Louisiana Administrative Code › Title 49 - PUBLIC HEALTH-FOOD, DRUGS, AND COSMETICS › Part I - Regulations › Chapter 5 - Registration of Foods, Drugs, Cosmetics and Prophylactic Devices › Section I-501 - Definitions [Formerly 49:2.2100]

Current through Register Vol. 50, No. 6, June 20, 2024
A. Unless
				otherwise specifically provided herein, the following words and terms used in
				this Chapter of Title 49, and all other Chapters of Title 49 which are adopted
				or may be adopted, are defined for the purposes thereof as follows.
Accrediting Body
-for the purposes of this
				  Chapter, the International Organization for Standardization (ISO).
Advertisement
-includes all representations
				  of fact or opinion disseminated to the public in any manner or by any means
				  other than by the labeling.
Adult-Use Consumable Hemp Product
-any
				  consumable hemp product that contains more than 0.5 milligrams of THC per
				  package.
Cannabidiol
-Repealed.
CBD
-Repealed.
Certificate of Analysis
-a document produced
				  by an approved laboratory attesting to the composition of a product.
Certificate of Consumable Hemp Product Registration
				  (FD-8a)
-certificate issued by the department attesting that consumable
				  hemp products produced or distributed by the holder's company have been
				  registered as required.
Certificate of IHDCP Registration
				  (FD-8a)
-Repealed.
Cosmetic
- includes all substances and
				  preparations intended for cleaning, altering the appearance of or promoting the
				  attractiveness of a person. The term includes soaps only when medicinal or
				  curative qualities are claimed by the use, thereof.
Consumable Hemp Product
-any product derived
				  from industrial hemp that contains any naturally-occurring cannabinoid,
				  including cannabidiol, and in intended for consumption or topical use. This
				  special class of products includes, but is not limited to, the following: food,
				  animal foods or feed, hemp flower, and pet products. No consumable hemp product
				  may contain a total THC concentration in excess of one percent on a dry-weight
				  basis.
Consumable Hemp Products Database
-repository
				  of information on products and firms that are registered with the Food and
				  Drug/Milk and Dairy Unit of LDH/OPH that fall into the category of consumable
				  hemp products.
Department
-for the purposes of this Chapter,
				  the Food and Drug/Milk and Dairy Unit of the Office of Public Health, Louisiana
				  Department of Health.
Device
-includes all devices intended for use
				  in diagnosis, treatment, cure or prevention of disease in man or beast or
				  intended to affect the structure of any function of the body.
Dietary Supplement
-a product other than
				  tobacco intended to supplement the diet that is not represented for use as a
				  conventional food, that is not a drug, and that is labeled as a dietary
				  supplement and bears or contains one or more of the following dietary
				  ingredients or a concentrate, metabolite, constituent, extract, or combination
				  thereof: a vitamin, a mineral, a botanical, an amino acid, or a dietary
				  substance for use by man to supplement the diet by increasing the total dietary
				  intake.
Drug
-includes all substances and
				  preparations recognized in the official compendium as defined in the State
				  Food, Drug and Cosmetic Law. It includes all substances and preparations
				  intended for use in the diagnosis, treatment, cure or prevention of disease in
				  man or beast, and all substances and preparations other than food and
				  cosmetics, intended to affect the structure or any function of the body.
E-Cigarette
-a battery-operated device that
				  is typically designed to resemble a traditional cigarette and is used to inhale
				  a (usually nicotine-containing) vapor atomized by the device's heating
				  element.
Examination and Investigation Fee
-as
				  required by
				  R.S.
				  40:628, shall be referred to as registration
				  fee.
Food
-includes all substances and
				  preparations used for or entering into the composition of food, drink,
				  confectionery, chewing gum or condiment for man or beast.
Federally Defined THC Level for Hemp
-the
				  greater of the following:
a. A delta-9
				THC concentration of not more than 0.3 percent on a dry weight basis.
b. The THC concentration for hemp defined in
				7
				U.S.C. 1639o.
Industrial Hemp
-the plant
Cannabis
				  sativa
L. and any part of that plant, including the seeds thereof and
				  all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of
				  isomers, whether growing or not, with a total delta-9 THC concentration of not
				  more than 0.3 percent on a dry weight basis.
Industrial Hemp-Derived Cannabidiol Products
				  (IHDCP)-
any industrial-hemp derived product that contains CBD
				  intended for consumption or topical use.
Industrial Hemp-Derived Cannabidiol Products
				  (IHDCP)
-any product intended for human use and containing cannabidiol
				  that was made from industrial hemp.
Industrial Hemp-Derived Cannabidiol Products
				  Database
-repository of information on products and firms that are
				  registered with the department that fall into the category of industrial
				  hemp-derived cannabidiol products.
Wood
-includes all substances and
				  preparations used for or entering into the composition of food, drink,
				  confectionery, chewing gum or condiment for man or beast.
Label
-the principal display or display of
				  written, printed or graphic matter upon any food, drug, cosmetic or device or
				  the immediate container, thereof, or upon the outside container or wrapper, if
				  any, of the retail package of any food, drug, cosmetic or device.
Labeling
-includes all labels and other
				  written, printed and graphic matter in any form whatsoever accompanying any
				  food, drug, cosmetic or device.
Medical Opinion
-the opinion, within their
				  respective fields, of the practitioners of any branch of the medical
				  profession, the practice of which is licensed by law in this State.
Package
-container or wrapping in which any
				  consumer commodity is enclosed for the purposes of display or delivery to
				  retail purchasers.
Patent or Proprietary Medicine
-any drug or
				  drug product covered by a patent from the U.S. Patent Office in Washington,
				  D.C. and/or products sold under proprietary marks or trademarks with a
				  distinctive device or brand to designate the source of origin.
QR Code
-quick response code, a type of
				  machine-readable, two-dimensional barcode that stores information about a
				  product.
Registration Fee
-examination and
				  investigation fee.
Safe
- that a product under the conditions of
				  its intended use is not dangerous to the health of man or animal.
Scientific Opinion
-the opinion, within
				  their respective fields, of competent pharmacologists, physiologists or
				  toxicologists [R.S.
				  40:602(12)].
Serving
-total quantity of discrete units or
				  of liquid in a package a processor recommends for consumption at one
				  time.
THC
-a combination of tetrahydrocannabinol
				  and tetrahydrocannabinolic acid.
Vape Cartridge
-the part of a vape pen
				  containing the liquid to be inhaled by the user.
Vape Pen
-a type of
				  e-cigarette.