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21 U.S.C. § 387Definitions

submitted 88 years ago by Pub. L. 111-31 to r/title-21-FOOD-AND-DRUGS · 1,090 words · no verdicts yet

in plain englishAI-generated · not legal advice

This law defines the key terms used in the tobacco-regulation subchapter — words like additive, cigarette, distributor, nicotine, retailer, and tobacco product manufacturer — so those other sections have a shared, precise meaning.

This section defines words used in this subchapter: (1) "Additive" means any substance meant to become part of a tobacco product, or to affect its qualities — including flavorings or colorings, or substances used in making, processing, or packaging it — but this does not include tobacco itself, or a pesticide residue on raw tobacco, or a pesticide chemical. (2) "Brand" means a variety of tobacco product told apart by things like the tobacco used, tar or nicotine level, flavoring, size, filter, packaging, logo, trademark, brand name, color pattern, or any mix of these. (3) "Cigarette" means a tobacco product that meets the definition of "cigarette" in section 1332(1) of title 15. It also includes any tobacco that's functional in the product and that, because of how it looks, the type of tobacco in its filler, or its packaging and labeling, is likely to be sold to or bought by consumers as a cigarette or as roll-your-own tobacco. (4) "Cigarette tobacco" means loose tobacco meant for consumers to use in a cigarette. Unless stated otherwise, the rules for cigarettes in this subchapter also apply to cigarette tobacco. (5) "Commerce" has the same meaning as in section 1332(2) of title 15. (6) "Counterfeit tobacco product" means a tobacco product — or its container or label — that, without permission, carries the trademark, trade name, or other identifying mark of a tobacco product listed in a registration under section 387e(i)(1). (7) "Distributor" means anyone, domestic or foreign, who moves a tobacco product further along — from where it was made to whoever sells or gives it to people for personal use. Common carriers (like shipping companies) don't count as distributors. (8) "Illicit trade" means any illegal activity involving the production, shipping, receiving, possessing, distributing, selling, or buying of tobacco products, including anything meant to help such activity happen. (9) "Indian country" has the meaning given in section 1151 of title 18. (10) "Indian tribe" has the meaning given in section 5304(e) of title 25. (11) "Little cigar" means a tobacco product that meets the definition of "little cigar" in section 1332(7) of title 15. (12) "Nicotine" means the chemical 3-(1-Methyl-2-pyrrolidinyl) pyridine, also written C10H14N2, including any salt or complex form of it. (13) "Package" means a pack, box, carton, or any other container — or, if there's no container, any wrapping like cellophane — that a tobacco product is sold or given out in. (14) "Retailer" means anyone — a person, government, or entity — who sells tobacco products to individuals for their own use, or who runs a place where self-service tobacco displays are allowed. (15) "Roll-your-own tobacco" means tobacco that, because of its look, type, packaging, or labeling, is fit for and likely to be sold to or bought by consumers to make their own cigarettes. (16) "Small tobacco product manufacturer" means a tobacco manufacturer with fewer than 350 employees. When counting employees, this includes employees of any company that controls, is controlled by, or shares common control with the manufacturer. (17) "Smoke constituent" means any chemical in cigarette smoke — whether inhaled or drifting from the burning end — that either comes from a part of the cigarette or forms when tobacco, additives, or other parts of the product burn or heat up. (18) "Smokeless tobacco" means a tobacco product made of cut, ground, powdered, or leaf tobacco meant to be placed in the mouth or nose. (19) "State" and "Territory" have the meanings given in section 321 of this title. (20) "Tobacco product manufacturer" means anyone — including a repacker or relabeler — who makes, assembles, processes, or labels a tobacco product, or who imports a finished tobacco product to sell or distribute in the United States. (21) "Tobacco warehouse" — with the exceptions below — includes anyone who: removes foreign material from tobacco leaf using only a mechanical process; adds moisture to tobacco leaf using only potable water as steam or mist; or de-stems, dries, and packs tobacco leaf for storage and shipping — as long as that person does nothing else to the tobacco leaf, and gives any manufacturer they sell to all the information about these actions needed for that manufacturer to comply with this chapter. This term does NOT include anyone who reconstitutes tobacco leaf, who is a manufacturer, distributor, or retailer of a tobacco product, or who applies any chemical or substance to the leaf besides potable water as steam or mist. The Secretary can also decide, through rulemaking, that this "tobacco warehouse" definition should not apply if regulating those actions is needed to protect public health. (22) "United States" means the 50 states, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other U.S. trust territory or possession.
the actual law source: uscode.house.gov ↗public domain

In this subchapter:

(1) Additive

The term “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 such term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical.

