Tobacco Product Initial Ingredient 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.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-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/RulesRegulationsGuidance/default.htm. You
may send an e-mail request to [email protected] to receive an electronic copy of
this guidance. You may send a request for hard copies to U.S. Food and Drug Administration,
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control
Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-2000.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products
July 2016
OMB control number: 0910-0650
Expiration Date: 1/31/2019
See additional PRA statement in section V of the guidance.
* This is the second 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 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? ........................................................................................................................................... 6
1. Registration Information .............................................................................................................. 6
2. Product Listing Information ......................................................................................................... 7
D. How to Make Registration and Product Listing Submissions .................................................... 8
E.

When Must You Register Your Establishment and List Your Products Under Section 905 of

the FD&C Act? ..................................................................................................................................... 9

V.

PAPERWORK REDUCTION ACT OF 1995 ................................................................ 9

DOCUMENT HISTORY ........................................................................................................... 10

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Contains Nonbinding R ecommendations

Registration and Product Listing for Owners
and Operators of Domestic Tobacco Product
Establishments
Guidance for Industry 1
This guidance represents the cunent thinking of the Food and Dmg 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, Dmg, and Cosmetic Act (FD&C Act) . 2 The guidance document explains, among other
things:
•

The statut01y requirement to make establishment registration and product listing
submissions;

•

The definitions of te1ms used in the statute and this guidan ce;

•

Who should make establishment registration and product listing submissions;

•

What inf01mation to include in the submissions;

•

How to submit the inf01mation;

•

When to submit the inf01mation; and

•

FDA's compliance policies.

FDA 's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's cunent 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 (21 U.S.C. 387e(h)).

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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 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&CAct (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&CAct (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.
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.

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.

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Contains Nonbinding Recommendations
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 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.

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.

•

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 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 formal 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 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

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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 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 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].

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Contains Nonbinding Recommendations
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.
In order 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.
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.

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.

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Contains Nonbinding Recommendations
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 are
amending our previous compliance policy. 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 is announcing a change to that policy because we believe we can obtain the
necessary information about tobacco product components and parts through other means, such as
premarket applications for finished tobacco products and through the use of master files, as
explained in the guidance Tobacco Product Master Files. 7 Additionally, we are aligning our
compliance policy for cigarettes, cigarette tobacco, RYO, and smokeless tobacco with the products
now regulated as a result of the deeming rule to reduce burden on industry. Should FDA find that
additional information is needed to protect the public health, the Agency may reconsider this
compliance policy. We intend 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:

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.

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Contains Nonbinding Recommendations
•

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
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

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.

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Contains Nonbinding Recommendations
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 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.
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
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).

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Contains Nonbinding Recommendations
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/GuidanceComplianceRegulatoryInformation/Manufa
cturing/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.
•

V.

As of August 8, 2016, persons who own or operate domestic manufacturing establishments
engaged in the manufacture of newly deemed tobacco products will be required to register
with FDA and submit product listing under section 905 of the FD&C Act. As such,
domestic establishments engaged in the manufacture of newly deemed products prior to
August 8, 2016 will be required to register and submit product listing under section 905 of
the FD&C Act by December 31, 2016.
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. 35013520).
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

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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 1/31/2019).
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 Web page 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 – Web site 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.
June 2016 — Registration and listing guidance revised to reflect changes in FDA authorities over
“deemed” tobacco products.
•

Throughout the document — A number of nonsubtantive changes were made for
clarification purposes.

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•

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
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.

11