Definition of the Term “Tobacco Product” in Regulations Issued Under the Federal Food, Drug, and Cosmetic Act, 16551-16553 [2023-03950]
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Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1107, 1114, 1140,
and 1143
[Docket No. FDA–2022–N–3262]
Definition of the Term ‘‘Tobacco
Product’’ in Regulations Issued Under
the Federal Food, Drug, and Cosmetic
Act
Food and Drug Administration,
Department of Health and Human
Services (HHS).
ACTION: Technical amendment.
AGENCY:
The Food and Drug
Administration (FDA) is announcing
conforming changes to its regulations
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.
DATES: The technical amendments to
title 21 of the Code of Federal
Regulations (CFR) are effective March
20, 2023.
FOR FURTHER INFORMATION CONTACT: Paul
Hart or Laura Chilaka, Center for
Tobacco Products, Food and Drug
Administration, Document Control
Center, 10903 New Hampshire Ave.,
Bldg. 71, Rm. G335, Silver Spring, MD
20993, 877–287–1373, AskCTP@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
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
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16:19 Mar 17, 2023
Jkt 259001
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);
• 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).
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16551
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, we are making
conforming changes to the CFR to reflect
the statutory amendments made by the
Appropriations Act to tobacco product
regulations issued in whole or in part
under the FD&C Act.1 Elsewhere in this
edition of the Federal Register, we are
issuing a notice to announce conforming
changes to the definition of tobacco
product in guidances issued in whole or
in part under the FD&C Act.
II. Description of Changes to FDA
Regulations
FDA is updating the definition of
‘‘tobacco product’’ in regulations 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 regulations, 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 definition of ‘‘tobacco
product’’ is being updated in the
following sections of the CFR:
1 The Office of the Federal Register (OFR) has
published this document under the category ‘‘Rules
and Regulations’’ with an action heading of
‘‘technical amendment’’ pursuant to its
interpretation of 1 CFR 5.9(b). We note that the
categorization as such for purposes of publication
in the Federal Register does not affect the legal
content or intent of the document. See, 1 CFR
5.1(c).
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16552
Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
TABLE 1—UPDATED REGULATIONS
21 CFR section
(part/heading)
OMB control No.
(if applicable) 2
1100.3 (Part 1100—General) ........................................................................................................................................
1100.202 (Part 1100—Subpart C—Maintenance of Records Demonstrating that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007).
1107.12 (Part 1107—Exemption Requests and Substantial Equivalence Reports) .....................................................
1114.3 (Part 1114—Premarket Tobacco Product Applications) ...................................................................................
1140.3 (Part 1140—Cigarettes, Smokeless Tobacco, and Covered Tobacco Products) .............................................
1143.1 (Part 1143—Minimum Required Warning Statements) .....................................................................................
FDA is also revising 21 CFR 1100.1
and 1100.2 by adding the phrase ‘‘any
tobacco product containing nicotine not
made or derived from tobacco’’ to the
list of tobacco products subject to
chapter IX of the FD&C Act without
needing to be deemed by regulation.
These changes simply reflect
amendments made by the
Appropriations Act to section 901(b) of
the FD&C Act.
III. Paperwork Reduction Act of 1995
The amendments made by the
Appropriations Act result in changes to
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.
Administrative practice and
procedure, Cigars and cigarettes,
Smoking, Tobacco.
21 CFR Part 1140
Authority: 21 U.S.C. 371, 374, 387a(b),
387e, 387i; Pub. L. 117–103, 136 Stat. 49.
2. Add a heading for subpart A before
§ 1100.1 to read as follows:
■
Subpart A—Tobacco Products Subject
to FDA Authority
■
3. Revise § 1100.1 to read as follows:
§ 1100.1
§ 1100.2
Scope.
[Amended]
Advertising, Labeling, Packaging and
containers, Smoking, Tobacco.
Therefore, under the Federal Food,
Drug, and Cosmetic Act, and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 1100,
2 See Section III for additional information about
the Paperwork Reduction Act of 1995 (44 U.S.C.
3501–3521) as it relates to the regulations listed in
table 1.
