Form FDA 3965 FDA 3965 Tobacco Substantial Evidence Report Submission

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)

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 (FD&C Act).
STATUTORY REQUIREMENTS
Section 910(a)(1) of the FD&C Act defines a new tobacco product as “(A)any tobacco product (including those
products in test markets) that was not commercially marketed in the United States as of February 15, 2007;
or (B) any modification (including a change in design, any component, any part, or any constituent, including
a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a
tobacco product where the modified product was commercially marketed in the United States after February
15, 2007.”
Section 910(a)(2) of the FD&C Act states that premarket review is required for new tobacco products. There
are three pathways to receive marketing authorization. Substantial equivalence is one of the three pathways.
Section 910(a)(3) of the FD&C Act states that “substantial equivalence” means, with respect to the tobacco
product being compared to the predicate tobacco product, that the Secretary by order has found that the
tobacco product ‘‘(i) has the same characteristics as the predicate tobacco product; or (ii) has different
characteristics and the information submitted contains information, including clinical data if deemed necessary
by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because
the product does not raise different questions of public health.”

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Section 905(j)(1)(A)(i) of the FD&C Act includes the timeframe and basis for submission of a substantial
equivalence Report (SE Report).

FORM FDA 3965 (02/19)

General Information

PSC Publishing Services (301) 443-6740

EF

This page is deliberately blank.

Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/201x
(See Burden Statement on last page.)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION
SECTION I – APPLICANT IDENTIFICATION
Type of Manufacturer (Check appropriate box)
Manufacture, fabricate, assemble, process, or label a
tobacco product (see section 900(20) of the FD&C Act)

Import a finished tobacco product for
sale or distribution in the U.S.

Manufacturer Name
FDA Establishment Identifier (FEI)

D&B DUNS Number of Headquarters
Designer note: This form will be
Building Number and Street made as a “508 compliant” Adobe
LiveCycle PDF with fillable entry
fields after FDA (along with OMB, if
City
applicable) gives final approval to this
“layout design” version.

Manufacturer Street Address
(Physical location)

Room, Suite, Office, etc. (If applicable)
State, Province, or Territory

Country

Postal Code

Authorized Representative

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(Responsible official authorized to represent the applicant)
Prefix (e.g., Mr., Ms., Dr.):
First Name

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M.I.

Professional
Suffix(e.g., MD,

Position Title

Last Name

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

Email Address

Ph.D.)

Telephone (Include Country Code if applicable)

FAX
Building Number and Street

Authorized Representative
Mailing Street Address
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory

City
Country

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 Name
Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

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

Ph.D.)

FORM FDA 3965 (02/19)

Page 1 of 17

PSC Publishing Services (301) 443-6740

EF

Telephone (Include Country Code if applicable)

FAX
Building Number and Street

U.S. Agent
Mailing Street Address
Room, Suite, Office, etc. (If applicable)

City

State, Province, or Territory

Country

Postal Code

Alternate Point of Contact

(Secondary point of contact for applicant)
Prefix (e.g., Mr., Ms., Dr.):
First Name
Professional
Suffix(e.g., MD,

M.I.

Last Name

Position Title

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

Ph.D.)

Telephone (Include Country Code if applicable)

FAX

SECTION II – SUBMISSION INFORMATION
Proposed modification(s) to the New Tobacco Product (as compared to the predicate tobacco product) (Check all
that apply)
Tobacco Blend
Container Closure System
Ingredients (Specify):

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Design
Heating Source

Material
Product Quantity

Other (Specify):
Submission Summary (As described in 21 C.F.R. 1107.18(d), please summarize the submission below)

Purpose of Application (Check only one)
This SE Report is for an individual new
tobacco product.

FORM FDA 3965 (02/19)

This SE Report is for a bundled submission containing
multiple new tobacco products with similar modifications in
comparison to one predicate tobacco product.

Page 2 of 17

References to Other Correspondence
Related Submission Tracking Numbers (STNs) (List below)

Cross Reference to Tobacco Product Master Files (As applicable, enter the STN, check the Attached Letter of
Authorization box (if letter will be attached to printout or otherwise provided), and provide Master File information.)
STN:

Attached Letter of Authorization

Information and Sections to be referenced from Master File (Enter below)

Formal Meetings Held with FDA pertaining to this tobacco product (For each meeting, as needed, enter the STN number
and meeting held date.)
STN

Meeting Held Date

1st Meeting
2nd Meeting
3rd Meeting

F
O
O

4th Meeting
5th Meeting
6th Meeting
7th Meeting
8th Meeting

PR

9th Meeting
10th Meeting

FORM FDA 3965 (02/19)

