Tobacco Health Document Submission

Health Document Submission
Requirements for
Tobacco Products (Revised)*
Guidance for Industry
Comments may be submitted at any time for Agency consideration. Electronic comments may be
submitted to http://www.regulations.gov. Alternatively, submit written comments to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061,
Rockville, MD, 20852. All comments should be identified with the docket No. FDA-2009-D-0600.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel)
1-877-CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT.
Additional copies are available online at
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. You
may send an e-mail request to smallbiz.tobacco@fda.hhs.gov to receive an electronic copy of
this guidance. You may send a request for hard copies to U.S. Food and Drug Administration,
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
[Month] [Year]
OMB control number: 0910-0654
Current expiration date
available at
https://www.reginfo.gov
See additional PRA statement in section IV of the guidance
* This is the sixth edition of this guidance, which originally issued in April 2010. Revisions are
noted by date at the end of the guidance.

Contains Nonbinding Recommendations

Table of Contents
I.

INTRODUCTION.................................................................................................................. 1

II. BACKGROUND .................................................................................................................... 2
III. DISCUSSION ......................................................................................................................... 3
A. What Definitions Apply to This Guidance? ................................................................. 3
B. Who Submits Health Documents? ................................................................................ 4
C. What Is FDA’s Compliance Policy for Regulated Tobacco Products? ...................... 5
D. What Information and Documents Are Included With the Tobacco Health
Documents Submission? ................................................................................................ 6
1.

Manufacturer/Importer Identification ....................................................................... 6

2.

Health Documents..................................................................................................... 6

E. How Do You Submit Health Document Information? .............................................. 12

F.

1.

Submitting Health Documents Electronically Using eSubmitter ............................ 12

2.

Submitting Documents When Not Using eSubmitter ............................................... 13

When Do You Submit Tobacco Health Documents?................................................. 14

G. Will FDA Maintain the Confidentiality of the Health Documents You Submit? .... 14
IV. PAPERWORK REDUCTION ACT of 1995 ..................................................................... 15
DOCUMENT HISTORY ............................................................................................................ 16

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Contains Nonbinding Recommendations

Health Document Submission
Requirements for
Tobacco Products (Revised)*
Guidance for Industry1
This guidance represents the current thinking of the Food and Drug Administration (FDA or
Agency) on this topic. It does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff
responsible for this guidance as listed on the title page.

I.

INTRODUCTION

This guidance describes FDA’s current thinking regarding the submission of health-related
documents required by section 904(a)(4) of the Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 387d(a)(4)). This guidance is intended for manufacturers and importers of cigarettes,
cigarette tobacco, roll your own tobacco (RYO), smokeless tobacco and those tobacco products
subject to FDA’s final rule, Deeming Tobacco Products To Be Subject to the Federal Food,
Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control
Act (81 FR 28974) (the deeming rule).
This guidance explains, among other things:
x
x
x
x
x
x
x

The statutory requirement to submit health documents
Definitions
Who should submit health documents
FDA’s compliance policies
What information to include in health document submissions
How to make health document submissions
When to make health document submissions

1

This guidance was prepared by the Office of Regulations and the Office of Science in the Center for Tobacco
Products at FDA.

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Contains Nonbinding Recommendations
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidance documents describe the Agency’s current thinking on a topic,
and should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance documents means that
something is suggested or recommended, but not required.
II.

