Form FDA 3742 FDA 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: x/xx/xxxx
(See page 12 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 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.”.
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 as of June 22, 2009 (for cigarettes, cigarette tobacco, roll-your-own (RYO), and
smokeless tobacco) or [publication date] (for other tobacco products).
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 XX. You may also refer to the Definitions and Instructions sections at page XX.

(Continued on next page)
FORM FDA 3742 (4/16)

General Information – Page i

PSC Graphics (301) 443-1090

EF

This page is deliberately blank.

Form Approved: OMB No. 0910-0650
Expiration Date: x/xx/xxxx
(See page 12 for Burden Statement)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

LISTING OF INGREDIENTS IN
TOBACCO PRODUCTS
See pages XX-XX for Instructions

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

SECTION I - SUBMISSION TYPE
1. Submission Type (Check only one box. Please ensure that all products under this submission meet the definition of
the checked submission type.)*
Type a: Initial submission per 904(a)(1) for product(s)
on the market as of June 22, 2009 (for cigarettes,
cigarette tobacco, RYO, and smokeless tobacco) or
as of (enter date)
(for other
tobacco products)

Type d: Initial submission per 904(c)(2) for
modification to existing product(s)†
Type e: Initial submission per 904(c)(3) for
modification to existing product(s)†
Type f: Amendment to correct previous product
ingredient submission(s)† †
If Type f submission, enter the previous
product ingredient submission tracking
number (STN): TI

Type b: Initial submission per 904(c)(1) for new
product(s)
Type c: Initial submission per 904(c)(1) for
modification to existing product(s)
†

††

If modification to a product involves more than one ingredient and is subject to both 904(c)(2) and 904(c)(3) reporting
requirements, treat the modification to the product as falling under 904(c)(2).
If you are only reporting an update or correction to contact information, do not use this form. Instead, please submit a
letter to FDA indicating the update or correction.

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

Manufacturer

Importer (Complete Section III)

Company Name*
Company Headquarters D&B D-U-N-S ® Number

Company Headquarters FDA-assigned Facility
Establishment Identifier (FEI) Number

Address*

City*

State, Province or Territory*

Country*

ZIP or Postal Code*

Authorized Representative (Responsible official authorized to represent the submitter)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

Email Address

Ph.D.)

Telephone (Include Country Code if applicable)

FORM FDA 3742 (4/16)

Generational Suffix
(e.g., Jr., III)

FAX

Page 1

Authorized Representative (Continued)
Company Name*
Address*

Check here if same as company previously identified as submitter, and skip to Address.

Check here if same as previous, and skip to Section III.

State, Province or Territory*

City*

Country*

ZIP or Postal Code*

SECTION III - MANUFACTURER OF IMPORTED PRODUCTS
(Complete if Submitter Type is checked as Importer in Section II)
Note: If you are reporting ingredient information for products from multiple manufacturers, please submit a separate
submission for each manufacturer.
Company Name*
Company Headquarters D&B D-U-N-S ® Number

Company Headquarters FDA-assigned Facility
Establishment Identifier (FEI) Number

Address*

City*

State, Province or Territory*

Country*

ZIP or Postal Code*

U.S. Agent (For foreign firm where Authorized Representative does not reside in the U.S.)
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

M.I.

Last Name

Position Title

Professional
Suffix(e.g., MD,

Generational Suffix
(e.g., Jr., III)
Email Address

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name*
Address*

FAX

Check here if same as company previously identified as manufacturer, and skip to Address.

Check here if same as previous, and skip to Section IV.

State, Province or Territory*

FORM FDA 3742 (4/16)

Country*

City*

ZIP or Postal Code*

Page 2

SECTION IV - TOBACCO PRODUCT IDENTIFICATION
1. Tobacco Product Brand/Sub-brand Name or Other Commercial Name* (e.g., Acme Lights 100’s or Acme
Reconstituted Tobacco #202)
2. FDA-Assigned Tracking Number
TP
3. If this product is under review or has been authorized under a marketing pathway, enter the submission tracking
number (STN) of the application (e.g., SE1234567)
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 (Stock Keeping Unit)
UPC Number (Universal Product Code)
EAN (International Article Number)
GTIN (Global Trade Item Number)
Other (Specify below)

5. Use of Product (Check one)*
Consumer Use

Further Manufacturing Use

6. Is this tobacco product a co-package?*
Yes

FORM FDA 3742 (4/16)

No

Page 3

Consumer Use and Further Manufacturing Use

7. Product Category and Subcategory, or Category and Component*
Cigarettes

Smokeless Tobacco Products

Combusted, Filtered

Loose Moist Snuff

Combusted, Non-Filtered

Portioned Moist Snuff

Non-combusted

Loose Snus

Other (Specify below)

Portioned Snus
Loose Dry Snuff

Cigarette Component

Dissolvable
Loose Chewing Tobacco

Cigars

Portioned Chewing Tobacco

Filtered, Sheet-Wrapped Cigar

Smokeless Tobacco Product Component

Unfiltered, Sheet-Wrapped Cigar
Leaf-Wrapped Cigar

Waterpipe Tobacco Products

Cigar Component

Waterpipe
Waterpipe Tobacco Filler

Electronic Nicotine Delivery Systems (ENDS)

Waterpipe Heat Source

Closed E-Cigarette

Waterpipe Component

Open E-Cigarette
E–Liquid

Other Tobacco Products (Specify below)

ENDS Component

Pipe Tobacco Products
Pipe
Pipe Tobacco Filler
Pipe Component

Roll-Your-Own Tobacco Products
Role-Your-Own Tobacco Filler
Rolling Paper
Filtered Cigarette Tube
Non-Filtered Cigarette Tube
Filter
Paper Tip
Roll-Your-Own Component

FORM FDA 3742 (4/16)

Page 4

8. Tobacco Product Identification Information – In the table below, you may record the identification information
for any tobacco product(s) that you manufacture that are identical to the product listed in item 1 above other than
packaging differences that do not affect the characteristics of the product. You do not then need to submit separate
ingredients listings (Sections V and VI) for each of the products.
Tobacco Product Brand/Sub-brand
Name or Other Commercial Name*
(e.g., Acme Lights 100’s or Acme
Reconstituted Tobacco #202

Tobacco Product
Tracking Number1
(TP#######)

Submission
tracking
number for this
product2 (e.g.,
SE1234567)

Product
Identification
Number3

Type of Product
Identification Number (see
list below)

If you have additional products to submit, you may attach additional pages.
Type of Product Identification Number
4. EAN (International Article Number)
5. GTIN (Global Trade Item Number)
6. Other (Specify)

1. Item/Catalog Number
2. SKU Number (Stock Keeping Unit)
3. UPC Number (Universal Product Code)

1

EDA Assigned Tobacco Product Tracking Number.

2

If this product is under review or has been authorized under a marketing pathway, enter the submission tracking number of the application.

3

If no FDA Assigned Tobacco Product Tracking Number is provided, at least one product identification number must be provided if needed to
uniquely identify the product.

FORM FDA 3742 (4/16)

Page 5

SECTION V – COMPONENT IDENTIFICATION
Note: If your tobacco product has multiple components, please submit a separate copy of Section V for each component
you list or update.
Product Name (As recorded in Section IV)*

Product Category (As recorded in Section IV)*

Component Type (Select the component type based on the product category.)*
Cigarette Component Types
Tobacco Filler
Tobacco Filler Additive
Adhesive
Filter
Ink (Rod Print)
Pack Inner Foil
Cigarette Paper
Tipping Paper
Plug Wrap
Other (Specify below)

Cigar Component Types
Tobacco Filler
Tobacco Filler Additive
Adhesive
Filter
Tip
Tipping Paper
Plug Wrap
Wrapper/Binder
Other (Specify below)

ENDS Component Types
Atomizer
Coil/Coil Heads
Mouthpiece
Tank/Cartridge
Wick
Other (Specify below)

Pipe Component Types
Tobacco Filler
Tobacco Filler Additive
Bowl
Mouthpiece
Shank (without bowl)
Other (Specify below)

Roll-Your-Own Component Types
Tobacco Filler
Tobacco Filler Additive
Adhesive
Filter
Ink (Rod Print)
Cigarette Paper
Tipping Paper
Plug Wrap
Other (Specify below)

