Next Upcoming Seminar: Implementing SQF 8.0 Systems – May 17-18, 2017

Specializing in FDA Regulatory Matters

Glossary of Terms

Tobacco

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:

  • Is not intended or reasonably expected to affect or alter the performance, composition, constituents, or characteristics of a tobacco product; or
  • Is intended or reasonably expected to affect or maintain the performance, composition, constituents, or characteristics of a tobacco product but
    • Solely controls moisture and/or temperature of a stored tobacco product; or
    • Solely provides an external heat source to initiate but not maintain combustion of a tobacco product (parts 1100, 1140, 1143 (21 CFR parts 1100, 1140, 1143)).

Cigar

means a tobacco product that: (1) is not a cigarette and (2) is a roll of tobacco wrapped in leaf tobacco or any substance containing tobacco (part 1143).

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 (part 1140).

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 (parts 1140, 1143).

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 (parts 1100, 1140, 1143).

Covered tobacco product

means any tobacco product deemed to be subject to the FD&C Act under § 1100.2 of this chapter (i.e., subchapter K), but excludes any component or part that is not made or derived from tobacco (parts 1140, 1143).

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 part 1140 (part 1140).

Finished Tobacco Product,

for the purposes of the deeming rule, a finished tobacco product refers to a tobacco product, including all components and parts, sealed in final packaging intended for consumer use (e.g., filters or filter tubes sold separately to consumers or as part of kits).

Importer

means any person who imports any tobacco product that is intended for sale or distribution to consumers in the United States (part 1140).

Manufacturer means any person, including any repacker and/or relabeler, who manufactures, fabricates, assembles, processes, or labels a finished tobacco product (part 1140).

Modified Risk Tobacco Product, as defined in Section 911 of the FD&C Act, means any tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.

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 (part 1140).

New Tobacco Product – A new tobacco product is defined in section 910(a)(1) of the FD&C Act as: (A) any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or (B) 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.

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 (parts 1100, 1140, 1143).

Point of sale means any location at which a consumer can purchase or otherwise obtain tobacco products for personal consumption (parts 1140, 1143).

Principal display panels means the panels of a package that are most likely to be displayed, presented, shown, or examined by the consumer (part 1143).

Required warning statement means a textual warning statement required to be on packaging and in advertisements for cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products (part 1143).

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 (parts 1140, 1143).

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 (parts 1140, 1143).

Small-scale tobacco product manufacturer, as defined in the Deeming rule, is a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with.

Small tobacco product manufacturer, as defined in section 900 of the FD&C Act, the term ‘small tobacco product manufacturer’ means a tobacco product manufacturer that employs fewer than 350 employees. For purposes of determining the number of employees of a manufacturer under the preceding sentence, the employees of a manufacturer are deemed to include the employees of each entity that controls, is controlled by, or is under common control with such manufacturer.

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 (part 1140).

Tobacco product – As stated in section 201(rr) of the FD&C Act in relevant part, a tobacco product: (1) Means any product made or derived from tobacco 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 defined under section 201(g)(1) of the FD&C Act, a device defined under section 201(h) of the FD&C Act, or a combination product described in section 503(g) of the FD&C Act (parts 1100, 1140, 1143 ).