Registration and Product Listing for 
Owners and Operators of Domestic 
Tobacco Product Establishments 
(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 Docket No. FDA-2009-D- 0500. 
For questions regarding this guidance, contact the Center for Tobacco Products at 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: 0910-0650  
Current expiration date available at 
https://www.reginfo.gov 
See additional PRA statement in section V of the guidance. 
*This is the eighth revision to the first edition of this guidance, which issued in November 2009.
Revisions are noted by date at the end of the guidance. Contains Nonbinding Recommendations 
Table of Contents 
I.  INTRODUCTION ................................................................................................................. 1 
II.  BACKGROUND .................................................................................................................... 2 
III. DEFINITIONS ....................................................................................................................... 3 
IV.  DISCUSSION ......................................................................................................................... 5 
A.  Who Registers their Establishment and Submits Product Listing Information 
Under Section 905 of the FD&C Act? .......................................................................... 5 
B.  FDAs Compliance Policy for Regulated Tobacco Products ..................................... 6 
C.  What Information is Submitted as Part of Establishment Registration and 
Product Listing Submissions? ....................................................................................... 7 
1.  Registration Information ...................................................................................... 7 
2.  Product Listing Information ................................................................................. 8 
D.  How to Make Establishment Registration and Product Listing Submissions........ 10 
E.  When Must You Register Your Establishment and List Your Products Under 
Section 905 of the FD&C Act? .................................................................................... 10 
V.  PAPERWORK REDUCTION ACT OF1995 ................................................................... 11 
APPENDIX A EXAMPLE PACKAGE LABEL PLAN........................................................ 15 
 
i  Contains Nonbinding Recommendations 
Registration and Product Listing for 
Owners and Operators of Domestic Tobacco 
Product Establishments 
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 document is intended to assist owners and operators of domestic tobacco product 
establishments with the registration and product listing submissions required by section 905 of 
the Food, Drug, and Cosmetic Act (FD&C Act).2 The guidance document explains, among other 
things: 
  The statutory requirement to make establishment registration and product listing 
submissions; 
  The definitions of terms used in the statute and this guidance; 
  Who should make establishment registration and product listing submissions; 
  What information to include in the submissions; 
  How to submit the information; 
  When to submit the information; and 
  FDAs compliance policies. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys current thinking on a topic and should 
 
1 This guidance was prepared by the Office of Regulations and the Office of Compliance and Enforcement in the 
Center for Tobacco Products at FDA. 
2 Foreign establishments are not required to register and list until FDA issues regulations 
establishing such requirements in accordance with section 905(h) of the FD&C Act (21U.S.C. 
387e(h)). 
1  Contains Nonbinding Recommendations 
be viewed only as recommendations, unless specific regulatory or statutory requirements 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 health (Pub. L. 111 31, 123 
Stat. 1776.) Among other things, the Tobacco Control Act adds section 905 to the FD&C Act (21 
U.S.C. 387e), requiring the owners and operators of domestic manufacturing establishments engaged 
in manufacturing tobacco products to register with FDA and submit product listings. 
Cigarettes, cigarette tobacco, roll-your-own tobacco (RYO), and smokeless tobacco were 
immediately covered by FDAs tobacco product authorities in chapter IX of the Act, including 
section 905, when the Tobacco Control Act went into effect. On March 15, 2022, the statutory 
definition of tobacco products was amended to include products containing nicotine from any 
source, and section 901(b) of the Act was amended to make tobacco products containing 
nicotine not made or derived from tobacco subject to the requirements of chapter IX of the Act, 
including section 905 of the FD&C Act (Pub. L. 117-103). 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. As a result, owners and operators of domestic establishments engaged in the 
manufacture, preparation, compounding, or processing of tobacco products subject to the deeming 
rule are now required to comply with chapter IX of the FD&C Act, including the establishment 
registration and product listing requirements in section 905. 4 
Section 905(b) of the FD&C Act requires that every person who owns or operates any 
establishment in any State engaged in the manufacture, preparation, compounding, or processing of a 
tobacco product or tobacco products register with FDA the name, places of business, and all 
 
3 Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rules deeming 
provision. 