Water Component Types
Tobacco Filler
Tobacco Filler Additive
Heat Source
Base
Bowl
Diffuser
Foil/Screen
Hose
Mouthpiece
Seal
Stem
Valve
Other (Specify below)

Other Tobacco Products (Specify
component type below)

Smokeless Tobacco Product
Component Types
Tobacco Filler
Tobacco Filler Additive
Pouch
Other (Specify below)

Component Name (e.g., Name/type of adhesive, such as Cigarette Rod Adhesive, Tipping Adhesive, Filter Seam Adhesive,
Anchor Line Adhesive; or Name/type of tobacco filler additive, such as Casing Tobacco Filler Additive, Top Flavoring Tobacco
Filler Additives)

FORM FDA 3742 (4/16)

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Enter the manufacturer’s name and the uniquely identifying item name and/or number used by the manufacturer. If
you obtain this component from multiple sources, enter all identifying information for each source below. You may use
continuation pages as necessary.
Manufacturer’s Uniquely Identifying
Component Name and/or Number*

Manufacturer Name*

SECTION VI – INGREDIENT LISTING
Use a separate copy of Section IV for each ingredient you list or update.
Product Name (As recorded in Section IV)*

Ingredient Name*

Subcategory or Component Type and Name (As recorded
in Section V; or record “NA” if not applicable)*

Ingredient Number (IN#)*

1. If submission type d or type e is checked in Section I, indicate the type of additive change (Check only one)*
Quantity of additive was increased*

Date of change (mm/dd/yyyy):

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

Date of change (mm/dd/yyyy):

Additive was added*

Date of change (mm/dd/yyyy):

PART 1: INGREDIENT IDENTIFICATION (Complete only A, B, or C, as appropriate)
A. Single Chemical Substance
1a. Unique Scientific Name
1b. Type of Name (Select one)
IUPAC Name

Other (Specify):

2a. Registry Code
2a. Type of Code
FDA UNII Code

CAS Number

3. Is this Ingredient a Reaction Product?

Other (Specify):
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#

FORM FDA 3742 (4/16)

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

Flue

2. Variety*

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 (e.g., flavor extracts, tobacco leaf blends, reconstituted tobacco, spices, fruit juice,
adhesives, charcoal)
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*

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

2. Is this ingredient made to your specifications?*

Yes (See immediately below)

No (Skip to Part 2)

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 (Applicable to “Single Chemical Substance” and “Complex Ingredient” only. Skip Part 2
for “Leaf Tobacco”. You may also skip Part 2 if you are eliminating the ingredient or reporting an increase or decrease in
the quantity of the ingredient as you have indicated in Question 1.)
1. Quality Unit of Measure and Value (Check only one and enter value)
Ash Content (%):

Degrees Brix (0 Bx):

Assayed Contents (%):

Density (g/cm3):

Solids Dry Basis (%):

Dextrose Equivalent:

Solids Wet Basist (%):
Proof:

Moisture (%):

Specific Gravity (unitless):

CORESTA Unit (cm3 min-1 cm-2 at 1 kPa):

Specific Rotation (degrees):
Quality Conforms to a Published Standard –
Citation for Standard (e.g., ‘21 CFR 175.105’, or
‘FCC 9 Acesulfame Potassium’):

FORM FDA 3742 (4/16)

Other (Specify units):
Value:

Page 8

,

2. Expected Function(s) (Identify all that apply; use Appendix A for list of functions.)

PART 3: QUANTITY (You may skip Part 3 if you are eliminating the ingredient, and Question 1 is checked ‘1c. Additive
was eliminated’.)
1. Unit of Measure*
1a. Unit (Check one)*
g

mg

1b. Reported per (Check one)*
mcg

ng

Unit of Use

pg

Gram of Product

2. Quantity (Check only one and complete the associated field(s).)*
Special Note: For each numeric field, enter a single value. Do not enter a value range (ex: 5.0-10.0, <1).
Amount Calculated
Singular Quantity:
Amount Tested
Mean Quantity:
Variability (Check only one then enter value(s)):
Standard Error:
95% Confidence Interval: upper limit

