Standard: HHS - 21 CFR PART 1143

MINIMUM REQUIRED WARNING STATEMENTS

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Scope:

Definitions.

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 performancecomposition, 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 tobacco product; or

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

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.

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 pursuant to § 1100.2 of this chapter, but excludes any component or part that is not made or derived from tobacco.

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.

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

Required warning statement means a textual warning statement required to be on packaging and in advertisementsfor cigarette tobacco, roll-your-own tobacco, cigars, and other covered tobacco products.

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.

Tobacco product. As stated in section 201(rr) of the Federal Food, Drug, and Cosmetic 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 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, or a combination product described in section 503(g) of the Federal Food, Drug, and Cosmetic Act.

Organization: Food and Drug Administration (Medical Products Quality Assurance)
Document Number: 21 cfr part 1143
Publish Date: 2017-04-01
Page Count: 6
Change Type: NEW ADDITION
Available Languages: EN
DOD Adopted: NO
ANSI Approved: NO
Most Recent Revision: YES
Current Version: YES
Status: Active
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