Tobacco Product Establishment Renewal Registration and Listing

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.regulat ions.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-CTP1373 (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/RulesRegulat ionsGuidance/default.ht m. You
may send an e-mail request to [email protected] to receive an electronic copy of
this guidance. You may send a request for hard copies to U.S. Food and Drug Administration,
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
December 2017
OMB control number: 0910-0650
Expiration Date: 1/31/2019
See additional PRA statement in section V of the guidance.
* This is the seventh revision to the first edition of this guidance, which issued in November
2009. Revisions are noted by date at the end of the guidance.

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 Act?....................................................5
B. FDA’s 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...........................................................................7
D. How to Make Registration and Product Listing Submissions.................................9
E. When Must You Register Your Establishment and List Your Products Under
Section 905 of the FD&C Act?....................................................................................10

V.

PAPERWORK REDUCTION ACT OF 1995 ..........................................................11

VI.

DOCUMENT HISTORY..............................................................................................11

APPENDIX A – EXAMPLE PACKAGE LABEL PLAN........................................................14

Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments
Guidance for Industry 1
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
• FDA’s compliance policies.
FDA’s guidance documents, including this guidance, do not establish legally
enforceable responsibilities. Instead, guidances describe the Agency’s current thinking
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 stablishing
such requirements in accordance with section 905(h) of the FD&C Act (21 U.S.C. 387e(h)).

1

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 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 FDA’s tobacco product authorities in chapter IX of the Act, including
section 905, when the Tobacco Control Act went into effect. As for other types of tobacco
products, section 901(b) of the FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem
those products subject to chapter IX of the FD&C Act. Pursuant to that authority, FDA issued a
proposed rule seeking to deem all other products that meet the statutory definition of tobacco
product set forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) (except for accessories
of those products) (79 FR 23142, April 25, 2014). 3 After review and consideration of
comments on the proposed rule, the final rule published on May 10, 2016 (81 FR 28974) (the
deeming rule) with the effective date of August 8, 2016. 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 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.
3

Accessories of tobacco products subject to the deeming rule are explicitly excluded from the rule’s 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/downloads/TobaccoProducts/Labeling/RulesRegulationsGuidance/UCM557716.pdf.

2

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,” along 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 sect ion 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
deemed 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
injunctio n. Although such actions may be authorized, it is the Agency’s practice to give
individuals and firms an opportunity to take voluntary and prompt corrective action before it
initiates an enforcement action when doing so is consistent with the FDA’s 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 sect ion 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,
composit ion, 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.

•

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
tobacco product for product testing where such products are not made available for
consumption or resale. For example, the term includes the distribut ion of a tobacco product
as a promotional sample and the delivery o f a tobacco product to another manufacturer for
further processing via contract without a change in the formal ownership of the product.
3

•

Component or part: The term component or part means any software or assembly of
materials intended or reasonably expected:
(1) To alter or affect the tobacco product’s performance, composition,
constituents, or characteristics; or
(2) To be used with or for the human consumption of a tobacco product.
Component or part excludes anything that is an accessory of a tobacco product.
FDA notes that component and part are separate and distinct terms within chapter IX of
the FD&C Act. However, for purposes of this guidance, FDA is using the terms
component and part interchangeably and without emphasizing the distinction. FDA may
clarify the distinctions between component and part in the future.

• 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 may 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 leaf 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 removing foreign material from tobacco leaves; and
humidifying tobacco leaf 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.

•

Operator: The term operator means a person, as defined in sect ion 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,
4

which states in relevant part:
(1) The term “tobacco product” means any product made or derived from tobacco that is
intended for human consumption, including any component, part, or accessory of a
tobacco product (except for raw materials other than tobacco used in manufacturing a
component, part, or accessory of a tobacco product).”
(2) The term “tobacco product” does not include an article that is a drug under [section
201(g)(1)], a device under [section 201(h)], or a combination product described in
section 503(g) [of the FD&C Act].
Note that this definition includes accessories and components and parts of tobacco
products, whether they are made or derived from tobacco, and whether they are
sold or distributed as finished tobacco products. 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 may 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 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.\
5

However, and as explained above, accessories of tobacco products subject to the deeming rule are explicitly
excluded from the rule’s 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 FDA’s compliance policy for tobacco products that are sold or distributed solely for further
manufacturing.

5

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.

FDA’s Compliance Policy for Regulated Tobacco Products

At this time, with respect to all tobacco products, including cigarettes, cigarette tobacco, RYO,
and smokeless tobacco, as well as other tobacco products now regulated as a result of the
deeming rule, FDA intends to enforce the registration and listing requirements of section 905
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 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 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
6

As explained above, the Secretary has not deemed accessories of tobacco products other than cigarettes,
cigarette tobacco, RYO, and smokeless tobacco, and so they are not currently subject to section 905.

7

This guidance is available on the CTP guidance Web page at
http://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/default.htm.

6

public health, the Agency may reconsider this compliance policy. We intend to
communicate any compliance policy changes by guidance or rulemaking.
What Information is Submitted as Part of Establishment Registration and
C.
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
informatio n:
• 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 email address, to facilitate correspondence between registrants and FDA.
• A Data Universal Numbering System (D-U-N-S) number 8 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-specific
D-U-N-S number for an entity will help prevent inaccuracies in FDA’s database.
2.