Page 3 of 17

SECTION III – NEW TOBACCO PRODUCT INFORMATION
Refer to Section VIII, Appendix B, and select the appropriate category and sub-category.
For a bundled or co-packaged submission, complete all parts of this Section III for each individual new tobacco
product.
For every comparison being made, the category and sub-category of both the new and predicate tobacco
product should be the same.
Select either or both, if applicable.
New tobacco product is a component

New tobacco product is co-packaged

Select all that apply below. Complete for each individual new tobacco product.
New Tobacco Product Name (Brand/Sub-Brand)
Product Category/Sub-Category
Cigarette

Roll-Your-Own Tobacco Products

Combusted, Filtered

Roll-Your-Own Tobacco Filler

Combusted, Non-Filtered

Rolling Paper

Non-combusted

Filtered Cigarette Tube

Combusted, Other (Specify below)

Non-Filtered Cigarette Tube
Filter
Paper Tip

Cigar

Roll-Your-Own, Other (Specify below)

F
O
O

Leaf-Wrapped
Filtered, Sheet-Wrapped
Non-Filtered, Sheet-Wrapped
Cigar Tobacco Filler
Cigar, Other (Specify below)

PR

Electronic Nicotine Delivery System (ENDS)
Open E-Liquid

Smokeless Tobacco Products
Loose Moist Snuff
Portioned Moist Snuff
Loose Snus
Portioned Snus
Loose Dry Snuff
Dissolvable

Closed E-Liquid

Loose Chewing

Open E-Cigarette

Portioned Chewing

Closed E-Cigarette

Smokeless, Other (Specify below)

ENDS, Other (Specify below)

Waterpipe Tobacco Products
Pipe Tobacco Products

Waterpipe

Pipe

Waterpipe Tobacco Filler

Pipe Tobacco Filler

Waterpipe Heat Source

Pipe, Other (Specify below)

Waterpipe, Other (Specify below)

FORM FDA 3965 (02/19)

Page 4 of 17

SECTION IV – PREDICATE TOBACCO PRODUCT INFORMATION
Refer to Section VIII, Appendix B, and select the appropriate category and sub-category.
The category and sub-category should be the same as each individual new tobacco product.
Select either or both, if applicable.
Predicate tobacco product is a component

Predicate tobacco product is co-packaged

Select all that apply below. Complete for each individual predicate tobacco product.
Predicate Tobacco Product Name (Brand/Sub-Brand)
Predicate Category/Sub-Category
Cigarette

Roll-Your-Own Tobacco Products

Combusted, Filtered

Roll-Your-Own Tobacco Filler

Combusted, Non-Filtered

Rolling Paper

Non-combusted

Filtered Cigarette Tube

Combusted, Other (Specify below)

Non-Filtered Cigarette Tube
Filter
Paper Tip

Cigar

Roll-Your-Own, Other (Specify below)

Leaf-Wrapped
Filtered, Sheet-Wrapped

Smokeless Tobacco Products

Non-Filtered, Sheet-Wrapped

F
O
O

Loose Moist Snuff

Cigar Tobacco Filler
Cigar, Other (Specify below)

PR

Electronic Nicotine Delivery System (ENDS)
Open E-Liquid
Closed E-Liquid

Portioned Moist Snuff
Loose Snus
Portioned Snus
Loose Dry Snuff
Dissolvable
Loose Chewing

Open E-Cigarette

Portioned Chewing

Closed E-Cigarette

Smokeless, Other (Specify below)

ENDS, Other (Specify below)

Waterpipe Tobacco Products
Pipe Tobacco Products

Waterpipe

Pipe

Waterpipe Tobacco Filler

Pipe Tobacco Filler

Waterpipe Heat Source

Pipe, Other (Specify below)

Waterpipe, Other (Specify below)

FORM FDA 3965 (02/19)

Page 5 of 17

Complete the subsection below for the predicate tobacco product if the Applicant is not the predicate tobacco product
manufacturer or the Applicant is an Importer of that individual predicate tobacco product.

