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]