4 Examples of currently marketed products that are subject to the deeming rule include: cigars, pipe tobacco, 
nicotine gel, dissolvable nicotine products, and electronic nicotine delivery systems (ENDS), including electronic 
cigarettes (also known as e-cigarettes or e-cigs), e-hookah, e-cigars, vape pens, personal vaporizers (also known as 
advanced personal vaporizers or APVs),electronic pipes, and nicotine-containing liquids, including the e-liquids 
used with ENDS products, among other products. For further information on compliance deadlines for 
requirements under the deeming rule, see FDA guidance for industry Extension of Certain Tobacco Product 
Compliance Deadlines Related to the Final Deeming Rule, available at https://www.fda.gov/tobacco-
products/rules-regulations-and-guidance/guidance. 
2  Contains Nonbinding Recommendations 
establishments engaged in these activities owned or operated by that person. Following the initial 
registration, every person must register annually by December 31 of each year. 
Section 905(i)(1) of the FD&C Act requires that all registrants shall, at the time of 
registration... file with [FDA] a list of all tobacco products which are being manufactured, prepared, 
compounded, or processed by that person for commercial distribution, a long with certain 
accompanying information, including all labeling. In addition, section 905(i)(3) of the FD&C Act 
requires that certain changes in the product list be submitted biannually. 
The failure to register in accordance with section 905 of the FD&C Act, the failure to provide any 
information required by section 905(i), or the failure to provide a notice required by section 905(i)(3) 
is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p)). In addition, under 
section 903(a)(6) of the FD&C Act (21 U.S.C. 387c), a tobacco product is dee med misbranded if it 
was manufactured, prepared, propagated, compounded, or processed in an establishment not duly 
registered under section 905 or if it was not included in a list required by section 905(i). Violations 
relating to registration and product listing under section 905 are subject to regulatory and enforcement 
action, including, but not limited to, seizure and injunction. Although such actions may be authorized, it 
is the Agencys practice to give individua ls and firms an opportunity to take voluntary and prompt 
corrective action before it initiates an enforcement action when doing so is consistent with the 
FDAs public protection responsibilities. An advisory action letter, such as a Warning Letter, may be 
issued by FDA to achieve voluntary compliance. 
III. DEFINITIONS
FDA intends to use the following definitions in implementing the establishment registration and 
product listing requirements of section 905 of the FD&C Act. 
 Accessory: The term accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a tobacco product; does not contain
tobacco and is not made or derived from tobacco; and meets either of the following:
(1) Is not intended or reasonably expected to affect or alter the performance,
composition, constituents, or characteristics of a tobacco product; or
(2) Is intended or reasonably expected to affect or maintain the performance,
composition, constituents, or characteristics of a tobacco product but
(i) Solely controls moisture and/or temperature of a stored tobacco product; or
(ii) Solely provides an external heat source to initiate but not maintain
combustion of a tobacco product.
Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule, available at 
https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance. 
 Commercial distribution: The term commercial distribution means any distribution of a
tobacco product to consumers or to another person through sale or otherwise, but does not
include internal or interplant transfer of a tobacco product between registered establishments
within the same parent, subsidiary, and/or affiliate company, nor does it include providing a
3  Contains Nonbinding Recommendations 
tobacco product for product testing where such products are not made available for 
consumption or resale. For example, the term includes the distribution of a tobacco product as a 
promotional sample and the delivery of a tobacco product to another manufacturer for further 
processing via contract without a change in the forma l ownership of the product. 
  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. 
  Domestic establishment: The term domestic establishment means an establishment in any 
State or Territory or possession of the United States. 
  Establishment: The term establishment means a place of business under one ownership at 
one general physical location. A single building ma y house more than one distinct 
establishment if the establishments are under separate ownership. 
  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). 
  Labeling: The term labeling, based on section 201(m) of the FD&C Act, means all labels 
and other written, printed, or graphic matter (1) upon any tobacco product or any of its 
containers or wrappers, or (2) accompanying such tobacco product. 
