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pdfDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
TOBACCO SUBSTANTIAL EQUIVALENCE
REPORT SUBMISSION
Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/202x
(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.” (Pre-Existing Tobacco Product) (PTP)
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.”
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 (11/20)
General Information
This page is deliberately blank.
Form Approved: OMB No. xxxx-xxxx
Expiration Date: xx/xx/202x
(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
Applicant Information
(The organization (manufacturer/importer) seeking a marketing authorization for a new tobacco product)
Type of Applicant (Check appropriate box)
Manufacturer (Manufacture, fabricate, assemble, process, or
label a tobacco product (see section 900(20) of the FD&C Act))
Importer (Import a finished tobacco product
for sale or distribution in the U.S.)
Date of Submission
Name of Applicant
(Provide an organization's name)
Organization Name
Company Headquarters' FDA-assigned
Facility Establishment Identifier (FEI) Number
Company Headquarters' D&B® DUNS Number
Primary Address (Street Address, P.O. Box)
Applicant Address and
Contact Information
Address 2 (Apt., Suite, Bldg., etc.)
City
Country
State, Province, or Territory
First Name
Contact Name
Prefix (e.g., Mr., Ms., Dr.)
ZIP or Postal Code
Professional Suffix (e.g., MD, Ph.D.)
Generational Suffix
(e.g., Jr., III)
Telephone (Include Country Code if applicable)
Last Name
M.I.
FAX
Position Title
Email Address
Authorized Representative Information
(Responsible official authorized to represent the applicant)
M.I.
Name of Authorized Representative First Name
(Provide a person’s name)
Prefix
(e.g., Mr., Ms., Dr.)
FORM FDA 3965 (11/20)
Generational Suffix
(e.g., Jr., III)
Professional Suffix
(e.g., MD, Ph.D.)
Page 2 of 21
Last Name
Position Title
Authorized Representative
Address and Contact Information
Primary Address (Street Address, P.O. Box)
Address 2 (Apt., Suite, Bldg., etc.)
City
State, Province, or Territory
Country
ZIP or Postal Code
Telephone (Include Country Code if applicable) FAX
Organization Name and
Address Information (Optional)
Email Address
Organization Name
Primary Address (Street Address, P.O. Box)
Select for same address as Authorized Representative
Address 2 (Apt., Suite, Bldg., etc.)
City
State, Province, or Territory
Country
ZIP or Postal Code
U.S. Agent Information
(For foreign firm where Authorized Representative does not reside in the U.S.)
Name of U.S. Agent
(Provide a person’s name)
Prefix
(e.g., Mr., Ms., Dr.)
First Name
Generational Suffix
(e.g., Jr., III)
M.I.
Professional Suffix
Position Title
(e.g., MD, Ph.D.)
Street Address (Physical Location)
U.S. Agent Address and
Contact Information
Address 2 (Apt., Suite, Bldg., etc.)
City
State, Province, or Territory
Telephone
(Include Country Code if applicable)
Country
ZIP or Postal Code
Email Address
FAX
Organization Name and
Address Information (Optional)
Organization Name
Primary Address (Street Address, P.O. Box)
Select for same address as U.S. Agent
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
FORM FDA 3965 (11/20)
Last Name
City
Country
Page 3 of 21
ZIP or Postal Code
Alternate Point of Contact
(Optional, select only one for each Alternate Point of Contact. Provide one or more persons to contact as an Alternate to
the Contacts provided elsewhere in this form.)
Applicant
Authorized Representative
Other, Regulatory
Manufacturer (Other than Applicant)
U.S. Agent
Other, Technical
First Name
Prefix (e.g., Mr., Ms., Dr.)
Professional Suffix (e.g., MD, Ph.D.)
M.I.
Generational Suffix (e.g., Jr., III)
Alternate Point of Contact Address and
Contact Information
Position Title
Primary Address (Street Address, P.O. Box)
City
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
Last Name
Country
Telephone (Include Country Code if applicable) FAX
ZIP or Postal Code
Email Address
SECTION II – TOBACCO PRODUCT INFORMATION
Unique Identification of New and Predicate Tobacco Products
You must uniquely identify both the new tobacco product(s) and the predicate tobacco product(s). Refer to
Section VII, Appendix A, to determine the appropriate table needed to document new tobacco products and
predicate tobacco products included in this application.
