Form FDA 4057 FDA 4057 Premarket Tobacco Product Application (PMTA) Submission

Form Approved: 0MB Control No. 0910-0879

DEPARTMENT OF HEAL TH AND HUMAN SERVICES
Food and Drug Administration

Expiration Date: 12/31/2024

Premarket Tobacco Product Application (PMTA) Submission

SECTION I - APPLICANT IDENTIFICATION

Applicant Information

First Name
Name of Applicant
(Provide only either a person’s name or an organization’s
name)
Prefix (e.g., Mr., Ms., Dr.)

See PRA Statement on page 22

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

M.I.

Last Name

Date of
Submission

Position Title

Professional Suffix (e.g., MD, Ph.D.)

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.)
State, Province, or Territory

City

First Name

Contact Name
(Optional, for use if Applicant is an Organization)
Prefix (e.g., Mr., Ms., Dr.)

ZIP or Postal Code

Country

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

Telephone (Include Country Code if applicable)

Professional Suffix (e.g., MD, Ph.D.)

FAX

Organization Name and Address Information
(Optional, for use if Applicant is an Individual)

Organization name

Select for same address as Applicant

Address 2 (Apt., Suite, Bldg., etc.)

FORM FDA 4057 (12/21)

Position Title

Email Address

Primary Address (Street Address, P.O. Box)

State, Province, or Territory

Last Name

M.I.

City
Country

Page 1 of 22

ZIP or Postal Code

Authorized Representative Information (Responsible official authorized to represent the applicant)
First Name

Name of Authorized Representative
(Provide only either a person’s name or an
organization’s name)
Prefix (e.g., Mr., Ms., Dr.)

Last Name

M.I.

Professional Suffix (e.g., MD, Ph.D.) Position Title

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

Organization name
Primary Address (Street Address, P.O. Box)

Authorized Representative Address and
Contact Information
Address 2 (Apt., Suite, Bldg., etc.)
State, Province, or Territory

City
Country

ZIP or Postal Code

Contact Name
First Name
(Optional, for use if Authorized Representative
is an Organization)
Prefix (e.g., Mr., Ms., Dr.)

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

M.I.

Last Name

Professional Suffix (e.g., MD, Ph.D.)

Telephone (Include Country Code if applicable) FAX

Organization name and Address Information
(Optional, for use if Authorized Representative is an Individual)

Position Title

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

Manufacturer Information (if different from Applicant)
Organization name
Company Headquarters' FDA-assigned Facility
Establishment Identifier (FEI) Number

Organization Address and Contact Information

Company Headquarters' D&B DUNS® Number

Street Address (Physical Location)

Address 2 (Apt, Suite, Bldg., etc.)
State, Province, or Territory

FORM FDA 4057 (12/21)

City
Country

ZIP or Postal Code

Page 2 of 22

U.S. Agent Information (For foreign firm where Authorized Representative does not reside in the U.S.)
Name of U.S. Agent
First Name
M.I. Last Name
(Provide only either a person’s name or an
organization’s name)
Prefix (e.g., Mr., Ms., Dr.) Generational Suffix
Professional Suffix (e.g., MD, Ph.D.) Position Title
(e.g., Jr., III)
Organization name

U.S. Agent Address and Contact Information

Primary Address (Street Address, P.O. Box)
City

Address 2 (Apt., Suite, Bldg., etc.)
State, Province or Territory

Country

ZIP or Postal Code
United States
M.I.

First Name
Contact Name
(Optional, for use if U.S. Agent is an Organization)
Prefix (e.g., Mr., Ms., Dr.)

Professional Suffix (e.g.,

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

Telephone (Include Country Code if applicable)

MD, Ph.D.)

FAX

Last Name

Position Title

Email Address
Organization name

Organization name and Address Information
(Optional, for use if U.S. Agent is an Individual)
Primary Address (Street Address, P.O. Box)

Select for same address as U.S. Agent

Address 2 (Apt., Suite, Bldg., etc.)

City

State, Province, or Territory

Country

ZIP or Postal Code

Alternate Point of Contact (Attach a separate sheet to list all alternate points of Contact)
Applicant

Authorized Representative

Other, Regulatory

Manufacturer (Other than Applicant)

U.S. Agent

Other, Technical

Prefix (e.g., Mr., Ms., Dr.)