  Manufacturing: The term manufacturing means the manufacture, preparation, 
compounding, or processing of a tobacco product, including repackaging or otherwise 
changing the container, wrapper, or labeling of any tobacco product package (section 
905(a)(1) of the FD&C Act). This term includes the activities of reconstituting and blending 
tobacco leaf; testing for quality control and product release; and applying any chemical, 
additive, or substance to the tobacco lea f other than potable water in the form of steam or 
mist. This term excludes the activities of de-stemming, drying, or packing tobacco leaf; 
mechanically re moving foreign material from tobacco leaves; and humidifying tobacco 
lea f with nothing other than potable water in the form of steam or mist. 
  Owner: The term owner means a person, as defined in section 201(e) of the FD&C Act, 
who has an ownership interest in an establishment. 
4  Contains Nonbinding Recommendations 
  Operator: The term operator means a person, as defined in section 201(e) of the FD&C Act, 
who has management authority over an establishment. 
  Tobacco product: The term 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 under [section 
201(g)(1)]; a device under [section 201(h)]; a combination product described in 
section 503(g) [of the FD&C Act]; or a food under [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 contain nicotine, or are made or derived from tobacco, and whether they are 
sold or distributed as finished tobacco products.5  
IV.  DISCUSSION 
A.  Who Registers their Establishment and Submits Product Listing Information 
Under Section 905 of the FD&C Act? 
Every person who owns or operates any domestic establishment engaged in 
manufacturing regulated tobacco products must register under section 905(b) of the 
FD&C Act, and every registrant must file a list of its regulated tobacco products in 
accordance with section 905(i) of the FD&C Act. An owner or operator ma y 
authorize a third-party agent to register their establishment and submit product listing 
information on its behalf. Establishment registration and product listing requirements 
currently apply only to those persons who own or operate domestic establishments 
engaged in manufacturing tobacco products; an importer who does not own or operate 
such an establishment is not subject to the requirements of section 905(b) or section 
905(i) of the FD&C Act. 
To reduce redundant submissions, FDA strongly encourages that the owner act as the 
agent for all operators within a given business structure in submitting establishment 
 
5 However, and as explained above, accessories of tobacco products subject to the deeming rule are explicitly excluded 
from the rules deeming provision. Thus, although they meet the definition of tobacco product, such accessories are 
not currently subject to regulation under the FD&C Act (including section 905). See below for details on FDAs 
compliance policy for tobacco products that are sold or distributed solely for further manufacturing. 
5  Contains Nonbinding Recommendations 
registration and product listing information.   Under this approach, the owner would 
register all establishments it owns and submit the associated product listing information, 
and the owner would also register on behalf of all operators with management authority 
over those establishments. An owner acting as the agent for one or more operators 
would need to submit all information required of the operator(s) (e.g., the operator 
name(s) and place(s) of business), but could submit all information for both the owner 
and the operator(s) in a single registration. If an owner registers/lists all of its 
establishments using this approach, the operators of those establishments would not 
need to register. For scenarios in which an owner is also the operator of a given 
establishment, the owner/operator can register in a single registration. 
The following example illustrates the registration and product listing requirements for a 
complex business structure: Firm A owns establishment X, which is engaged in 
manufacturing tobacco products. Firm B does not own an establishment engaged in 
manufacturing tobacco products. Firm A and Firm B are wholly owned subsidiaries of 
Holding Company C. Holding Company C does not own or operate any establishments 
engaged in manufacturing tobacco products. In this scenario, Firm A would be required 
to register establishment X and list products, but neither Firm B nor Holding Company C 
would be subject to registration or product listing requirements. 
B.  FDAs Compliance Policy for Regulated Tobacco Products 
At this time, with respect to all tobacco products, FDA intends to enforce the 
registration and listing requirements of section 905 with respect to finished tobacco 
products only (excluding accessories). 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 registration and listing requirements under section 905 with 
respect to such 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.6  
Based on our experience with cigarettes, cigarette tobacco, RYO, and smokeless 
tobacco, we amended our previous compliance policy in July 2016. Under our previous 
policy, FDA intended to enforce the establishment registration and product listing 
requirements with respect to owners and operators engaged in the manufacture of 
tobacco, paper, filters, and pouches whether or not such products were for further 
 
6 As explained above accessories of deemed tobacco products are not currently subject to section 905. 
6  Contains Nonbinding Recommendations 
manufacturing of, or for consumer use as, regulated tobacco products. However, FDA 
announced 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 for finished tobacco products and through the use of master 
files, as explained in the guidance Tobacco Product Master Files.7 Additionally, we 
aligned 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 health, the Agency may reconsider this compliance policy. We intent to 
communicate any compliance policy changes by guidance or rulemaking.  
