Document ID: FDA-2023-D-4128-0001
Agency: fda
Document Type: Notice
Title: Guidance Documents Referencing Pre- Existing Tobacco Products; Guidance for Industry; Availability; Withdrawal
Posted Date: 2023-10-18T04:00Z

[Federal Register Volume 88, Number 200 (Wednesday, October 18, 2023)]
[Notices]
[Pages 71873-71875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22976]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4128]

Guidance Documents Referencing Pre-Existing Tobacco Products; 
Guidance for Industry; Availability; Withdrawal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of revised final guidances for industry entitled 
``Demonstrating the Substantial Equivalence of a New Tobacco Product: 
Responses to Frequently Asked Questions,'' and ``Establishing That a 
Tobacco Product Was Commercially Marketed in the United States as of 
February 15, 2007.'' Following the issuance of the final rules entitled 
``Content and Format of Substantial Equivalence Reports; Food and Drug 
Administration Actions on Substantial Equivalence Reports'' (SE) and 
``Premarket Tobacco Product Applications and Recordkeeping 
Requirements'' (PMTA), FDA has made minor updates to these guidances 
for consistency with the terminology used in those rules. FDA is also 
announcing the withdrawal of the final guidances entitled ``Section 
905(j) Reports: Demonstrating Substantial Equivalence for Tobacco 
Products,'' and ``Investigational Use of Deemed, Finished Tobacco 
Products That Were on the U.S. Market on August 8, 2016, During the 
Deeming Compliance Periods,'' and a draft guidance entitled 
``Substantial Equivalence Reports: Manufacturer Requests for Extensions 
or to Change the Predicate Tobacco Product,'' which are obsolete due to 
the issuance of the SE final rule or the end of the compliance period 
for deemed, finished tobacco products that were on the U.S. market on 
August 8, 2016.

DATES: The announcement of the guidance is published in the Federal 
Register on October 18, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-4128 for ``Guidance Documents Referencing Pre-Existing 
Tobacco Products.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential

[[Page 71874]]

Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through 
Friday, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of these guidances to the 
Center for Tobacco Products, Food and Drug Administration, Document 
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the guidances may be sent. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance documents.

FOR FURTHER INFORMATION CONTACT: Natalie Gibson, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
877-287-1373, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On June 22, 2009, the Family Smoking Prevention and Tobacco Control 
Act (Pub. L. 111-31) (Tobacco Control Act) was signed into law. The 
Tobacco Control Act grants FDA authority to regulate the manufacture, 
marketing, and distribution of tobacco products to protect public 
health generally and to reduce tobacco use by youth. FDA is announcing 
the availability of revised final guidances for industry, collectively 
entitled ``Guidance Documents Referencing Pre-Existing Tobacco 
Products.''
    In the PMTA final rule (86 FR 55300, October 5, 2021) and the SE 
final rule (86 FR 55224, October 5, 2021), FDA has changed the term 
``grandfathered tobacco product'' to ``pre-existing tobacco product'' 
because it more appropriately describes these products. Specifically, 
FDA considers a ``pre-existing tobacco product'' to mean a tobacco 
product that was commercially marketed in the United States as of 
February 15, 2007. FDA also made other minor changes to the revised 
guidances to reflect updated terminology used in the SE final rule, 
when appropriate. Details of the changes are described in the revision 
history page included with each guidance.
    FDA is also withdrawing three guidances that are obsolete due to 
the issuance of the SE final rule or due to the end of the compliance 
period for deemed, finished tobacco products that were on the U.S. 
market on August 8, 2016. The guidances along with their docket numbers 
and status are listed in table 1.

                Table 1--Revised and Withdrawn Guidances
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              Title                   Docket No.            Status
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Demonstrating the Substantial     FDA-2011-D-0147...  Revised.
 Equivalence of a New Tobacco
 Product: Responses to
 Frequently Asked Questions.
Establishing That a Tobacco       FDA-2011-D-0125...  Revised.
 Product Was Commercially
 Marketed in the United States
 as of February 15, 2007.
Investigational Use of Deemed,    FDA-2016-D-3276...  Withdrawn.
 Finished Tobacco Products That
 Were on the U.S. Market on
 August 8, 2016, During the
 Deeming Compliance Periods.
Section 905(j) Reports:           FDA-2010-D-0635...  Withdrawn.
 Demonstrating Substantial
 Equivalence for Tobacco
 Products.
Substantial Equivalence Reports:  FDA-2014-D-0800...  Withdrawn.
 Manufacturer Requests for
 Extensions or to Change the
 Predicate Tobacco Product,
 Draft Guidance.
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    The revised final guidances are being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115) and represent the 
current thinking of FDA on, among other things, the incorporation of 
the term ``pre-existing tobacco product.'' They do not establish any 
rights for any person and are not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While these guidances contain no collections of information, they 
do refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in FDA's guidance entitled ``Establishing That a Tobacco Product Was 
Commercially Marketed in the United States as of February 15, 2007'' 
have been approved under OMB control number 0910-0775.

III. Electronic Access

    Persons with access to the internet may obtain an electronic 
version of the guidances at https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/TobaccoProducts/

[[Page 71875]]

Labeling/RulesRegulationsGuidance/default.htm, or https://www.regulations.gov.

    Dated: October 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22976 Filed 10-17-23; 8:45 am]
BILLING CODE 4164-01-P