First Name

Professional Suffix (e.g., MD, Ph.D.)

M.I.

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

Alternate Point of Contact Address and
Contact Information

City
Country

Telephone (Include Country Code if applicable) FAX

FORM FDA 4057 (12/21)

Position Title

Primary Address (Street Address, P.O. Box)

Address 2 (Apt., Suite, Bldg., etc.)
State, Province or Territory

Last Name

Page 3 of 22

ZIP or Postal Code
Email Address

SECTION II - NEW TOBACCO PRODUCT INFORMATION
Complete this section for each individual new tobacco product.
Check here if you are submitting a co-packaged product.
For a co-packaged tobacco product, please complete Section III for each new tobacco product included within the co-package.
New Tobacco Product Name (Brand/Sub-Brand)
Product Category/Sub-Category:
Roll-Your-Own Tobacco Products

Electronic Nicotine Delivery System (Vapes)
E-Liquid, Open

Roll Your Own Tobacco Filler

E-Liquid, Closed

Rolling Paper

E-Cigarette, Closed

Cigarette Tube, Filtered

E-Cigarette, Open

Cigarette Tube, Non-filtered

ENDS Component

Filter

Other .

Paper Tip
Other .

Pipe Tobacco Products
Cigarettes

Pipe
Pipe Tobacco Filler

Filtered

Pipe Component

Non-filtered
Other .

Other .

Waterpipe Tobacco Products

Smokeless Tobacco Products

Waterpipe

Moist Snuff, Loose

Waterpipe Tobacco Filler

Moist Snuff, Portioned

Waterpipe Heat Source

Snus, Loose

Waterpipe Component
Other .

Snus, Portioned
Dry Snuff, Loose
Dissolvable

Cigars

Chewing Tobacco, Loose
Chewing Tobacco, Portioned

Filtered, Sheet-Wrapped

Other .

Unfiltered, Sheet-Wrapped
Unfiltered, Leaf-Wrapped
Cigar Component

Heated Tobacco Products (HTP)

Cigar Tobacco Filler
Other .

Closed HTP
Open HTP
HTP Consumable

Other .

HTP Component

Other .

Other .

FORM FDA 4057 (12/21)

Page 4 of 22

Unique Identification of New Tobacco Products

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 new tobacco product. Provide data for each required property by filling in the table below, and
provide the target value for the new tobacco products (s). Attach additional tables to this section as needed.
Refer to section VIII, Appendix A, for examples of how a new tobacco product should be uniquely identified.
In the following table, please enter both the name of the new tobacco product(s) and the properties of each product below
its name.

Product Identification
New Tobacco Product
Name:
1
2

Properties

3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26

FORM FDA 4057 (12/21)

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SECTION III - SUBMISSION INFORMATION
Specify submission type (Select one submission type per form)
(Select one submission type per form)
(check only one)

Standard PMTA

Resubmission

This PMTA is for an individual new tobacco product

Supplemental PMTA

This is a group of PMTAs covering
multiple new tobacco products

Cross-referenced Content: Identify Cross-referenced Submission Type as one of the following: Standard PMTA, Tobaccco
Product Master File, or Modified Risk Tobacco Product Application (MRTPA)
New Tobacco Product Name (Provide product name if this Cross-referenced content is relevant to a specific product in
your bundled submission)
Select if this Cross-referenced Content is relevant to all bundled 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., ITP, SE, MRTPA) 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 bundled products
Related Submission STN

Related Submission Type

Formal Meetings Held with FDA pertaining to this tobacco product (For each meeting, as needed, enter the STN number
and meeting held date.)
New Tobacco Product Name
(Provide product name if
meeting is relevant to a
specific product)

Select if this Meeting
is relevant to
all bundled products

Submission STN

Meeting Held Date

For products that have been previously commercially marketed in the U.S., please list the date(s) during which the tobacco
product was marketed.

