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<subtitle article="ghg" title_number="21" subtitle_number="1" title_name="Food, Drugs, and Cosmetics" subtitle_name="Definitions; General Provisions">
  <section article="ghg" article_name="Health - General" number="21-101" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="1" subtitle_name="Definitions; General Provisions">
    <level label="a">
      <text>In this title the following words have the meanings indicated.</text>
    </level>
    <level label="b">
      <text>“Advertisement” means any representation that:</text>
      <level label="1">
        <text>Is intended or is likely to induce, directly or indirectly, any person to purchase any food, drug, device, or cosmetic; and</text>
      </level>
      <level label="2">
        <text>Is published by any means other than labeling.</text>
      </level>
    </level>
    <level label="c">
      <level label="1">
        <text>“Color additive” means any material that:</text>
        <level label="i">
          <text>Is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source; or</text>
        </level>
        <level label="ii">
          <text>When added or applied to a food, drug, or cosmetic, or to any part of the human body, is capable, alone or through reaction with any other substance, of imparting color, including black, white, or intermediate grays, to the food, drug, cosmetic, or body.</text>
        </level>
      </level>
      <level label="2">
        <text>“Color additive” does not include any material that is not a color additive under the federal act.</text>
      </level>
    </level>
    <level label="d">
      <text>“Consumer commodity” means any food, drug, device, or cosmetic that is not:</text>
      <level label="1">
        <text>Tobacco or a tobacco product;</text>
      </level>
      <level label="2">
        <text>A commodity that is subject to packaging or labeling requirements imposed under the Federal Insecticide, Fungicide, and Rodenticide Act or the federal Animal Virus, Serum, Toxin, Antitoxin Act;</text>
      </level>
      <level label="3">
        <text>A drug that is subject to the provisions of § 353(b)(1) of the federal act;</text>
      </level>
      <level label="4">
        <text>A beverage that is subject to or complies with packaging or labeling requirements imposed by the federal Bureau of Alcohol, Tobacco, Firearms and Explosives; or</text>
      </level>
      <level label="5">
        <text>A seed or other commodity that is subject to the provisions of §§ 9–206 through 9–213 of the Agriculture Article.</text>
      </level>
    </level>
    <level label="e">
      <level label="1">
        <text>“Cosmetic” means any substance, or any component of a substance, that is intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.</text>
      </level>
      <level label="2">
        <text>“Cosmetic” does not include soap.</text>
      </level>
    </level>
    <level label="f">
      <text>“Device” means any instrument, apparatus, or contrivance, or any part or accessory of an instrument, apparatus, or contrivance, that is intended:</text>
      <level label="1">
        <text>For use in the diagnosis, cure, mitigation, treatment, or prevention of human disease; or</text>
      </level>
      <level label="2">
        <text>To affect the structure or any function of the human body for medical, surgical, or therapeutic purposes.</text>
      </level>
    </level>
    <level label="g">
      <level label="1">
        <text>“Drug” means any substance or component of a substance:</text>
        <level label="i">
          <text>That is recognized in an official compendium;</text>
        </level>
        <level label="ii">
          <text>That is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings; or</text>
        </level>
        <level label="iii">
          <text>Except for food, that is intended to affect the structure or any function of the human body.</text>
        </level>
      </level>
      <level label="2">
        <text>“Drug” does not include a device.</text>
      </level>
    </level>
    <level label="h">
      <text>“Federal act” means the Federal Food, Drug, and Cosmetic Act as that act appears at 21 U.S.C. § 301 et seq.</text>
    </level>
    <level label="i">
      <text>“Food” means:</text>
      <level label="1">
        <text>Any substance that is used as food or drink for human beings or as a component of food or drink for human beings; or</text>
      </level>
      <level label="2">
        <text>Chewing gum or any substance that is used as a component of chewing gum.</text>
      </level>
    </level>
    <level label="j">
      <level label="1">
        <text>“Food additive” means any substance:</text>
        <level label="i">
          <text>The intended use of which results or reasonably may be expected to result, directly or indirectly, in the substance becoming a component of food or otherwise affecting the characteristics of food, including any substance used to produce, manufacture, pack, process, prepare, treat, package, transport, or hold food, or any source of radiation that is intended for any of these uses; and</text>
        </level>
        <level label="ii">
          <text>That is not recognized generally by qualified scientific experts as having been shown to be safe under the conditions of its intended use:</text>
          <level label="1">
            <text>Through scientific procedures; or</text>
          </level>
          <level label="2">
            <text>Through either scientific procedures or experience based on common use, if the substance was used in a food before January 1, 1958.</text>
          </level>
        </level>
      </level>
      <level label="2">
        <text>“Food additive” does not include a color additive.</text>
      </level>
    </level>
    <level label="k">
      <text>“Label” means a display of written, printed, or graphic matter on the container, other than the package liner, of a substance.</text>
    </level>
    <level label="l">
      <text>“Labeling” means any label or other written or graphic material that:</text>
      <level label="1">
        <text>Is on a substance or its container or its wrapping; or</text>
      </level>
      <level label="2">
        <text>Accompanies a substance.</text>
      </level>
    </level>
    <level label="m">
      <text>“Official compendium” means the most recent revision of the United States Pharmacopoeia and National Formulary, the official Homeopathic Pharmacopoeia of the United States, or any of their current supplements.</text>
    </level>
    <level label="n">
      <level label="1">
        <text>“Package” means any container or wrapping of a consumer commodity that is used for delivery or display to retail consumers.</text>
      </level>
      <level label="2">
        <text>“Package” does not include any container or wrapping that is used only for:</text>
        <level label="i">
          <text>Transportation of a consumer commodity in bulk or quantity to a manufacturer, packer, processor, or wholesale or retail distributor; or</text>
        </level>
        <level label="ii">
          <text>Shipment or delivery of a consumer commodity to a retail customer, if the container or wrapping bears no printed material that relates to a particular consumer commodity.</text>
        </level>
      </level>
    </level>
    <level label="o">
      <text>“Person” includes:</text>
      <level label="1">
        <text>An operator of a facility that is owned by a State or local unit of government; or</text>
      </level>
      <level label="2">
        <text>A State or local unit of government if the State or local unit of government is the operator of the facility.</text>
      </level>
    </level>
    <level label="p">
      <text>“Secretary” means for the purposes of this subtitle and Subtitles 2, 3, 4, 8, and 11 of this title, the Secretary of Health or the Secretary’s designee.</text>
    </level>
  </section>
  <section article="ghg" article_name="Health - General" number="21-102" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="1" subtitle_name="Definitions; General Provisions">
    <level label="a">
      <text>The provisions of this title that relate to the sale of a consumer commodity also apply to:</text>
      <level label="1">
        <text>Manufacturing, producing, processing, packing, exposing, offering, possessing, or holding the consumer commodity for sale;</text>
      </level>
      <level label="2">
        <text>Dispensing or giving the consumer commodity; and</text>
      </level>
      <level label="3">
        <text>Supplying or applying the consumer commodity in the operation of any food, drug, or cosmetic establishment.</text>
      </level>
    </level>
    <level label="b">
      <text>If a substance is alleged to be misbranded because the labeling is misleading or if an advertisement is alleged to be false because it is misleading, there shall be taken into account:</text>
      <level label="1">
        <text>The representations made or suggested by statement, word, design, symbol, or sound, alone or in combination; and</text>
      </level>
      <level label="2">
        <text>The extent to which the labeling or advertisement fails to reveal consequences that may result from use of the substance.</text>
      </level>
    </level>
  </section>
</subtitle>