Tobacco Product Initial Ingredient Listing

Guidance for Industry
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments
(Revised)*
Written comments and suggestions may be submitted at any time for Agency consideration to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Alternatively, electronic comments may be submitted to
http://www.regulations.gov. All comments should be identified with the docket number listed in
the notice of availability that publishes in the Federal Register.

Additional copies are available from:
Food and Drug Administration
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
(Tel) 301-796-4800
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
April 2014
* This is a revision to the first edition of this guidance, which issued in November 2009. Revisions are noted
by date at the end of the guidance.

OMB control number: 0910-0650
Expiration Date: xx/xx/201x
See additional PRA statement in Section IV of the guidance.

Contains Nonbinding Recommendations

Table of Contents

I.

Introduction

II.

Background

III. Discussion
IV. Paperwork Reduction Act of 1995

Contains Nonbinding Recommendations

Guidance for Industry1
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments2
This guidance represents the Food and Drug Administration's (FDA's) current thinking on
this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate telephone number listed on the title
page of this guidance.

I.

Introduction

This guidance document is intended to assist persons making tobacco product establishment
registration and product listing submissions to FDA. The guidance document explains, among
other things:
•
•
•
•
•
•
•

The statutory requirement to submit tobacco product establishment registration and
product listing submissions;
Definitions;
Who is responsible for providing registration and product listing submissions;
What information is included 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 on a topic and should
1

This guidance has been prepared by the Center for Tobacco Products at the U.S. Food and Drug Administration.
Foreign establishments are not required to register and list until FDA issues regulations establishing such
requirements in accordance with section 905(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387e(h)).

2

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

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act
(the Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act granted
FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco
products to protect the public health generally and to reduce tobacco use by minors. Among its
many provisions, the Tobacco Control Act added section 905 to the Federal Food, Drug, and
Cosmetic Act (the act) (21 U.S.C. 387e), establishing requirements for tobacco product
establishment registration and product listing.
Section 905(b) of the 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. Every person must
register by December 31 of each year.
Section 905(i)(1) of the 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 act requires that certain
changes in the product list be submitted biannually.
The failure to register in accordance with section 905 of the act, the failure to provide any
information required by section 905(i), and the failure to provide a notice required by section
905(i)(3) is a prohibited act under section 301(p) of the act (21 U.S.C. 331(p)). In addition, under
section 903(a)(6) of the 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 injunction.

III. Discussion
A. What definitions apply?
FDA intends to use the following definitions in implementing the registration and product
listing requirements of section 905 of the act.
1. Commercial Distribution: The term “commercial distribution” includes any distribution
of a tobacco product to consumers or to another person for further manufacturing through
sale or otherwise. As examples, it includes the distribution of a tobacco product as a
promotional sample and the delivery of a tobacco product to another manufacturer for
2

Contains Nonbinding Recommendations

2.
3.

4.

5.

6.
7.
8.
9.

further processing via contract without a change in the formal ownership of the product.
Commercial distribution does not include internal or interplant transfer of a tobacco
product between registered establishments within the same parent, subsidiary, and/or
affiliate company, and it does not include providing a tobacco product for product testing
where such products are not made available for consumption or resale.
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.
Labeling: The term “labeling,” based on section 201(m) of the act (21 U.S.C. 321(m)),
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 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 act (21
U.S.C. 321(e)), who has an ownership interest in an establishment.
Operator: The term “operator” means a person, as defined in section 201(e) of the act
(21 U.S.C. 321(e)) who has management authority over an establishment.
Pouch: The term “pouch” means a permeable pouch, intended to be filled with preportioned tobacco product and placed in the oral cavity with the tobacco product.
Tobacco Product: 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)” (section 201(rr) of
the act (21 U.S.C. 321(rr)). This term does not include an article that is a drug, a device,
or a combination product as defined in the act (section 201(rr) of the act (21 U.S.C.
321(rr)). Thus, the term is not limited to products containing tobacco, but also includes
components, parts, and accessories of tobacco products, whether they are for further
manufacturing or are ready for consumer use. For example, tobacco, papers, and filters
are tobacco products, whether they are sold to consumers for use with roll-your-own
tobacco or are sold for further manufacturing into a product sold to a consumer, such as a
cigarette.

B. Who registers and submits product listing information under section 905 of the act?
Every person who owns or operates any domestic establishment engaged in manufacturing
regulated tobacco products must register under section 905(b) of the act, and every registrant
must file a list of its regulated tobacco products in accordance with section 905(i) of the act.