FORM FDA 4057 (12/21)

Page 6 of 22

SECTION IV - APPLICATION CONTENTS
This application contains the following items (Select all that apply)
Administrative

Scientific Content (see Appendix C for examples and description)

Cover Letter

General Information*

Comprehensive Index*

Descriptive Information*

Table of Contents*

Product Samples**

English* Translations for Non-English Information

Statement of Compliance with 21 CFR part 25*

Request for FDA to refer PMTA to Tobacco Product
Science Advisory Committee (TPSAC)

Summary*
Product Formulation*
Manufacturing*

Labeling and Marketing Plans
Specimens of all Proposed Labelling*

Literature Search*

Description of Marketing Plans*

Organized References
Health Risk Investigations*

Inspections
Location and Contact Information for Each Location Subject to
Potential Inspection

Study Reports*
Other (Specify below)

*Required content and format as per §1114.7 (Standard PMTA), 1114.15 (Supplemental PMTA) and 1114.17 (Resubmission).
**FDA generally expects that product samples will be a required part of a PMTA and that an applicant should be prepared to submit
them in accordance with FDA instructions within 30 days after submitting a PMTA; however there may be situations in which sample
submission may not be necessary (see Appendix C for additional information)

FORM FDA 4057 (12/21)

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SECTION V - MANUFACTURING/PACKAGING/STERILIZATION SITES RELATING TO A SUBMISSION
(Add additional manufacturing/packaging/sterilization 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)

Contact Name
Prefix
(e.g., Mr., Ms., Dr.)

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

ZIP or Postal Code

Country

FAX
First Name
Professional Suffix
(e.g., MD, Ph.D.)

The Manufacturing/Packaging/Sterilization Site is ready for inspection

M.I.

Last Name

Position Title

Yes

No

Section VI - Statements of Compliance with the Federal Food, Drug and Cosmetic (FD&C) Act
Includes a brief description of how the PMTA satisfies content requirements of section 910(b)(1) of the FD&C Act (specify in the table
of contents where the brief description is located)
Includes a brief description of how marketing the new tobacco product would be appropriate for the protection of public health as
determined with respect to the population as a whole, including users and non-users of the tobacco product, and taking into account
the following (specify in the table of contents where the brief description is located)
a.

The increased or decreased likelihood that existing users of tobacco products will stop using such products and;

b.

The increased or decreased likelihood that those who do not use tobacco products will start using such products

FORM FDA 4057 (12/21)

Page 8 of 22

Section VII - Certification Statements
The application must contain the following certifications, as appropriate for the specific type of PMTA, with the appropriate information
inserted, as described in each parenthetical, signed by an authorized representative of the applicant.
1. Certification statement for standard PMTAs
2. Modified tobacco product certification for supplemental PMTAs
3. Same product certification for resubmissions
4. Different product certification for resubmissions
5. Certification Statement of Financial Interests and Arrangements by Clinical Investigators
1. General Application Certification Statement for all applications:*
I, (name of responsible official)

, on behalf of the applicant, (applicant name)
, hereby certify that the applicant will maintain all records to substantiate

the accuracy of this application for the period of time required in 21 CFR 1114.45 and ensure that records remain readily available to
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 or representation in any
matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to criminal
penalties."

Signature

Date

2. Modified tobacco product certification for supplemental PMTAs.*
"I (name of responsible official)

, on behalf of (name of applicant)
, certify that (new tobacco product name)
, has a different (describe each modification to the

product)
than (name of original tobacco product)
described in (STN of PMTA for the original product)
but is otherwise identical to (name of original tobacco product)

.

I certify that (name of applicant)

understands this means

there is no other modification to the materials, ingredients, design, composition, heating source, or any other feature of the original
tobacco product. I also certify that (name of applicant)
will maintain all records that substantiate the accuracy of this application, and ensure that such records remain readily available to FDA
upon request for the period of time required in 21 CFR 1114.45. I certify that this information and the accompanying submission are
true and correct, 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 or representation in
any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States is subject to
criminal penalties."

