DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

Food and Drug Administration 

REGISTRATION AND LISTING FOR 

OWNERS AND OPERATORS OF DOMESTIC TOBACCO 

PRODUCT ESTABLISHMENTS 

Form Approved: 0MB No. 0910-0650 

Expiration Date: 10/31/2025

(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) 

Page 1 PSC Publishing Services (301) 443-6740 EF 

DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

Food and Drug Administration 

REGISTRATION AND LISTING FOR 

OWNERS AND OPERATORS OF DOMESTIC TOBACCO 

PRODUCT ESTABLISHMENTS 

Form Approved: 0MB No. 0910-0650 

Expiration Date: 10/31/2025

(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) 

Page 1 PSC Publishing Services (301) 443-6740 EF 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

REGISTRATION AND LISTING FOR 

OWNERS AND OPERATORS OF DOMESTIC TOBACCO 

PRODUCT ESTABLISHMENTS 

Form Approved: 0MB No. 0910-0650 

Expiration Date: 9/30/2022 

(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 (3/20) Page 1 FORM FDA 3741 (9/23) 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 (9/23) Page 2 

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 (3/20) Page 2 
DEPARTMENT OF HEAL TH AND HUMAN SERVICES 

Food and Drug Administration 

Form Approved: 0MB No. 0910-0650 

Expiration Date: 10/31/2025 

(See page 11 for PRA Statement) REGISTRATION AND LISTING FOR 

OWNERS AND OPERATORS OF DOMESTIC TOBACCO 

PRODUCT ESTABLISHMENTS 

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 

FE/ number or the DUNS 

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) 

Number used in your Identification Number (If update) 

original submission. 

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 1118) 

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 /IA and 118) 

5 Operator registering on behalf of owner (Complete all sections) 

SECTION - REGISTRATION

Owner Information 

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

Address* City* 

IIAHA

State, Province, or Territory* Country* ZIP or Postal Code* 

Owner Headquarters' D&B DUNS Number: 

Owner Point of Contact 

Title (e.g., Mr., Ms., Dr.): 

First/Given Name I

Middle Name I

Last Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (9/23) Page 3 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

Food and Drug Administration 

Form Approved: 0MB No. 0910-0650 

Expiration Date: 9/30/2022 

(See page 11 for PRA Statement) REGISTRATION AND LISTING FOR 

OWNERS AND OPERATORS OF DOMESTIC TOBACCO 

PRODUCT ESTABLISHMENTS 

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 

FE/ number or the DUNS 

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) 

Number used in your Identification Number (If update) 

original submission. 

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 II/A and 1/IB) 

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 /IA and 1/B) 

5 Operator registering on behalf of owner (Complete all sections) 

SECTION - REGISTRATION 

Owner Information 

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

Address* City* 

State, Province or Territory* Country* ZIP or Postal Code* 

Owner Headquarters D&B DUNS Number: 

Owner Point of Contact 

Title (e.g., Mr., Ms., Dr.): 

First/Given Name I MKJdle Name I Last Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (3/20) Page3 
SECTION 118 - 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 (9/23) Page 4 

SECTION 11B - REGISTRATION 

Owner Business Structure 

Select the type of business structure (Sale 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 (3/20) Page4 
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

State• [ZIP Code" 

Operator D&B DUNS Number: 

Operator Point of Contact 

Title (e.g., Mr., Ms., Dr.): 

First/Given Name I

Middle Name ILast Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (9/23) Page 5 

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 State• I

ZIP Code" 

Operator D&B DUNS Number: 

Operator Point of Contact 

Title (e.g., Mr., Ms., Dr.): 

FirsUGiven Name I Middle Name I Last Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (3/20) Page 5 
SECTION 1118 - 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 (9/23) Page6 

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 

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 (3/20) 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* 

Establishment D&B DUNS Number: 

Operation (Check all that apply) 

Blending 

Manufacturing 

Reconstituting Tobacco 

Title (e.g., Mr., Ms., Dr.): 

First/Given Name 

Position Title 

Email Address 

Packaging 

Labeling 

Saucing (or casing) 

I State• 

Storing 

Testing 

'ZIP Code" 

Other (Specify): ___________ _ 

Establishment Point of Contact 

I

Middle Name '

Last Name 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (9/23) Page 7 

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* 

Establishment D&B DUNS Number: 

Operation (Check all that apply) 

Blending 

Manufacturing 

Reconstituting Tobacco 

Title (e.g., Mr., Ms., Dr.): 

FirsUGiven Name 

Position Title 

Email Address 

Packaging 

Labeling 

Saucing (or casing) 

I State• 

Storing 

Testing 

[

ZIP Code" 

