RELATES TO: KRS Chapter 13B, 217.015, 217.025, 217.035, 217.037, 217.039, 217.992, 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 permit requirements for retail sale of hemp-derived cannabinoid products, including the permit fee, and methods for use of hemp-derived cannabinoid as an additive to food products. Retail establishments registered with the department prior to the effective date of this administrative regulation shall be exempted from the permit fee requirement until the annual renewal date. In accordance with 2023 Ky. Act ch. 78, in order to limit the ability of minor children accessing adult-use hemp-derived cannabinoid use products, this administrative regulation prohibits the sale of adult-use products within 1,000 feet of an elementary, middle, or high school. Retail establishments registered with the department prior to the effective date of this administrative regulation shall be exempted from this location requirement.
Section 1. Retail Establishment and Food Service Establishment Registration. (1)(a) Only approved cannabinoid products or class of products in accordance with 902 KAR 45:021 may be sold in retail and food service establishments. All other cannabinoid products or class of products shall be prohibited.(b) Adult-use cannabinoid products or class of products shall be registered in accordance with 902 KAR 45:021, Section 1(5).(c) A retailer shall ensure that all cannabinoid products sold are properly registered with the department.(d) A retailer may register a product in lieu of the processor or manufacturer.(2) Retail establishments and food service establishments offering adult-use cannabinoid products shall be permitted by the cabinet in accordance with this administrative regulation.(3) The permit shall be:(b) Nontransferable in regard to person or address;(c) Renewed annually; and(d) Include a $2,000 annual permit fee.(4) All retail establishments registered with the department prior to April 27, 2024, shall have the fee required by subsection (3)(d) of this section waived until the date of the next annual renewal.(5) A retailer shall ensure all locations are permitted by the cabinet.(6) Retail establishments and food service establishments offering adult-use cannabinoid products at a temporary event or festival shall: (b) Include a $250 temporary event registration fee.(7) Retail establishments offering adult-use cannabinoid products shall not be located within 1,000 feet of an elementary, middle, or high school. Retail establishments registered with the department prior to April 27, 2024, shall be exempted from the location requirements.(8) A business that distributes, sells, or serves adult-use hemp-derived cannabinoid products shall not employ any person who is under twenty-one (21) years of age, unless the person employed is at least eighteen (18) years of age and under the direct supervision of a person twenty-one (21) years of age or older.Section 2. Retail Sale of Cannabinoid Products.(1) All cannabinoid products sold in a retail establishment shall: (a) Be from an approved source;(b) Be packaged and labeled in accordance with 902 KAR 45:021, Section 3; and(c) Have a valid printed certificate of analysis available upon request.(2) Cannabinoid retailers shall maintain records of wholesale cannabinoid product purchase, including the name and address of the cannabinoid processor or manufacturer, and the wholesaler or distributor.(3) The following hemp-derived products shall not be marketed, sold, or distributed to any person in the Commonwealth:(b) Ground hemp floral material;(c) Ground hemp leaf material; and(d) Any hemp product with a delta-9-THC concentration in excess of zero and three-tenths (0.3) percent.(4) All adult-use cannabinoid products shall:(a) Be secured in the retail setting to prevent theft or other access to persons under the age of twenty-one (21); and(b) Not be sold, gifted, or otherwise transferred to any person under the age of twenty-one (21).(5)(a) Any person who sells adult-use cannabinoid products at retail shall require proof of age of the buyer to verify the buyer is age twenty-one (21) years or older; and(b) May deliver or ship adult-use cannabinoid products to consumers over twenty-one (21) years of age in packages clearly marked "Adult-use only".(6) All persons located in another state or country who deliver, ship, or cause to be delivered or shipped cannabinoid products directly to any Kentucky consumer shall hold a valid hemp cannabinoid wholesaler or distributor permit issued by the Commonwealth.Section 3. Ingestible Cannabinoid Products at Food Service Establishments.(1) Only registered, pre-packaged adult-use ingestible cannabinoid products may be offered as ready-to-consume or for direct consumption at food service establishments.