C.  What Information is Submitted as Part of Establishment Registration and 
Product Listing Submissions? 
1.  Registration Information 
Section 905(b) of the FD&C Act sets forth the requirements for submission of 
establishment registration information. As required by the statute, any person engaged 
in the manufacturing of tobacco products must register with FDA and submit the 
following information: 
  The name and full address of each establishment engaged in manufacturing the 
registrant owns or operates, as of the date of registration. 
  The name and places of business of the owner or operator. In the case of a 
partnership, include the name of each partner. In the case of a corporation, 
include the name of each corporate officer and director, and the State of 
incorporation. 
The registration and listing electronic submission system and the paper form request 
additional optional information that FDA also recommends be submitted, including: 
  An e mail address, to facilitate correspondence between registrants and FDA. 
  A Data Universal Numbering System (D-U-N-S) number8 or other unique identifier 
(codes) for the place of business of the owner, the place of business of the operator, 
and the location of the establishment. The business entity identifier recognized by the 
FDA Data Standards Council is the D-U-N-S number, and providing the site-
 
7This guidance is available on the CTP guidance Web page at 
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm. 
8 D-U-N-S numbers are proprietary to and controlled by Dun & Bradstreet. If the D-U-N-S number for a location 
has not been assigned, a business may obtain one for no cost directly from Dun & Bradstreet (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. Please note that the D-U-N-S Number is 
not required. Alternatively, you may elect to receive a D-U-N-S number within one business day by paying a fee. 
Please consult Dun & Bradstreet (http://www.dnb.com) directly for more information. 
7  Contains Nonbinding Recommendations 
specific D-U-N-S number for an entity will help prevent inaccuracies in FDAs 
database. 
2.  Product Listing Information 
Section 905(i) of the FD&C Act sets forth the requirements for submitting product 
listing information. The FD&C Act requires that, at the time of registration, the registrant 
submit a list of all tobacco products that are being manufactured by the registrant for 
commercial distribution. 
The product listing must include certain accompanying information, which will vary 
depending on the circumstances. These circumstances are as follows: 
  Under section 905(i)(1)(A), if a tobacco product standard has been established 
under section 907 of the FD&C Act (21 U.S.C. 387g) with respect to the tobacco 
product or the tobacco product is subject to premarket review under section 910 of 
the FD&C Act (21 U.S.C. 387j), then the product listing must include a reference to 
the authority for the marketing of the tobacco product and a copy of all labeling for 
that product. We interpret this to mean that labeling is to be submitted as an exact, 
legible, full color copy. 
  Under section 905(i)(1)(B), the product listing for all other tobacco products must 
include all labeling for that product. It must also include a representative sampling 
of advertisements for the product. If requested by FDA for good cause, a copy 
of all advertisements for a particular tobacco product must be submitted. We 
interpret a representative sampling of advertisements to mean typical 
advertising material that reflects the full range of promotional statements made for 
the tobacco product. For example, if more than one magazine advertisement is 
used, but the promotional content is essentially identical, only one need be 
submitted. In addition, the product listing must include a copy of all consumer 
information to the extent the information is not advertising and has not already 
been provided as a form of product labeling. Consumer information does not include 
information directed at wholesalers, distributors, or retailers, where such 
information is not available to consumers. For example, consumer information 
does not include product specifications intended for manufacturing purposes, 
photos of components or parts not intended for individua l sale, or communications 
between companies. 
If a registrant has determined that a product in its product listing is not subject to a 
tobacco product standard established under section 907 of the FD&C Act, FDA ma y 
request that the registrant provide a brief statement of the basis for that determination. 
We are interpreting section 905(i) of the FD&C Act to require that each product 
included in a product listing be clearly identified and distinguished. Products that differ in 
any way, including a difference in any component or part, should be listed separately 
for purposes of section 905(i). For example, a soft pack and a hard pack of cigarettes 
should be listed separately, even if the cigarettes included in the pack are identical. 