BACKGROUND

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), enacted on
June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate the
manufacture, marketing, and distribution of tobacco products to protect the public’s health (Pub.
L. 111– 31, 123 Stat. 1776). Among other things, the Tobacco Control Act adds section
904(a)(4) to the FD&C Act, requiring each tobacco product manufacturer or importer, or agents
thereof, to submit all documents developed after June 22, 2009, that relate to any “health,
toxicological, behavioral, or physiological effects of current or future tobacco products, their
constituents (including smoke constituents), ingredients, components, and additives.”2
Upon initial enactment of the Tobacco Control Act the FD&C Act provided FDA authority to
regulate cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), smokeless tobacco, and any
other tobacco products that the Agency by regulation deems to be subject to the law. FDA
issued a final rule to deem products meeting the statutory definition of “tobacco product” to be
subject to the FD&C Act on May 10, 2016 (81 FR 28973), which became effective on August 8,
2016. This final rule extends the Agency’s “tobacco product” authorities to all other categories
of products that meet the statutory definition of “tobacco product” in the FD&C Act, except
accessories of such deemed tobacco products. 3
The definition of “tobacco product” in Section 201 (rr) of the FD&C Act was amended on March
15, 2022, by the Consolidated Appropriations Act, 2022 (CAA) to include products containing
nicotine from any source (Pub. L. 117-103). The term “tobacco product” does not mean an
article that under the FD&C Act is: a drug (section 201(g)(1)); a device (section 201(h)); a
combination product (section 503(g)); or a food (section 201(f)) if such article contains no
nicotine, or no more than trace amounts of naturally occurring nicotine. Section 901(b) of the
FD&C Act, as amended by the CAA, also makes tobacco products containing nicotine not made
or derived from tobacco immediately subject to FDA’s tobacco product authorities under
Chapter IX, without having to be deemed by regulation.
Manufacturers and importers of tobacco products that have been deemed subject to the FD&C
Act, or that contain nicotine not made or derived from tobacco, are now required to comply with
section 904(a)(4), which requires immediate and ongoing submission of health documents.

2

This guidance uses the term health documents to refer to the documents required under section 904(a)(4).
Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule’s deeming
provision. Reference the deeming rule for further information about accessories (81 FR 28974).

3

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Failure to submit the required health documents has consequences. First, under section
903(a)(10)(A) of the FD&C Act (21 U.S.C. 387c(a)(10)(A)), a tobacco product is deemed
misbranded if there is a failure or refusal to comply with any requirement prescribed under
section 904. Additionally, the failure or refusal to furnish any information required by section
904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. 331(q)(1)(B)).
Violations relating to section 904(a)(4) are subject to regulatory and enforcement action by FDA,
including seizure and injunction.
III.

DISCUSSION
A. What Definitions Apply to This Guidance?
FDA intends to use the following definitions in implementing the health document
submission requirements of section 904(a)(4) of the FD&C Act.
x

Component or part: The term component or part means any software or
assembly of materials intended or reasonably expected:
(1)
(2)

to alter or affect the tobacco product’s performance, composition,
constituents, or characteristics; or
to be used with or for the human consumption of a tobacco product.
Component or part excludes anything that is an accessory of a tobacco
product.

FDA notes that component and part are separate and distinct terms within
chapter IX of the FD&C Act. However, for purposes of this guidance, FDA is
using the terms component and part interchangeably and without emphasizing
the distinction. FDA may clarify the distinctions between component and part
in the future.
x

Document: FDA views Federal Rule of Civil Procedure (FRCP) 34 as
providing guidance in this area. Rule 34 defines “documents or electronicallystored information” as including “writings, drawings, graphs, charts,
photographs, sound recordings, images, and other data or data compilations –
stored in any medium from which information can be obtained either directly
or, if necessary, after translation by the responding party into a reasonably
usable form” (Fed. R. Civ. P. 34(a)(1)(A)). FDA understands the term
document in section 904(a)(4) to include the types of documents or
electronically stored information referenced in FRCP Rule 34.
The term document includes any original or any modified version or draft
varying in any way, which is saved or stored separately from other versions
and/or distributed to others.

x

Finished tobacco product: The term finished tobacco product means a tobacco
product, including all components and parts, sealed in final packaging intended
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x
x

x

for consumer use (e.g., filters or filter tubes sold separately to consumers or as
part of kits).
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.
Small-scale tobacco product manufacturer: The term small-scale tobacco
product manufacturer means a manufacturer of any regulated tobacco product
that employs 150 or fewer full-time equivalent employees and has annual
total revenues of $5 million or less. FDA considers a manufacturer to include
each entity that it controls, is controlled by, or is under common control with.
Tobacco product is defined in section 201(rr) of the FD&C Act, which states
in relevant part:
(1)

(2)

The term “tobacco product” means any product made or derived from
tobacco, or containing nicotine from any source, 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).
The term “tobacco product” does not mean an article that is a drug
(section 201(g)(1)), a device (section 201(h)), a combination product
(section 503(g)), or a food (section 201(f)) if such article contains no
nicotine, or no more than trace amounts of naturally occurring nicotine.

