§1107.12. Definitions.

Composition means the materials in a tobacco product, including ingredients, additives, and biological organisms. The term includes the manner in which the materials, for example, ingredients, additives, and biological organisms, are arranged and integrated to produce a tobacco product.

Constituent means any chemical or chemical compound in a tobacco product that is or potentially is inhaled, ingested, or absorbed into the body, any chemical or chemical compound in an emission (e.g., smoke, aerosol, droplets) from a tobacco product, that either transfers from any component or part of the tobacco product to the emission or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product.

Container closure system means any packaging materials that are a component or part of a tobacco product.

Design means the form and structure concerning, and the manner in which, components or parts, ingredients, software, and materials are integrated to produce a tobacco product.

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.

Finished tobacco product means a tobacco product, including all components and parts, sealed in final packaging (e.g., filters or filter tubes sold to consumers separately or as part of kits) or in the final form in which it is intended to be sold to consumers.

Harmful or potentially harmful constituent (HPHC) means any chemical or chemical compound in a tobacco product or tobacco smoke or emission that:

Health information summary means a summary, submitted under section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act, of any health information related to a new tobacco product.

Heating source means the source of energy used to burn or heat the tobacco product.

Ingredient means tobacco, substances, compounds, or additives contained within or added to the tobacco, paper, filter, or any other component or part of a tobacco product, including substances and compounds reasonably expected to be formed through a chemical reaction during tobacco product manufacturing.

Material means an assembly of ingredients. Materials are assembled to form a tobacco product or components or parts of tobacco products.

New tobacco product means:

Other features means any distinguishing qualities of a tobacco product similar to those specifically enumerated in section 910(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act. Such other features include harmful and potentially harmful constituents and any other product characteristics that relate to the chemical, biological, and physical properties of the 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.

Predicate tobacco product means a tobacco product that was commercially marketed (other than for test marketing) in the United States as of February 15, 2007, or a tobacco product that FDA has previously found substantially equivalent under section 910(a)(2)(A)(i) of the Federal Food, Drug, and Cosmetic Act.

Premium cigars means a type of cigar that:

Substantial equivalence or substantially equivalent means, with respect to a new tobacco product being compared to a predicate tobacco product, that FDA by order has found that the new tobacco product:

Substantial equivalence report or SE Report means a submission under section 905(j)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act that includes the basis for the applicant's determination that a new tobacco product is substantially equivalent to a predicate tobacco product. This term includes the initial substantial equivalence report and all subsequent amendments.

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 (section 201(f)) if such article contains no nicotine or no more than trace amounts of naturally occurring nicotine.

Tobacco product manufacturer means any person, including a repacker or relabeler, who: