- 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)).
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).
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.
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.
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).
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 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).