Note that this definition includes accessories and components and parts of
tobacco products, whether they are made or derived from tobacco or nicotine
and whether they are sold or distributed as finished tobacco products.4
x

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

B. Who Submits Health Documents?
Section 904(a)(4) provides, in pertinent part:

4

However, accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule’s
deeming provision (see note 3). Thus, although they meet the definition of tobacco product, such accessories
are not currently subject to regulation under the FD&C Act (including section 904(a)(4)). See section III.C for
details on FDA’s compliance policy for tobacco products that are sold or distributed solely for further
manufacturing.

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(a) Requirement—Each tobacco product manufacturer or importer, or agents
thereof, shall submit to the Secretary the following information:
(4) Beginning 6 months after the date of enactment of the Family Smoking
Prevention and Tobacco Control Act, all documents developed after such date of
enactment that relate to health, toxicological, behavioral, or physiologic effects of
current or future tobacco products, their constituents (including smoke
constituents), ingredients, components, and additives
Section 904(a)(4) requires “[e]ach tobacco product manufacturer or importer” to
submit health documents. We interpret this to mean that for products made in the
United States, health documents related to current or future tobacco products are to
be submitted by the manufacturer. For products made outside of the United States,
health documents for tobacco products that are or will be imported are to be
submitted by either the foreign manufacturer or the importer of the product. The
foreign manufacturer and the importer or importers of the product should work
together to ensure that the health documents are submitted to FDA as required by
section 904(a)(4).
C. What Is FDA’s Compliance Policy for Regulated Tobacco Products?
At this time, with respect to all tobacco products, — including tobacco products
now regulated as a result of the deeming rule, FDA intends to enforce the health
document requirements of section 904(a)(1) with respect to finished tobacco
products only. FDA does not, at this time, intend to enforce these requirements with
respect to products that are sold or distributed solely for further manufacturing.
As defined above, the term finished tobacco product means a tobacco product,
including all components and parts, sealed in final packaging intended for consumer
use (e.g., filters or filter tubes sold separately to consumers or as part of kits).
Components and parts that are sold separately from other tobacco products are also
finished tobacco products if they are sold in final packaging intended for consumer
use. FDA intends to enforce the health document requirements under section
904(a)(4) with respect to these products. Examples of components and parts that are
sold or may be sold as finished tobacco products include pipe tobacco filler, filter
tubes, e-cigarette batteries, and e-liquids, whether sold separately to consumers or
as part of kits.5

5

As explained in note 3, the Secretary has not deemed accessories of tobacco products other than cigarettes,
cigarette tobacco, RYO, and smokeless tobacco to be subject to chapter IX of the FD&C Act, and so they are not
currently subject to section 904(a)(4).

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D. What Information and Documents Are Included With the Tobacco
Health Documents Submission?
1. Manufacturer/Importer Identification
You should include the following information about the entity making the
submission:
x
x
x
x
x
x

The name and address of the business entity
Whether the entity is a manufacturer or an importer
The name, title, and contact information for a point-of-contact, including an
address, telephone number, and fax number
An email address for the point-of-contact, to facilitate communication about
your submission
The FDA facility establishment identifier (FEI) number assigned to your
establishment, if any6
The Data Universal Numbering System (D-U-N-S) number assigned to your
business entity7

If the submission is made by the importer of a foreign product, you should also
include the following information about the manufacturer of the imported product:
x
x
x
x
x

The name and address of the business entity
The name, title, and contact information for a point-of-contact at the
manufacturer, including an address, telephone number, and fax number
An email address for the point-of-contact at the manufacturer
The FEI number assigned to the manufacturer’s establishment by FDA, if any
The D-U-N-S number assigned to the business entity or, if you do not have a
D-U-N-S number, a unique identifier (code) of your business entity

2. Health Documents
Under section 904(a)(4) of the FD&C Act, documents developed after June 22,
2009, that relate to health, toxicological, behavioral, or physiologic effects of
current or future tobacco products, their constituents (including smoke
constituents), ingredients, components, and additives, are responsive to the health
6

In most cases, FDA assigns an FEI number after receiving the establishment’s initial registration submission
required under section 905 of the FD&C Act (21 U.S.C. 387e).
7
D-U-N-S is the unique business identifier recognized by the FDA Data Standards Council. D-U-N-S Numbers are
proprietary to, and controlled by, Dun & Bradstreet (D&B). If the D-U-N-S number for a location has not been
assigned, a business may obtain one for no cost directly from D&B (http://www.dnb.com). Please note that
registrants who wish to obtain a new D-U-N-S number should obtain one well in advance of FDA’s deadline,
because it may take 30 days (or longer) to process a new number. Alternatively, you may elect to receive a D-U-N-T
number within one business day by paying a fee. If you do not have a D-U-N-S number, include a unique identifier
(code) of your business entity.