Jkt 259001
Definitions.
*
21 CFR Part 1143
*
*
*
*
Tobacco product, as stated in section
201(rr) of the Federal Food, Drug, and
Cosmetic Act in relevant part:
(1) Means 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);
and
PO 00000
Frm 00022
Fmt 4700
0910–0684 and 0910–0673.
0910–0879.
N/A.
0910–0768.
(2) Does not mean an article that is a
drug under section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act;
a device under section 201(h) of the
Federal Food, Drug, and Cosmetic Act;
a combination product described in
section 503(g) of the Federal Food, Drug,
and Cosmetic Act; or a food under 201(f)
of the Federal Food, Drug, and Cosmetic
Act if such article contains no nicotine
or no more than trace amounts of
naturally occurring nicotine.
■ 6. In § 1100.202, revise the definition
of ‘‘Tobacco product’’ to read as follows:
§ 1100.202
Definitions.
*
In addition to FDA’s authority over
cigarettes, cigarette tobacco, roll-yourown tobacco, smokeless tobacco, and
any tobacco product containing nicotine
not made or derived from tobacco, FDA
deems all other products meeting the
definition of tobacco product under
section 201(rr) of the Federal Food,
Drug, and Cosmetic Act, except
accessories of such other tobacco
products, to be subject to the Federal
Food, Drug, and Cosmetic Act.
§ 1100.3
Advertising, Labeling, Smoking,
Tobacco.
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1. The authority citation for part 1100
is revised to read as follows:
■
4. In § 1100.2, in the first sentence,
add the words ‘‘, and any tobacco
product containing nicotine not made or
derived from tobacco’’ after ‘‘smokeless
tobacco’’.
■ 5. In § 1100.3, revise the definition of
‘‘Tobacco product’’ to read as follows:
21 CFR Parts 1100, 1107, and 1114
16:19 Mar 17, 2023
PART 1100—GENERAL
■
List of Subjects
VerDate Sep<11>2014
1107, 1114, 1140, and 1143 are
amended as follows:
N/A.
0910–0775.
Sfmt 4700
*
*
*
*
Tobacco product means 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). The
term ‘‘tobacco product’’ does not mean
an article that under the Federal Food,
Drug, and Cosmetic 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 such
article contains no nicotine or no more
than trace amounts of naturally
occurring nicotine.
*
*
*
*
*
PART 1107—EXEMPTION REQUESTS
AND SUBSTANTIAL EQUIVALENCE
REPORTS
7. The authority citation for part 1107
is revised to read as follows:
■
Authority: 21 U.S.C. 371, 374, 387e(j),
387i, 387j; Pub. L. 117–103, 136 Stat. 49.
8. In § 1107.12, revise the definition of
‘‘Tobacco product’’ to read as follows:
■
§ 1107.12
Definitions.
*
*
*
*
*
Tobacco product means any product
made or derived from tobacco, or
containing nicotine from any source,
that is intended for human
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20MRR1
Federal Register / Vol. 88, No. 53 / Monday, March 20, 2023 / Rules and Regulations
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). The
term ‘‘tobacco product’’ does not mean
an article that under the Federal Food,
Drug, and Cosmetic 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 such
article contains no nicotine or no more
than trace amounts of naturally
occurring nicotine.
*
*
*
*
*
PART 1114—PREMARKET TOBACCO
PRODUCT APPLICATIONS
9. The authority citation for part 1114
is revised to read as follows:
■
Authority: 21 U.S.C. 371, 374, 387a, 387i,
387j; Pub. L. 117–103, 136 Stat. 49.
PART 1143—MINIMUM REQUIRED
WARNING STATEMENTS
10. In § 1114.3, revise the definition of
‘‘Tobacco product’’ to read as follows:
■
■
§ 1114.3
Definitions.
*
*
*
*
*
Tobacco product means 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). The
term ‘‘tobacco product’’ does not mean
an article that under the Federal Food,
Drug, and Cosmetic 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 such
article contains no nicotine or no more
than trace amounts of naturally
occurring nicotine.
