FDA Form 3742 Listing of Ingredients in Tobacco Products

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

LISTING OF INGREDIENTS IN
TOBACCO PRODUCTS

Form Approved: OMB No. 0910-0650
Expiration Date: xx/xx/xxxx
(See page 8 for Burden 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 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.
STATUTORY REQUIREMENTS
Section 904(a)(1) of the act requires that each tobacco product manufacturer or importer submit "a listing of all
ingredients, including tobacco, substances, compounds, and additives that are, as of such date, added by the
manufacturer to the tobacco, paper, filter, or other part of each tobacco product by brand and by quantity in each
brand and subbrand" by December 22, 2009. This section applies only to those tobacco products manufactured and
distributed before June 22, 2009, and which are still manufactured as of the date of ingredient listing submission.
Section 904(c)(1) of the act requires that a tobacco product manufacturer provide all information required under
section 904(a) "at least 90 days prior to the delivery for introduction into interstate commerce of a tobacco product
not on the market on the date of enactment" of the Tobacco Control Act.
Section 904(c)(2) of the act requires that a tobacco product manufacturer advise the FDA in writing at least 90 days
prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive, except for those
additives that have been designated by the FDA through regulation as not a human or animal carcinogen, or
otherwise harmful to health under intended conditions of use.
Section 904(c)(3) of the act requires that a tobacco product manufacturer advise the FDA in writing within 60 days
of eliminating or decreasing an existing additive, or adding or increasing an additive that has been designated by the
FDA through regulation as not a human or animal carcinogen, or otherwise harmful to health under intended
conditions of use.
To assist persons making these ingredient submissions, FDA has issued its Guidance for Industry: Listing of
Ingredients in Tobacco Products (Guidance). This Guidance and the Tobacco Control Act are available through the
web links listed on page 8.
DEFINITIONS
FDA intends to use the following definitions in implementing the ingredient listing requirements of section 904 of the
act.
1. Additive: The term "additive" means "any substance the intended use of which results or may reasonably be
expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic
of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing,
manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that such
term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical"
(section 900(1) of the act (21 U.S.C. 387(1)).
2. Importer: The term "importer" means the importer of record at the time of entry of a tobacco product into the
United States.
3. 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.
(Continued on next page)
FORM FDA 3742 (12/10)

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PSC Graphics (301) 443-6740

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DEFINITIONS (Continued)
4. 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 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.
5. Tobacco Product Manufacturer: The term "tobacco product manufacturer" means "any person, including any
repacker or relabeler, who (A) manufactures, fabricates, assembles, processes, or labels a tobacco product; or
(B) imports a finished tobacco product for sale or distribution in the United States" (section 900(20) of the act
(21 U.S.C. 387(20)). Thus, the term is not limited to persons who manufacture products containing tobacco, but
includes anyone who manufactures any tobacco product as defined above.

FORM FDA 3742 (12/10)

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Form Approved: OMB No. 0910-0650
Expiration Date: 12/31/2012
(See page 8 for Burden Statement)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

LISTING OF INGREDIENTS IN
TOBACCO PRODUCTS
See pages 10-13 for Instructions

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

SECTION I - SUBMISSION TYPE
1. Submission Type (Check only one)*
Update to Previous Submission (See instructions on
pages 10-13 for required fields.)

New Submission
1a.
1b.

Ingredient listing for tobacco product(s) on the
market as of June 22, 2009
Ingredient listing for tobacco product(s) not on
the market as of June 22, 2009

1c.

Add, delete, or change the quantity of additive(s)

1d.

Other update (e.g., address changes) (Specify
below)

SECTION II - SUBMITTER IDENTIFICATION
Submitter Type (Check one)*
Manufacturer

Importer

Company Name*

Company Headquarters DUNS Number

Company Headquarters FEI Number

Address*

State, Province or Territory*

City*

Country*

ZIP or Postal Code*

Submitter 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 3742 (12/10)

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SECTION III - TOBACCO PRODUCT IDENTIFICATION
Submit a separate copy of this page for each tobacco product.
1. FDA-Assigned Tracking Number (TP#####)

2. Tobacco Product Brand/Sub-brand Name or Other Commercial Name* (e.g., Acme Lights 100's or Acme Reconstituted
Tobacco #202).