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document submission requirement. We discuss FDA’s interpretation of the statute
and the Agency’s compliance policies in the following paragraphs.
FDA interprets “health, toxicological, behavioral, or physiologic” broadly to
include, for example, cell-based, tissue-based, animal, or human studies,
computational toxicology models, information on addiction, intentions to use,
cognition, emotion, motivation, and other behavioral effects at both the populationlevel (epidemiology) as well as the individual level (such as abuse liability).
For tobacco products subject to the deeming rule, FDA understands “current or
future tobacco products” to refer to products commercially distributed on or after
August 8, 2016, or products in any stage of research or development at any time
after August 8, 2016, including experimental products, and developmental products
intended for introduction into the market for consumer use.
For cigarettes, cigarette tobacco, RYO, and smokeless tobacco, FDA understands
“current or future tobacco products” to refer to products commercially distributed
after June 22, 2009, or products in any stage of research or development at any time
after June 22, 2009, including experimental products, and developmental products
that were intended for introduction into the market for consumer use.
Section 904(a) applies to “all documents developed” after June 22, 2009, whether
the document is developed by you or by any other party. A document is developed
when it is created or modified in any way. Thus, a document that was first created
before June 22, 2009, but was updated or revised after that date, is responsive to
section 904(a)(4).
FDA intends to enforce section 904(a)(4) with respect to documents in the
possession, custody, or control of the manufacturer (in the case of domestic
products) or either the manufacturer or importer (in the case of imported products),
only. For documents relating to tobacco products that are or will be imported, the
required tobacco health documents are to be submitted by either the foreign
manufacturer or the importer of the product. Thus, where the importer makes the
submission, the importer should work with the manufacturer to ensure that the
submission includes documents in the possession, custody, or control of the
manufacturer.
Because of the inefficiencies associated with processing and reviewing duplicative
documents, substantively identical documents, or publicly available information,
FDA does not intend, at this time, to enforce section 904(a)(4) with respect to the
following:
x
x

Documents that are exact duplicates of another document that is included in the
same or a prior submission under section 904(a)(4)
Documents that are substantively identical to another document that is included
in the same or a prior submission under section 904(a)(4), where any

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x
x

a.

differences are minor and do not affect the meaning or substance of the
document (e.g., changes in formatting, spelling, pagination, and letterhead)
Redacted documents, where an unredacted copy of the same document is
included in the same or a prior submission under section 904(a)(4)8
Unaltered or unmarked documents, written in English, that fall into the
following categories:
•
Articles published in peer-reviewed journals
•
Published news articles, books, and other documents available to
the general public
•
Material Safety Data Sheets (MSDS)
•
HHS correspondence
Document Identification

Section 904(a)(4) requires that you submit documents that relate to health,
toxicological, behavioral, or physiologic effects of current or future tobacco
products, their constituents (including smoke constituents), ingredients,
components, and additives. FDA understands section 904(a)(4) to mean that you are
to organize and label the documents in your submission to correspond to the
categories of documents set out in section 904(a)(4), as follows:
i.

Health, toxicological, behavioral, or physiologic effects

Each document is to be identified as to whether the content relates to health,
toxicological, behavioral, or physiologic effects. Many documents may relate to
more than one of these topics, e.g., a document relating to the health and behavioral
effects of nicotine. You are to identify all relevant topics for each document.
Examples of documents that relate to health, toxicological, behavioral, or
physiologic effects may include but are not limited to:
x
x
x
x

8

Estimates of the impact of the assessed tobacco product on the health of both
users and nonusers of the tobacco product
The potential for a tobacco product or its constituents to cause acute and
chronic toxicity
Information to address known tobacco target organs of toxicity, as appropriate
for the product and/or route of administration
The toxicological profile of the current or future tobacco products including
information regarding the ingredients, additives, and harmful and potentially
harmful constituents (HPHCs) relative to the route of administration and the
range of the potential levels of exposure, resulting from the use of or other
exposure to the product

See section III.D.2.b regarding redacted documents.

