(a) Subparts B through E of this part apply to a substantial equivalence report (or an SE Report) for a new tobacco product, other than “premium” cigars as defined in § 1107.12, that has:

(1) Characteristics different from a predicate tobacco product and for which information is submitted to demonstrate it is not appropriate to regulate the product under section 910(b) and (c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health or

(2) The same characteristics as a predicate tobacco product.

(b) These subparts set forth procedures and requirements for the submission to FDA of an SE Report under sections 905 and 910 of the Federal, Food, Drug, and Cosmetic Act; the basic criteria for establishing substantial equivalence; and the general procedures FDA will follow when evaluating submissions.

For 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.

Additive means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding), except that the term does not include tobacco or a pesticide chemical residue in or on raw tobacco, or a pesticide chemical.

Applicant means any manufacturer of tobacco products who is subject to chapter IX of the Federal Food, Drug, and Cosmetic Act that submits a premarket application to receive marketing authorization for a new tobacco product.

Brand means a variety of tobacco product distinguished by the tobacco used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo, registered trademark, brand name(s), identifiable pattern of colors, or any combination of such attributes.

Characteristic means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.

Commercial distribution means any distribution of a tobacco product, whether domestic or imported, to consumers or to any person, but does not include interplant transfers of a tobacco product between establishments within the same parent, subsidiary, and/or affiliate company, nor does it include providing a tobacco product for product testing where such product is not made available for personal consumption or resale. “Commercial distribution” does not include the handing or transfer of a tobacco product from one consumer to another for personal consumption.

Commercially marketed means selling or offering for sale a tobacco product in the United States to consumers or to any person for the eventual purchase by consumers in the United States.

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.

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:

(1) Is or potentially is inhaled, ingested, or absorbed into the body, including as an aerosol or any other emission; and

(2) Causes or has the potential to cause direct or indirect harm to users or nonusers of tobacco products.

Health information statement means a statement, made under section 910(a)(4) of the Federal Food, Drug, and Cosmetic Act, that the health information related to a new tobacco product will be made available upon request by any person.

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:

(1) Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or

(2) Any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.

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:

(1) Is wrapped in whole tobacco leaf;

(2) Contains a 100 percent leaf tobacco binder;

(3) Contains at least 50 percent (of the filler by weight) long filler tobacco (i.e., whole tobacco leaves that run the length of the cigar);

(4) Is handmade or hand rolled (i.e., no machinery was used apart from simple tools, such as scissors to cut the tobacco prior to rolling);

(5) Has no filter, nontobacco tip, or nontobacco mouthpiece;

(6) Does not have a characterizing flavor other than tobacco;

(7) Contains only tobacco, water, and vegetable gum with no other ingredients or additives; and

(8) Weighs more than 6 pounds per 1,000 units.

Submission tracking number or STN means the number that FDA assigns to submissions that are received from a manufacturer of tobacco products, such as SE Reports and voluntary requests for determinations that a tobacco product was commercially marketed in the United States as of February 15, 2007.

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:

(1) Has the same characteristics as the predicate tobacco product; or

(2) Has different characteristics and the information submitted contains information, including clinical data if deemed necessary by FDA, that demonstrates that it is not appropriate to require premarket review under section 910(b) and (c) of the Federal Food, Drug, and Cosmetic Act because the new tobacco product does not raise different questions of public health.

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:

(1) Manufactures, fabricates, assembles, processes, or labels a tobacco product, or

(2) Imports a finished tobacco product for sale or distribution in the United States.