C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER K—TOBACCO PRODUCTS › PART 1100—General › Subpart A—Tobacco Products Subject to FDA Authority

21 C.F.R. § 1100.3

Definitions

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For the 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 tobacco product; does not contain tobacco 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 tobacco product; or

(2) Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but

(i) Solely controls moisture and/or temperature of a stored tobacco product; or

(ii) Solely provides an external heat source to initiate but not maintain combustion of a tobacco product.

Component or part means any software or assembly of materials intended or reasonably expected:

(1) To alter or affect the tobacco product's performance, composition, constituents, or characteristics; or

(2) To be used with or for the human consumption of a tobacco product. Component or part excludes anything that is an accessory of a tobacco product.

Package or packaging means a pack, box, carton, or container of any kind or, if no other container, any wrapping (including cellophane), in which a tobacco product is offered for sale, sold, or otherwise distributed to consumers.

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.

[81 FR 29102, May 10, 2016, as amended at 88 FR 16552, Mar. 20, 2023]
Notes of Decisions
Cited in 2 cases, 2018–2018 · leading case: Cigar Ass'n of Am. v. U.S. Food & Drug Admin., 315 F. Supp. 3d 143 (D.C. Cir. 2018).
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Cigar Ass'n of Am. v. U.S. Food & Drug Admin., 315 F. Supp. 3d 143 (D.C. Cir. 2018). · cites it 2× “at 29 ,102 ; 21 C.F.R. § 1100.3 . Within the category of "component or part," the FDA included pipes used to consume pipe tobacco.”
Cigar Ass'n of Am. v. United States Food & Drug Admin. (D.D.C. 2018). · cites it 2× “at 29,102; 21 C.F.R. § 1100.3 . Within the category of “component or part,” the FDA included pipes used to consume pipe tobacco.”
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