*
*
*
*
*
PART 1140—CIGARETTES,
SMOKELESS TOBACCO, AND
COVERED TOBACCO PRODUCTS
11. The authority citation for part
1140 is revised to read as follows:
■
Authority: 21 U.S.C. 301 et seq., 21 U.S.C.
387a–1, and Pub. L. 117–103, 136 Stat. 49.
12. In § 1140.3, revise the definition of
‘‘Tobacco product’’ to read as follows:
■
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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);
and
(2) Does not mean an article that is a
drug under section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act;
a device under section 201(h) of the
Federal Food, Drug, and Cosmetic Act;
a combination product described in
section 503(g) of the Federal Food, Drug,
and Cosmetic Act; or a food under 201(f)
of the Federal Food, Drug, and Cosmetic
Act if such article contains no nicotine
or no more than trace amounts of
naturally occurring nicotine.
§ 1140.3
Definitions.
*
*
*
*
*
Tobacco product, as stated in section
201(rr) of the Federal Food, Drug, and
Cosmetic Act in relevant part:
(1) Means any product made or
derived from tobacco, or containing
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16:19 Mar 17, 2023
Jkt 259001
13. The authority citation for part
1143 is revised to read as follows:
Authority: 21 U.S.C. 387a(b), 387f(d), Pub.
L. 117–103, 136 Stat. 49.
14. In § 1143.1, revise the definition of
‘‘Tobacco product’’ to read as follows:
■
§ 1143.1
Definitions.
*
*
*
*
*
Tobacco product, as stated in section
201(rr) of the Federal Food, Drug, and
Cosmetic Act in relevant part:
(1) Means 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);
and
(2) Does not mean an article that is a
drug under section 201(g)(1) of the
Federal Food, Drug, and Cosmetic Act;
a device under section 201(h) of the
Federal Food, Drug, and Cosmetic Act;
a combination product described in
section 503(g) of the Federal Food, Drug,
and Cosmetic Act; or a food under 201(f)
of the Federal Food, Drug, and Cosmetic
Act if such article contains no nicotine
or no more than trace amounts of
naturally occurring nicotine.
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03950 Filed 3–17–23; 8:45 am]
BILLING CODE 4164–01–P
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16553
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2023–0220]
RIN 1625–AA00
Safety Zone; Atlantic Ocean, Cape
Canaveral Offshore Launch Area, FL
Coast Guard, Department of
Homeland Security (DHS).
ACTION: Temporary final rule.
AGENCY:
The Coast Guard is
establishing a temporary safety zone for
waters of the Atlantic Ocean, adjacent to
Cape Canaveral, FL. This safety zone
would implement a special activities
provision of the William M. (Mac)
Thornberry National Defense
Authorization Act for Fiscal Year 2021.
The Coast Guard is establishing this
safety zone for the launch of the Terran
1 rocket, which is being launched by
Relativity Space. The temporary safety
zone will be located within the Coast
Guard District Seven area of
responsibility offshore of Cape
Canaveral, Florida. This rule prohibits
U.S.-flagged vessels from entering the
temporary safety zone unless authorized
by the District Commander of the
Seventh Coast Guard District or a
designated representative. Foreignflagged vessels are encouraged to remain
outside the safety zone. This action is
necessary to protect vessels and
waterway users from the potential
hazards created by launch of the Terran
1 rocket, flying over the U.S. Exclusive
Economic Zone (EEZ).
DATES: This rule is effective without
actual notice from March 20, 2023,
through 4 p.m. on March 23, 2023. For
the purposes of enforcement, actual
notice will be used from 10 a.m. on
March 16, 2023, through March 20,
2023.
SUMMARY:
To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type USCG–2022–
0220 in the search box and click
‘‘Search.’’ Next, in the Document Type
column, select ‘‘Supporting & Related
Material.’’
ADDRESSES:
If
you have questions on this rule, call or
email LT Ryan Gilbert, District Seven,
Waterways Management Branch, U.S.