, lower limit

Other (Specify type):

, (Value):

Amount to Achieve An Outcome
Target Outcome Type (Check only one):
Color
pH
Total Sugars
Moisture
Other (Specify):
Target Outcome Units and Value(s) (Check only one then enter value):
CIE L*a*b*: L*:

, a*:

, b*:

pH Units:
Grams of Total Sugars per Unit of Use:
Grams of Total Sugars per Gram of Product:
Other (Specify Unit):
Typical Quantity:
Residual Amount
Residual Quantity:

FORM FDA 3742 (4/16)

, (Value):
, or Minimum Quantity:

, Limit of Detection:

Page 9

, or Maximum Quantity:

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 (4/16)

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SECTION VII – 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.
Signature of Authorized Representative or U.S. Agent

Date

Check here if same as the submitter point of contact information in Section II. If so, you may skip to
Company Name.
Prefix (e.g., Mr., Ms., Dr.):
First/Given Name

M.I.

Last Name

Position Title

Professional
Suffix(e.g., MD,

Generational Suffix
(e.g., Jr., III)
Email Address

Ph.D.)

Telephone (Include Country Code if applicable)
Company Name*
Address*

FAX

Check here if same as submitter, and skip to Address.

Check here if same as submitter company’s, and skip address items.

State, Province or Territory*

FORM FDA 3742 (4/16)

Country

City*

ZIP or Postal Code*

Page 11

REFERENCES

Reference for the Tobacco Control Act:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm298595.htm
Reference for Guidance on Listing of Ingredients in Tobacco Products:
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm281147.htm
Reference for SRS UNII:
http://www.fda.gov/ForIndustry/DataStandards/SubstanceRegistrationSystemUniqueIngredientIdentifierUNII/default.htm
For regulatory questions regarding sections 904 and 905 of the act,
email TobaccoIndustryQuestions@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 ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 3 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 OMB number.”
FORM FDA 3742 (4/16)

Page 12

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)

25. Fuel for heat source

2. Adhesive

28. Humectant

3. Aerosol forming agent

29. Ink

4. Anti-foaming agent

30. Lip release agent

5. Anti-plasticizer

31. Menthol delivery

6. Anti-sticking agent

32. Moisture barrier

7. Antioxidant

33. Moisturizer

8. Binder

34. Nicotine source

9. Biocide

35. Oxygen barrier

10. Carrier

36. pH adjuster

11. Casing

37. pH buffer

12. Chemo-sensory agent that affects
perception of mainstream or sidestream
smoke including smoke color modifiers,
smoke odor modifiers and smoke
enhancers)

38. Plasticizer

13. Coating agent
14. Color
15. Combustion modifier
16. Dispersant
17. Drying agent
18. Emulsifier
19. Fermentation agent
20. Fiber
21. Filler
22. Film-forming agent

26. Heat conductor
27. Heat insulator

39. Porosity control agent
40. Preservative
41. Processing aid
42. Reduced ignition propensity
43. Sizing agent
44. Solvent
45. Surfactant
46. Sweetener
47. Texture control agent
48. Whitener
49. Wrapper
50. Other (Specify below):

23. Filtration
24. Flavor

FORM FDA 3742 (4/16)

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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

Co-package: A co-package is a tobacco product that is offered for sale containing multiple distinct tobacco
products (e.g., a can of RYO tobacco that includes a booklet of rolling paper), as opposed to containing a
quantity of the same tobacco product (e.g., a pack of 20 cigarettes).

3. Component or Part: Component or part means any software or assembly of materials intended or
reasonably expected: 1) to alter or affect the tobacco product’s performance, composition, constituents or
characteristics; or 2) to be used with or for the human consumption of a tobacco product. The term excludes
anything that is an accessory of a tobacco product.
4. Importer: The term “importer” means any person who imports any tobacco product that is intended for sale
or distribution to consumers in the United States.
5. Manufacturer: The term manufacturer means any person, including any repacker and/or relabeler, who
manufactures, fabricates, assembles, processes, or labels a finished tobacco product.
6. Pouch: The term “pouch” means a permeable material, intended to be filled with pre-portioned tobacco
product and placed in the oral cavity with the tobacco product.
7. 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-yourown tobacco or are sold for further manufacturing into a product sold to a consumer, such as a cigarette.