3. If this is an ingredient listing under 904(c)(1), enter the projected date (mm/dd/yyyy) on
which the product will be introduced into interstate commerce:
4. Product Identification Number (At least one product identification number must be provided if needed to uniquely
identify the product.)
Type of Product Identification Number

Product Identification Number

Item/Catalog Number
SKU Number
UPC Number
Other (Specify below)

5. Use of Product (Check one)*
Consumer Use (Go to item 5a)

Further Manufacturing Use (Go to item 5b)

5a. Consumer Use Product Category (Check one, then skip to Section IV)*
Cigarettes

Roll-Your-Own Tobacco

Snuff

Chewing Tobacco

Roll-Your-Own Paper

Snus

Dissolvables

Roll-Your-Own Filters

Accessory Filters

Other (Specify):
5b. Further Manufacturing Use Product Category (Check one)*
Tobacco

Pouch for Portioned Tobacco

Paper

Additive

Filters

Other (Specify):

FORM FDA 3742 (12/10)

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SECTION IV - INGREDIENT LISTING
Use a separate copy of Section IV for each ingredient you list or update.
Product Name*

Ingredient Name

FDA-Assigned Tracking Number

Ingredient Number (IN#)

1. If this is an update to report a change in an additive, identify type of update and the date that the change was made.
1a.

Quantity of additive was increased*

1b.

Quantity of additive was decreased* Date of change (mm/dd/yyyy):

1c.

Additive was eliminated*

Date of change (mm/dd/yyyy):

1d.

Additive was added*

Date of change (mm/dd/yyyy):

Date of change (mm/dd/yyyy):

PART 1: INGREDIENT IDENTIFICATION (Complete only A, B, or C, as appropriate)
A. Single Chemical Substance
1. Unique Scientific Name or Code*
2. Type of Code

FDA UNII Code

CAS Number

IUPAC Name

Other (Specify):

3. Is this Ingredient a Reaction Product?

Yes (See immediately below)

No (Skip to Part 2)

If Yes, FDA requests that you list the IN# of all ingredients known or intended to form this product.
IN#

IN#

IN#

IN#

IN#

IN#

B. Leaf Tobacco
2. Variety*

1. Type (e.g., Burley, Bright, Oriental)*
3. Cure Method (Select only one)*
Sun

Flue

Air

Steam

Fire

4. Heat Source (e.g., propane, wood)*

Other (Specify):

5. Describe any DNA recombinant technology used to engineer the tobacco (If none, enter "none")*

C. Complex Purchased Ingredients
Enter the manufacturer's name and the unique identifying item name and/or number used by the manufacturer. If
you obtain this ingredient from multiple sources, enter all identifying information for each source below. You may use
continuation pages as necessary.
1a. Manufacturer Name*

FORM FDA 3742 (12/10)

1b. Unique Identifying Item Name and/or Number*

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SECTION IV - INGREDIENT LISTING (Continued)
Product Name*

Ingredient Name

FDA-Assigned Tracking Number

Ingredient Number (IN#)

PART 1 (Continued)
C. Complex Purchased Ingredients (Continued)
2. Is this ingredient made to your specifications?*

No (Skip to Part 2)

Yes (See immediately below)

If Yes, enter each specified ingredient by IN#.* You may use continuation pages if necessary. We also request that you
attach specifications for this ingredient (e.g., release specifications).
IN#

IN#

IN#

IN#

IN#

IN#

PART 2: INGREDIENT DETAILS
1. Quality (e.g., % purity, published standard)
2. Expected Function(s) (Identify all that apply; use Appendix A for list of functions.)

3. Part ingredient is added to (Check all that apply)*
Paper

Other (Specify):

Filter

Tobacco (Specify):

PART 3: QUANTITY
1. Quantity*

1a. Unit*
mcg

g

mg

ng

pg

1b. Reported per*
Unit of Use

Gram of Product

2. Enter targeted outcome if variable amount has been added to achieve specific product characteristics (e.g., achieve
pH of 7.1).*

3. If you approximated quantity at or near "0," enter limit of detection.*

3a.Unit*
mcg

g

mg

ng

pg

PART 4: ADDITIONAL COMMENTS
Please provide any additional information or comments about this ingredient, including any internal identifying numbers.
If you are adding, deleting, or changing the quantity of an ingredient, please explain why the change was made. If
changing the quantity of an ingredient, you are also required to include the quantity prior to the change.

FORM FDA 3742 (12/10)

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SECTION V - 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 904(c) of the act.