For a co-packaged tobacco product, complete Section II for each new tobacco product included within the copackage.
For grouped submissions, complete Section II for each tobacco product included in the bundle.
FORM FDA 3965 (11/20)
Page 4 of 21
Individual Tobacco Product
New Tobacco Product Identification
Complete for each individual new tobacco product. Refer to Section VII, Appendix B, and select the appropriate category
and subcategory. For bundled submissions or co-packaged products, select all that apply.
Check this box if your product is co-packaged, meaning multiple components are contained in the same container
closure system (e.g., a tin that contains both loose tobacco filler and rolling papers together).
Fill out Section II for all components of your co-packaged product.
New Tobacco Product Name (Brand/Sub-Brand)
Product Category and Subcategory or Product Category and Component
Roll-Your-Own Tobacco Products
Cigarettes
Filtered
Roll-Your-Own Tobacco Filler
Non-Filtered
Rolling Paper
Other (Specify below)
Filtered Cigarette Tube
Non-Filtered Cigarette Tube
Filter
Cigars
Paper Tip
Filtered, Sheet-Wrapped
Roll-Your-Own, Other (Specify below)
Unfiltered, Sheet-Wrapped
Unfiltered, Leaf-Wrapped
Cigar Tobacco Filler
Cigar Component
Smokeless Tobacco Products
Moist Snuff, Loose
Cigar, Other (Specify below)
Moist Snuff, Portioned
Snus, Loose
Electronic Nicotine Delivery Systems (Vapes)
Open E-Liquid
Snus, Portioned
Dry Snuff, Loose
Dissolvable
Closed E-Liquid
Chewing Tobacco, Loose
Open E-Cigarette
Chewing Tobacco, Portioned
Closed E-Cigarette
ENDS Component
Smokeless, Other (Specify below)
ENDS, Other (Specify below)
Waterpipe Tobacco Products
Waterpipe
Pipe Tobacco Products
Waterpipe Tobacco Filler
Pipe
Waterpipe Heat Source
Pipe Tobacco Filler
Waterpipe Component
Pipe Component
Pipe, Other (Specify below)
Waterpipe, Other (Specify below)
Other (Specify below)
Heated Tobacco Products (HTP)
Closed HTP
Open HTP
HTP Consumable
HTP Component
Other (Specify below)
HTP, Other (Specify below)
FORM FDA 3965 (11/20)
Page 5 of 21
Predicate Tobacco Product Identification
Complete for each individual predicate tobacco product. Refer to Section VII, Appendix B, and select the
appropriate category and subcategory. For bundled submissions or co-packaged products, select all that apply.
Predicate Tobacco Product Name (Brand/Sub-Brand)
Predicate Category and Subcategory or Predicate Category and Component
Cigarettes
Roll-Your-Own Tobacco Products
Filtered
Roll-Your-Own Tobacco Filler
Non-Filtered
Rolling Paper
Other (Specify below)
Filtered Cigarette Tube
Non-Filtered Cigarette Tube
Filter
Cigars
Paper Tip
Filtered, Sheet-Wrapped
Roll-Your-Own, Other (Specify below)
Unfiltered, Sheet-Wrapped
Unfiltered, Leaf-Wrapped
Smokeless Tobacco Products
Cigar Tobacco Filler
Cigar Component
Moist Snuff, Loose
Cigar, Other (Specify below)
Moist Snuff, Portioned
Snus, Loose
Electronic Nicotine Delivery Systems (Vapes)
Open E-Liquid
Snus, Portioned
Dry Snuff, Loose
Dissolvable
Closed E-Liquid
Chewing Tobacco, Loose
Open E-Cigarette
Chewing Tobacco, Portioned
Closed E-Cigarette
Smokeless, Other (Specify below)
ENDS Component
ENDS, Other (Specify below)
Waterpipe Tobacco Products
Waterpipe
Pipe Tobacco Products
Waterpipe Tobacco Filler
Pipe
Waterpipe Heat Source
Pipe Tobacco Filler
Waterpipe Component
Pipe Component
Waterpipe, Other (Specify below)
Pipe, Other (Specify below)
Heated Tobacco Products (HTP)
Other (Specify below)
Closed HTP
Open HTP
HTP Consumable
HTP Component
Other (Specify below)
HTP, Other (Specify below)
FORM FDA 3965 (11/20)
Page 6 of 21
Tobacco Product Properties
Refer to Section VII, Appendix B, to determine the specific tobacco product properties that need to be reported
based on the category and subcategory of the tobacco product. Provide data for each required property by filling in
the Tobacco Product Properties table below, and provide the target value for both the new tobacco product(s) and
predicate tobacco product.