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x
x
x

ii.

Discussion of the toxicological effects of any leachables and extractables from
the container closure system and the ingredient mixture, such as additive or
synergistic effects
Characterization of tobacco product design parameters and toxic effects of
HPHCs from any finished tobacco products to which users and nonusers may
be exposed
Discussion of the increased or decreased likelihood of changes in tobacco
product use behavior, including switching (e.g., complete transition to a
different tobacco product), initiation, cessation, and polyuse by tobacco
product users, including youth, young adults, and other relevant vulnerable
populations.
Identify tobacco products, constituents, ingredients, components, and additives

Each document is to be identified as to the name of each tobacco product (current
and future), ingredient, additive, component, and constituent (including constituents
from tobacco product emissions, such as in smoke or aerosol, which some refer to
as vapor) to which the document relates. Each marketed tobacco product must be
identified as necessary to distinguish it from any other product (e.g., by brand,
subbrand, characterizing flavor, size, package type, product quantity). Any tobacco
product in research or development should be referenced using a unique, consistent
identifying name. Many documents may relate to more than one product,
constituent, ingredient, component, and additive. You are to identify all relevant
tobacco products, constituents (including smoke constituents), ingredients,
components, and additives for each document.
iii. Consistent Terminology
You should use consistent terminology to identify tobacco products, constituents,
ingredients, components, and additives across all of the documents in your
submission. FDA also recommends the following practices to identify products,
constituents, ingredients, components, and additives:
x

x
x

Identify a constituent or ingredient with a unique, consistent, identifying name
that distinguishes it from similar or related materials, according to the
framework described in the guidance for industry Listing of Ingredients in
Tobacco Products.9
If a document relates to a class of constituents, ingredients, components, and
additives (e.g., tobacco specific nitrosamines), identify the class to which the
document relates.
If a document relates to more than one current or future tobacco product or an
entire class of tobacco products, identify the product category (e.g., ENDS,

9

FDA’s guidance for industry Listing of Ingredients in Tobacco Products is available on the Tobacco Products
guidance Web site at https://www.fda.gov/regulatory-information/search-fda-guidance-documents

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cigars, waterpipe, pipes, cigarettes, roll-your-own, and smokeless) to which the
document applies.
You should use consistent terminology in your submissions under section 904(a)(4)
and sections 904(a)(1), 904(c) and 905 in order for FDA to verify that all
requirements have been met.
b.

Document Readability and Accessibility

To ensure accessibility of your documents and facilitate more fluent and efficient
communication between you and FDA regarding your submissions, FDA
recommends that you ensure that your documents meet the following criteria:
x

x

x
x

Unredacted. Ensure that your documents are not redacted. If you have more
than one version of a document, be sure to submit an unredacted version. If
there is no unredacted version in your possession, custody or control, you
should submit all redacted versions of the document.
Page numbered. Ensure that the pages of each document in your submission
are numbered consecutively so that FDA is able to determine that there are no
pages missing. in a document and that the pages are in proper order. If your
documents have Bates numbers, the Bates numbers may serve as page numbers
for this purpose.
Translated. Translate all foreign language documents into English.
Glossary. Create and submit a consolidated glossary or explanation of any
abbreviations, jargon, or internal names (e.g., code names).

The documents in your submission should be saved in file formats that FDA can
readily process, read, and archive. These formats include portable document format
(PDF), plain text (TXT), comma-separated values (CSV), rich text format (RTF),
SAS export (XPT), AVI, TIFF, JPG, GIF, HTML, XML, and similar formats
established by the National Archives and Records Administration for preservation
of document content and format. You can find more information on file formats in
the FDA eSubmitter User Manual, available at https://www.fda.gov/industry/fdaesubmitter/using-esubmitter-prepare-tobacco-product-submissions.
FDA asks that spreadsheets or datasets be submitted both in PDF and in a file type
and structured format that allows for meaningful review and analysis of the data
such as Excel (XLS), CSV, or XPT file formats. Where relevant, data submissions
should be accompanied by the name and version of software used to create the file,
names and definitions of variables, and copies of programs and macros needed to
generate your analyses. We request that your submission include any data analyses
that stratify scientific results by sex, race/ethnicity, age, health condition, and other
similar factors.
FDA recommends that you submit documents in a digital format file that is text
selectable and searchable. If you scan paper documents to PDF, you should perform
optical character recognition (OCR). If you do not save the document as a PDF file
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with selectable and searchable text, provide the OCR extracted searchable text as a
separate text file. The text file should be named the same as the PDF file and
included in the load file.
c.