Other (Specify): ____________ 

Establishment Point of Contact 

I

Middle Name [Last Name 

Telephone (Include Country Code if applicable) FAX 

FORM FDA 3741 (3/20) 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

1 00'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)*

Roll-Your-Own Tobacco

Roll-Your-Own Paper

Roll-Your-Own Filters

Dry Snuff

Moist Snuff

Snus

Cigarettes

Chewing Tobacco

Dissolvables

Accessory Filters Other (Specify): ________________ _ 

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

Tobacco

Paper

Filters

7. Flavor (Check applicable) 

Menthol None 

Pouch for Portioned Tobacco

Additive

Other (Specify): ________________ _ 

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. , TPlffl#lf!fifl!) 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:* 

Page 8 

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

1 00'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)*

Roll-Your-Own Tobacco

Roll-Your-Own Paper

Roll-Your-Own Filters

Dry Snuff

Moist Snuff

Snus

Cigarettes

Chewing Tobacco

Dissolvables

Accessory Filters Other (Specify): ________________ _ 

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

Tobacco

Paper

Filters

7. Flavor (Check applicable) 

Menthol None 

Pouch for Portioned Tobacco

Additive

Other (Specify): ________________ _ 

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. , TPlffl#lf!fifl!) 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:* 

Page 8 

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

1 00'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)*

Roll-Your-Own Tobacco

Roll-Your-Own Paper

Roll-Your-Own Filters

Dry Snuff

Moist Snuff

Snus

Cigarettes

Chewing Tobacco

Dissolvables

Accessory Filters Other (Specify): ________________ _ 

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

Tobacco

Paper

Filters

7. Flavor (Check applicable) 

Menthol None 

Pouch for Portioned Tobacco

Additive

Other (Specify): ________________ _ 

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. , TPlffl#lf!fifl!) 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:* 

Page 8 

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

1 00'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)*

Roll-Your-Own Tobacco

Roll-Your-Own Paper

Roll-Your-Own Filters

Dry Snuff

Moist Snuff

Snus

Cigarettes

Chewing Tobacco

Dissolvables

Accessory Filters Other (Specify): ________________ _ 

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

Tobacco

Paper

Filters

7. Flavor (Check applicable) 

Menthol None 

Pouch for Portioned Tobacco

Additive

Other (Specify): ________________ _ 

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. , TPlffl#lf!fifl!) 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:* 

Page 8 

SECTION V - PRODUCT LISTING 

Section V should be completed far 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 

1 00'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)* 

Roll-Your-Own Tobacco 

Roll-Your-Own Paper 

Roll-Your-Own Filters 

Dry Snuff 

Moist Snuff 

Snus 

Cigarettes 

Chewing Tobacco 

Dissolvables 

Accessory Filters Other (Specify): _________________ 

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

Tobacco 

Paper 

Filters 

7. Flavor (Check applicable) 

Menthol None 

Pouch for Portioned Tobacco 

Additive 

Other (Specify): _________________ 

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##fffflfffl/:) 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 (9/23) FORM FDA 3741 (3/20) Page 8 
9. Advertising (A representative sampling of advertising may be required. Please see the guidance document, Section

Ill. 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 9b. Title 9c. Unique ID or 9d. Date First 

(e.g., magazine ad) Internal ID Number Disseminated (mmlddlyyyy) 

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 B as a continuation sheet if needed.) 

1 Oa. Universal Product Code(s) (UPC) 

1 Ob. Type of Labeling 10c. Title 1 Od. Unique ID or 1 Oe. Date First 

Material (e.g., package label) Internal ID Number Disseminated (mmldd/yyyy) 

1 1. Consumer Information (Consumer information may be required. Please see the guidance document, Section Ill. 

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.) 

11 a. Type of Consumer 11b. Title 11 c. Unique ID or 11 d. Date First 

Information (e.g., consumer brochure) Internal ID Number Disseminated (mmlddlyyyy) 

FORM FDA 3741 (9/23) Page 9 

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

Ill. 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 9b. Title 9c. Unique ID or 9d. Date First 

(e.g., magazine ad) Internal ID Number Disseminated (mmldd/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 Bas a continuation sheet if needed.) 

