[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]]

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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.

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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.
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    \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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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
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                                                    OMB control No. (if
          21 CFR section (part/heading)               applicable) \2\
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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