Signature

FORM FDA 4057 (12/21)

Date

Page 9 of 22

3. Same tobacco product certification for resubmission*
"I (name of responsible official)

, on behalf of (name of applicant)
, certify that this submission for (new tobacco product name)
responds to all deficiencies outlined in the marketing denial order issued in response to (STN of

the previously submitted PMTA)

and the new tobacco product

described herein is identical to the product described in the previously submitted PMTA. I certify that (name of applicant)
understands this means there is no modification to the
materials, ingredients, design, composition, heating source, or any other feature. I also certify that (name of applicant)
will maintain all records that substantiate the accuracy of
this statement, and ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR
1114.45. I certify that this information and the accompanying submission are true and correct, and that I am authorized to submit this
on the company'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 or representation in any matter within the jurisdiction of the executive,
legislative, or judicial branch of the Government of the United States is subject to criminal penalties."

Signature

Date

4. Different tobacco product certification for resubmission*
"I, (name of responsible official)

, on behalf of (name of applicant)
, certify that this submission for (new tobacco product name)
responds to all deficiencies outlined in the marketing denial order issued in response to (STN of

the previously submitted PMTA)

and the new tobacco product described herein

has a different (describe each modification to the product)
than (name of original tobacco product)

described in (STN of the previously submitted PMTA)
but is otherwise identical to (name of original tobacco product)
described in (STN of the previously submitted PMTA)

. I certify that (name of applicant)
understands this means there is no modification to the materials, ingredients, design, composition, heating source, or any other
feature of the original tobacco product, except for the (describe each modification to the tobacco product)
. I also certify that (name of applicant)
will maintain all records that substantiate the accuracy of this statement,
and ensure that such records remain readily available to FDA upon request for the period of time required in 21 CFR 1114.45. I certify
that this information and the accompanying submission are true and correct, and that I am authorized to submit this on the company'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 or representation in any matter within the jurisdiction of the executive, legislative, or judicial branch
of the Government of the United States is subject to criminal penalties."

Signature

FORM FDA 4057 (12/21)

Date

Page 10 of 22

5. Financial Interest and Arrangements of Clinical Investigators Certification Statement*:
"I, (name of responsible official),

on behalf of (name of company)

, certify that there are no financial conflicts of interest or have included
documentation fully disclosing any potential financial conflicts of interest required by 21 CFR § 1114.7(k)(3)(ii).
No, there are no financial conflicts of interest
Yes, there are financial conflicts of interest and documentation is provided (please specify in the table of contents where the
documentation is located)

Signature

Date

*Required certification statement as per proposed§ 1114.7 (Standard PMTA), 1114.15 (Supplemental PMTA) and 1114.17 (Resubmission).

FORM FDA 4057 (12/21)

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SECTION VIII – APPENDICES
Appendix A: New 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. Refer to Appendix B for the list of properties necessary to
uniquely identify a product depending upon the category and sub-category to which that product belongs.
Unique Product Identification
New Tobacco Product
Name: Product A

Properties
(Inserted on form)
Package Type

Box

Product Quantity

20 Cigarettes per box

Diameter

100 mm

Length

6 mm

Ventilation

None

Characterizing Flavor

None

Additional Properties

N/A

Below is an example of multiple new tobacco products.
Unique Product Identification
New Product 1
Name: Product A

New Product 2
Name: Product A

New Product 3
Name: Product A

STN: N/A

STN: N/A

STN: N/A

Box

Box

Box

20 Cigarettes per box

20 Cigarettes per box

20 Cigarettes per box

100 mm

100 mm

100 mm

Length

6 mm

6 mm

6 mm

Ventilation

None

None

None

Characterizing Flavor

None

None

None

Additional Properties

N/A

N/A

N/A

Properties
(Inserted on form)
Package Type
Product Quantity
Diameter

FORM FDA 4057 (12/21)

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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

Bag

Package Quantity

100 g

Characterizing Flavor

None

Additional Properties

Re-sealable Bag

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

Package Type

Name: Product B
Booklet

Package Quantity

100 sheets

Length

100 mm

Width

56 mm

Characterizing Flavor

None

Additional Properties

Black Box

FORM FDA 4057 (12/21)

Page 13 of 22

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 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 IV.
Cigarette Tobacco Products
Sub-Categories

Properties

All Cigarettes
Package Type

X

Product Quantity

X

Diameter

X

Length

X
X

Ventilation

(except non-filtered)

