[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Notices]
[Pages 16636-16639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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:
     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 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 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 (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, [email protected].

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:
     Adulteration and misbranding provisions (sections 902 and 
903 of the FD&C Act);
     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]]

     Required establishment registration and product listing 
(section 905 of the FD&C Act);
     Prohibition of selling tobacco products to individuals 
under 21 years of age (section 906(d)(5) of the FD&C Act);
     Requirement that new tobacco products have an FDA 
marketing order (section 910 of the FD&C Act) in effect; and
     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:
     Refuse to accept criteria for premarket submissions (21 
CFR 1105.10);
     Content and format requirements for premarket tobacco 
product applications (21 CFR part 1114);
     Exemption from substantial equivalence requirements (21 
CFR part 1107, subpart A); and
     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 https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/guidance, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    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