Submit evidence of commercial marketing in the United States as of February 15, 2007

Guidance for Industry

Establishing That a Tobacco
Product Was Commercially
Marketed in the United States
as of February 15, 2007
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-2011-D-0125.
For questions regarding this guidance, contact the Center for Tobacco Products at (Tel) 1-877­
CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. EDT.
Additional copies are available online at
http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/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, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring, Maryland,
20993-0002.

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Tobacco Products

September 2014
OMB Control No. 0910-0775
Expiration Date: 06/30/2019
See additional PRA statement in Section VI of this guidance.

Table of Contents

I.

INTRODUCTION...............................................................................................................1

II.

DEFINITIONS ....................................................................................................................1

A.

What is a tobacco product? ..............................................................................................1

B.

What is a new tobacco product?.......................................................................................2

C.

What is a grandfathered tobacco product?........................................................................2

D.

How is “as of” defined? ...................................................................................................3

III. ADMINISTRATIVE INFORMATION ...............................................................................3

A.

Who may request a grandfathered status review? .............................................................3

B.

How should a request for a grandfathered status review be submitted to FDA? ................3

C.

How will FDA review the Grandfathered Submission? ....................................................4

IV. RECOMMENDED CONTENT OF A REQUEST ...............................................................4

V.

A.

Description of the Tobacco Product .................................................................................4

B.

Evidence Demonstrating the Grandfathered Status of the Tobacco Product......................4

PUBLIC AVAILABILITY OF INFORMATION ................................................................5

VI. PAPERWORK REDUCTION ACT OF 1995......................................................................5

i

Guidance for Industry1

Establishing That a Tobacco Product Was

Commercially Marketed in the United States

as of February 15, 2007

This guidance repr esents 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
number listed on the title page of this guidance.

I.

INTRODUCTION

This guidance provides information on how a manufacturer may establish that a tobacco product
was commercially marketed in the United States as of February 15, 2007. The guidance includes
a description of the types of evidence recommended to demonstrate that a tobacco product was
commercially marketed in the United States as of February 15, 2007. The guidance also includes
definitions and administrative information, such as who may submit a request for a grandfathered
status review and how to submit a request.
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
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.

DEFINITIONS

This section provides the definitions of certain terms used in this guidance document.
A.

What is a tobacco product?

A tobacco product is “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

1

This guidance was prepared by the Office of Compliance and Enforcement and the Office of Regulations in the
Center for Tobacco Products at FDA.

Contains Nonbinding Recommendations
product)” (section 201(rr) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)). 2 This
term does not include an article that is a drug, a device, or a combination product as defined in
the FD&C Act (see section 201(rr) of the FD&C Act). The term is not limited to products
containing tobacco, but also includes components, parts, or accessories of tobacco products,
whether they are sold for further manufacturing or 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.

What is a new tobacco product?

A new tobacco product is defined in section 910(a)(1) of the FD&C Act 3 as:
(A) any tobacco product (including those products in test markets) that was
not commercially marketed in the United States as of February 15, 2007;
or
(B) any modification (including a change in design, any component, any part,
or any constituent, including a smoke constituent, or in the content,
delivery or form of nicotine, or any other additive or ingredient) of a
tobacco product where the modified product was commercially marketed
in the United States after February 15, 2007.
In general, a tobacco product manufacturer must obtain an order under section 910(c)(1)(A)(i)
(order after review of a premarket application) before the manufacturer may introduce a new
tobacco product into interstate commerce (section 910 of the FD&C Act). An order under
section 910(c)(1)(A)(i) is not required, however:
•

if a manufacturer submits a substantial equivalence report under section 905(j) of the
FD&C Act 4 (a 905(j) report) and obtains an order under section 910(a)(2)(A)(i);
or

• if FDA has granted a substantial equivalence exemption request submitted under
21 CFR 1107.1 and the manufacturer submits the required report under section 905(j).
C.

What is a grandfathered tobacco product?

For the purposes of this guidance, FDA refers to tobacco products that were commercially
marketed (other than exclusively in test markets) in the United States as of February 15, 2007, as
grandfathered tobacco products. Grandfathered tobacco products are not considered new
tobacco products and thus are not subject to the premarket requirements of the FD&C Act
(section 910 of the FD&C Act).

2

21 U.S.C. 321(rr)
21 U.S.C. 387j(a)(1)
4
21 U.S.C. 387e(j)
3

2

Contains Nonbinding Recommendations
A grandfathered tobacco product may serve as the predicate tobacco product in a 905(j) report
(intended to be used toward demonstrating substantial equivalence) for a new tobacco product
(section 905(j)(1)A)(i) of the FD&C Act, 21 U.S.C. 387e(j)(1)(A)(i)). As discussed earlier,
under section 201(rr) of the FD&C Act, 5 a product made or derived from tobacco that is intended
for human consumption is not a tobacco product if it fits the definition of a drug, device, or
combination product under the FD&C Act. Such products, even if they were on the market as of
February 15, 2007, may not be grandfathered tobacco products and cannot serve as predicate
tobacco products for a 905(j) report.
D.

How is “as of” defined?

We interpret the phrase “as of” February 15, 2007, as meaning that the tobacco product was
commercially marketed (other than exclusively in test markets) in the United States on February
15, 2007. If your tobacco product had been commercially marketed in the United States before
February 15, 2007, but was not commercially marketed on that date, it is not a grandfathered
product and may not be commercially marketed unless you comply with the premarket
requirements of section 910 of the FD&C Act and obtain a marketing order. Section IV.B
describes how you can demonstrate that a tobacco product was commercially marketed (other
than exclusively in test markets) in the United States as of February 15, 2007.
III.