-
New Tobacco Product
Predicate Tobacco Product
Target Value
Target Value
Name:
Property
1
2
3
4
5
6
7
8
9
10
FORM FDA 3965 (11/20)
Page 7 of 21
Tobacco Product Manufacturer Identification
Complete the subsection below for the new tobacco product if the Applicant is not the new tobacco product
manufacturer or the Applicant is an Importer of that individual new tobacco product.
Select if Applicant is an Importer
New Tobacco Product Manufacturer (If different from Applicant or Applicant is an Importer)
New Tobacco Product Name
Organization Name
Company Headquarters FDA-assigned
Facility Establishment Identifier (FEI) Number
Company Headquarters' D&B DUNS® Number
Street Address (Physical Location)
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
City
Country
ZIP or Postal Code
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 different from Applicant or Applicant is an Importer)
Predicate Tobacco Product Name
Organization Name
Company Headquarters' FDA-assigned
Facility Establishment Identifier (FEI) Number
Company Headquarters' D&B DUNS® Number
Street Address (Physical Location)
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
FORM FDA 3965 (11/20)
City
Country
Page 8 of 21
ZIP or Postal Code
Basis for Predicate Tobacco Product Eligibility
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 PTP review independently of this SE Report
and was determined to be a pre-existing tobacco product (PTP) and may be eligible to serve as a predicate.
Name of Product
PTP STN
Date of FDA’s PTP Determination
The predicate tobacco product was previously found to be substantially equivalent.
Name of Product
SE STN
Date of FDA’s previous SE Determination
The predicate tobacco product was not previously submitted for PTP review and was not previously
found to be substantially equivalent, but we believe it to be a pre-existing tobacco product.
Complete section B below if the first check box above is selected. Complete A and B below if the third check box above
is selected and attach all documentation needed to demonstrate that the predicate tobacco product identified above was
commercially marketed other than for test marketing in the United States as of February 15, 2007. Neither section A or
B is required if you are relying on a predicate product that was previously found to be substantially equivalent (second
check box).
A. Evidence of Commercial Marketing as of February 15, 2007
Date of Evidence
Type of Evidence (e.g., Invoice)
Evidence Identifier (e.g., Invoice Number)
Commercial Information (e.g., UPC Code, SKU Number)
Street Address (Physical Location)
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory
City
Country
ZIP or Postal Code
B. Statement of Affirmation
I
(Name of responsible official)
, confirm that the predicate tobacco product
, was commercially marketed (other than
(Name of predicate tobacco product)
exclusively for test marketing) in the United States as of February 15, 2007.
Signature
FORM FDA 3965 (11/20)
Date
Page 9 of 21
SECTION III – SUBMISSION INFORMATION
For a co-packaged tobacco product, complete Section III for each new tobacco product included within the copackage.
For grouped submissions, complete Section III for each tobacco product included in the bundle.
Proposed modification(s) to the New Tobacco Product (as compared to the predicate tobacco product) (Check all
that apply)
Tobacco Blend
Container Closure System
Design
Heating Source
Material
Product Quantity
Ingredients (Specify):
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.
This is a group of SE Reports containing multiple new
tobacco products with similar modifications in comparison
to one predicate tobacco product.
Type of Application (Check only one)
Same Characteristics report
Different Characteristics report
Cross-Referenced Content: 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)
FORM FDA 3965 (11/20)
Page 10 of 21
Identify Cross-referenced Submission Type as one of the following: SE, PTP, or Tobacco Product Master File (TPMF)
New Tobacco Product Name (Provide product name if this Cross-referenced Content is relevant to a specific product)
Select if this Cross-referenced Content is relevant to all grouped products
Cross-referenced Submission Type
Cross-referenced Submission STN
Related Submissions: List the FDA submission tracking numbers (STNs) for all your previous requests for the new
tobacco products (e.g., SE, PTP, TPMF) where applicable
New Tobacco Product Name (Provide product name if this Related Submission is relevant to a specific product)
Select if this Related Submission is relevant to all grouped products
Related Submission Type
Related Submission STN
Formal Meetings Held with FDA pertaining to this tobacco product (For each meeting, as needed, enter the Submission
STN number and meeting held date.)
