21 CFR § 1100.3 - Definitions.

---
identifier: "/us/cfr/t21/s1100.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1100.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "1100.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "K"
subchapter_name: "TOBACCO PRODUCTS"
part_number: "1100"
part_name: "General"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 371, 374, 387a(b), 387e, 387i; Pub. L. 117-103, 136 Stat. 49."
regulatory_source: "81 FR 29102, May 10, 2016, unless otherwise noted."
cfr_part: "1100"
---


# 1100.3 Definitions.

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]