3

Contains Nonbinding Recommendations
An owner or operator may authorize a third party agent to register and submit product listing
information on its behalf. Registration and product listing requirements 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 act.
At this time, FDA intends to enforce the registration and product listing requirements with
respect to:
•

establishments engaged in the manufacturing of cigarettes, smokeless tobacco, and
roll-your-own tobacco for consumer use; and

•

establishments engaged in the manufacturing of tobacco, papers, filters, or pouches,
whether such products are for further manufacturing of, or for consumer use as,
regulated tobacco products. This includes tobacco, papers, and filters sold separately,
in kits (such as for roll-your-own tobacco), or as part of accessories.

At this time, FDA does not intend to enforce the registration and product listing requirements
in other circumstances.
FDA intends to focus enforcement of the registration and product listing requirements on
owners and operators engaged in the manufacture of cigarettes, smokeless tobacco, and rollyour-own tobacco for consumer use, as well as owners and operators engaged in the
manufacture of tobacco, papers, filters, and pouches because these comprise the principal
components of most tobacco products sold to consumers. Should the agency find that
additional information is needed to protect the public health, the agency may reconsider this
compliance policy. We intend to communicate any such compliance policy changes by
guidance and/or rulemaking.
In order to reduce redundant submissions, FDA strongly encourages that the owner act as the
agent of all operators within a given business structure in submitting registration and product
listing information. Under this approach, the owner would register all establishments it owns
and submit the associated product listing information, and would also register on behalf of all
operators with management authority over those establishments. An owner acting as the
agent of one or more operators would need to submit all information required of the
operator(s) (e.g., the operator(s) name and places 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 those 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

4

Contains Nonbinding Recommendations
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.
C. What information is submitted as part of registration and product listing under
section 905 of the act?
1. Registration
Section 905(b) of the act sets forth the requirements for submission of 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 email address, to facilitate correspondence between registrants and FDA.
A Data Universal Numbering System (D-U-N-S®) Number 3 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 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. Dun & Bradstreet assigns and maintains a database of the D-U-N-S®
Numbers, which serve as unique identifiers (codes) of business entities. Upon
application, each business entity is assigned a distinct site-specific 9-digit D-U-N-S®
Number. 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).

2. Product listing information
Section 905(i) of the act sets forth the requirements for submitting product listing
information. The act requires that, at the time of registration, the registrant submit a list of all
tobacco products which 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 are as follows:

3

D-U-N-S® Numbers are proprietary to and controlled by Dun & Bradstreet (D&B).

5

Contains Nonbinding Recommendations
a. If a tobacco product standard has been established under section 907 of the 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 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 all labeling for that product. We interpret this to mean that labeling is to
be submitted as an exact, legible, full color copy.
b. 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
(excluding labeling) 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.
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 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 act to require that each product included in a product
listing be clearly identified and distinguished. Products that differ in any way, other than
packaging differences that do not affect characteristics of the product, are considered to be
distinct tobacco products. For example, if a soft pack and a hard pack of cigarettes have
different moisture content, shelf life, or ingredient composition (including ingredients
introduced in packaging but known or reasonably expected to become incorporated into the
consumed product), they are to be reported as distinct products for purposes of section 905(i).
Each product is to be clearly and uniquely identified by the product category (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.
Section 905(i)(3) of the 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.

6

Contains Nonbinding Recommendations

•

For any tobacco products you have discontinued manufacturing for commercial
distribution since the last report, notice of such discontinuance containing the 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 such resumption
containing the date of resumption and complete product listing information as
described above.

D. How do you submit registration and product listing information?
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). While
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 http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForManufacturers/default.htm.
E. When must you register and list under section 905 of the act?
Section 905(b) of the act requires 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 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 register
immediately as described above. In addition, section 905(d) of the act requires registered
owners and operators to immediately register any new establishment that begins
manufacturing tobacco products.
Section 905(i)(1) of the 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.
Registrants who wish to obtain a new D-U-N-S® Number should obtain one well in advance
of FDA’s deadline since the processing time involved in receiving a D-U-N-S® Number may
take at least 30 days. 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.

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).
7

Contains Nonbinding Recommendations

The time required to complete this information collection is estimated to average between 1 and
2 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 (expires xx/xx/201x).
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 FDA’s webpage at
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForManufacturers/default.htm and
to remove obsolete timeframe 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 – Website address where the electronic submission system and
FDA Form 3741 are available updated from http://www.fda.gov/tobacco to
http://www.fda.gov/TobaccoProducts/ResourcesforYou/ForManufacturers/default.h
tm.
• 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.
8