FDA 3471 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: 6/30/2019
(See page 11 for PRA Statement)

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.
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.
(Continued on next page)
FORM FDA 3741 (6/16)

Page 1

PSC Publishing Services (301) 443-6740

EF

DEFINITIONS (Continued)
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. 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 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)"
(section 201(rr) of the act (21 U.S.C. 321 (rr)). This term does not include an article that is a drug, a device, or a
combination product as defined in the act (section 201(rr) of the act (21 U.S.C. 321 (rr)). Thus, the term is not
limited to products containing tobacco, but also includes components, parts and accessories of tobacco products,
whether they are sold for further manufacturing or are ready for consumer use. For example, tobacco papers and
filters are tobacco products, whether they are sold to consumers for use with roll-your-own tobacco or are sold
for further manufacturing into a product sold to a consumer, such as a cigarette.

FORM FDA 3741 (6/16)

Page 2

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: 6/30/2019
(See page 11 for PRA Statement)

See page 15 for Instructions

Please type. An item followed by an asterisk (*) denotes a required field.
Check one of the following.*
For updates, FDA requests
that you also provide your
FEI number or the DUNS
Number used in your
original submission.

New Submission and
Product Listing (per
905(b) and 905(i)(1))

Update to a Registration
(per 905(b)) (previously
submitted to FDA)

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

Identification Number (If update)

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

1

Owner registering alone (Complete all sections EXCEPT IIIA and IIIB)

2

Owner registering on behalf of operator (Complete all sections)

3

Owner who is also operator of all establishments (Complete all sections)

4

Operator registering alone (Complete all sections EXCEPT IIA and IIB)

5

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*

Country*

ZIP or Postal Code*

Owner Headquarters D&B DUNS Number:
Owner Point of Contact
Title (e.g., Mr., Ms., Dr.):
First/Given Name

Middle Name

Last Name

Position Title
Email Address
FAX

Telephone (Include Country Code if applicable)

FORM FDA 3741 (6/16)

Page 3

SECTION IIB - 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.)
Sole Proprietorship (Enter owner name)

Partnership (Enter name of each partner)
1.
2.
3.
4.
5.
6.
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 3741 (6/16)

Page 4

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*

State*

ZIP Code*

Operator D&B DUNS Number:
Operator Point of Contact
Title (e.g., Mr., Ms., Dr.):
First/Given Name

Middle Name

Last Name

Position Title
Email Address
FAX

Telephone (Include Country Code if applicable)

FORM FDA 3741 (6/16)

Page 5

SECTION IIIB - 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
registering on behalf of multiple operators.)
Sole Proprietorship (Enter operator name)

Partnership (Enter name of each partner)
1.
2.
3.
4.
5.
6.
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 operator does business by any other name, please list all such names.
1.

2.

3.

4.

FORM FDA 3741 (6/16)

Page 6

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*

State*

ZIP Code*

Establishment D&B DUNS Number:
Operation (Check all that apply)
Blending

Packaging

Storing

Manufacturing

Labeling

Testing

Reconstituting Tobacco

Saucing (or casing)

Other (Specify):

Establishment Point of Contact
Title (e.g., Mr., Ms., Dr.):
First/Given Name

Middle Name

Last Name

Position Title
Email Address
FAX

Telephone (Include Country Code if applicable)

FORM FDA 3741 (6/16)

Page 7

SECTION V - PRODUCT LISTING
Section V should be completed for each product listed. (Multiple copies of pages 8 and 9 may be submitted.)
1. Product Name* (i.e., brand/sub-brand or other commercial name used in commercial distribution - e.g., Acme Blue
100's or Acme Reconstituted Tobacco #202)
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
4. Intended Use of Product (Check one)*
Consumer Use (Go to question 5)

Further Manufacturing Use (Skip to question 6)

5. Consumer Use Product Category (Check applicable, then skip to question 7)*
Cigarettes

Roll-Your-Own Tobacco

Dry Snuff

Chewing Tobacco

Roll-Your-Own Paper

Moist Snuff

Dissolvables

Roll-Your-Own Filters

Snus

Accessory Filters

Other (Specify):