8  Contains Nonbinding Recommendations 
Each product is to be clearly and uniquely identified by the product category9 (e.g., 
cigarette, smokeless tobacco, paper, filter) and unique name (i.e., brand/sub-brand or 
other commercial name used in commercial distribution). Tobacco products are to be 
identified in this way because such names are needed to determine whether products in 
commercial distribution are listed as required. You are to include product identification 
numbers (e.g., SKU, catalog number, UPC) as needed to uniquely identify the product. 
However, FDA recognizes that product listing for some tobacco products may result in 
numerous labeling submissions that the manufacturer must prepare and submit. For 
example, variations in package size, nicotine strength, Propylene Glycol (PG)/ 
Vegetable Glycerin (VG) ratio, and flavor can result in thousands of individual product 
labeling submissions. 
In order to reduce the amount of uploaded labeling submissions, FDA does not, at this 
time, intend to enforce the requirements that owners and operators submit the labeling 
for each individua l listed tobacco product if the registrant submits information that 
represents the labeling for a selected line of products. In deciding whether a 
registrants submitted information falls within this compliance policy, FDA may 
consider whether the tobacco products labeling is essentially identical (e.g., the same 
formatting, fonts, colors, background text, and images) and whether the variations are 
limited to package size, nicotine strength, PG/VG ratio, and flavor. 
However, we recommend that zero nicotine formulas of a product, or product line, be 
grouped separately from products with nicotine. Appendix A contains an example of 
how a registrant could submit information that represents the labeling for a selected line 
of products, and FDA would not intend to enforce the requirements in subsections 
905(i)(1)(A) and (B) with regard to labeling submissions. 
For any questions regarding this compliance policy, please contact 
CTPRegistrationandListing@fda.hhs.gov for assistance and include registration 
and listing labeling submissions in the subject line. 
Section 905(i)(3) of the FD&C Act requires the following changes to the product 
list to be reported twice a year: 
  For any tobacco products you have introduced for commercial distribution and have 
not included in a previous product listing, the complete product listing information as 
described above. 
  For any tobacco products you have discontinued manufacturing for commercial 
distribution since the last report, notice of the discontinuance containing the 
established name of the product as previously listed and the date of discontinuance. 
 
9 At this time, some product categories used for product listing may fall under a subcategory for a premarket tobacco 
product submission (e.g., a filter is a category for listing purposes, but a subcategory under roll your own for a 
premarket submission). 
9  Contains Nonbinding Recommendations 
 For any tobacco products you had given notice as being discontinued and have since
resumed manufacturing for commercial distribution, notice of the resumption
containing the date of resumption and complete product listing information as
described above.
 Any material change in any information   previously submitted
D. How to Make Establishment Registration and Product Listing Submissions
The registration and listing electronic submission system is designed to streamline the
data entry process for registration and product listing at the Center for Tobacco
Products (CTP). Although electronic submission is not required, FDA is strongly
encouraging electronic submission to facilitate efficiency and timeliness of data
submission and management. The electronic submission system and FDA Form 3741, an
alternative tool for paper submissions, are available at
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/
Manufacturing/default.htm.
E. When Must You Register Your Establishment and List Your Products Under
Section 905 of the FD&C Act?10
Section 905(b) of the FD&C Act requires establishment registration information to be
submitted by December 31, 2009, and to be resubmitted annually on or before
December 31st of each year.
Section 905(c) of the FD&C Act requires every person upon first engaging in the
manufacturing of a tobacco product in any domestic establishment owned or operated
by that person to immediately register. In addition, section 905(d) requires registered
owners and operators to immediately register any new establishment that begins
manufacturing tobacco products.
Section 905(i)(1) of the FD&C Act requires the complete product list information to be
submitted at the time of first registration. In addition, section 905(i)(3) of the Act
requires that certain changes in the product list be submitted biannually, once during
June and once during December.
We encourage manufacturers to begin the process as early as possible. Manufacturers
may contact FDA to discuss issues relating to registration and listing of their
products, such as large volumes of products and labeling files, by emailing FDA at
CTPRegistrationandListing@fda.hhs.gov.