1 Oa. Universal Product Code(s) (UPC) 

1 Ob. Type of Labeling 10c. Title 1 Od. Unique ID or 1 Oe. Date First 

Material (e.g., package label) Internal ID Number Disseminated (mmlddlyyyy) 

11. Consumer Information (Consumer information may be required. Please see the guidance document, Section Ill. 

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 11b. Title 11c. Unique ID or 11d. Date First 

Information (e g , consumer brochure) Internal ID Number Disseminated (mmlddlyyyy) 

FORM FDA 3741 (3120) Page9 
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 

Identity of the Signatory 

Owner (Listed in section /IA) 

Operator (Listed in section II/A) 

Typed Name and Title 

Authorized Agent (Complete section below) 

Authorized Agent Contact Information 

Title (e.g., Mr., Ms., Dr.): 

First/Given Name I Middle Name I Last Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

Company Name 

Address City 

State, Province, or Territory Country 

FORM FDA 3741 (9/23) Page 10 

Date (mm/dd/yyyy)

ZIP or Postal Code 

I 

Agree 

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 

Identity of the Signatory 

Owner (Listed in section /IA) 

Operator (Listed in section II/A) 

Typed Name and Title 

Authorized Agent (Complete section below) 

Authorized Agent Contact Information 

Title (e.g., Mr., Ms., Dr.): 

FirsUGiven Name IMiddle Name I Last Name 

Position Title 

Email Address 

Telephone (Include Country Code if applicable) FAX 

Company Name 

Address City 

State, Province or Territory Country 

FORM FDA 3741 (3/20) Page 10 

Date 

ZIP or Postal Code 

I 

Agree 
REFERENCES 

For regulatory questions 904 and 905 of act, email TobaccoindustzyOuestions@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 

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 

PRAStaff@fda.hhs.gov 

"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 0MB control number. " 

FORM FDA 3741 (9/23) Page 11 

REFERENCES 

Reference for the Tobacco Control Act: 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatorylnformation/ucm298595.htm 

Reference for Guidance on Registration and Product Listing for Owners and Operators 

of Domestic Tobacco Product Establishments: 

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatorylnformation/ucm281147.htm 

For regulatory questions 904 and 905 of act, email TobaccoindustryOuestions@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 

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 

PRAStaff@fda.hhs.gov 

"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 0MB control number. " 

FORM FDA 3741 (3/20) Page 11 

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 Product Establishments: 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/registration-andproduct-listing-owners-and-operators-domestic-tobacco-product-establishments
APPENDIX A - ADVERTISING

Continuation Sheet 

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

Product Name Product Identification Number 

Type of Advertising Material Title Unique ID or Date First Disseminated 

(e.g., magazine ad) Internal ID Number (mmldd/yyyy) 

FORM FDA 3741 (9/23) Page 12 

APPENDIX A - ADVERTISING 

Continuation Sheet 

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

Product Name Product Identification Number 

Type of Advertising Material Title Unique ID or Date First Disseminated 

(e.g., magazine ad) Internal ID Number (mmldd/yyyy) 

FORM FDA 3741 (3/20) Page 12 
APPENDIX 8 - 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 Title Unique ID or 

(e.g., package label) Internal ID Number 

FORM FDA 3741 (9/23) Page 13 

Date First Disseminated 

(mmldd/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 Title Unique ID or 

(e.g., package label) Internal ID Number 

FORM FDA 3741 (3/20) Page 13 

Date First Disseminated 

(mmldd/yyyy) 
APPENDIX C - CONSUMER INFORMATION

Continuation Sheet 

Enter consumer information below. (See Section V for details.) 

Product Name Product ldentication Number 

Type of Consumer Information Title Unique ID or 

(e.g. , consumer brochure) Internal ID Number 

FORM FDA 3741 (9/23) Page 14 

Date First Disseminated 

(mmldd/yyyy) 

APPENDIX C - CONSUMER INFORMATION 

Continuation Sheet 

Enter consumer information below. (See Section V for details.) 

Product Name Product ldent1cat1on Number 

Type of Consumer Information Title Unique ID or 

(e.g., consumer brochure) Internal ID Number 

FORM FDA 3741 (3/20) Page 14 

Date First Disseminated 

(mmldd/yyyy) 
INSTRUCTIONS 

Section I 

• If you check box 1, complete all sections except IIIA and 111B. 

• 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 11B. 

• 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 

I IA and 11B. 

Section 118 

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 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 IIIA and 

111B. If you are an Owner or Operator registering on behalf of multiple Operators, you must submit a separate IIIA 

and 111B for each Operator. 

Section 1118 

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. 

Page 15 

INSTRUCTIONS 

Section I 

• If you check box 1, complete all sections except IIIA and 1118. 

• 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 118. 

• If you check box 5, complete all sections. 

Section HA 

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 118. 

Section 118 

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 

1118. If you are an Owner or Operator registering on behalf of multiple Operators, you must submit a separate IIIA 

and 1118 for each Operator. 

Section 1118 

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 8 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 (9/23) FORM FDA 3741 (3/20) Page 15