Coast Guard; telephone 305–415–6750,
email Ryan.A.Gilbert@uscg.mil.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
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]]>Agencies
[Federal Register Volume 88, Number 53 (Monday, March 20, 2023)]
[Rules and Regulations]
[Pages 16551-16553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03950]
[[Page 16551]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1100, 1107, 1114, 1140, and 1143
[Docket No. FDA-2022-N-3262]
Definition of the Term ``Tobacco Product'' in Regulations Issued
Under the Federal Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, Department of Health and Human
Services (HHS).
ACTION: Technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing
conforming changes to its regulations 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.
DATES: The technical amendments to title 21 of the Code of Federal
Regulations (CFR) are effective March 20, 2023.
FOR FURTHER INFORMATION CONTACT: Paul Hart or Laura Chilaka, Center for
Tobacco Products, 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);
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, we are making conforming changes to the CFR to reflect the
statutory amendments made by the Appropriations Act to tobacco product
regulations issued in whole or in part under the FD&C Act.\1\ Elsewhere
in this edition of the Federal Register, we are issuing a notice to
announce conforming changes to the definition of tobacco product in
guidances issued in whole or in part under the FD&C Act.
---------------------------------------------------------------------------
\1\ The Office of the Federal Register (OFR) has published this
document under the category ``Rules and Regulations'' with an action
heading of ``technical amendment'' pursuant to its interpretation of
1 CFR 5.9(b). We note that the categorization as such for purposes
of publication in the Federal Register does not affect the legal
content or intent of the document. See, 1 CFR 5.1(c).
---------------------------------------------------------------------------
II. Description of Changes to FDA Regulations
FDA is updating the definition of ``tobacco product'' in
regulations 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 regulations, 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 definition of ``tobacco product'' is being updated in the
following sections of the CFR:
[[Page 16552]]
Table 1--Updated Regulations
------------------------------------------------------------------------
OMB control No. (if
21 CFR section (part/heading) applicable) \2\
------------------------------------------------------------------------
1100.3 (Part 1100--General)..................... N/A.
1100.202 (Part 1100--Subpart C--Maintenance of 0910-0775.
Records Demonstrating that a Tobacco Product
was Commercially Marketed in the United States
as of February 15, 2007).
1107.12 (Part 1107--Exemption Requests and 0910-0684 and 0910-
Substantial Equivalence Reports). 0673.
1114.3 (Part 1114--Premarket Tobacco Product 0910-0879.
Applications).
1140.3 (Part 1140--Cigarettes, Smokeless N/A.
Tobacco, and Covered Tobacco Products).
1143.1 (Part 1143--Minimum Required Warning 0910-0768.
Statements).
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FDA is also revising 21 CFR 1100.1 and 1100.2 by adding the phrase
``any tobacco product containing nicotine not made or derived from
tobacco'' to the list of tobacco products subject to chapter IX of the
FD&C Act without needing to be deemed by regulation. These changes
simply reflect amendments made by the Appropriations Act to section
901(b) of the FD&C Act.
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\2\ See Section III for additional information about the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) as it relates
to the regulations listed in table 1.
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III. Paperwork Reduction Act of 1995
The amendments made by the Appropriations Act result in changes to
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.
List of Subjects
21 CFR Parts 1100, 1107, and 1114
Administrative practice and procedure, Cigars and cigarettes,
Smoking, Tobacco.
21 CFR Part 1140
Advertising, Labeling, Smoking, Tobacco.
21 CFR Part 1143
Advertising, Labeling, Packaging and containers, Smoking, Tobacco.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
parts 1100, 1107, 1114, 1140, and 1143 are amended as follows:
PART 1100--GENERAL
0
1. The authority citation for part 1100 is revised to read as follows:
Authority: 21 U.S.C. 371, 374, 387a(b), 387e, 387i; Pub. L. 117-
103, 136 Stat. 49.
0
2. Add a heading for subpart A before Sec. 1100.1 to read as follows:
Subpart A--Tobacco Products Subject to FDA Authority
0
3. Revise Sec. 1100.1 to read as follows:
Sec. 1100.1 Scope.