FORM FDA 3742 (4/16)

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INSTRUCTIONS
NOTE: Required fields in this form are designated by asterisks (*).
NOTE: Sections I, II, III, IV and VII only need to be completed once for each unique tobacco product or
tobacco product co-package.
For additional details and instructions or specific questions, please refer to the FDA Guidance for Industry: Listing
of Ingredients in Tobacco Products

Section I – Submission Type
Check one Submission Type as appropriate. Please refer to definitions on page 1 and the special notes on the
bottom of Section I.

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.

Section III – Manufacturer of Imported Products
Complete all contact fields as indicated. If you are reporting ingredient information for products from multiple
manufacturers, please submit a separate submission for each manufacturer.

Section IV – 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 item 4. If you do not have an FDA-assigned
tracking number for your product, complete all required identifying information in Section IV. Complete this
section for each brand and sub-brand for which ingredient information is being submitted.
Report in item 5 if the product is to be sold to consumers for their use, for further manufacture, or both sale for
consumer use and also further manufacture.
Report in item 7 the Category and Subcategory or Category and Component for all tobacco products.
For example: if you were reporting on a finished cigarette you might check category: “Cigarettes”,
subcategory: “Combusted, Filtered” and then move to Section V to provide each component and its
ingredients. Alternatively, if you were reporting on a cigarette filter sold for further manufacture you might
check category cigarette and component and then move to Section to fill out component type.
For reporting of a co-packaged product, consisting of multiple product categories and/or subcategories, check
the Yes box at item 6 and all relevant boxes in item 7.
For example: if you were reporting on a Roll-Your-Own Tobacco Filler with Rolling Papers included, you
would check category: “Roll-Your-Own Tobacco Products”, subcategory: “Roll-Your-Own Tobacco Filler”,

FORM FDA 3742 (4/16)

Page 15

and subcategory: “Rolling Paper”. You would then move to Section V to provide each component and its
ingredients.

Section V – Component Identification
Complete all fields as indicated. If this tobacco product has multiple components, list each component and
its ingredients separately. Complete a separate copy of Section V for each component for which ingredient
information is being submitted.
For Component Type, enter only a single component type and the specific component name here each time.
If the reported product is a co-packaged product consisting of components of more than one product category
(e.g., Cigarette and RYO), ensure to identify the product categories and the component names (e.g., Cigarette
Filter; RYO Filter).
For example if you are reporting on the adhesives for cigarettes including the tipping paper and the rod,
you would report the component type as adhesive and the specific component name as tipping paper
adhesive and then you would list the ingredients within that tipping paper adhesive; you would then fill out
Section V for cigarette rod adhesive and provide the ingredients for the cigarette rod.

Section VI – Ingredient Listing
If you are submitting ingredient lists for multiple products in a single submission, enter the product name and/or
tracking number on Sections IV, V and VI, 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 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.
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, tobacco blends or
reconstituted tobacco is reported in Part 1.C.
Part 1.C: Complex Ingredients
Item 1: Complex 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.

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Part 2: Ingredient Details
Complete this section for single chemical substances and complex ingredients. If you are eliminating or reporting
a change (increase or decrease) in the quantity of an additive, you may skip Part 3. If you are reporting a new
single chemical substance or complex ingredient, complete all required fields.
Part 3: Quantity
Complete this section for all ingredients. If you are eliminating an additive, you may skip to Section VII. 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 attach or use this space to provide any additional information or comments about this ingredient,
including any internal identifying numbers. If you are adding, eliminating 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.
NOTE: All ingredient information included in Section VI corresponding to a component listed in Section V,
should be attached (in a paper form) immediately after the component information in Section V. For example,
following the information for the e-liquid component of an ENDS tobacco product, should be separate ingredient
information sheets corresponding to each of the ingredients in the e-liquid (e.g., nicotine, propylene glycol,
glycerin, flavorant).

Section VII - Confirmation Statement
Please sign and date your submission. 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.

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