Tobacco Health Document Submission Guidance

Health Document Submission
Requirements for Tobacco
Products
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) 1-877CTP-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 [email protected] 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
November 2016
OMB control number: 0910-0654
Expiration Date: 06/30/2019
See additional PRA statement in section IV of the guidance

* This is the first revision to the first edition of this guidance, which 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....................................................................................................................... 7
E. How Do You Submit Health Document Information? ........................................................... 11
1. Submitting Health Documents Electronically Using eSubmitter ................................................. 12
2. Submitting Documents When Not Using eSubmitter................................................................... 12
F. When Do You Submit Tobacco Health Documents? ............................................................. 13
1. Tobacco Products Other Than Cigarette, Cigarette Tobacco, RYO, and Smokeless Tobacco ..... 13
2. Cigarettes, Cigarette Tobacco, RYO, and Smokeless Tobacco ................................................... 14
G. Will FDA Maintain the Confidentiality of the Health Documents You Submit? .................. 15

IV.

PAPERWORK REDUCTION ACT OF 1995...............................................................16

DOCUMENT HISTORY ........................................................................................................17

i

Health Document Submission
Requirements for Tobacco Products
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:
•

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

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic, and
should be viewed only as recommendations, unless specific regulatory or statutory requirements
1

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

1

are cited. The use of the word should in Agency guidances 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
Cigarettes, cigarette tobacco, RYO, and smokeless tobacco were immediately covered by FDA’s
tobacco product authorities in chapter IX of the Act, including section 904, when the Tobacco
Control Act went into effect. As for other types of tobacco products, section 901(b) of the
FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those products subject to chapter
IX of the FD&C Act. Pursuant to that authority, FDA issued a proposed rule seeking to deem all
other products that meet the statutory definition of “tobacco product” set forth in section 201(rr)
of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories of those products) (79 FR 23142,
April 25, 2014).3 After review and consideration of comments on the proposed rule, the final
rule published on May 10, 2016, (81 FR 28974) (the deeming rule) with the effective date of
August 8, 2016. Manufacturers and importers of tobacco products that have been deemed
subject to the FD&C Act are now required to comply with section 904(a)(4), which requires
immediate and ongoing submission of health documents. However, as explained in the preamble
to the deeming rule, FDA generally does not intend to enforce the requirement at this time with
respect to all such health documents relating to the newly deemed tobacco products (i.e., other
than cigarettes, cigarette tobacco, RYO, and smokeless tobacco), so long as a specified set of
documents are submitted by February 8, 2017, or in the case of small-scale tobacco product
manufacturers (small-scale manufacturers), by August 8, 2017 (81 FR 28974 at 29008-09).
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.

2

This guidance uses the term health documents to refer to the documents required under section 904(a)(4).

3

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).

2

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.
•

Component or part: The term component or part means any software or assembly of
materials intended or reasonably expected:
(1) to alter or affect the tobacco product’s performance, composition, constituents, or
characteristics; or
(2) to be used with or for the human consumption of a tobacco product.
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.

•

Document: FDA views Federal Rule of Civil Procedure (FRCP) 34 as providing
guidance in this area. Rule 34 defines “documents or electronically-stored 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.

•

Finished tobacco product: 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).

•

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.

3

•

Tobacco product is defined in section 201(rr) of the FD&C Act, which states in relevant
part:
(1) The term “tobacco product” means any product made or derived from
tobacco that is intended for human consumption, including any
component, part, or accessory of a tobacco product (except for raw
materials other than tobacco used in manufacturing a component, part, or
accessory of a tobacco product).
(2) The term “tobacco product” does not mean an article that is a drug under
[section 201(g)(1)], a device under [section 201(h)], or a combination
product described in section 503(g) [of the FD&C Act].
Note that this definition includes accessories and components and parts of tobacco
products, whether they are made or derived from tobacco and whether they are sold or
distributed as finished tobacco products. 4

•

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:
(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.

The discussion below provides FDA’s current thinking with respect to the application of section
904(a)(4) to tobacco products deemed subject to FDA authority (those tobacco products other
than cigarettes, cigarette tobacco, RYO, and smokeless tobacco) and to tobacco products that
were immediately covered by FDA’s tobacco product authorities (cigarettes, cigarette tobacco,
RYO, and smokeless tobacco).
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
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.

4

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 cigarettes, cigarette tobacco, RYO,
and smokeless tobacco, as well as other 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
Based on our experience with cigarettes, cigarette tobacco, RYO and smokeless tobacco, we are
amending our previous compliance policy. Under our previous policy, FDA intended to enforce
the health document requirements with respect to manufacturers and importers of tobacco,
papers, filters, and pouches whether or not the products were for further manufacturing of, or for
consumer use as, regulated tobacco products. However, FDA is announcing a change to that
policy because we believe we can obtain the necessary information about tobacco product
components and parts through other means, such as premarket applications and health documents
for finished tobacco products and through the use of master files, as explained in the Master File
guidance. 6
Additionally, we are aligning our compliance policy for cigarettes, cigarette tobacco, RYO, and
smokeless tobacco with the products now regulated as a result of the deeming rule to reduce
burden on industry. Should FDA find that additional information is needed to protect the public
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).