Document Metadata Included in a Load File

Metadata is information, or data, about each document or set of documents.
Metadata provides structure and context for the information contained within the
document. Whether or not you are using eSubmitter, you should submit the
document information and metadata specified below in an index referred to as a
“load file.” The load file should be in electronic CSV format and include the
information for each document, as below:
x
x
x
x
x
x
x
x
x
x

x
x
x
x
x
x

Filename
Document date
Document author(s)
Document recipient(s)
Document custodian, i.e., the individual with physical control of the document
Document title, subject, or identification number
Beginning and ending page numbers, or Bates numbers, if the document is
Bates stamped
Page number or Bates number ranges for other documents physically or
digitally attached to the document, e.g., an attachment to an email
Document type, using one of the following descriptions: Email, Briefing
Slides, Publication, Memo, Report, Meeting Minutes, Proposal, Study Design,
Teleconference, Lab Notes, Other
We also request that you identify the presence of the document in the
University of California San Francisco Truth Tobacco Documents database10
as one of the following: present with the Bates number range (begin Bates
number to end Bates number), not present, or unknown.
Whether the content relates to health, toxicological, behavioral, or physiologic
effects of tobacco products11.
The name of each tobacco product the document relates to.
The category or categories of products the document relates to.
Any specific ingredients, constituents, components, and additives to which the
document relates
Any classes of ingredients, constituents, components, and additives to which
the document relates
The extracted or OCR text for any documents that you submitted in a format
that does allow for searching, selecting, or copying text.

10

The Truth Tobacco Documents database is online at https://industrydocuments.library.ucsf.edu/tobacco/.
If a document relates to more than one of these subjects, you should identify all those subjects that are related to
the document.

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E. How Do You Submit Health Document Information?
Although electronic submission is not required, FDA strongly encourages you to
send your submission electronically via eSubmitter, FDA’s electronic submission
tool. Electronic submission reduces paper and facilitates an efficient (and timely)
submission on your end, and efficient processing, review, and archiving of the
submission once at FDA. As discussed above, FDA also strongly encourages you to
submit the documents in an electronic format that is text searchable and selectable.
You should do the following to ensure that FDA is able to access the information in
your electronic submission:
x
x
x

x

x

Identify the document format and any software used to create the document
production (and associated load file).
Provide contact information for your IT professionals who, if needed, can
provide technical details about your submission.
Ensure that no part of the submission is encrypted, password protected, or that
any document protection or restriction settings are active. For example, settings
should allow for printing, selecting text and graphics, and adding or changing
notes and form fields.
Ensure that any and all files submitted to FDA are computer virus-free. Include
a statement confirming that all the media is virus-free, along with a description
of the software (name, version, and company) used to check the files for
viruses.
Ensure the files are in formats that FDA can readily process, read, and archive,
as described in section III.D.2.b (Document Readability and Accessibility).

If you choose to not use eSubmitter, read and follow the instructions for Form FDA
3743. Form FDA 3743 and all tools and forms for preparing your submission are
available at:
https://www.fda.gov/tobacco-products/manufacturing/electronic-submissions-tobaccoproducts
1. Submitting Health Documents Electronically Using eSubmitter
The FDA eSubmitter tool is software provided by FDA for the preparation of
electronic submissions. This tool provides an automatic acknowledgement of FDA
receipt and allows users to attach large numbers of files, such as PDF documents.
To use eSubmitter, first download the tool from the FDA Web site at
http://www.fda.gov/ForIndustry/FDAeSubmitter and install it on your computer.12
Select the “CTP Tobacco Health Document Submission” form within the
eSubmitter program and enter information about your submission directly into the
software. This includes the information described in III.D.1-2 (What is Included in
12

The eSubmitter tool requires a computer that runs MS Windows.