(2) Adult-use cannabinoids shall not be added to an ingestible food product at a food service establishment.(3) Non-intoxicating cannabinoids may be added to an ingestible product prior to retail sale at a food service establishment.(4) The non-intoxicating cannabinoid shall be obtained from an approved source.(5) The food service establishment shall obtain a valid certificate of analysis from the approved source and provide a copy upon inspection.(6) A food service establishment offering non-intoxicating cannabinoid products in a finished food product shall provide to consumers upon request:(a) The common name of the product; and(b) The manufacturer or distributor of the product.(7) A food service establishment shall notify the cabinet within twenty-four (24) hours of becoming aware or within twenty-four (24) hours of when the food service establishment should have been aware of any serious adverse event to a hemp-derived cannabinoid product sold by the establishment.Section 4. Inspection and Enforcement. (1)(a) Retail establishments offering adult-use cannabinoid products shall be inspected by the cabinet or its duly authorized agent; and(b) Retail establishments offering only non-intoxicating cannabinoid products may be inspected by the cabinet or its duly authorized agent upon complaint, receipt of a report of a serious adverse event, or at the discretion of the cabinet.(2) The location of the permitted establishment, all general business records, including employee records, and vehicles utilized to transport products are subject to reasonable inspection.(3) All cannabinoid establishments, whether permitted or not, shall cooperate with the cabinet or its duly authorized agent during any inspections, complaint investigation, requests for information or data, in order to verify compliance with this administrative regulation.(4) Products not in compliance with this administrative regulation shall be seized and destroyed by the cabinet or its duly authorized agent.(5) The permit holder shall take immediate steps to correct conditions that have caused an imminent health hazard.(6)(a) The permit holder shall notify the cabinet within twenty-four (24) hours of the knowledge of an imminent health hazard that cannot be controlled by immediate corrective action or if product, product packaging, cosmetic, or cosmetic packaging has become contaminated because of an imminent health hazard.(b) Notification to the cabinet shall be made by:1. Email to food.safety@ky.gov; or2. Phone to (502) 564-7181.(7) If the cabinet has evidence that a permit holder has failed to act to correct an imminent health hazard:(a) The permit shall be suspended immediately; and(b) The permit holder may request an administrative hearing in accordance with KRS Chapter 13B.(8) A permit holder shall notify the cabinet within twenty-four (24) hours of becoming aware of any serious adverse event to a cannabinoid product sold or transferred by the permit holder.(9) In all other instances of violation of this administrative regulation, the cabinet shall serve the permit holder with a written notice specifying the violation and afford the holder an opportunity to correct.(10) If a permit holder has failed to comply with the written notice within the timeframe granted, the cabinet shall issue a notice of intent to suspend the permit.(11)(a) The notice in subsection (11) of this section shall include notification that the permit shall be suspended at the end of ten (10) days following service of the notice, unless a written request for an administrative hearing is filed with the cabinet by the permit holder within the ten (10) day period; and(b) The administrative hearing shall be conducted in accordance with KRS 13B.080.(12) For a permitted establishment that has had a suspended permit two (2) or more times within a five (5) year period, the cabinet shall initiate permit revocation proceedings. Prior to this action, the cabinet shall notify the permit holder in writing, stating the reasons for which the permit revocation is being sought and advising that the permit shall be permanently revoked at the end of ten (10) days following service of the notice, unless a request for an administrative hearing is filed with the cabinet pursuant to KRS Chapter 13B by the permit holder within the ten (10) day period.(13) Any person who violates any provision of this administrative regulation may be fined, found guilty or a criminal offense, or both pursuant to KRS 217.992.(14) State and local law enforcement officers shall have concurrent jurisdiction to enforce violations of this section.50 Ky.R. 2364; eff. 4/24/2024, exp. 5/7/2031 (Emergency).STATUTORY AUTHORITY: KRS 217.125, 217.127, 217.135, 217.155