6

FDA’s guidance for industry Tobacco Product Master Files is available on the Tobacco Products guidance Web
site at http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

5

health, the Agency may reconsider this compliance policy. We intend to communicate any such
compliance policy changes by guidance or rulemaking. Accordingly, you are to preserve
tobacco health documents relating to components and parts for future submission to FDA.
Failure to submit tobacco health documents relating to components and parts because of a failure
to preserve them will constitute a violation of section 904(a)(4).
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:
•

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
any 7

•

The Data Universal Numbering System (D-U-N-S) number assigned to your business
entity8

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:
•

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

7

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).

8

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-S 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.

6

•

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 heath 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 population-level (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:

7

•

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 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) 9

•

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
a.

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.
ii.

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,
9

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

8

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:
•

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. 10

•

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, 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:
•

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,
10

FDA’s guidance for industry Listing of Ingredients in Tobacco Products is available on the Tobacco Products
guidance Web site at http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

9

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
http://www.fda.gov/downloads/ForIndustry/FDAeSubmitter/UCM449686.pdf.
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 gender, 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 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:
•

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

10

•

We also request that you identify the presence of the document in the University of
California San Francisco Truth Tobacco Documents database 11 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 products12.

•

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.
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:

11

•

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.

The Truth Tobacco Documents database is online at https://industrydocuments.library.ucsf.edu/tobacco/.

12

If a document relates to more than one of these subjects, you should identify all those subjects that are related to
the document.

11

•

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:
http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/manufacturing/d
efault.htm
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. 13 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 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 or FDA Electronic Submissions Gateway (ESG). You will need to apply
for a free account to upload data through either the CTP Portal
(https://ctpportal.fda.gov/ctpportal/login.jsp) 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 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:
•
•
•
•

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:
• The name of the manufacturer or importer making the submission
13

The eSubmitter tool requires a computer that runs MS Windows.

12

•
•
•
•
•

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.
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
http://www.fda.gov/tobaccoproducts/aboutctp/contactus/default.htm); 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 recognizes the challenges associated with the collection, review, organization, and
production of documents. We also recognize that additional time may be necessary for you to
produce documents in a digital format, as FDA strongly encourages you to do. FDA is taking an
incremental approach to enforcing this provision with respect to the time frame that documents
were developed and the date that documents must be submitted. However, FDA intends to
expand these compliance policies in the near future to further pursue the important public health
goals of this provision. Accordingly, FDA has adopted the following compliance policies.
1.

Tobacco Products Other Than Cigarette, Cigarette Tobacco, RYO, and Smokeless
Tobacco

FDA adopted a compliance policy to apply to health documents that relate to tobacco products
that are subject to the deeming rule. For this group—which includes all regulated tobacco
products, except for cigarettes, cigarette tobacco, RYO, and smokeless tobacco—FDA does not
intend to enforce section 904(a)(4) until February 8, 2017, or at least 90 days prior to the
delivery for introduction into interstate commerce of the tobacco product to which the health
document relates, whichever is later. Moreover, although section 904(a)(4) requires ongoing
submission of health documents, at this time, FDA does not intend to enforce section 904(a)(4)
with respect to documents developed after December 31, 2009. Instead, at this time, FDA

13

intends to enforce section 904(a)(4) with respect to health documents developed between June
23, 2009, and December 31, 2009.
● Small-Scale Manufacturers
As stated in the preamble to the deeming rule, to address concerns of small-scale manufacturers,
and in recognition of FDA’s current enforcement priorities, at this time, FDA does not intend to
enforce section 904(a)(4) against small-scale manufacturers until August 8, 2017, or at least 90
days prior to the delivery for introduction into interstate commerce of tobacco products to which
the health documents relate, whichever is later. At such time, FDA intends to enforce section
904(a)(4) with respect to documents developed between June 23, 2009, and December 31, 2009.
FDA’s Compliance Policy for Health Document Submissions
(for Products Other Than Cigarettes, Cigarette Tobacco, RYO, and Smokeless Tobacco)
Submit Health Documents
that Relate to …

. . . and That Were
Developed

Compliance Date
February 8, 2017

Current or future finished
tobacco products

Between
June 23, 2009, and
December 31, 2009

August 8, 2017, for smallscale manufacturers
Otherwise, at least 90 days
prior to delivery for
introduction into interstate
commerce

Retention Policy
Preserve all health
documents, including
those that relate to
products for further
manufacturing and 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, at this time, 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 by
February 8, 2017, or August 8, 2017 (small-scale manufacturers). 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.
2.

Cigarettes, Cigarette Tobacco, RYO, and Smokeless Tobacco

Section 904(a)(4) of the FD&C Act requires submission of tobacco health documents beginning
on December 22, 2009. Although section 904(a)(4) requires ongoing submission of health
documents, at this time, FDA does not intend to enforce section 904(a)(4) with respect to
documents developed after December 31, 2009, that relate to cigarettes, cigarette tobacco, RYO,
and smokeless tobacco. Manufacturers or importers of cigarettes, cigarette tobacco, RYO, or
14

smokeless tobacco products must provide all health documents developed between June 23,
2009, and December 31, 2009, at least 90 days prior to the delivery for introduction of tobacco
products into interstate commerce.
FDA’s Compliance Policy for Health Document Submissions
(for Cigarettes, Cigarette Tobacco, RYO, and Smokeless Tobacco)
Submit Health Documents
that Relate to …

Current or future finished
tobacco products

. . . and That Were
Developed

Between
June 23, 2009, and
December 31, 2009

Compliance Date

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

Retention Policy
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 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
15

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

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 (expires June 30, 2019).

16

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:
•

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

•

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

•

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.

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

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

•

Section IV — PRA section updated

17