Characterizing Flavor

X

Additional Properties
(if applicable)

X

Roll-Your-Own Tobacco Products
Properties

Sub-Categories
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

X

X

X

X

X

X

Properties

Diameter
Length

X

Ventilation

X

X

Width

X

X

Characterizing Flavor

X

X

X

X

X

X

X

Additional Properties
(if applicable)

X

X

X

X

X

X

X

FORM FDA 4057 (12/21)

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Cigar
Properties

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

Wrapper Material

X

Tip

X

Characterizing Flavor

X

X

X

X

X

X

Additional Properties
(if applicable)

X

X

X

X

X

X

Smokeless Tobacco Products
Properties
Properties

Sub-Categories
Loose Moist Portioned
Snuff
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

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
(if applicable)

X

X

X

X

X

X

X

X

X

FORM FDA 4057 (12/21)

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Electronic Nicotine Delivery System (Vapes)
Properties
Properties

Sub-Categories
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
(if applicable)

X

X

X

X

X

X

Heated Tobacco Products (HTP)
Properties
Properties

Sub-Categories
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

X

Characterizing Flavor

X

X

X

X

X

Additional Properties
(if applicable)

X

X

X

X

X

FORM FDA 4057 (12/21)

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Pipe Tobacco Products
Properties

Sub-Categories

Properties

Component

Pipe

Tobacco
Filler

Other

Package Type

X

X

X

X

Product Quantity

X

X

X

X

X

X

Length

X

Diameter

X

Characterizing Flavor

X

X

Tobacco Cut Size

X

Additional Properties (if applicable)

X

X

X

X

Waterpipe Tobacco Products
Properties

Sub-Categories

Properties

Component

Waterpipe Heat Source

Tobacco
Filler

Other

Package Type

X

X

X

X

X

Product Quantity

X

X

X

X

X

X

X

X

X

X

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

Height

X

Diameter

X

Additional Properties (if applicable)

X

X

Other Tobacco Products
Properties

FORM FDA 4057 (12/21)

Other Sub-Categories

Package Type

X

Product Quantity

X

Characterizing Flavor

X

Additional Properties (if applicable)

X

Page 17 of 22

APPENDIX C
INSTRUCTIONS FOR COMPLETION OF PMTA FORM
This form and the instructions for use are solely intended to provide the applicant an organized format to supply information required for
submission of a Premarket Tobacco Product Application (PMTA)
Section I - Applicant Identification
1.

Provide applicant name (means any person that submits a premarket tobacco product application to receive a marketing granted
order for a new tobacco product)
2. Provide submission date of application
3. Provide name and address information of manufacturer (if different from applicant)
4. Provide the FDA Establishment Identifier (if applicable)
5. Provide the DUNS Number of headquarters (if applicable)
6. Provide applicant address and contact information
7. Provide name of Authorized Representative (responsible official authorized to represent the applicant)
8. Provide Authorized Representative contact information
9. Provide name of U.S. Agent
10. Provide U.S. Agent address and contact information
11. Provide name of alternate point of contact
12. Provide alternate point of contact address and contact information
Section Il - New Tobacco Product Information (Provide information that uniquely identifies the tobacco product)
13. Provide name of tobacco product (full tobacco product name including brand name/sub-brand name or other commercial name used in
commercial distribution)
14. Provide tobacco product category and sub-category
15. Provide tobacco product package type (e.g., can/box/bag)
16. Provide tobacco product quantity
17. Provide co-package information. If an applicant submits an PMTA for a co-packaged tobacco product, the unique identification of this
co-packaged product would include the specific items needed to identify each product within the co-package. For example, if the copackage is a pouch of roll-your-own tobacco filler that contains rolling papers inside the pouch, the applicant would identify the tobacco
product as a co-packaged product and provide the unique identification for both roll-your-own tobacco filler and rolling papers.
18. Provide tobacco product characterizing flavors applicable to the new tobacco product. If you believe that your tobacco product does not
have a characterizing flavor, state "none." For example: Orange and mint can be characterizing flavors
19. Provide tobacco product descriptive properties as required by 21 CFR § 1114.7(c)(3)(iii). For example: The product is a portioned
smokeless tobacco product made using a blend of burley and bright tobacco