Agree

WARNING:
A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.
Typed Name and Title

Signature of Responsible Person or Agent

Date

Identity of the Signatory
Submitter (Listed in Section II)
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 3742 (12/10)

City*

Country*

ZIP or Postal Code*

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REFERENCES

Reference for the Tobacco Control Act: http://www.fda.gov/tobaccoinfoindustry

Reference for Guidance on Listing of Ingredients in Tobacco Products:
http://www.fda.gov/tobaccoinfoindustry

Reference for SRS UNII: http://www.fda.gov/ForIndustry/DataStandards/
SubstanceRegistrationSystem-UniqueIngredientIdentifierUNII

Public reporting burden for this collection of information is estimated to average 3.0 hours per response, including the time
for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing
and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this
collection of information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850
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 3742 (12/10)

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APPENDIX A - INGREDIENT FUNCTION LIST

1. Addictiveness enhancer (including nicotine addictiveness enhancer
such as an agent that affects the dosing, perception or action of
nicotine)
2. Adhesive
3. Binder
4. Carrier
5. Casing
6. Chemo-sensory agent that affects perception of smoke including sidestream smoke (including smoke color modifiers, smoke odor modifiers
and smoke enhancers)
7. Color
8. Combustion modifier
9. Fiber
10. Filler
11. Filtration
12. Flavor
13. Humectant
14. Plasticizer
15. Preservative
16. Processing aid
17. Reduced ignition propensity
18. Solvent
19. Sizing agent
20. Wrapper
21. Other (Specify below)

FORM FDA 3742 (12/10)

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INSTRUCTIONS
Please note that required fields in this form are designated by an asterisk.

NEW SUBMISSIONS
For additional details and instructions on specific questions, please refer to the FDA Guidance for Industry: Listing of
Ingredients in Tobacco Products.

Section I - Submission Type
Item 1a: Check if you are submitting ingredient information, under section 904(a)(1) of the act, for tobacco
product(s) manufactured as of June 22, 2009. Move to Section II.
Item 1b: Check if you are submitting ingredient information, under section 904(c)(1) of the act, for tobacco
product(s) introduced into interstate commerce after June 22, 2009. Continue to Section II.

Section II - Submission Identification
Identify whether the submitter is the manufacturer or the importer. Under section 904(a)(1), submission of ingredient
information for imported products may be submitted by either the manufacturer or the importer. Submission of
ingredient information under 904(c)(1) of the act must be submitted by the manufacturer.
If you are reporting as an importer, and you are also a domestic tobacco product manufacturer, then you are also to
submit the ingredient information for the products you manufacture. In this situation, you would submit twice -- once
as an importer and once as a tobacco product manufacturer.
You must provide the submitting party's name and address. If you are submitting on behalf of the manufacturer or
importer as an agent, report information for the manufacturer or importer, not your own information.
Continue to Section III.

Section III - Tobacco Product Identification
If you have previously submitted registration and listing information under section 905 of the act, you should have
received an acknowledgement containing FDA-assigned tracking numbers (TP#####) for each of your products. If
you choose to enter this tracking number, you may skip items 4 and 5. If you do not have an FDA-assigned tracking
number for your product, complete all required identifying information in Section III. Complete this section for each
brand and sub-brand for which ingredient information is being submitted. Multiple copies of this page may be
submitted. Continue to Section IV.

Section IV - Ingredient Listing
If you are submitting ingredient lists for multiple products in a single submission, enter the product name and/or
tracking number at the top of both page 5 and page 6, such that the ingredient information can be linked to a
given product. This section should be completed for each ingredient listed. Multiple copies of this section may be
submitted.
You should also assign a unique ingredient number (IN#) for each ingredient. This may be done by sequential
numbering or by any other system you devise. Keep records of these numbers for reporting updates to your
ingredients. Ingredient numbers must be used when linking specified ingredients to complex purchased ingredients.
Part 1: Ingredient Identification
Complete the section of Part 1.A, 1.B, or 1.C, as applicable for the type of ingredient. If you are listing a single
chemical substance, for instance, you would complete only Part 1.A before moving on to Part 2.

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Part 1.A: Single Chemical Substance
Item 3: If this ingredient is a reaction product, FDA requests that you identify each ingredient known or intended to
form this product using their ingredient numbers (IN#). You may use continuation sheets if necessary.
Part 1.B: Leaf Tobacco
Each type of leaf tobacco is to be reported as a separate ingredient. Tobacco that has been processed with any
chemical, additive, or substance other than potable water is listed in Part 1.C. Similarly, purchased tobacco blends
or reconstituted tobacco are reported in Part 1.C.
Part 1.C: Complex Purchased Ingredients
Item 1: Complex purchased ingredients must be identified by a manufacturer's name and a uniquely identifying
item name and/or number. If you obtain this ingredient from multiple sources, you must list the manufacturer's
name and uniquely identifying item name and/or number for each source. You may use continuation pages as
necessary.
Item 2: For a complex ingredient custom made to your specifications, each specified ingredient must be identified
by its ingredient number (IN#). FDA requests that you submit any additional specifications (e.g. release
specifications, acceptance criteria, certificate of analysis) by attaching separate pages to this form.
Part 2: Ingredient Details
Complete this section for single chemical substances and complex purchased ingredients.
Part 3: Quantity
Complete this section for all ingredients.
Part 4: Additional Comments
Please use this space to attach any additional information or comments.
Continue to Section V.