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Contains Nonbinding Recommendations
the Submission of Tobacco Health Documents). You will not need to prepare
additional documents with this information, and you will not need to complete
Form FDA 3743.
You can then use eSubmitter to enter data, attach files, and upload the completed
submission through the CTP Portal Next Generation or FDA Electronic
Submissions Gateway (ESG). You will need to apply for a free account to upload
data through either the CTP Portal Next Generation (https://ctpportalng.fda.gov/portal/) or ESG. Due to the time needed to create new accounts, FDA
urges submitters to apply for accounts several weeks in advance of when you intend
to submit. The CTP Portal Next Generation and ESG are both available 24 hours a
day, 7 days a week.
2. Submitting Documents When Not Using eSubmitter
If you choose not to use eSubmitter, you should produce your entire submission on
a hard drive, CD, DVD, or USB drive, depending on the overall size of the
submission. The disk or drive should include the following:
x
x
x
x

The identifying information described in section III.D.1
(Manufacturer/Importer Identification)
The health documents, submitted as individual files
A load file containing document-level information and metadata, as described
in section III.D.2.c (Document Metadata Included in a Load File)
FDA Form 3743

Label digital media and any containers, including, e.g., envelopes, boxes, or volume
jackets, with the following information:
x
x
x
x
x
x

The name of the manufacturer or importer making the submission
The business entity’s DUNS number
The name and phone number for a point-of-contact
The statutory provision, i.e., section 904(a)(4)
The date of submittal
A series number (e.g., “disc 1 of 2,” “box 4 of 4”)

Send your electronic media or paper documents to the following address:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Although FDA strongly encourages electronic submission, FDA Form 3743 should
be submitted with any paper documents and delivered to the above address.
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Contains Nonbinding Recommendations
Submissions delivered to CTP’s Document Control Center by couriers or physical
mail will be considered timely if received during delivery hours on or before the
due date (see); if the due date falls on a weekend or holiday, the delivery must be
received on the prior business day. We are unable to accept regulatory submissions
by e-mail.
F. When Do You Submit Tobacco Health Documents?
FDA’s Compliance Policy for Health Document Submissions
Submit Health
Documents that
Relate to …

. . . and That Were
Developed

Current or future
finished tobacco
products

Between
June 23, 2009, and
December 31, 2009

Compliance Date

Retention Policy

At least 90 days
prior to delivery for
introduction into
interstate commerce

Preserve all health
documents including those
that relate to products for
further manufacturing and
including those developed
after December 31, 2009, for
future submission to FDA.

Although FDA does not intend to take enforcement action with respect to the
submission of documents developed after December 31, 2009, currently, FDA does
intend to collect health documents developed after December 31, 2009, in the
future. At that time, FDA will publish additional guidance specifying the details and
timing of subsequent submissions. Note that you are to preserve tobacco health
documents developed after December 31, 2009, for future submission to FDA.
Failure to submit tobacco health documents developed after December 31, 2009,
because of a failure to preserve them will constitute a violation of section 904(a)(4).
If you do not have any health documents to report, you should inform FDA of
this. You may use FDA Form 3743 or the eSubmitter tool to make this notification.
If you do not anticipate having any health documents to submit in the future, you
may state this in a single section 904(a)(4) submission. You remain obligated,
however, to preserve any documents covered under section 904(a)(4) of the FD&C
Act should they be developed at a later date.
G. Will FDA Maintain the Confidentiality of the Health Documents You Submit?
Information submitted under section 904(a)(4) may include a company's nonpublic
trade secret or confidential commercial information. Several laws govern the
confidentiality of that information, including section 301(j) and section 906(c) of
the FD&C Act, the Trade Secrets Act (18 U.S.C. 1905), and the Freedom of

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Contains Nonbinding Recommendations
Information Act (FOIA) (5 U.S.C. 552), as well as FDA’s implementing
regulations.
Section 906(c) prohibits FDA from disclosing any information reported to or
otherwise obtained by FDA under section 904(a)(4), among other provisions, if that
information is confidential commercial or trade secret information exempt from
disclosure under FOIA Exemption 4 (5
U.S.C. 552(b)(4)). The provision contains exceptions allowing disclosure of the
information to other officers or employees concerned with carrying out chapter IX
of the FD&C Act and, when relevant, in any proceeding under chapter IX of the
FD&C Act.
Section 301(j) generally prohibits the release of trade secret information obtained
by FDA under section 904(a)(4), among other provisions, outside of the Department
of Health and Human Services, except to courts when relevant in any judicial
proceeding under the FD&C Act and to Congress in response to an authorized
Congressional request.
FDA’s general regulations concerning the public availability of FDA records are
codified at 21 CFR part 20.
IV.