20. Provide product properties that uniquely identify the tobacco product as set forth in 21 CFR § 1114.7(c)(3)(iii)

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Section III - Submission Information (Select the submission type(s) that apply to your application)
21. Standard PMTA 21 CFR § 1114.7
• A standard PMTA is a submission from an applicant seeking a marketing granted order to introduce a new tobacco product into
interstate commerce. A standard PMTA contains the full text of the information required by§ 1114.7, except where included by
cross reference to a tobacco product master file or a pending modified risk tobacco application for the same product.
22. Resubmission 21 CFR § 1114.17
• A resubmission is an alternative way of submitting an application that meets the requirements of §1114.7 or §1114.15 to seek a
marketing granted order for a new tobacco product by providing new information to address the deficiencies outlined in a
marketing denial order and cross-referencing applicable content from the denied PMTA. An applicant may submit a resubmission
for the same tobacco product that received a marketing denial order or for a different new tobacco product that results from
changes necessary to address the deficiencies outlined in a marketing denial order.
23. Supplemental PMTA 21 CFR § 1114.15
• A supplemental PMTA may be submitted by an applicant that is seeking authorization for modifications made to a new tobacco
product for which they have already received a marketing granted order. The following are examples of tobacco products
modifications that may be appropriate for a supplemental PMTA:
• Changes in connection type/thread size (e.g., 510)
• Minor Software Changes not affecting device functionality, such as:
• Changes to user interface
• Changes in recording/data capture properties
• Certain changes to account for improvements in electronics technology or to improve use and convenience (e.g., use of haptics
or simplification of device functions like cleaning cycle)
• Minor changes in e-liquid volume, viscosity or boiling temperature
• Minor changes in draw resistance
• Minor changes in air flow rate
• Changes to coil configuration if number of coils, coil gauge, material, and overall coil resistance remain unchanged
• Changes to amount of wicking material
24. If you included content in your PMTA by cross-reference to another submission or a master file, provide cross-reference information.
See 21 CFR §1114.7(b), § 1114.15(b), or §1114.17(b), as applicable, for restrictions on what may be cross referenced.
25. Provide FDA submission tracking numbers (STN) for all previous related request for the new tobacco products
26. Provide previous meeting dates
27. If the product has previously been commercially marketed in the US, provide the date(s) which the tobacco product was
marketed.

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Section IV - Application Contents (The application contains the following items)
Administrative
a. Cover Letter
b. Comprehensive Index (required by 21 CFR § 1114.7(b)(1))
c. Table of Contents (required by 21 CFR § 1114.7(b)(1))
d.
e.

Written in English or accompanied by an English translation for non-English information (required by 21 CFR § 114.7(b)(1)
Optional Request for FDA to Refer PMTA to Tobacco Product Scientific Advisory Committee (required by 21 CFR § 1114.7(c)(5))

Labeling and Marketing Plans
a. Specimens of all proposed labeling (required by 21 CFR § 1114.7(f)(1))
b. Marketing Plans (required by 21 CFR § 1114.7(f)(2))
Inspections
a.

Location and contact information for each location subject to potential inspection (required by 21 CFR § 1114.7(k)(3)(vii))

Scientific Content
a.

General information (e.g., product name, product category, subcategory and product properties) (required by 21 CFR § 1114.7(c))

b.

Descriptive information (required by 21 CFR § 1114.7(d))

c.

Product samples (as required by FDA in accordance with 21 CFR § 1114.7(e))
FDA generally expects that product samples will be a required part of a PMTA and that an applicant should be prepared to submit
them in accordance with FDA instructions within 30 days after submitting a PMTA. There may be situations in which sample
submission may not be necessary, including, in some circumstances, PMTAs that are resubmitted for the same product after a
marketing denial order (such as resubmissions as described in § 1114.17) or PMTAs submitted for modifications to an authorized
product where the modifications do not require review of new samples as part of the PMTA evaluation process. Presubmission
meetings with FDA may help provide additional information about whether product samples will need to be included in a PMTA;
however, in most situations, FDA will only be able to determine the need for product samples after a PMTA is accepted for review.

d.

