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  5. Section 900 of the Federal Food, Drug, and Cosmetic Act - Definitions
  1. Rules, Regulations, and Guidance Related to Tobacco Products

Section 900 of the Federal Food, Drug, and Cosmetic Act - Definitions

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In this chapter: 

  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'  
    1. means a product that  
      1. is a tobacco product; and   
      2. 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.  
  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 chapter shall also apply to cigarette tobacco.  
  5. Commerce. The term 'commerce' has the meaning given that term by section 3(2) of the Federal Cigarette Labeling and Advertising Act.  
  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 905(i)(1).  
  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 chapter.  
  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, United States Code.  
  10. Indian tribe. The term 'Indian tribe' has the meaning given such term in section 4(e) of the Indian Self-Determination and Education Assistance Act.  
  11. Little cigar. The term 'little cigar' means a product that  
    1. is a tobacco product; and  
    2. meets the definition of the term 'little cigar' in section 3(7) of the Federal Cigarette Labeling and Advertising Act.  
  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 201.  
  20. Tobacco product manufacturer. The term 'tobacco product manufacturer' means any person, including any 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.  
  21. Tobacco warehouse.
    1. (A) Subject to subparagraphs (B) and (C), the term 'tobacco warehouse' includes any person--  
      1. who  
        1. removes foreign material from tobacco leaf through nothing other than a mechanical process;  
        2. humidifies tobacco leaf with nothing other than potable water in the form of steam or mist; or  
        3. de-stems, dries, and packs tobacco leaf for storage and shipment;  
      2. who performs no other actions with respect to tobacco leaf; and  
      3. 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 Act.  
    2. The term 'tobacco warehouse' excludes any person who  
      1. reconstitutes tobacco leaf;  
      2. is a manufacturer, distributor, or retailer of a tobacco product; or  
      3. applies any chemical, additive, or substance to the tobacco leaf other than potable water in the form of steam or mist.  
    3. 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 chapter 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.

 

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