Predicate Tobacco Product Manufacturer

(If other than Applicant or Applicant is an Importer)
Predicate Name
Manufacturer Name
FDA Establishment Identifier (FEI)

Street Address

D&B DUNS Number of Headquarters
Building Number and Street

Room, Suite, Office, etc. (If applicable)
State, Province, or Territory

City
Country

Postal Code

Predicate Tobacco Product Basis
Check the statement below that applies to the predicate tobacco product, and then complete all necessary information
for that statement.
The predicate tobacco product identified above was submitted for GF review independently of this SE Report
and was determined to be a grandfathered (GF) product.
Name of Product
GF/SE STN

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Date of FDA’s GF Determination

The predicate tobacco product was previously found to be substantially equivalent.
Name of Product
GF/SE STN

Date of FDA’s GF Determination

The predicate tobacco product was not previously submitted for GF review and was not previously found to be
substantially equivalent, but we believe it to be a grandfathered product.

FORM FDA 3965 (02/19)

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Complete A and B below and attach all documentation, which must demonstrate the predicate tobacco product
identified above was commercially marketed other than for test marketing in the United States as of February 15, 2007.
Subsection A should be completed for each attached document.
A. Evidence of Commercial Marketing as of February 15, 2007
Type of Evidence (e.g., Invoice)

Date of Evidence

Evidence Identifier (e.g., Invoice Number)

Commercial Information (e.g., UPC Code, SKU Number)
Building Number and Street

Commercially Marketed
Business Address
Room, Suite, Office, etc. (If applicable)
State, Province, or Territory

City
Country

Postal Code

B. Statement of Affirmation

I

, confirm that the predicate tobacco product

(Name of responsible official)

, was commercially marketed (other than

(Name of predicate tobacco product)

exclusively for test marketing) in the United States as of February 15, 2007.
Signature

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FORM FDA 3965 (02/19)

Page 7 of 17

Date

SECTION V – UNIQUE IDENTIFICATION OF NEW AND PREDICATE TOBACCO PRODUCTS
Each individual new tobacco product must be in comparison to one predicate tobacco product. Refer to the table below
and to section VIII, Appendix A, to determine the appropriate table needed to document all new tobacco products and
predicate tobacco products listed within this application. Fill in the table below and/or attach additional tables to this
section as needed.
Refer to Section VIII, Appendix B, to determine the specific properties that need to be reported based on the category
and sub-category of the tobacco product. Provide data for each required property by filling in the table below, and
provide the target value for both the new tobacco product(s) and predicate tobacco product(s).
Tobacco Product – Component or Co-Packaged? (If applicable, select the appropriate box(es))
Tobacco product is a component

Tobacco product is co-packaged

In the following table, please enter the name of both the new and predicate tobacco products, and list the properties of each
product below its name. Twenty-six rows for properties are provided, as needed, for each name.

Product Identification
New Tobacco Product

Predicate Tobacco Product

Name:
1

1

2

2

3

3

4

Designer note: Currently plan to have 26 separate entry

4

5

fields within each column (one user line of text per

5

6

field).

6

7
8

Properties

9

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7
8
9

10

10

11

11

12

12

13

13

14

14

15

15

16

16

17

17

18

18

19

19

20

20

21

21

22

22

23

23

24

24

25

25

26

26

FORM FDA 3965 (02/19)

Page 8 of 17

SECTION VI – CERTIFICATION STATEMENTS
For the following section, state the name of the responsible official, the name of the company being represented within
this application, the individual new tobacco product(s), and the individual predicate tobacco product(s). Complete the
information for all applications.
Name of authorized representative (In this section, referred to as “the authorized representative”)
Name company being represented (In this section, referred to as “the company”)
Name of new tobacco product(s) (In this section, referred to as “new tobacco product”)
Name of predicate tobacco product(s) (In this section, referred to as “predicate tobacco product”)
Complete the certification statement below.

I (name of responsible official)

, on behalf of (applicant)
, hereby certify that (applicant)
, will maintain all records to substantiate the
accuracy of this SE Report for the period of time required in § 1107.58 and ensure that such records remain
readily available to the FDA upon request. I certify that this information and the accompanying submission are
true and correct, that no material fact has been omitted, and that I am authorized to submit this on the applicant’s
behalf. I understand that under section 1001 of title 18 of the United States Code anyone who knowingly and
willfully makes a materially false, fictitious, or fraudulent statement to the Government of the United States is
subject to criminal penalties.

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Complete the statement below if choosing to certify that certain characteristics are identical in lieu of providing
data for each characteristic of the new and predicate tobacco products.

I (name of responsible official)

, on behalf of (name of company)
, certify that (new tobacco product name)
, has the following modification(s) as compared
to (name of predicate tobacco product)
due to
the following modification(s): (describe modification(s), e.g., change in product quantity or change in container
closure system)
.
Aside from these modifications, the characteristics of (new tobacco product name)
and (name of predicate tobacco product)
are identical. I certify that (name of
company)
understands this means there is no
other modification to the materials, ingredients, design features, heating source, or any other feature. I also certify
that (name of company)
will maintain records to
support the comparison information in § 1107.19 that substantiate the accuracy of this statement for the period of
time required in § 1107.58, and ensure that such records remain readily available to FDA upon request.