ADMINISTRATIVE INFORMATION
A.

Who may request a grandfathered status review?

If you believe that your tobacco product should be considered a grandfathered tobacco product
and would like an Agency determination on the status of your product, you may submit a request
for review as described in section III.B below.
At this time, FDA intends to limit its review of grandfathered status to finished, regulated
tobacco products. These finished, regulated tobacco products include the tobacco products
named in section 901(b) of the FD&C Act (i.e., cigarettes, cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco) and tobacco products deemed by regulation to be regulated
under Chapter IX, as well as the component parts of regulated tobacco products sold or
distributed for consumer use (e.g., cigarette rolling papers, filters, or filter tubes sold separately
to consumers or as part of kits). FDA does not intend to review grandfathered status for
component parts of regulated tobacco products that are sold or distributed solely for further
manufacturing into finished tobacco products because at this time the Agency does not intend to
enforce the requirements of sections 910 and 905(j) of the FD&C Act for these components. 6

B.

How should a request for a grandfathered status review be submitted to
FDA?

5

21 U.S.C. 321(rr).

See the Guidance for Industry and FDA Staff, Section 905(j) Reports: Demonstrating Substantial Equivalence for

Tobacco Products (January 2011), available on the Internet at

http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

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Contains Nonbinding Recommendations
For the purposes of this guidance, a submission requesting a grandfathered status review is
referred to as a Grandfathered Submission. Each tobacco product should be submitted in a
separate Grandfathered Submission. 7 Grandfathered Submissions can be submitted
electronically via the FDA’s Electronic Submissions Gateway 8 (ESG) using FDA’s eSubmitter
tool9. Although electronic submission is not required, FDA strongly encourages electronic
submission for efficient and timely data submission and management. Alternatively,
submissions can be mailed 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

C.

How will FDA review the Grandfathered Submission?

FDA will review the Grandfathered Submission to determine whether the tobacco product is a
grandfathered tobacco product (i.e., the tobacco product was commercially marketed (other than
exclusively in test markets) in the United States as of February 15, 2007). FDA will notify you
of its determination in writing. If FDA is unable to determine the grandfathered status of your
product, the Agency may contact you to request further information.
IV.

RECOMMENDED CONTENT OF A REQUEST
A.

Description of the Tobacco Product

FDA recommends that you specifically identify the product (e.g., name) and provide a brief
description of the tobacco product that will allow FDA to review your request in context. For
example, the description could include a list of components that comprise the product, a basic
description of the materials, and how the product is used by the consumer. In addition, to better
assist our review of your request, the description should include a legible photograph or
schematic diagram of the tobacco product.
B.

Evidence Demonstrating the Grandfathered Status of the Tobacco Product

FDA recommends that you provide adequate information to demonstrate that the tobacco product
was commercially marketed (other than exclusively in test markets) in the United States as of
7

These procedures pertain specifically to Grandfathered Submissions. The procedures related to grandfathered
evidence submitted as part of a 905(j) report are not within the scope of this guidance document.
8
The FDA ESG system requires users to apply for a free account before submitting data, a process which can take
one to three weeks. Once approved, the user can send all submissions to CTP using the eSubmitter tool and FDA
ESG. Instructions on obtaining an ESG account are available at
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm188949.htm.
9
The FDA eSubmitter tool is an electronic application designed to streamline the process for regulatory
submissions. Users of the eSubmitter tool first download and install the computer application and then enter all
data. The eSubmitter tool is available at http://www.fda.gov/ForIndustry/FDAeSubmitter.

4

Contains Nonbinding Recommendations
February 15, 2007. As stated in section II.D, we interpret “as of” to mean “on.” Accordingly,
the information submitted should demonstrate (individually or collectively) that the tobacco
product was commercially marketed (other than exclusively in test markets) in the United States
on February 15, 2007. If you cannot provide documentation specifically dated on
February 15, 2007, FDA suggests you provide documentation of commercial marketing for a
reasonable period of time before and after February 15, 2007.
Examples of such information may include, but are not limited to, the following:
•
•
•
•
•
•
•
•
•
•
•
•
•

dated copies of advertisements
dated catalog pages
dated promotional material
dated trade publications
dated bills of lading
dated freight bills
dated waybills
dated invoices
dated purchase orders
dated customer receipts
dated manufacturing documents
dated distributor or retailer inventory lists
any other document you believe demonstrates that the tobacco product was commercially
marketed (other than exclusively in test markets) in the United States as of February 15,
2007

FDA will consider and evaluate all of the information provided on a case-by-case basis.
V.

PUBLIC AVAILABILITY OF INFORMATION

Your Grandfathered Submission may include nonpublic trade secret or confidential commercial
information. Several laws govern the confidentiality of information submitted under the FD&C
Act, including section 906(c) of the FD&C Act (21 U.S.C. 387f(c)), the Trade Secrets Act (18
U.S.C. 1905), and the Freedom of Information Act (FOIA) (5 U.S.C. 552), as well as FDA’s
regulations implementing these laws. FDA’s general regulations concerning the public
availability of FDA records are contained in 21 CFR part 20.
VI.

PAPERWORK REDUCTION ACT OF 1995

This guidance contains information collection provisions that are subject to review by the Office
of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520).
The time required to complete this information collection is estimated to average 5 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:
5

Contains Nonbinding Recommendations
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 0910-0775 (expires 09/30/2017).

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