Kentucky Administrative Regulations › Title 902 - CABINET FOR HEALTH AND FAMILY SERVICES - DEPARTMENT FOR PUBLIC HEALTH › Chapter 45 - Food and Cosmetics › Section 902 KAR 45:190 - Hemp-derived cannabinoid products; packaging and labeling requirements

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035,
				217.037, 217.039, 260.850, 438.305(4), 2023 Ky Acts ch. 78
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				217.125(1) authorizes the
				secretary of the Cabinet for Health and Family Services to promulgate
				administrative regulations for the efficient administration and enforcement of
				the Kentucky Food, Drug and Cosmetic Act,
				KRS
				217.005 through
				217.215.
				KRS
				217.125(2) requires the
				secretary to provide by administrative regulation a schedule of fees for
				permits to operate and for inspection activities carried out by the cabinet
				pursuant to KRS
				217.025 through
				217.390.
				KRS
				217.135 authorizes the secretary to establish
				food standards by administrative regulation including a reasonable definition,
				standard of identity, and designation of optional ingredients that shall be
				named on the label. KRS 217.155 allows the cabinet
				or its duly authorized agent free access at reasonable times for the purpose of
				inspection any factory, warehouse, or establishment where foods, drugs,
				devices, or cosmetics are manufactured or held for sale. This administrative
				regulation establishes the registration, processing, and manufacturing
				procedures to utilize hemp-derived cannabinoid products in foods and cosmetics,
				the labeling and packaging requirements for products containing hemp-derived
				cannabinoids, the requirements for retail sale of hemp-derived cannabinoid
				products, and methods for use of hemp-derived cannabinoid as an additive to
				food products.
Section 1. Definitions.
(1) "Adult-use cannabinoid" means a product
			 with intoxicating properties that changes the function of the nervous system
			 and results in alterations of perception, cognition, or behavior.
(2) "Approved source" means:
(a) A Kentucky hemp grower or handler
			 licensed by the Kentucky Department of Agriculture, or an out-of-state hemp
			 grower or handler who is duly authorized to produce hemp under the laws of the
			 applicable jurisdiction;
(b) A hemp
			 product manufacturer or processor permitted by the Kentucky Department for
			 Public Health or
(c) A manufacturer
			 or processor permitted by another state regulatory authority for hemp-derived
			 cannabinoid products if that state has been approved by the department as
			 having equivalent state standards for processing, laboratory testing, and
			 labeling requirements.
(3) "Cabinet" is defined by
			 KRS
			 217.015(3).
(4) "Cannabidiol" or "CBD" is defined by
			 KRS
			 217.039(1)(a).
(5) "Cannabinoid" means a compound found in
			 the hemp plant Cannabis sativa. L from a United States Department of
			 Agriculture sanctioned domestic hemp production program and does not include
			 cannabinoids derived from any other substance.
(6) ''Child-resistant'' means packaging that
			 is:
(a) Designed or constructed to be
			 significantly difficult for children under five (5) years of age to open and
			 not difficult for adults to use properly; and
(b) Resealable to maintain this effectiveness
			 for children through multiple openings for any product intended for more than a
			 single use or containing multiple servings.
(7) "Cosmetic" is defined by
			 KRS
			 217.015(7).
(8) "Food service establishment" is defined
			 by KRS
			 217.015(21).
(9) "Hemp" is defined by
			 KRS
			 260.850(5).
(10) "Hemp-derived cannabinoid" means an
			 ingestible, inhalable, or cosmetic product that is processed or derived from
			 hemp.
(11) "Home-based processor"
			 is defined by KRS
			 217.015(56).
(12) "Hydrogenation" means the chemical
			 reaction between molecular hydrogen (H2) and another
			 compound or element.
(13) "Imminent
			 health hazard" is defined by
			 KRS
			 217.015(24).
(14) "Infused" means adding a cannabinoid
			 concentrate ingredient to an ingestible cannabinoid product.
(15) "Non-intoxicating cannabinoid" means a
			 product with non-psychoactive properties that does not change the function of
			 the nervous system and does not result in alteration of perception, cognition,
			 or behavior.
(16) "Person" is
			 defined by KRS
			 217.015(32).
(17) "Proof of age" is defined by
			 KRS
			 438.305(4).
(18) "Revocation" means the permit to operate
			 is cancelled by the department.
(19) "Serious adverse event" means a medical
			 occurrence associated with the use of a cannabinoid product that results in one
			 or more of the following:
(a)
			 Death;
(b) A life-threatening
			 event;
(c) Inpatient
			 hospitalization, or prolongation of an existing hospitalization;
(d) A persistent or significant incapacity,
			 or substantial disruption in the ability to conduct normal life functions;
			 or
(e) A congenital anomaly or
			 birth defect.
(20)
			 "Tentatively identified compounds" or "TIC" means compounds detected in a
			 sample that are not among the target analytes.