PAPERWORK REDUCTION ACT of 1995

This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 50 hours per
response, including the time to review instructions, search existing data sources, gather the data
needed, and complete and review the information collection. Send comments regarding this
burden estimate or suggestions for reducing this burden 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

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An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. The OMB control
number for this information collection is 0910-0654. To find the current expiration date,
search for this OMB control number at https://www.reginfo.gov.
DOCUMENT HISTORY
April 2010 — First edition of guidance issued.
November 2016 — Health Document Submission Requirements guidance revised to reflect
changes in FDA authorities over “deemed” tobacco products. Revisions include minor clarifying
and editorial changes to promote consistency throughout our guidances, incorporate “plain
language,” and employ grammatically correct phrasing. Specific revisions include the following:
x

Section II — Background updated to reflect changes in FDA authorities over “deemed”
tobacco products arising from “deeming” rule.

x

Section III.A — Definitions of component or part, finished tobacco product, and smallscale tobacco product manufacturer added, definition of pouch removed, definition of
importer updated.

x

Section III.C — Information on FDA’s compliance policy for regulated tobacco products
added; compliance policy for cigarettes, cigarette tobacco, RYO, and smokeless tobacco
amended.

x

Section III.D — Former section C retitled and is now section D.

x

Section III.D — Information to identify the manufacturer/importer updated.

x

Section III.D.1 — Information on Data Universal Numbering System updated.

x

Section III.D.2.a — Section reorganized and subsection titles added.

x

Section III.D.2.b — “Document Readability and Accessibility” updated.

x

Section III.D.2.c — Subsection retitled “Document Metadata Included in a Load File” and
updated.

x

Section III.E — Former section D is now section E and subsections 1 and 2 added.

x

Section III.F — Former section E is now section F and updated to include newly deemed
tobacco products.

x

Section III.G — Former section F titled revised and is now section G.

x

Section IV — PRA section updated
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Contains Nonbinding Recommendations
October 2017 — Revised compliance dates (1) to reflect compliance dates in the “Extension of
Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule” guidance
issued in August 2017 and (2) to provide a six-month extension for small-scale tobacco product
manufacturers in areas affected by recent natural disasters.
September 2022 – Health Document Submission Requirements guidance revised to reflect
ending of compliance deadlines. Revisions include minor clarifying and editorial changes to
promote consistency throughout our guidances, incorporate “plain language,” and employ
grammatically correct phrasing. Specific revisions include the following:
x

Section II — Background reorganized and updated to reflect changes in compliance period
for the immediate and ongoing submission requirement. An amendment to the definition of
tobacco product added.

x

Section III.A — Definition of tobacco product updated.

x

Section III.C — Information on FDA’s compliance policy for regulated tobacco products
updated.

x

Section III.D.2 — Expands on FDA’s examples of “health, toxicological, behavioral, or
physiologic” effects.

x

Section III.D.2.a.i — Includes examples of documents that relate to health, toxicological,
behavioral, or physiologic effects.

x

Section III.D.2.c — Information on “Document Metadata Included in a Load File” updated.

x

Section III.F — Information on “When Do You Submit Tobacco Health Documents”
updated.

March 2023 – Health Document Submission Requirements revisions include minor clarifying
and editorial changes to promote consistency throughout our guidances and also include the
following:
x

Section III. A — Definition of tobacco product updated to reflect statutory amendments
made by the Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among other things,
the legislation amends the definition of “tobacco product” in section 201(rr) of the FD&C
Act to include products “containing nicotine from any source.”

x

Section III.C- Guidance is revised to include references to deemed tobacco products to
avoid confusion about the scope of products that are subject to the Deeming Rule.

x

Section III.F- Guidance is revised to include references to deemed tobacco products to avoid
confusion about the scope of products that are subject to the Deeming Rule.

[DATE YEAR] – Revised references to current FDA websites (1) Tobacco guidance (2)
Information and forms for submission preparation (3) CTP Portal Next Generation and (4)
CTP’s Document Control Center.
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