FORM FDA 3965 (02/19)

Page 9 of 17

In accordance with proposed 1107.18, the following information is provided within the SE Report. Check all applicable
statements to which you attest, and then sign the statement below

General Information (1107.18(c)
Summary (1107.18(d)(1-3))
New tobacco product description (1107.18(e))
Predicate tobacco product description (1107.18(f))
Comparison information (1107.18(g))
Comparative testing information (1107.18(h))
Statement of compliance with applicable product standards (1107.18(i))
Health information summary or statement that health information is available upon request (1107.18(j))
Compliance with 21 CFR part 25 (1107.18(k))
Certification (As set out in Section IV of this form, and includes certifications on record maintenance and
availability, truthfulness, and as applicable, that certain characteristics are identical.) (1107.18(l)(1) and/or (2))

By signing below, I,
are true.

, certify that statements selected above

Signature

Date

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FORM FDA 3965 (02/19)

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SECTION VII – SUBMISSION INFORMATION AND CONTENTS
Ensure all appropriate documents are included in this SE Report. Check all that apply
Administrative
Cover Letter
Table of Contents
Submission Summary
Basis of SE Determination
Unique Identification of new tobacco product(s) and
predicate tobacco product(s)
Statements of Certification (Section VI)

Comparisons (Continued)
Composition
Materials
Ingredients, Tobacco
Ingredients, non-Tobacco
Other features
HPHCs

Product Information
List of Ingredients
Information on Manufacturing Process

Other (Specify below)
Stability
Applicant’s basis for SE
Comparison to grandfathered product (Check only if
predicate product was previously found SE.)

Health and Research (Select only one if this applies)
Health Information Summary
OR
Health Information Statement

Environmental Considerations (Select only one if this
applies)

Comparisons (New vs. Predicate Tobacco Product)
Product Design
Heating Sources

Environmental Assessment
OR
Claim for Categorical Exclusion

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FORM FDA 3965 (02/19)

Page 11 of 17

SECTION VIII – APPENDICES
Appendix A: New Tobacco Product and Predicate Tobacco Product Details
Use the tables below as examples of how to format and capture data necessary to uniquely identify products in
Section V.
Below is an example of a single new tobacco product in comparison to a single predicate tobacco product. Refer to
Appendix B for the list of properties necessary to uniquely identify a product depending upon the category and subcategory to which that product belongs.
Unique Product Identification
New Tobacco Product
Name: Product A

Predicate Tobacco Product
Name: Predicate A

Box

Box

20 Cigarettes per box

20 Cigarettes per box

100 mm

92 mm

Length

6 mm

6 mm

Ventilation

None

None

Characterizing Flavor

None

None

Additional Properties

Red color box

Blue color box

Properties
(Inserted on form)
Package Type
Product Quantity
Diameter

F
O
O

PR

Below is an example of multiple new tobacco products in comparison to a single predicate tobacco product.
Unique Product Identification
New Product 2
Name: Product B

New Product 3
Name: Product C

Predicate
Name: Predicate A

STN: N/A

STN: N/A

STN: N/A

STN: GF1234567

Box

Box

Box

Box

20 Cigarettes per box

20 Cigarettes per box

20 Cigarettes per box

20 Cigarettes per box

100 mm

96 mm

94 mm

92 mm

Diameter

6 mm

4 mm

6 mm

6 mm

Ventilation

None

None

None

None

Characterizing Flavor

None

None

None

None

Additional Properties

Red color box

Purple color box

Red color box

Blue color box

Properties
(Inserted on form)
Package Type
Product Quantity
Length

FORM FDA 3965 (02/19)

New Product 1
Name: Product A

Page 12 of 17

Below is an example of new tobacco products that are co-packaged together as part of one submission.
Name of Co-Package: Variety Pack A/B

Unique Product Identification
Co-Packaged Categories and
Unique Identification Properties

New Tobacco Product(s)

Category: Roll-Your-Own
Sub-Category: Roll-Your-Own
Tobacco Filler

Name: Product A

Package Type

Predicate Tobacco Product(s)
Name: Predicate A
Related STN: GF1234567

Bag

Bag

Product Quantity

100 g

100 g

Characterizing Flavor

None

None

Additional Properties

Re-sealable Bag

Blue Bag

Category: Roll-Your-Own
Sub-Category: Roll-Your-Own
Rolling Paper

Package Type

Name: Product B

Name: Predicate B
Related STN: GF7654321

Booklet

Booklet

100 sheets

85 sheets

Length

100 mm

98 mm

Width

56 mm

52 mm

None

None

Black Box

Black Box

Product Quantity

Characterizing Flavor
Additional Properties

FORM FDA 3965 (02/19)

