Guidance for Industry   
 
 
Establishing That a Tobacco Product 
Was Commercially Marketed in the 
 
United States as of February 15, 2007
(Revised)* 
 
 
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 SmallBiz.Tobacco@fda.hhs.gov to receive an electronic copy 
of this guidance. You may send a request for hard copies to U.S. Food and Drug Administration, 
Center for Tobacco Products, Attn: Office of Small Business Assistance, Document Control 
Center, 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 
October 2023 
OMB Control No. 0910-0775  
Current expiration date available at https://www.reginfo.gov  
 
See additional PRA statement in Section VI of this guidance. 
 
* This is a revision to the first edition of this guidance, which FDA issued in September 2014. A  
   summary of the revisions are listed at the end of the guidance.  
   
 
  Table of Contents 
I. INTRODUCTION ........................................................................................................................... 3 
II. DEFINITIONS ................................................................................................................................. 3 
A. What is a tobacco product? ....................................................................................................... 3 
B. What is a new tobacco product? ............................................................................................... 4 
C. What is a pre-existing tobacco product? .................................................................................. 5 
D. How is as of defined? ............................................................................................................ 5 
III. ADMINISTRATIVE INFORMATION .......................................................................................... 5 
A. Who may request a pre-existing status review? ....................................................................... 5 
B. How should a request for a pre-existing status review be submitted to FDA? ......................... 6 
C. How will FDA review the pre-existing tobacco product submission? .................................... 6 
IV. RECOMMENDED CONTENT OF A REQUEST .......................................................................... 6 
A. Description of the tobacco product .......................................................................................... 6 
B. Evidence demonstrating the pre-existing status of the tobacco product................................... 7 
V. PUBLIC AVAILABILITY OF INFORMATION ........................................................................... 7 
VI. PAPERWORK REDUCTION ACT OF 1995 ................................................................................. 8 
i   
Contains Nonbinding Recommendations 
Guidance for Industry1
 
Establishing That a Tobacco Product Was 
Commercially Marketed in the United States 
as of February 15, 2007 
 
 
 
This guidance represents the Food and Drug Administrations (FDAs) 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 pre-existing 
status review and how to submit a request. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agencys 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, or containing nicotine from 
any source, that is intended for human consumption, including any component, part, or 
accessory of a tobacco product (except for raw materials other than tobacco used in 
manufacturing a component, part, or accessory of a tobacco product).  
 
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. 
   
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Contains Nonbinding Recommendations 
 
 
The term tobacco product does not mean an article that under the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) is: a drug (section 201(g)(1)); a device (section 201(h)); a 
combination product (section 503(g)); or a food (section 201(f)) if the food contains no nicotine, 
or no more than trace amounts of naturally occurring nicotine (section 201(rr) of FD&C Act).2  
 
The term is not limited to products containing tobacco or nicotine, 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 Act3 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 Act4 (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). 
   
 
 
 
 
2 21 U.S.C. 321(rr) 
3 21 U.S.C. 387j(a)(1) 
4 21 U.S.C. 387e(j) 
   
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Contains Nonbinding Recommendations 
 
C.  What is a pre-existing tobacco product? 
 
A pre-existing tobacco product refers to a tobacco product (including those products in test 
markets) that was commercially marketed in the United States as of February 15, 2007 (21 CFR 
1100.202). Pre-existing 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).  
Commercially marketed means selling or offering for sale a tobacco product in the United 
States to consumers or to any person for the eventual purchase by consumers in the United 
States. (21 CFR 1100.202). 
 
 
D.  How is as of defined? 
 
We interpret the phrase as of February 15, 2007, as meaning that the tobacco product was 
commercially marketed (including those products 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 pre-
existing 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 in the 
United States as of February 15, 2007. 
 
III.  ADMINISTRATIVE INFORMATION 
 
A.  Who may request a pre-existing status review? 
 
If you believe that your tobacco product should be considered a pre-existing 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.  Submitting a tobacco product for pre-existing status 
review is voluntary and not required under the FD&C Act.  
 
At this time, FDA intends to limit its review of pre-existing 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, 
smokeless tobacco, and products containing nicotine not made or derived from 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 pre-existing 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.  
 
 
 
 
 
 
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Contains Nonbinding Recommendations 
                   
                                        
B.  How should a request for a pre-existing status review be submitted to 
FDA? 
For the purposes of this guidance, a submission requesting a pre-existing status review is 
referred to as a pre-existing tobacco product submission. Each tobacco product should be 
submitted in a separate pre-existing tobacco product submission.5 Pre-existing tobacco product 
submissions can be submitted electronically via the FDAs Electronic Submissions Gateway 
(ESG) 6 using FDAs eSubmitter tool.7 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 pre-existing tobacco product submission? 
 
FDA will review the pre-existing tobacco product submission to determine whether the tobacco 
product is a pre-existing tobacco product, i.e., a tobacco product (including those products in 
test markets) that was commercially marketed 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 pre-
existing 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. 
 
 
5 These procedures pertain specifically to pre-existing tobacco product submissions. The procedures related to 
pre-existing tobacco product evidence submitted as part of a 905(j) report are not within the scope of this 
guidance document. 
6The 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 https://www.fda.gov/industry/electronic-
submissions-gateway/create-esg-account. 
7 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 https://www.fda.gov/industry/fda-esubmitter/using-esubmitter-
prepare-tobacco-product-submissions 
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Contains Nonbinding Recommendations 
 
 
B.  Evidence demonstrating the pre-existing status of the tobacco product 
 
FDA recommends that you provide adequate information to demonstrate that the tobacco product 
was commercially marketed in the United States as of 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 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 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 pre-existing tobacco product 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 
FDAs regulations implementing these laws. FDAs general regulations concerning the public 
availability of FDA records are contained in 21 CFR part 20.
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Contains Nonbinding Recommendations 
 
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: 
 
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. To find the current expiration date, search for this 
OMB control number at https://www.reginfo.gov. 
 
 
   
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Contains Nonbinding Recommendations 
 
VII.  DOCUMENT HISTORY 
 
March 2023  Guidance updated to reflect statutory amendments made by the 
Consolidated Appropriations Act, 2022 (Pub. L. 117-103). Among other things, the 
legislation amends the definition of tobacco product in section 201(rr) of FD&C Act to 
include products containing nicotine from any source. 
 
  Section IIIEdits to reflect amendments to 201(rr) and 901(b) of the FD&C Act.  
 
October 2023  Revisions included the following: 
 
  Replaced grandfathered with pre-existing / pre-existing tobacco product to be 
consistent with 21 CFR 1100.202. 
  Clarifying and editorial changes to promote consistency throughout our guidances and with 
the 21 CFR part 1107. 
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