Section V - Confirmation Statement
Please sign and date your submission. If you are submitting as an authorized agent, enter all required identifying
information in this section. Check your submission to ensure that all continuation pages or attachments are
appropriately identified at the top of the page with the product name, FDA-assigned tracking number, ingredient
name and IN#, as appropriate.

UPDATES
For additional details and instructions on specific questions, see the corresponding section under "New Submission"
or refer to the FDA Guidance for Industry: Listing of Ingredients in Tobacco Products.

Section I - Submission Type
Item 1c: Check if you are updating a previous submission, under sections 904(c)(2) or 904(c)(3) of the act, by
reporting the addition of an addition, elimination, or change to the quantity of an additive. Move to Section II.
Item 1d: Check if you are updating a previous submission by reporting any changes to the submission other than
the quantity of an additive. Examples of such changes may be changes in the submitter address or point of
contact. Move to Section II.

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Section II - Submission Identification
Identify whether the submitter is the manufacturer or the importer. Submission of updates under section 904(c) must
be submitted by the manufacturer. Submission of updates to any other information may be submitted by either the
manufacturer or the importer.
You must provide the submitting party's name and address. If you are submitting on behalf of the manufacturer or
importer as an agent, report information for the manufacturer or importer, not your own information.
If you are only reporting an update or correction to contact information contained in Section II, you may skip to
Section V. Otherwise, continue to Section III.

Section III - Tobacco Product Identification
If you are updating your product identification number, you must complete items 2 and 4. If this is the only
information being updated at this time, you may skip to Section V.
If you are updating ingredient information under sections 904(c)(2) and 904(c)(3) of the act, you must complete all
required fields to fully identify the product to which the change is being made. If you enter your FDA-assigned
tracking number, you may skip items 4 and 5. This section should be completed for each brand and sub-brand for
which ingredient information is being submitted. Multiple copies of this page may be submitted. Continue to Section
IV.

Section IV - Ingredient Listing
If you are updating your ingredient list for multiple products in a single submission, enter the product name and/or
tracking number at the top of both page 5 and page 6, such that the ingredient information can be linked to a given
product. Complete this section for each ingredient listed. Multiple copies of this section may be submitted.
For each update being reported, identify the type of update and the actual or projected date that the update was or
will be made.
Part 1: Ingredient Identification
Complete the section of Part 1 (A, B, or C) that applies to the additive being reported. If, in Section IV, you enter
both the Ingredient Name and Ingredient Number (IN#) that you used in your previous submission for this ingredient,
then you may skip to Part 2.
Part 1.A: Single Chemical Substance
If you are reporting any update to a Single Chemical Substance, you must complete all required fields in this
section.
Part 1.B: Leaf Tobacco
If you are reporting any update to leaf tobacco, you must complete all required fields in this section.
Part 1.C: Complex Purchased Ingredients
If you are eliminating or reporting a change (increase or decrease) in the quantity of an additive, you may skip
item 2.
For new additives, you must complete all required fields. If you obtain, or plan to obtain, this ingredient from multiple
sources, you are to complete all identifying information for each source. If you are reporting a new ingredient custom
made to your specifications, you must also list each ingredient that you specified to be used in the manufacturing
process.

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Part 2: Ingredient Details
If you are eliminating or reporting a change (increase or decrease) in the quantity of an additive, you may skip to
Part 3. If you are reporting a new single chemical substance or complex purchased ingredient, complete all required
fields.
Part 3: Quantity
If you are eliminating an additive, you may skip to Section V. If you are reporting a new additive or a change in the
quantity of an additive, complete all required fields.
Part 4: Additional Comments
Please provide any additional information or comments about this ingredient, including any internal identifying
numbers. If you are adding, deleting or changing the quantity of an ingredient, please explain why the change was
made. If changing the quantity of an ingredient, you are also required to include the quantity prior to the change.

Section V - Confirmation Statement
Please sign and date your submission. If you are submitting as an authorized agent, enter all required identifying
information in this section.

FORM FDA 3742 (12/10)

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