10 On April 14, 2022, owners and operators of establishments engaged in the manufacture, preparation, 
compounding, or processing of tobacco products containing nicotine not made or derived from tobacco became 
subject to the requirements of section 905 of the FD&C Act described in this section. 
10  Contains Nonbinding Recommendations 
V. PAPERWORK REDUCTION ACT OF 1995
This guidance contains information collection provisions that are subject to erview 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 3.75 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 0910-0650. To find the current expiration date, search 
for this OMB control number at https://www.reginfo.gov. 
11  Contains Nonbinding Recommendations 
DOCUMENT HISTORY 
November 2009  First edition of guidance issued. 
April 2014  Section III of guidance revised to reflect the change in the electronic submission 
tool for registration and listing from eSubmitter to a new system available on FDAs Web page 
at https://www.fda.gov/tobacco-products/compliance-enforcement-training/manufacturing and to 
remove obsolete time frame information. 
  Throughout section III  The phrase registration and listing electronic submission system 
replaces the phrases eSubmitter application, and FDA eSubmitter tool. 
  Section III, page 2  First paragraph in section III describing eSubmitter tool deleted. 
  Section III.D, page 7  Sentences in first paragraph describing eSubmitter tool deleted. 
  Section III.D, page 7 Web site address where the electronic submission system and FDA 
Form 3741 are available was updated. 
  Section III.D, page 7  Third paragraph describing how to access the eSubmitter tool 
deleted. 
  Section III.E, page 8  Paragraph describing when to submit information for registration 
and listing information in 2010 deleted. 
  Section III.E, page 8  Paragraph providing November 2009 as the availability date for the 
eSubmitter tool deleted. 
  Section IV, page 8  Expiration date for the information collection updated from 12/31/2012 
to 10/31/2015. 
May 2014  Cover page, and section IV, Page 8  Physical mailing address changed to reflect 
the centers relocation to the White Oak Campus. 
July 2016  Registration and listing guidance revised to reflect changes in FDA authorities over 
deemed tobacco products. 
  Throughout the document  A number of non-substantive changes were made for 
clarification purposes. 
  Section II, page 2  Background updated to reflect changes in FDA authorities over 
deemed tobacco products arising from deeming rule. 
  Section III, page 3  Accessory, components or part, and finished tobacco product 
definitions added. 
12  Contains Nonbinding Recommendations 
  Section IV.B, page 5  Former Section B Who Registers and Submits Product Listing 
Information under Section 905 of the Act becomes Section A. Compliance policy for 
cigarettes, cigarette tobacco, RYO, and smokeless tobacco deleted. 
  Section IV.B, page 6  FDAs Compliance Policy for Regulated Tobacco Products 
added; compliance policy for cigarettes, cigarette tobacco, RYO, and smokeless tobacco 
amended. 
  Section IV.C, page 6  Title changed. 
  Section IV.C, page 7  Information on Data Universal Numbering System is updated. 
  Section IV.D, page 9  Title changed. 
  Section IV.E page 9  Title changed. 
  Section IV.E, page 9  Last paragraph added to explain when owners and operators of 
domestic manufacturing establishments engaged in the manufacture of newly deemed 
tobacco products will need to register and submit product listings. 
  Section IV.E  Data Universal Numbering System information incorporated to section C. 
November 2016  Section IV.E. revised to: (1) clarify that persons who owned or operated 
domestic manufacturing establishments that were only engaged in the manufacture of newly deemed 
products prior to August 8, 2016, but not on or after August 8, 2016, do not have to register with 
FDA or submit product listing, and (2) explain that FDA does not intend to enforce the requirement 
to register and submit product listing information by December 31, 2016 for persons who owned or 
operated domestic manufacturing establishments engaged in the manufacture of newly deemed 
products prior to August 8, 2016, and continued to own or operate such establishments on or after 
August 8, 2016, provided the submissions  are received by FDA on or before June 30, 2017. 
September 2017  Section II added clarifications to background section. Sections IV.C.2 
revised to provide compliance policy for certain product listing labeling submissions. Section 
IV.E amended compliance date to September 30, 2017. 
September 2017  Section IV.E amended compliance date to October 12, 2017. 
December 2017  Section IV.E amended to provide compliance policy for product listing 
updates for December 2017 with respect to the manufacture of newly deemed tobacco products 
provided they registered and listed those products by October 12, 2017. 