New Tobacco Product Name
(Provide product name if
meeting is relevant to a
specific product)
FORM FDA 3965 (11/20)
Select if this Meeting
is relevant to
all grouped products
Submission STN
Page 11 of 21
Meeting Held Date
SECTION IV – APPLICATION CONTENTS
Ensure all appropriate documents are included in this SE Report. Check all that apply.
Administrative
Cover Letter
Table of Contents
Submission Summary
Comparisons (Continued)
Composition
Materials
Ingredients, Tobacco
Basis of SE Determination
Ingredients, non-Tobacco
Unique Identification of new tobacco product(s) and
predicate tobacco product(s)
Other features
HPHCs
Other (Specify below)
Statements of Certification (Section VI)
Product Information
List of Ingredients
Information on Manufacturing Process
Health and Research (Select only one)
Health Information Summary
OR
Health Information Statement
Stability
Applicant’s basis for SE
Comparison to pre-existing tobacco product (Check
only if predicate product was previously found SE.)
Environmental Considerations (Select only one)
Environmental Assessment
OR
Claim for Categorical Exclusion
Comparisons (New vs. Predicate Tobacco Product)
Product Design
Heating Sources
FORM FDA 3965 (11/20)
Page 12 of 21
SECTION V - MANUFACTURING / PACKAGING SITES RELATING TO A SUBMISSION
(Add additional Manufacturing/Packaging sites as needed)
Company/Institution Name
Manufacturer
Contract Manufacturer
Repacker/Relabeler
Company Headquarters' FDA-assigned
Facility Establishment Identifier (FEI) Number
Company Headquarters' D&B DUNS® Number
Division Name (If applicable)
Primary Address (Street Address, P.O. Box)
City
State, Province or Territory
Telephone (Include Country Code if applicable)
Generational Suffix
(e.g., Jr., III)
Country
Email Address
FAX
First Name
Contact Name
Prefix
(e.g., Mr., Ms., Dr.)
ZIP or Postal Code
Professional Suffix
(e.g., MD, Ph.D.)
M.I.
Last Name
Position Title
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 of 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.
FORM FDA 3965 (11/20)
Page 13 of 21
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.
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 C.F.R. 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
FORM FDA 3965 (11/20)
Date
Page 14 of 21
SECTION VII – 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 II.
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
N/A
N/A
Properties
(Inserted on form)
Package Type
Package Quantity
Diameter
Below is an example of multiple new tobacco products in comparison to a single predicate tobacco product.
Unique Product Identification
New Product 1
Name: Product A
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: As Assigned by FDA
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
N/A
N/A
N/A
N/A
Properties
(Inserted on form)
Package Type
Package Quantity
Length
FORM FDA 3965 (11/20)
Page 15 of 21
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
Category: Roll-Your-Own
Subcategory: Roll-Your-Own Tobacco Filler
Package Type
New Tobacco Product(s)
Name: Component A
Name: Predicate A
Bag
Bag
Package Quantity
100 g
150 g
Characterizing Flavor
None
None
Additional Properties
Re-sealable Bag
Re-sealable Bag
Name: Component B
Name: Predicate B
Booklet
Booklet
100 sheets
100 sheets
Length
100 mm
85 mm
Width
56 mm
56 mm
Characterizing Flavor
None
None
Additional Properties
N/A
N/A
Category: Roll-Your-Own
Subcategory: Roll-Your-Own Rolling Paper
Package Type
Package Quantity
FORM FDA 3965 (11/20)
Page 16 of 21
Appendix B: Properties Needed to Uniquely Identify the Tobacco Product, by Category and Subcategory
The following are tables outlining all necessary properties to be captured for each category and subcategory of tobacco
products. An “X” denotes a required property for that given subcategory.
Reference the charts below for completing tables necessary for Section V.
