2013 Maryland Code
HEALTH - GENERAL
§ 21-101 - Definitions

§21-101.

(a) In this title the following words have the meanings indicated.

(b) “Advertisement” means any representation that:

(1) Is intended or is likely to induce, directly or indirectly, any person to purchase any food, drug, device, or cosmetic; and

(2) Is published by any means other than labeling.

(c) (1) “Color additive” means any material that:

(i) 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

(ii) 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.

(2) “Color additive” does not include any material that is not a color additive under the federal act.

(d) “Consumer commodity” means any food, drug, device, or cosmetic that is not:

(1) Tobacco or a tobacco product;

(2) 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;

(3) A drug that is subject to the provisions of § 353(b)(1) of the federal act;

(4) A beverage that is subject to or complies with packaging or labeling requirements imposed by the federal Bureau of Alcohol, Tobacco and Firearms; or

(5) A seed or other commodity that is subject to the provisions of §§ 9-206 through 9-213 of the Agriculture Article.

(e) (1) “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.

(2) “Cosmetic” does not include soap.

(f) “Device” means any instrument, apparatus, or contrivance, or any part or accessory of an instrument, apparatus, or contrivance, that is intended:

(1) For use in the diagnosis, cure, mitigation, treatment, or prevention of human disease; or

(2) To affect the structure or any function of the human body for medical, surgical, or therapeutic purposes.

(g) (1) “Drug” means any substance or component of a substance:

(i) That is recognized in an official compendium;

(ii) That is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings; or

(iii) Except for food, that is intended to affect the structure or any function of the human body.

(2) “Drug” does not include a device.

(h) “Federal act” means the Federal Food, Drug, and Cosmetic Act as that act appears at 21 U.S.C. § 301 et seq.

(i) “Food” means:

(1) Any substance that is used as food or drink for human beings or as a component of food or drink for human beings; or

(2) Chewing gum or any substance that is used as a component of chewing gum.

(j) (1) “Food additive” means any substance:

(i) 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

(ii) That is not recognized generally by qualified scientific experts as having been shown to be safe under the conditions of its intended use:

1. Through scientific procedures; or

2. Through either scientific procedures or experience based on common use, if the substance was used in a food before January 1, 1958.

(2) “Food additive” does not include a color additive.

(k) “Label” means a display of written, printed, or graphic matter on the container, other than the package liner, of a substance.

(l) “Labeling” means any label or other written or graphic material that:

(1) Is on a substance or its container or its wrapping; or

(2) Accompanies a substance.

(m) “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.

(n) (1) “Package” means any container or wrapping of a consumer commodity that is used for delivery or display to retail consumers.

(2) “Package” does not include any container or wrapping that is used only for:

(i) Transportation of a consumer commodity in bulk or quantity to a manufacturer, packer, processor, or wholesale or retail distributor; or

(ii) 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.

(o) “Person” includes:

(1) An operator of a facility that is owned by a State or local unit of government; or

(2) A State or local unit of government if the State or local unit of government is the operator of the facility.

(p) “Secretary” means for the purposes of Subtitles 1, 2, 3, 4, 8, and 11 of this title, the Secretary of Health and Mental Hygiene or the Secretary’s designee.