In addition to FDA's authority over cigarettes, cigarette tobacco,
roll-your-own tobacco, smokeless tobacco, and any tobacco product
containing nicotine not made or derived from tobacco, FDA deems all
other products meeting the definition of tobacco product under section
201(rr) of the Federal Food, Drug, and Cosmetic Act, except accessories
of such other tobacco products, to be subject to the Federal Food,
Drug, and Cosmetic Act.
Sec. 1100.2 [Amended]
0
4. In Sec. 1100.2, in the first sentence, add the words ``, and any
tobacco product containing nicotine not made or derived from tobacco''
after ``smokeless tobacco''.
0
5. In Sec. 1100.3, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1100.3 Definitions.
* * * * *
Tobacco product, as stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part:
(1) Means 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); and
(2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act; a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and
Cosmetic Act if such article contains no nicotine or no more than trace
amounts of naturally occurring nicotine.
0
6. In Sec. 1100.202, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1100.202 Definitions.
* * * * *
Tobacco product means 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).
The term ``tobacco product'' does not mean an article that under the
Federal Food, Drug, and Cosmetic 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 such article contains no nicotine or no more
than trace amounts of naturally occurring nicotine.
* * * * *
PART 1107--EXEMPTION REQUESTS AND SUBSTANTIAL EQUIVALENCE REPORTS
0
7. The authority citation for part 1107 is revised to read as follows:
Authority: 21 U.S.C. 371, 374, 387e(j), 387i, 387j; Pub. L.
117-103, 136 Stat. 49.
0
8. In Sec. 1107.12, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1107.12 Definitions.
* * * * *
Tobacco product means any product made or derived from tobacco, or
containing nicotine from any source, that is intended for human
[[Page 16553]]
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).
The term ``tobacco product'' does not mean an article that under the
Federal Food, Drug, and Cosmetic 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 such article contains no nicotine or no more
than trace amounts of naturally occurring nicotine.
* * * * *
PART 1114--PREMARKET TOBACCO PRODUCT APPLICATIONS
0
9. The authority citation for part 1114 is revised to read as follows:
Authority: 21 U.S.C. 371, 374, 387a, 387i, 387j; Pub. L. 117-
103, 136 Stat. 49.
0
10. In Sec. 1114.3, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1114.3 Definitions.
* * * * *
Tobacco product means 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).
The term ``tobacco product'' does not mean an article that under the
Federal Food, Drug, and Cosmetic 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 such article contains no nicotine or no more
than trace amounts of naturally occurring nicotine.
* * * * *
PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO
PRODUCTS
0
11. The authority citation for part 1140 is revised to read as follows:
Authority: 21 U.S.C. 301 et seq., 21 U.S.C. 387a-1, and Pub. L.
117-103, 136 Stat. 49.
0
12. In Sec. 1140.3, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1140.3 Definitions.
* * * * *
Tobacco product, as stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part:
(1) Means 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); and
(2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act; a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and
Cosmetic Act if such article contains no nicotine or no more than trace
amounts of naturally occurring nicotine.
PART 1143--MINIMUM REQUIRED WARNING STATEMENTS
0
13. The authority citation for part 1143 is revised to read as follows:
Authority: 21 U.S.C. 387a(b), 387f(d), Pub. L. 117-103, 136
Stat. 49.
0
14. In Sec. 1143.1, revise the definition of ``Tobacco product'' to
read as follows:
Sec. 1143.1 Definitions.
* * * * *
Tobacco product, as stated in section 201(rr) of the Federal Food,
Drug, and Cosmetic Act in relevant part:
(1) Means 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); and
(2) Does not mean an article that is a drug under section 201(g)(1)
of the Federal Food, Drug, and Cosmetic Act; a device under section
201(h) of the Federal Food, Drug, and Cosmetic Act; a combination
product described in section 503(g) of the Federal Food, Drug, and
Cosmetic Act; or a food under 201(f) of the Federal Food, Drug, and
Cosmetic Act if such article contains no nicotine or no more than trace
amounts of naturally occurring nicotine.
Dated: February 22, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03950 Filed 3-17-23; 8:45 am]
BILLING CODE 4164-01-P