(2) Brand

The term “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, identifiable pattern of colors, or any combination of such attributes.

(3) Cigarette

The term “cigarette”—

(A)

means a product that—

(i)

is a tobacco product; and

(ii)

meets the definition of the term “cigarette” in section 1332(1) of title 15; and

(B)

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.

(4) Cigarette tobacco

The term “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 subchapter shall also apply to cigarette tobacco.

(5) Commerce

The term “commerce” has the meaning given that term by section 1332(2) of title 15.

(6) Counterfeit tobacco product

The term “counterfeit tobacco product” means a tobacco product (or the container or labeling of such a product) that, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a tobacco product listed in a registration under section 387e(i)(1) of this title.

(7) Distributor

The term “distributor” as regards a tobacco product 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 purposes of this subchapter.

(8) Illicit trade

The term “illicit trade” means any practice or conduct prohibited by law which relates to production, shipment, receipt, possession, distribution, sale, or purchase of tobacco products including any practice or conduct intended to facilitate such activity.

(9) Indian country

The term “Indian country” has the meaning given such term in section 1151 of title 18.

(10) Indian tribe

The term “Indian tribe” has the meaning given such term in section 5304(e) of title 25.

(11) Little cigar

The term “little cigar” means a product that—

(A)

is a tobacco product; and

(B)

meets the definition of the term “little cigar” in section 1332(7) of title 15.

(12) Nicotine

The term “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.

(13) Package

The term “package” 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.

(14) Retailer

The term “retailer” means any person, government, or entity who sells tobacco products to individuals for personal consumption, or who operates a facility where self-service displays of tobacco products are permitted.

(15) Roll-your-own tobacco

The term “roll-your-own tobacco” means any tobacco product which, 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.

(16) Small tobacco product manufacturer

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.

(17) Smoke constituent

The term “smoke constituent” means any chemical or chemical compound in mainstream or sidestream tobacco smoke that either transfers from any component of the cigarette to the smoke or that is formed by the combustion or heating of tobacco, additives, or other component of the tobacco product.

(18) Smokeless tobacco

The term “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.

(19) State; Territory

The terms “State” and “Territory” shall have the meanings given to such terms in section 321 of this title.

(20) Tobacco product manufacturer

The term “tobacco product manufacturer” means any person, including any repacker or relabeler, who—

(A)

manufactures, fabricates, assembles, processes, or labels a tobacco product; or

(B)

imports a finished tobacco product for sale or distribution in the United States.

(21) Tobacco warehouse
(A)

Subject to subparagraphs (B) and (C), the term “tobacco warehouse” includes any person—

(i)

who—

(I)

removes foreign material from tobacco leaf through nothing other than a mechanical process;

(II)

humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or

(III)

de-stems, dries, and packs tobacco leaf for storage and shipment;

(ii)

who performs no other actions with respect to tobacco leaf; and

(iii)

who provides to any manufacturer to whom the person sells tobacco all information related to the person’s actions described in clause (i) that is necessary for compliance with this chapter.

(B)

The term “tobacco warehouse” excludes any person who—

(i)

reconstitutes tobacco leaf;

(ii)

is a manufacturer, distributor, or retailer of a tobacco product; or

(iii)

applies any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist.

(C)

The definition of the term “tobacco warehouse” in subparagraph (A) shall not apply to the extent to which the Secretary determines, through rulemaking, that regulation under this subchapter of the actions described in such subparagraph is appropriate for the protection of the public health.

(22) United States

The term “United States” means the 50 States of the United States of America and the District of Columbia, the Commonwealth of Puerto Rico, Guam, the Virgin Islands, American Samoa, Wake Island, Midway Islands, Kingman Reef, Johnston Atoll, the Northern Mariana Islands, and any other trust territory or possession of the United States.

Source credit: (June 25, 1938, ch. 675, § 900, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1784.)

history & why it existsrecord from the source credit
  • 1938Enacted · Pub. L. 111-31 · 123 Stat. 1784

A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-31 on 1938-06-25.

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