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Page 13 of 17

Appendix B: Unique Identification of Category and Sub-Categories and Properties
The following are tables outlining all necessary properties to be captured for each category and sub-category of tobacco
products. An “X” denotes a required property for that given sub-category.
Reference the charts below for completing tables necessary for Section V.
Cigarette Tobacco Products
Sub-Categories

Properties

All Cigarettes

Package Type

X

Product Quantity

X

Diameter

X

Length

X
X

Ventilation

(except combusted, non-filtered)

Characterizing Flavor

X

Additional Properties

X

Note: For non-combusted cigarettes, include the source of energy.

F
O
O

Roll-Your-Own Tobacco Products

Properties

Tobacco
Filler

PR

Sub-Categories

Rolling
Paper

Filtered
Cigarette
Tube

NonFiltered
Cigarette
Tube

Filter

Paper Tip

Other

Package Type

X

X

X

X

X

X

X

Product Quantity

X

X

X

X

X

X

X

X

X

X

X

X

X

Diameter
Length

X

Ventilation

X

Width

X

X

X

X

Characterizing Flavor

X

X

X

X

X

X

X

Additional Properties

X

X

X

X

X

X

X

FORM FDA 3965 (02/19)

Page 14 of 17

Cigar
Sub-Categories
Component

Filtered
SheetWrapped

Unfiltered
SheetWrapped

LeafWrapped

Tobacco
Filler

Other

Package Type

X

X

X

X

X

X

Product Quantity

X

X

X

X

X

X

Length

X

X

X

Diameter

X

X

X

Ventilation

X

Properties

Tobacco Cut Size

X

Wrapper Material

X

Tip

X

Characterizing Flavor

X

X

X

X

X

X

Additional Properties

X

X

X

X

X

X

Smokeless Tobacco Products

F
O
O

Sub-Categories

Properties

PR

Loose Moist
Snuff

Portioned
Moist Snuff

Loose
Snus

Portioned
Snus

Loose Dry
Snuff

Dissolvable

Loose
Chewing

Portioned
Chewing

Other

Package Type

X

X

X

X

X

X

X

X

X

Product Quantity

X

X

X

X

X

X

X

X

X

Portion Count
Tobacco Cut Size

X
X

X

X
X

X

X
X

X

X
X

Portion Length

X

X

X

X

Portion Width

X

X

X

X

Portion Mass

X

X

X

X

Portion Thickness

X

X

X

X

Characterizing
Flavor

X

X

X

X

X

X

X

X

X

Additional
Properties

X

X

X

X

X

X

X

X

X

FORM FDA 3965 (02/19)

Page 15 of 17

Electronic Nicotine Delivery System (ENDS)
Sub-Categories
Properties

Component

Open ELiquid

Closed ELiquid

Open ECigarette

Closed ECigarette

Other

Package Type

X

X

X

X

X

X

Product Quantity

X

X

X

X

X

X

Length

X

X

Diameter

X

X

X

X

E-Liquid Volume

X

X

Nicotine Concentration

X

X

X

PG/VG Ratio

X

X

X

Battery Capacity

X

X

Wattage

X

X

Characterizing Flavor

X

X

X

X

X

X

Additional Properties

X

X

X

X

X

X

F
O
O

Pipe Tobacco Products
Properties

Package Type
Product Quantity

PR

Sub-Categories

Component

Pipe

Tobacco
Filler

Other

X

X

X

X

X

X

X

X

Length

X

Diameter

X

Characterizing Flavor

X

X

X

X

Additional Properties

X

X

X

X

FORM FDA 3965 (02/19)

Page 16 of 17

Waterpipe Tobacco Products
Sub-Categories
Properties

Component

Waterpipe

Heat Source

Tobacco
Filler

Other

Package Type

X

X

X

X

X

Product Quantity

X

X

X

X

X

Length

X

Width

X

Portion Count

X

Portion Length

X

Portion Width

X

Portion Mass

X

Portion Thickness

X

Number of Hoses

X

Source(s) of Energy

X

Characterizing Flavor

X

X

X

X

X

Additional Properties

X

X

X

X

X

F
O
O

PR

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

FORM FDA 3965 (02/19)

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