March 2023  Registration and listing guidance revised to reflect changes in the statutory 
definition of tobacco product and FDA authority over products containing nicotine not made 
or derived from tobacco.  
  Section III - definition of tobacco product is updated to reflect statutory amendments 
made by the Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among other 
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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 IV.E outdated compliance policy for deemed tobacco products removed.  
Footnote 10 revised to note applicability of section 905 of the FD&C Act to tobacco 
products containing non-tobacco nicotine.  
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APPENDIX A EXAMPLE PACKAGE LABEL PLAN 
Note:  Appendix A is intended to serve as one example of a circumstance in which FDA does not 
intend to enforce the requirements in subsections 905(i)(1)(A) and (B) with regard to 
labeling submissions. It describes a package label plan, which could be submitted by a 
registrant to represent the labeling for a selected line of products. FDA may exercise 
enforcement discretion in other circumstances as described in the guidance. 
In this example, a package label plan consists of two parts submitted together, a model label 
and a product variation index. 
The model label contains a proxy, such as placeholder text, for the variations in the label, such as 
variations in package size, nicotine strength, PG/VG ratio, and flavor. The proxy, such as 
placeholder text, is the same size, font, and color as it will appear on the actual label for the 
individual product. All formatting, fonts, colors, background text, and images are represented on 
the model label as they will appear on the actual label. 
The product variation index is a listing of all variations for a specific tobacco product; limited to 
variations in package size, nicotine strength, PG/VG ratio, and flavor. A product variation index lists 
all combinations of the variations that will be using the model label. Each tobacco product listing on 
the index corresponds with the attached model label. The product variation index indicates the 
corresponding model label and also includes product name and product identification number 
columns. 
The package label plan would be uploaded to the electronic submission portal, as discussed in 
Section IV.D of the guidance, and be associated with all product listings represented in the variation 
index. For the products using a particular package label plan, the registrant would upload one file and 
that file would be associated with the relevant product listings by selecting those listings. Associating 
a label submission with a product that does not use that label or is not covered by that package label 
plan would not fall within the above stated compliance policy. 
Upon reviewing the package label plan, if FDA determined that it needed additional labeling 
submissions, it would notify the firm that the submission of additional labeling is needed. In 
addition, the package labeling must comply with all other applicable labeling requirements under the 
FD&C Act and implementing regulations. 
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The examples below are for Generic E-Juice an e-liquid product, which comes in three package 
sizes, three different nicotine strengths, including a zero nicotine formula, two variations of PG/VG 
ratio, and three flavors. 
Example A: 
I. Sample 
 
Note:  In the above model label, the proxy for package size, nicotine strength, PG/VG ratio and 
flavor are all being represented by placeholder text. Here, the variable elements are 
represented by Xs and the text Flavor Here. 
Formatting, fonts, colors, background text, and images, and any other elements except 
package size, nicotine strength, PG/VG ratio, and flavor should remain identical across 
labels for all products listed under this package label plan. All proxies,  including placeholder 
text, should be represented in the font, size, and color in which they will appear on the actual 
label. 
