(a) This part sets out the restrictions under the Federal Food, Drug, and Cosmetic Act on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products. Section 1140.16(d) sets out restrictions on the distribution of free samples for cigarettes, smokeless tobacco, and other tobacco products (as such term is defined in section 201 of the Federal Food, Drug, and Cosmetic Act).

(b) The failure to comply with any applicable provision in this part in the sale, distribution, and use of cigarettes, smokeless tobacco, covered tobacco products, or other tobacco products renders the product misbranded under the Federal Food, Drug, and Cosmetic Act.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

The purpose of this part is to establish restrictions on the sale, distribution, and use of cigarettes, smokeless tobacco, and covered tobacco products in order to reduce the number of children and adolescents who use these products, and to reduce the life-threatening consequences associated with tobacco use.

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 product; or

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

Cigarette. (1) Means a product that:

(i) Is a tobacco product and

(ii) Meets the definition of the term “cigarette” in section 3(1) of the Federal Cigarette Labeling and Advertising Act; and

(2) Includes tobacco, in any form, that is functional in the product, which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette or as roll-your-own tobacco.

Cigarette tobacco means any product that consists of loose tobacco that is intended for use by consumers in a cigarette. Unless otherwise stated, the requirements applicable to cigarettes under this chapter also apply to cigarette tobacco.

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.

Covered tobacco product means any tobacco product deemed to be subject to the Federal Food, Drug, and Cosmetic Act under § 1100.2 of this chapter, but excludes any component or part that is not made or derived from tobacco.

Distributor means any person who furthers the distribution of a tobacco product, whether domestic or imported, at any point from the original place of manufacture to the person who sells or distributes the product to individuals for personal consumption. Common carriers are not considered distributors for the purposes of this part.

Importer means any person who imports any tobacco product that is intended for sale or distribution to consumers in the United States.

Manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product.

Nicotine means the chemical substance named 3-(1-Methyl-2-pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex of nicotine.

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.

Point of sale means any location at which a consumer can purchase or otherwise obtain tobacco products for personal consumption.

Retailer means any person who sells tobacco products to individuals for personal consumption, or who operates a facility where vending machines or self-service displays are permitted under this part.

Roll-your-own tobacco means any tobacco product that, because of its appearance, type, packaging, or labeling, is suitable for use and likely to be offered to, or purchased by, consumers as tobacco for making cigarettes.

Smokeless tobacco means any tobacco product that consists of cut, ground, powdered, or leaf tobacco and that is intended to be placed in the oral or nasal cavity.

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.