Cigarette Tobacco Products
Properties
Subcategories
Properties
All Cigarettes
Package Type
X
Product Quantity
X
Diameter
X
Length
X
X
(except non-filtered)
Ventilation
Characterizing Flavor
X
Additional Properties (if applicable)
X
Roll-Your-Own Tobacco Products
Subcategories
Properties
Tobacco
Filler
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
Diameter
-
X
X
X
X
X
X
Properties
Length
-
Ventilation
-
Width
-
X
-
X
X
-
X
-
-
-
-
-
X
-
Characterizing Flavor
X
X
X
X
X
X
X
Additional Properties (if applicable)
X
X
X
X
X
X
X
FORM FDA 3965 (11/20)
Page 17 of 21
Cigar
Properties
Subcategories
Component
Filtered
SheetWrapped
Unfiltered
SheetWrapped
Unfiltered
LeafWrapped
Tobacco
Filler
Other
Package Type
X
X
X
X
X
X
Product Quantity
X
X
X
X
X
X
Properties
Length
-
X
X
X
-
-
Diameter
-
X
X
X
-
-
Ventilation
-
X
-
-
Wrapper Material
-
-
Tip
-
-
-
X
X
-
-
-
-
-
Characterizing Flavor
X
X
X
X
X
X
Additional Properties (if applicable)
X
X
X
X
X
X
Smokeless Tobacco Products
Properties
Properties
Subcategories
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
-
X
Portion Length
-
X
Portion Width
-
X
Portion Mass
-
X
Portion Thickness
-
X
X
-
-
X
-
X
-
-
X
-
X
-
X
-
X
X
-
X
X
-
X
-
X
-
X
-
X
-
X
-
-
Characterizing
Flavor
X
X
X
X
X
X
X
X
X
Additional
Properties (if
applicable)
X
X
X
X
X
X
X
X
X
FORM FDA 3965 (11/20)
Page 18 of 21
Electronic Nicotine Delivery Systems (Vapes)
Properties
Properties
Subcategories
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
-
E-Liquid Volume
-
X
X
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 (if applicable)
X
X
X
X
X
X
Heated Tobacco Products (HTP)
Properties
Subcategories
Properties
Component
Closed HTP
Open HTP
Consumable
Other
Package Type
X
X
X
X
X
Product Quantity
X
X
X
X
X
Length
-
X
X
X
-
Diameter
-
X
X
X
-
Ventilation
-
X
-
Wattage
-
X
X
-
-
Battery Capacity
-
X
X
-
-
-
-
Characterizing Flavor
X
X
X
X
X
Additional Properties (if applicable)
X
X
X
X
X
FORM FDA 3965 (11/20)
Page 19 of 21
Pipe Tobacco Products
Properties
Subcategories
Properties
Component
Pipe
Tobacco
Filler
Other
Package Type
X
X
X
X
Product Quantity
X
X
X
X
Tobacco Cut Style
-
Length
-
-
X
-
Diameter
-
X
X
-
-
Characterizing Flavor
X
X
X
X
Additional Properties (if applicable)
X
X
X
X
Waterpipe Tobacco Products
Properties
Properties
Subcategories
Component
Waterpipe
Heat Source
Tobacco
Filler
Other
Package Type
X
X
X
X
X
Product Quantity
X
X
X
X
X
Height
-
X
-
-
-
Width
-
X
-
-
-
Diameter
-
X
-
-
-
Portion Count
-
-
X
-
-
Portion Length
-
-
X
-
-
Portion Width
-
-
X
-
-
Portion Mass
-
-
X
-
-
-
X
Portion Thickness
-
Number of Hoses
-
Source(s) of Energy
-
X
-
X
-
-
-
-
-
Characterizing Flavor
X
X
X
X
X
Additional Properties (if applicable)
X
X
X
X
X
FORM FDA 3965 (11/20)
Page 20 of 21
Other Products
Properties
Subcategory
Properties
Other
Package Type
X
Product Quantity
X
Characterizing Flavor
X
Additional Properties (if applicable)
X
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.*
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FORM FDA 3965 (11/20)
Page 21 of 21
| File Type | application/pdf |
| File Title | Tobacco Substantial Equivalence Report Submission Form |
| Subject | Tobacco Substantial Equivalence Report, Amendment, General Correspondence, Submission, Application, FDA, Food and Drug Administr |
| Author | Department of Health and Human Services |
| File Modified | 2020-12-17 |
| File Created | 2020-11-19 |