Product Listing Information

Section 905(i) of the FD&C Act sets forth the requirements for submitting product listing
informatio n. 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
distributio n.
The product listing must include certain accompanying information, which will vary depending
on the circumstances. These circumstances are as follows:
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 FDA’s
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

•

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
informat ion 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 individual 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 may 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.
Each product is to be clearly and uniquely identified by the product category 9 (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.

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).

8

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
individual listed tobacco product if the registrant submits information that represents the labeling
for a selected line of products. In deciding whether a registrant’s 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
[email protected] 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.
• 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
9

at
https://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/Manufactur
ing/default.htm.
E.
When Must You Register Your Establishment and List Your Products
Under Section 905 of the FD&C Act?
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.
Under section 905 of the FD&C Act, persons who owned or operated domestic manufacturing
establishments engaged in the manufacture of newly deemed tobacco products prior to August 8,
2016, and continued to own or operate such establishments(s) on or after August 8, 2016, are
required to register with FDA and submit product listing by December 31, 2016. In addition,
every person upon first engaging in the manufacturing of a tobacco product in any domestic
establishment owned or operated by that person on or after August 8, 2016, must immediately
register.
However, FDA recognizes that the forms developed by FDA are new to some manufacturers of
newly deemed products and may require additional time to complete accurately. In addition, we
are aware that product listing for newly deemed products may result in multiple submissions that
the manufacturer must prepare and submit.
Therefore, at this time, with respect to persons who owned or operated domestic manufacturing
establishments engaged in the manufacture of newly deemed tobacco products prior to August 8,
2016, and continued to own or operate such establishments(s) on or after August 8, 2016, FDA
does not intend to enforce the requirement to register and submit product listing information
under section 905 of the FD&C Act by December 31, 2016, provided that the submissions are
received by FDA on or before October 12, 2017. Additionally, subject to the qualification at the
end of this paragraph, FDA does not intend to enforce the requirement for persons who own or
operate domestic manufacturing establishments engaged in the manufacture of newly deemed
tobacco products to update product listing information during the month of December 2017
provided they registered and listed their products by October 12, 2017. 10 As a result, registrants
of newly deemed products would update their product listing by June 30, 2018, and complete
10

Registration by such persons by October 12, 2017, satisfies the requirement in section 905(b) of the FD&C Act
that such persons register their establishments annually on or before December 31, 2017.

10

their next annual registration by December 31, 2018. If an establishment is engaged in the
manufacture of both newly deemed tobacco products and tobacco products originally regulated
under the FD&C Act, FDA intends to enforce the registration and product listing information
requirements for tobacco products originally regulated under the FD&C Act.
FDA believes that this additional time for manufacturers of such newly deemed tobacco products
will allow for submission of higher quality information and increase efficiency for manufacturers
and FDA. However, 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
[email protected].

V.

PAPERWORK REDUCTION ACT OF 1995

This guidance contains information collect ion 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 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 collect ion. 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 collect ion is 0910-0650 (expires 1/31/2019).

DOCUMENT HISTORY
November 2009 — First edit ion of guidance issued.
April 2014 — Sect ion 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 FDA’s Web page at
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForManufacturers/default.ht m
and to remove obsolete timeframe information.
11

•

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 center’s 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 nonsubstantive 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.
• 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 — “FDA’s 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
12

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.

13

.
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.

14

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 X’s 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.

15

II. Product Variation Index

Product
Name
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice

Product
Identification
Number
G001
G002
G003
G004
G005
G006
G007
G008
G009
G010
G011
G012
G013
G014
G015
G016
G017
G018
G019
G020
G021
G022
G023
G024
G025
G026
G027
G028
G029
G030
G031
G032
G033
G034
G035
G036

Size

Nicotine
Strength

5ml
5ml
5ml
5ml
5ml
5ml
5ml
5ml
5ml
5ml
5ml
5ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
10ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml
15ml

3mg
3mg
3mg
3mg
3mg
3mg
6mg
6mg
6mg
6mg
6mg
6mg
3mg
3mg
3mg
3mg
3mg
3mg
6mg
6mg
6mg
6mg
6mg
6mg
3mg
3mg
3mg
3mg
3mg
3mg
6mg
6mg
6mg
6mg
6mg
6mg

16

PG/VG Ratio

50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG

Flavor

A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C

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.
17

II. Product Variation Index

Product Name

Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice
Generic E-Juice

Product
Identification
Number
G037
G038
G039
G040
G041
G042
G043
G044
G045
G046
G047
G048
G049
G050
G051
G052
G053
G054

Size

Nicotine
Strength

5ml
5ml
5ml
5ml
5ml
5ml
10ml
10ml
10ml
10ml
10ml
10ml
15ml
15ml
15ml
15ml
15ml
15ml

0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg
0mg

18

PG/VG Ratio

50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG
50%PG/50%VG
50%PG/50%VG
50%PG/50%VG
70%PG/30%VG
70%PG/30%VG
70%PG/30%VG

Flavor

A
B
C
A
B
C
A
B
C
A
B
C
A
B
C
A
B
C