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II. Product Variation Index 
Product   Product  Size  Nicotine  PG/VG Ratio  Flavor 
Name  Identification  Strength 
Number 
Generic E-Juice  G001  5ml  3mg  50%PG/50%VG  A 
Generic E-Juice  G002  5ml  3mg  50%PG/50%VG  B 
Generic E-Juice  G003  5ml  3mg  50%PG/50%VG  C 
Generic E-Juice  G004  5ml  3mg  70%PG/30%VG  A 
Generic E-Juice  G005  5ml  3mg  70%PG/30%VG  B 
Generic E-Juice  G006  5ml  3mg  70%PG/30%VG  C 
Generic E-Juice  G007  5ml  6mg  50%PG/50%VG  A 
Generic E-Juice  G008  5ml  6mg  50%PG/50%VG  B 
Generic E-Juice  G009  5ml  6mg  50%PG/50%VG  C 
Generic E-Juice  G010  5ml  6mg  70%PG/30%VG  A 
Generic E-Juice  G011  5ml  6mg  70%PG/30%VG  B 
Generic E-Juice  G012  5ml  6mg  70%PG/30%VG  C 
Generic E-Juice  G013  10ml  3mg  50%PG/50%VG  A 
Generic E-Juice  G014  10ml  3mg  50%PG/50%VG  B 
Generic E-Juice  G015  10ml  3mg  50%PG/50%VG  C 
Generic E-Juice  G016  10ml  3mg  70%PG/30%VG  A 
Generic E-Juice  G017  10ml  3mg  70%PG/30%VG  B 
Generic E-Juice  G018  10ml  3mg  70%PG/30%VG  C 
Generic E-Juice  G019  10ml  6mg  50%PG/50%VG  A 
Generic E-Juice  G020  10ml  6mg  50%PG/50%VG  B 
Generic E-Juice  G021  10ml  6mg  50%PG/50%VG  C 
Generic E-Juice  G022  10ml  6mg  70%PG/30%VG  A 
Generic E-Juice  G023  10ml  6mg  70%PG/30%VG  B 
Generic E-Juice  G024  10ml  6mg  70%PG/30%VG  C 
Generic E-Juice  G025  15ml  3mg  50%PG/50%VG  A 
Generic E-Juice  G026  15ml  3mg  50%PG/50%VG  B 
Generic E-Juice  G027  15ml  3mg  50%PG/50%VG  C 
Generic E-Juice  G028  15ml  3mg  70%PG/30%VG  A 
Generic E-Juice  G029  15ml  3mg  70%PG/30%VG  B 
Generic E-Juice  G030  15ml  3mg  70%PG/30%VG  C 
Generic E-Juice  G031  15ml  6mg  50%PG/50%VG  A 
Generic E-Juice  G032  15ml  6mg  50%PG/50%VG  B 
Generic E-Juice  G033  15ml  6mg  50%PG/50%VG  C 
Generic E-Juice  G034  15ml  6mg  70%PG/30%VG  A 
Generic E-Juice  G035  15ml  6mg  70%PG/30%VG  B 
Generic E-Juice  G036  15ml  6mg  70%PG/30%VG  C 
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Example B: 
I. Sample 
 
Note:  In the above model label for the zero nicotine formulation, the proxy for size and PG/VG 
ratio are represented with unmarked checkboxes and the flavor is indicated with the 
placeholder text Flavor Here. 
Formatting, fonts, colors, background text, and images, and any other elements except 
package size, PG/VG ratio, and flavor, should remain identical across labels for all products 
listed under this package label plan. All proxies, including placeholder text, should be 
represented in the font, size, and color in which they will appear on the actual label. 
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II. Product Variation Index 
Product   Product  Size  Nicotine  PG/VG Ratio  Flavor 
Name  Identification  Strength 
Number 
Generic E-Juice  G037  5ml  0mg  50%PG/50%VG  A 
Generic E-Juice  G038  5ml  0mg  50%PG/50%VG  B 
Generic E-Juice  G039  5ml  0mg  50%PG/50%VG  C 
Generic E-Juice  G040  5ml  0mg  70%PG/30%VG  A 
Generic E-Juice  G041  5ml  0mg  70%PG/30%VG  B 
Generic E-Juice  G042  5ml  0mg  70%PG/30%VG  C 
Generic E-Juice  G043  10ml  0mg  50%PG/50%VG  A 
Generic E-Juice  G044  10ml  0mg  50%PG/50%VG  B 
Generic E-Juice  G045  10ml  0mg  50%PG/50%VG  C 
Generic E-Juice  G046  10ml  0mg  70%PG/30%VG  A 
Generic E-Juice  G047  10ml  0mg  70%PG/30%VG  B 
Generic E-Juice  G048  10ml  0mg  70%PG/30%VG  C 
Generic E-Juice  G049  15ml  0mg  50%PG/50%VG  A 
Generic E-Juice  G050  15ml  0mg  50%PG/50%VG  B 
Generic E-Juice  G051  15ml  0mg  50%PG/50%VG  C 
Generic E-Juice  G052  15ml  0mg  70%PG/30%VG  A 
Generic E-Juice  G053  15ml  0mg  70%PG/30%VG  B 
Generic E-Juice  G054  15ml  0mg  70%PG/30%VG  C 
 
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