Statement of compliance with 21 CFR part 25 (e.g. Environmental Assessment) (required by 21 CFR § 1114. 7(g))

e.

Summary (required by 21 CFR §1114.7(h))

f.

Product formulation (e.g., components, ingredients, additives, properties, and principles of operations) (required by 21 CFR §
1114.7(i))

g.

Manufacturing (e.g., methods, facilities, controls) (required by 21 CFR § 1114.7(j))

h.

i.
j.

Literature Search (required by 21 CFR § 1114.7(k)(2))
A literature search is a search of available is a search of available documents that includes: 1) clear search objectives 2) a
description of methodologies used in the search in detail 3) an identification of relevant documents 4) a formal or informal evaluation
of study quality 5) a bibliography of referenced publications.
Organized references used to compile information in the submission
Health Risk Investigations 21 CFR 1114.7(k)
Examples of health risk investigations include but not limited to: Toxicological Risk Evaluation, Health Impact (e.g., use behavior,
health risk), Tobacco Product Perception and Intention Studies

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k.

Study Report(s) - examples of documents include:
• Study protocol
• Statistical analysis plan
• Study report
• Statistical software programming code
• Study instruments (e.g. surveys/questionnaires)
• Informed consent form
• Case Report Forms (as appropriate)
In general Case Report Forms (CRFs) from clinical studies are not needed for filing a PMTA. However, FDA will require for
filing the CFRs from clinical studies that have been made to show the health risks of the PMTA product and whether such
product presents less risk than other tobacco products where the CRF: 1) relates to participant deaths, other serious and
unexpected adverse experiences, or participant discontinuation (including withdrawals) AND 2) where the study participant
was exposed to the tobacco product(s) which is/are the subject of the PMTA(s) or to a similar/related product that the
applicant is using to show that the PMTA product meets the standard for marketing authorization under section 910.
Additional information may be requested on a case-by-case basis during FDA review. FDA expects all CRFs would be
available for review during Agency inspections of clinical and/or nonclinical study sites.
• Analyzable Data sets
In general raw data such as raw chromatograms/spectra/mass spectra arising from analytical chemistry testing and raw
(meaning no integration of the data) output from high-throughput (e.g., genomic) studies are not needed for filing a PMTA. Line
data/analyzable datasets that are representative chromatograms/spectra/mass spectra that demonstrate the adequacy of
separations/specificity, standard solution, and sample solutions should be included. The line data/analyzable data sets may be
used to replicate findings or conduct alternative analyses of the underlying data. Additional information may be requested on a
case-by-case basis during FDA review. FDA expects all raw data would be available for review during Agency inspection of
clinical and/or nonclinical study sites.
• Other

Section V - Manufacturing/Packaging Sites Relating to a Submission
a.
b.
c.
d.
e.
f.
g.
h.

Provide the name of the Manufacturing/Packaging site (required by 21 CFR § 1114.7(j))
Select the appropriate box about company/institution manufacturing/packaging site
Provide Facility Establishment Identifier (FEI) Number (if applicable) (required by 21 CFR § 1114.7(j))
Provide D&B DUNS Number of Headquarters (if applicable)
Provide division name (required by 21 CFR § 1114.7(j))
Provide contact information (required by 21 CFR § 1114.7(j))
Provide information about the inspection readiness of the Manufacturing/Packaging facility
Provide information about additional sites as described in the submittal form, as applicable

Section VI - Statements of Compliance with the Federal Food, Drug and Cosmetic (FD&C) Act
Provide information for how the application meets the requirements and addresses the question(s) in each of the statements according to
the Federal Food, Drug and Cosmetic (FD&C) Act as required by 21 CFR § 1114.7(c)(10) and (11).
Other Information
Identify and provide information for any additional information not captured in the PMTA submittal form that is pertinent to your application
We remind you that all regulatory correspondence can be submitted via the FDA Electronic Submission Gateway (www.fda.gov/esg)
using eSubmitter.
We are unable to accept regulatory submissions by electronic mail.

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This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 45 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

For PRA questions:
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OMB Statement: "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."

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