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List of Subjects in 21 CFR Part 1166

    Labeling, Smoke, Smoking, Tobacco, Tobacco products.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that chapter I of title 21 of the Code of Federal Regulations
be amended by adding part 1166 to subchapter K to read as follows:

PART 1166--PRODUCT STANDARD: FLAVORS IN CIGARS

Subpart A--General Provisions
Sec.
1166.1 Scope.
1166.3 Definitions.
Subpart B--Tobacco Product Standard for Flavors in Cigars
1166.5 Prohibition on use of characterizing flavors in cigars.

    Authority:  21 U.S.C. 331, 333, 371(a), 387b, 387c, 387f(d),
387g(a).

Subpart A--General Provisions

Sec.  1166.1   Scope.

    (a) This part sets out a tobacco product standard under the Federal
Food, Drug, and Cosmetic Act regarding the use of characterizing
flavors in cigars.
    (b) No person may manufacture, distribute, sell, or offer for
distribution or sale, within the United States a cigar or any of its
components or parts that is not in compliance with this part.

Sec.  1166.3   Definitions.

    For purposes of this part:
    Accessory means any product that is intended or reasonably expected
to be used with or for the human consumption of a cigar; does not
contain tobacco or nicotine from any source and is not made or derived
from tobacco; and meets either of the following:
    (1) Is not intended or reasonably expected to affect or alter the
performance, composition, constituents, or characteristics of a cigar;
or
    (2) Is intended or reasonably expected to affect or maintain the
performance, composition, constituents, or characteristics of a cigar;
but
    (i) Solely controls moisture and/or temperature of a stored cigar;
or
    (ii) Solely provides an external heat source to initiate but not
maintain combustion of a cigar.
    Cigar means a tobacco product that:
    (1) Is not a cigarette; and
    (2) Is a roll of tobacco wrapped in leaf tobacco or any substance
containing tobacco.
    Component or part means any software or assembly of materials
intended or reasonably expected:
    (1) To alter or affect the cigar's performance, composition,
constituents, or characteristics; or
    (2) To be used with or for the human consumption of a cigar. The
term excludes anything that is an accessory of a cigar.
    Person includes an individual, partnership, corporation, and
association.
    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 under section 201(f) if such article contains no nicotine, or no
more than trace amounts of naturally occurring nicotine.
    United States means the 50 States of the United States of America
and the District of Columbia, the Commonwealth of Puerto Rico, Guam,
the Virgin Islands, American Samoa, Wake Island, Midway Islands,
Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any
other trust territory or possession of the United States.

Subpart B--Tobacco Product Standard for Flavors in Cigars

Sec.  1166.5   Prohibition on use of characterizing flavors in cigars.

    A cigar or any of its components or parts (including the tobacco,
filter, or wrapper, as applicable) shall not contain, as a constituent
(including a smoke constituent) or additive, an artificial or natural
flavor (other than tobacco) or an herb or spice, including, but not
limited to, strawberry, grape, orange, clove, cinnamon, pineapple,
vanilla, coconut, licorice, cocoa, chocolate, cherry, coffee, mint, or
menthol, that is a characterizing flavor of the tobacco product or
tobacco smoke.

    Dated: April 22, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-08993 Filed 4-28-22; 11:15 am]
BILLING CODE 4164-01-P