer
□ ENDS Coil
□ ENDS Digital Display/Lights
□ ENDS Drip Tip
0 ENDS Drip Well
□ ENDS Filler Material
□ ENDS Filter
□ ENDS Mouthpiece
□ ENDS Software
□ ENDS Tank
D

Other (Specify below)

D Other (Specify below)

ENDS Closed (Select from list)
Electronic Nicotine Delivery
System Component or Part
E-Liquid

□
□ ENDS Adapter
D

ENDS Atomizer

7. Flavor (Check applicable)

D
D

D None
Menthol
Other (Specify): ===============
=

8. If submission is an Update to a Product List (per 905(i) (3)) (previously submitted to FDA) (Make applicable entries)
If known, enter the FDA-assigned tracking number (e.g., TP!NfJtiliff!ff) for your tobacco product.
If your product has been introduced to market, discontinued or reintroduced since your last product listing,
indicate the most recent change.*
Provide the appropriate date:*

FORM FDA 3741a (xx/25)

Page7

9. Advertising (A representative sampling of advertising may be required. Please see the guidance document, Section

IV.C.2. for additional details. Representative samples, appropriately identified, are to be submitted with this form. For
each advertisement, we request that you provide the following optional information below. You may use Appendix A as
a continuation sheet if needed.)

9a. Type of Advertising Material
(e.g., magazine ad)

9c. Unique ID or
Internal ID Number

9b. Title

9d. Date First
Disseminated (mmldd/yyyyJ

1 0. Labeling* (All labeling, appropriately identified, is to be submitted with this form. For each item of labeling, we request

that you provide the following optional information below. You may use Appendix Bas a continuation sheet if needed.)

1 0a. Universal Product Code(s) (UPC)
1Ob. Type of Labeling Material
(e.g., package label)

1Od. Unique ID or
Internal ID Number

10c. Title

1Oe. Date First
Disseminated (mmldd/yyyy)

1 1 . Consumer Information (Consumer information may be required. Please see the guidance document, Section
IV. C.2. for additional details. All consumer information, appropriately identified, is to be submitted with this form. For

each item, we request that you provide the following optional information below. You may use Appendix C as a
continuation sheet if needed.)

11a. Type of Consumer
Information (e.g., consumer brochure)

FORM FDA 3741a (xx/25)

11c. Unique ID or
Internal ID Number

11b. Title

Page8

11d. Date First
Disseminated (mmldd/yyyy)

I

SECTION VI - CONFIRMATION 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 report changes to this
information as required under section 905(i)(3) of the act.
WARNING:
A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.

Signature of Responsible Person or Agent

Typed Name and Title

D
Date

Identity of the Signatory

D
D
D

Owner (Listed in section /IA)

Operator (Listed in section I/IA)

Authorized Agent (Complete section below)

Title (e.g., Mr., Ms., Dr.):
First/Given Name
Position Title

Authorized Agent Contact Information

I

Middle Name

I

Email Address

Last Name

Telephone (Include Country Code if applicable)

FAX

Address

City

Company Name

State, Province or Territory

FORM FDA 3741a (xx/25)

Country

ZIP or Postal Code

Page9

Agree

REFERENCES
Reference for the Tobacco Control Act:
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-preventionand-tobacco-control-act-table-contents
Reference for Guidance on Registration and Product Listing for Owners and Operators of
Domestic Tobacco Prod
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-andproduct-listing-owners-and-operators-domestic-tobacco-product-establishments
For regulatory questions regarding sections 904 and 905 of the act,
email TobaccolndustryQuestions@fda.hhs.gov .
Regulatory Submissions can be mailed to:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

FORM FDA 3741a (xx/25)

Page10

APPENDIX A - ADVERTISING
Continuation Sheet

Enter information below for a representative sample of advertising. (See Section V for details.)
Product Identification Number

Product Name

Type of Advertising Material
(e.g., magazine ad)

FORM FDA 3741a (xx/25)

Unique ID or
Internal ID Number

Title

Page11

Date First Disseminated
(mmlddlyyyy)

APPENDIX B - LABELING
Continuation Sheet

Enter labeling information below. * (See Section V for details.)

Product Identification Number

Product Name

Universal Product Code(s) (UPC):
Type of Labeling Material
(e.g., package label)

FORM FDA 3741a (xx/25)

Unique ID or
Internal I D Number

Title

Page12

Date First Disseminated
(mmlddlyyyy)

APPENDIX C - CONSUMER INFORMATION
Continuation Sheet

Enter consumer information below. (See Sec tion V for details.)
P rod uct N ame

Type of Consumer Information
(e.g., consumer brochure)

FORM FDA 3741a (xx/25)

Prod uct Identification N u mber

Unique ID or
Internal I D Number

Title

Page13

Date First Disseminated
(mmlddlyyyy)

I NSTRUCTIONS
Section I
• I f you check box 1, complete all sections except I I IA and 1 1 1 8.
• I f you check box 2, complete all sections.
• I f you check box 3, complete all sections.
• I f you check box 4, complete all sections except I IA and 1 1 8.
• I f you check box 5, complete all sections.
Section IIA
Provide all required information for the Owner. FDA requests that you also provide a point of contact, to facilitate
communication between the Owner and FDA. I f an Operator is registering alone, the Operator may skip Sections
I IA and 1 1 8.
Section 118
Owners must provide the specified details for their business structure. Only one business structure should be
selected. I f an Owner uses any trade names to conduct business other than the company name identified in
Section I IA, FDA requests that such names be listed here.
Section IIIA
Provide all required information for the Operator. FDA requests that you also provide a point of contact, to
facilitate communication between the Operator and FDA. Owners registering alone may skip Sections I I IA and
1 1 1 8. I f you an Owner or Operator registering on behalf of multiple Operators, you must submit a separate I I IA and
1 1 1 8 for each Operator.
Section 1118
Operators must provide the specified details for their business structure. Only one business structure should be
selected. I f an Operator uses any trade names to conduct business other than the company name identified in
Section I I IA, FDA requests that such names be listed here.
Section IV
Provide all required information for each Establishment. FDA requests that you also provide a point of contact, to
facilitate communication between the Establishment and FDA. The contact person for a given Establishment
does not need to be the Operator, but should be an individual authorized to communicate with FDA. Owners and
Operators must register and submit a separate Section IV for each Establishment they own or operate. I f you are
an Operator registering on behalf of an Owner, you must complete a separate Section IV for each Establishment
owned by that Owner, even if you are not the Operator of all of the Establishments.
Section V
This section applies to each product manufactured by the registrant. I f an Owner or Operator intends to list
multiple products, multiple copies of Section V may be submitted. I f additional space is needed for submission
of advertising information, registrants may use Appendix A to identify additional items of advertising submitted
per product. I f additional space is needed for submission of labeling information, registrants may use Appendix
8 to identify additional items of labeling submitted per product. I f additional space is needed for submission of
consumer information, registrants may use Appendix C to identify additional items of consumer information
submitted per product.
Section VI
Registration and listing information may be submitted only by an owner, operator, or authorized agent thereof. I f
an agent has been authorized to submit registration and listing information, FDA requests that contact information
for that agent be entered in this section.

FORM FDA 3741a (xx/25)

Page14