Notice2023-03951
Definition of the Term “Tobacco Product” in Guidances Issued Under the Federal Food, Drug, and Cosmetic Act
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Published
March 20, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing conforming changes to its guidances issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022, which amended the term "tobacco product" in the FD&C Act to include products that contain nicotine from any source.
Full Text
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<title>Federal Register, Volume 88 Issue 53 (Monday, March 20, 2023)</title>
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[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16636-16639]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03951]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-3261]
Definition of the Term ``Tobacco Product'' in Guidances Issued
Under the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing conforming changes to its guidances issued under the Federal
Food, Drug, and Cosmetic Act (FD&C
[[Page 16637]]
Act) as required by the Consolidated Appropriations Act of 2022, which
amended the term ``tobacco product'' in the FD&C Act to include
products that contain nicotine from any source.
DATES: Conforming changes to reflect the changes to FDA's guidance are
made beginning March 20, 2023.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 name of the
guidance(s) that the comments address and the docket number for the
guidance(s) (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number (see table 1) 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 this guidance 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 guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Paul Hart or Laura Chilaka, Center for
Tobacco Products (CTP), Food and Drug Administration, Document Control
Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD
20993, 877-287-1373, <a href="/cdn-cgi/l/email-protection#b9f8cad2faede9f9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="4a0b3921091e1a0a2c2e2b64222239642d253c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
The Family Smoking Prevention and Tobacco Control Act (Tobacco
Control Act) (Pub. L. 111-31) was enacted on June 22, 2009, amending
the FD&C Act and providing FDA with the authority to regulate tobacco
products. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as
amended by the Tobacco Control Act, defined the term ``tobacco
product'' to mean 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). It further stated that the term ``tobacco product''
does not mean 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 (21 U.S.C. 353(g)).
The Consolidated Appropriations Act of 2022 (the Appropriations
Act) (Pub. L. 117-103), enacted on March 15, 2022, amended the
definition of the term ``tobacco product'' in section 201(rr) of the
FD&C Act to include products that contain nicotine from any source. It
further amended the definition to exclude articles that are foods under
section 201(f) of the FD&C Act if such articles contain no nicotine or
no more than trace amounts of naturally occurring nicotine. The
Appropriations Act also amended section 901(b) of the FD&C Act (21
U.S.C. 387a(b)), which concerns FDA authority over tobacco products, by
adding a sentence stating chapter IX of the FD&C Act shall also apply
to any tobacco product containing nicotine that is not made or derived
from tobacco. As a result, tobacco products that contain non-tobacco
nicotine (NTN), including synthetic nicotine, are now subject to the
provisions in chapter IX of the FD&C Act (21 U.S.C. 387 to 387t),
including but not limited, to the:
<bullet> Adulteration and misbranding provisions (sections 902 and
903 of the FD&C Act);
<bullet> Required submission of ingredient listing and reporting of
harmful and potentially harmful constituents for all tobacco products
(section 904 of the FD&C Act);
[[Page 16638]]
<bullet> Required establishment registration and product listing
(section 905 of the FD&C Act);
<bullet> Prohibition of selling tobacco products to individuals
under 21 years of age (section 906(d)(5) of the FD&C Act);
<bullet> Requirement that new tobacco products have an FDA
marketing order (section 910 of the FD&C Act) in effect; and
<bullet> Requirement that modified risk tobacco products have a
modified risk order in effect (section 911 of the FD&C Act).
The Appropriations Act further states that products that are
tobacco products under the amended definition in section 201(rr) of the
FD&C Act shall be subject to all requirements of regulations for
tobacco products and specifies that the term ``tobacco product'' in
regulations and guidance issued, in whole or in part, under the FD&C
Act shall have the meaning of, and shall be deemed amended to reflect
the meaning of, the amended definition in section 201(rr). As a result,
beginning April 14, 2022, tobacco products that contain NTN, including
synthetic nicotine, are subject to the provisions that apply to tobacco
products in FDA's regulations, including, but not limited to:
<bullet> Refuse to accept criteria for premarket submissions (21
CFR 1105.10);
<bullet> Content and format requirements for premarket tobacco
product applications (21 CFR part 1114);
<bullet> Exemption from substantial equivalence requirements (21
CFR part 1107, subpart A); and
<bullet> Prohibition of the distribution of free samples (21 CFR
1140.16(d)).
The Appropriations Act directs FDA to publish a notice in the
Federal Register to update the Code of Federal Regulations (CFR) to
reflect the deemed amendment to existing regulations and guidance.
Accordingly, in this notice we are making conforming changes to reflect
the statutory amendments made by the Appropriations Act to tobacco
product guidance issued in whole or in part under the FD&C Act.
Elsewhere in this edition of the Federal Register, we are issuing a
final amendment to make conforming changes to regulations to reflect
the statutory amendments made by the Appropriations Act.
II. Description of Changes to FDA Guidances
FDA is updating the definition of ``tobacco product'' in guidances
issued, in whole or in part, under the FD&C Act, to reflect the
amendments made by the Appropriations Act. The definition of ``tobacco
product,'' where included in the text of FDA guidance, is being updated
to reflect the statutory amendments by adding the phrase ``or
containing nicotine from any source'' after the words ``from tobacco,''
and incorporating the exclusion of articles that are foods as defined
in section 201(f) of the FD&C Act if such articles contain no nicotine
or no more than trace amounts of naturally occurring nicotine.
The guidance documents listed in table 1 are, or will be,\1\
updated to reflect the statutory amendments made by the Appropriations
Act. In certain cases, FDA is also making Level 2 changes to these
guidance documents for clarity in light of the statutory amendments.
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\1\ Guidance titles in table 1 marked with an asterisk will be
published in updated form as changes are finalized or when the
associated information collections are updated in accordance with
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Table 1--Updated Guidance Documents
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OMB control No.
Title of guidance Docket No. (if applicable)
\1\
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FDA Deems Certain Tobacco FDA-2014-N-0189 N/A.
Products Subject to FDA
Authority, Sales and
Distribution Restrictions,
and Health Warning
Requirements for Packages
and Advertisements *.
Premarket Tobacco Product FDA-2015-D-2496 Refers to
Applications for Electronic previously
Nicotine Delivery Systems. approved FDA
collections of
information.
Interpretation of and FDA-2017-D-0120 N/A.
Compliance Policy for
Certain Label Requirements;
Applicability for Certain
Federal Food, Drug, and
Cosmetic Act Requirements
to Vape Shops.
Listing of Ingredients in FDA-2009-D-0524 0910-0650.
Tobacco Products *.
Registration and Product FDA-2009-D-0508 0910-0650.
Listing for Owners and
Operators of Domestic
Tobacco Product
Establishments *.
Health Document Submission FDA-2009-D-0600 0910-0654.
Requirements for Tobacco
Products *.
Prohibition of Distributing FDA-2017-D-0113 N/A.
Free Samples of Tobacco
Products.
Civil Money Penalties and No- FDA-2010-D-0431 N/A.
Tobacco-Sale Orders for
Tobacco Retailers.
Demonstrating the FDA-2011-D-0147 0910-0673.
Substantial Equivalence of
a New Tobacco Product:
Responses to Frequently
Asked Questions.
Determination of the Period FDA-2015-D-0404 N/A.
Covered by a No-Tobacco-
Sale Order and Compliance
with an Order.
Establishing That a Tobacco FDA-2011-D-0125 0910-0775.
Product Was Commercially
Marketed in the United
States as of February 15,
2007 *.
Small Entity Compliance FDA-2011-N-0121 N/A.
Guide: Further Amendments
to General Regulations of
the Food and Drug
Administration to
Incorporate Tobacco
Products.
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\1\ See section III of this document for additional information about
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) as it
relates to these guidance documents.
These 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 the topic discussed in each guidance.
They do not establish any legally enforceable rights or
responsibilities for any person and are not legally binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. You may submit
comments on any guidance at any time (see ADDRESSES).
III. Paperwork Reduction Act of 1995
The amendments made by the Appropriations Act result in changes to
[[Page 16639]]
some previously approved collections of information that are subject to
review and approval by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The
OMB control numbers for these information collections are listed in
table 1. FDA has published, and intends to continue publishing, notices
concerning proposed changes to the relevant information collection
activities in other editions of the Federal Register. In addition, in
compliance with the PRA, we will submit revisions to the current
information collections to OMB for review.
IV. Electronic Access
Persons with access to the internet may obtain an electronic
version of the guidance documents at <a href="https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance">https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03951 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P
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