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

Pouch for Portioned Tobacco

Paper

Additive

Filters

Other (Specify):

7. Flavor (Check applicable)
Menthol

None

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#######) 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 3741 (6/16)

Page 8

9. Advertising (A representative sampling of advertising may be required. Please see the guidance document, Section
III.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 (mm/dd/yyyy)

10. 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 B as a continuation sheet if needed.)
10a. Universal Product Code(s) (UPC)
10b. Type of Labeling
Material (e.g., package label)

10d. Unique ID or
Internal ID Number

10c. Title

10e. Date First
Disseminated (mm/dd/yyyy)

11. Consumer Information (Consumer information may be required. Please see the guidance document, Section III.
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 3741 (6/16)

11c. Unique ID or
Internal ID Number

11b. Title

Page 9

11d. Date First
Disseminated (mm/dd/yyyy)

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.

Agree

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

Date

Identity of the Signatory
Owner (Listed in section IIA)
Operator (Listed in section IIIA)
Authorized Agent (Complete section below)
Authorized Agent Contact Information
Title (e.g., Mr., Ms., Dr.):
First/Given Name

Middle Name

Last Name

Position Title
Email Address
FAX

Telephone (Include Country Code if applicable)
Company Name
Address

State, Province or Territory

FORM FDA 3741 (6/16)

City

Country

ZIP or Postal Code

Page 10

REFERENCES

Reference for the Tobacco Control Act:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm
Reference for Guidance on Registration and Product Listing for Owners and Operators
of Domestic Tobacco Product Establishments:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm281147.htm

For regulatory questions 904 and 905 of act, email [email protected]. 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

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL BELOW.*

The burden time for this collection of information is estimated to average 3.75 hours per response, including the time to
review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection
of information. Send comments regarding this burden estimate or any other aspect of this information collection, including
suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Operations
Paperwork Reduction Act (PRA) Staff
[email protected]
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number."

FORM FDA 3741 (6/16)

Page 11

APPENDIX A - ADVERTISING
Continuation Sheet
Enter information below for a representative sample of advertising. (See Section V for details.)
Product Name

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

FORM FDA 3741 (6/16)

Product Identification Number

Unique ID or
Internal ID Number

Title

Page 12

Date First Disseminated
(mm/dd/yyyy)

APPENDIX B - LABELING
Continuation Sheet
Enter labeling information below.* (See Section V for details.)
Product Name

Product Identification Number

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

FORM FDA 3741 (6/16)

Unique ID or
Internal ID Number

Title

Page 13

Date First Disseminated
(mm/dd/yyyy)

APPENDIX C - CONSUMER INFORMATION
Continuation Sheet
Enter consumer information below. (See Section V for details.)
Product Identication Number

Product Name

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

FORM FDA 3741 (6/16)

Unique ID or
Internal ID Number

Title

Page 14

Date First Disseminated
(mm/dd/yyyy)

INSTRUCTIONS
Section I
If you check box 1, complete all sections except IIIA and IIIB.
If you check box 2, complete all sections.
If you check box 3, complete all sections.
If you check box 4, complete all sections except IIA and IIB.
If 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. If an Operator is registering alone, the Operator may skip Sections
IIA and IIB.
Section IIB
Owners must provide the specified details for their business structure. Only one business structure should be
selected. If an Owner uses any trade names to conduct business other than the company name identified in
Section IIA, 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 IIIA and
IIIB. If you are an Owner or Operator registering on behalf of multiple Operators, you must submit a separate IIIA
and IIIB for each Operator.
Section IIIB
Operators must provide the specified details for their business structure. Only one business structure should be
selected. If an Operator uses any trade names to conduct business other than the company name identified in
Section IIIA, 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. If 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. If an Owner or Operator intends to list
multiple products, multiple copies of Section V may be submitted. If additional space is needed for submission of
advertising information, registrants may use Appendix A to identify additional items of advertising submitted per
product. If additional space is needed for submission of labeling information, registrants may use Appendix B to
identify additional items of labeling submitted per product. If 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. If
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 3741 (6/16)

Page 15