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  
March 2023 
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 fifth 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 FDAs 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 
1. Submitting Health Documents Electronically Using eSubmitter ........................... 12 
2. Submitting Documents When Not Using eSubmitter .............................................. 13 
F. 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 
i  Contains Nonbinding Recommendations 
Health Document Submission 
Requirements for  
Tobacco Products (Revised)* 
1
Guidance for Industry  
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 FDAs 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 FDAs 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 
  FDAs 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. 
1  Contains Nonbinding Recommendations 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidance documents describe the Agencys 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 publics 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 Agencys 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 FDAs 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). 
3 Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rules deeming 
provision. Reference the deeming rule for further information about accessories (81 FR 28974). 
2  Contains Nonbinding Recommendations 
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. 
  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 products 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 
3  Contains Nonbinding Recommendations 
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 150or 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)  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). 
(2)  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  
  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 rules 
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 FDAs compliance policy for tobacco products that are sold or distributed solely for further 
manufacturing. 
4  Contains Nonbinding Recommendations 
(a) RequirementEach 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 FDAs 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). 
5  Contains Nonbinding Recommendations 
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 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: 
  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 manufacturers 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 heath 
 
6 In most cases, FDA assigns an FEI number after receiving the establishments 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 FDAs 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. 
6  Contains Nonbinding Recommendations 
document submission requirement. We discuss FDAs interpretation of the statute 
and the Agencys 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: 
  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 
7  Contains Nonbinding Recommendations 
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 
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. 
Examples of documents that relate to health, toxicological, behavioral, or 
physiologic effects may include but are not limited to: 
  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 
 
8 See section III.D.2.b regarding redacted documents. 
8  Contains Nonbinding Recommendations 
 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.
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, 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.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 FDAs 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  Contains Nonbinding Recommendations 
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, 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/fda-
esubmitter/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 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 
10  Contains Nonbinding Recommendations 
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 
  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/. 
11 If a document relates to more than one of these subjects, you should identify all those subjects that are related to 
the document. 
11  Contains Nonbinding Recommendations 
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, FDAs 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: 
  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: 
http://www.fda.gov/tobaccoproducts/guidancecomplianceregulatoryinformation/ma
nufacturing/default.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.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. 
12  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 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 
  The business entitys 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. 
13  Contains Nonbinding Recommendations 
Submissions delivered to CTPs 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? 
FDAs Compliance Policy for Health Document Submissions 
Submit Health 
. . . and That Were 
Documents that  Compliance Date  Retention Policy 
Developed 
Relate to ... 
Current or future  Between   At least 90 days  Preserve all health 
finished tobacco  June 23, 2009, and  prior to delivery for  documents including those 
products  December 31, 2009  introduction into  that relate to products for 
interstate commerce  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 
14  Contains Nonbinding Recommendations 
Information Act (FOIA) (5 U.S.C. 552), as well as FDAs 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. 
FDAs 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
15  Contains Nonbinding Recommendations 
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: 
  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 FDAs 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 
16  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: 
  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. 
  Section III.A  Definition of tobacco product updated. 
  Section III.C  Information on FDAs compliance policy for regulated tobacco products 
updated. 
  Section III.D.2  Expands on FDAs examples of health, toxicological, behavioral, or 
physiologic effects. 
  Section III.D.2.a.i  Includes examples of documents that relate to health, toxicological, 
behavioral, or physiologic effects.  
  Section III.D.2.c  Information on Document Metadata Included in a Load File updated.  
  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: 
  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. 
  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.  
  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.  
17