Hemp-Derived Cannabinoid Product Regulations:
The administrative regulation 902 KAR 45:001E defines the terms that are used in the hemp-derived cannabinoid regulations.
902 KAR 45:012E explains the requirements for retail sale and food service establishments selling adult use cannabinoids. Including the need for permits, restrictions on types of products sold, checking proof of age of the buyer, and records requirements.
902 KAR 45:021E explains requirements for product registration, processing, manufacturing, storage and distribution. Including a list of allowable adult-use and non-intoxicating cannabinoids, fees, restrictions on hemp plant material, approved solvents, prohibited substances in products intended for inhalation, record keeping, packaging, labeling, and warning statements.
902 KAR 45:031E explains sampling and testing requirements, including: frequency; reserve samples; laboratory requirements; testing for cannabinoids, microbial impurities, mycotoxins, residual pesticides, heavy metals, and residual solvents; product remediation; and certificate of analysis requirements.
Business Registration:
Retailers selling adult-use or intoxicating hemp-derived cannabinoid products shall follow the requirements set forth in emergency regulation 902 KAR 45:012E. This includes Retailer Permit Registry, Product Registration, and no sales of adult-use products to minors.
Business Registry: All adult-use cannabinoid retailers are required to have a permit for their business from the Cabinet for Health and Family Services' Department for Public Health. This requirement is in effect immediately. Permit Registration can be found here: Cannabinoid Business Registry.
Retailer registration status can be checked here: Cannabinoid Retail Business Registry Status
Product Registration: All cannabinoid products offered by retailers must be listed on the Cabinet for Health and Family Services Hemp-derived Cannabinoid Products Registry. The list of cannabinoid products registered can be found at: Registered Hemp-derived Cannabinoid Products List.
No sales to minors:
- Adult-use products shall not be sold, gifted, or otherwise transferred to any person under the age of twenty-one (21).
- Any person who sells adult-use hemp-derived cannabinoid products at retail shall require proof of age of the buyer to verify the buyer is at least age twenty-one (21).
- All adult-use cannabinoid products shall be secured in the retail setting to prevent theft or other access to persons under the age of twenty-one (21).
Frequently Asked Questions for Retailers:
If you are selling adult-use hemp derived cannabinoid products your business must have a permit with the Cabinet for Health and Family Services. If you are only selling non-intoxicating cannabinoid products your business does not have to be registered with the Cabinet. To know if your business is registered with the Cabinet for Health and Family Services, please go to: Cannabinoid Retail Business Registry (ky.gov)
To register your business with the Cabinet for Health and Family Services, please go to: Cannabinoid Retail Business Registry
Only non-intoxicating cannabinoid products and cosmetic products may be sold to individuals under the age of 21. Adult-use cannabinoid products are not permitted to be sold to individuals under the age of 21.
The product must be 2.5 mg of THC or less per serving and must have a 15:1 ratio of non-intoxicating cannabinoids to THC.
Although the retail business does not need to be registered for selling non-intoxicating cannabinoids, all cannabinoid products must be registered with the Cabinet for Health and Family Services prior to sale. The following non-intoxicating cannabinoids may be registered:
Cannabidiol (CBD)
Cannabidiolic acid (CBDA)
Cannabidivarin (CBDV)
Cannabidivarinic acid (CBDVA)
Cannabichromene (CBC)
Cannabichromenic acid (CBCA)
Cannabigerolic acid (CBGA)
Cannabigerol (CBG)
Cannabinol (CBN)
Cannabitriol (CBT)
To see if your products are registered go to: Hemp-derived Cannabinoid Products (ky.gov)
Your business must be registered with the Cabinet for Health and Family Services to sell adult-use cannabinoids, and all cannabinoid products must be on the product registry list prior to sale. The following hemp derived cannabinoid products may be registered:
Delta-10-tetrahydrocannabinol.
Delta-9-tetrahydrocannabinol (THC) with three tenths of one percent or less of
Total THC.
Delta-8-tetrahydrocannabinol
Delta-9-tetrahydrocannabinolic acid A with three tenths of
one percent or less of Total THC
Delta-9-tetrahydrocannabivarin (THCV)
Delta-9-tetrahydrocannabivarinic acid (THCVA)
Delta-6-tetrahydrocannabinol (Delta 6)
Hexahydrocannabinol (HHC)(-)
Tetrahydrocannabiphorol (THCp)
Tetrahydrocannabinol (THCM)
To know if your business is registered with the Cabinet, please go to: Cannabinoid Retail Business Registry (ky.gov) . To see if your products are registered and approved in the state of KY go to: Hemp-derived Cannabinoid Products (ky.gov)
All retail businesses selling adult-use hemp cannabinoid products must have a permit for each retail location that they own. Retail businesses that sell only non-intoxicating hemp cannabinoids are exempt from registering their business. Each retail business is responsible for making sure that the products that they sell have been registered with the Cabinet for Health and Family Services by either the manufacturer, the distributor, or the retailer.
All cannabinoid products for sale must be listed on Hemp-derived Cannabinoid Products (ky.gov). Products that are not registered are prohibited from sale. Just because a product has been submitted does not mean it is approved. Retailers may submit the product registration on behalf of the manufacturer and will have to provide all required information and pay the registration fee.
Any person selling adult-use cannabinoid products shall require proof of age, meaning a driver's license or other documentary or written evidence of an individual's age as defined by KRS 438.305(4), to verify the buyer is twenty-one (21) years of age or older.
Adult-use cannabinoid products must be secured in the retail setting to prevent theft or other access to persons under the age of 21.
Yes, all adult-use cannabinoid products must be in child-resistant packaging. Cannabinoid product packaging shall not include any cartoon images; or likeness to images, characters, or phrases that are popularly used to advertise to children; or likeness to or imitation of any commercially available candy, snack, baked good, or beverage packaging or labeling; or the terms "candy" or "candies", or any variation in the spelling of these words.
No. Only hemp-derived cannabinoid products registered with the Cabinet for Health and Family Services can be sold.
The serving size must be in whole units and cannot be a portion. The serving size must be equal to the maximum amount recommended on the label for consumption per occasion and must be based on the amount a person would typically consume.
No. Adult-use cannabinoids shall not be added to an ingestible food product at a food service establishment. Only registered, pre-packaged adult-use ingestible cannabinoid products may be offered as ready-to-consume or for direct consumption at food service establishments.
You must notify the Cabinet for Health and Family Services within 24 hours by emailing food.safety@ky.gov or calling (502) 564-7181.
Processors and Manufacturers
Manufacturers or Processors of Hemp-Derived Cannabinoids must follow the requirements set forth in 902 KAR 45:021E, including product registration. In addition to product registration, out-of-state Manufacturers and Processors must show proof of permit and that their state's regulatory standards are equivalent to or exceed the requirements in Kentucky regulation for products to be marketed in the Commonwealth.
Product Registration:
- All fees submitted for product registration are non-refundable. All adult-use cannabinoid products offered by retailers must be listed on the Cabinet for Health and Family Services Approved Product Registry. Products may be registered at: Hemp Derived Cannabinoid Product Registry for products that will be sold at retail in Kentucky.
- Once a product has been submitted to the Cabinet for Health and Family Services' Product Registry it may take up to 90 days to receive a decision. Once completed you will either get a letter rejecting your product, a request for more information, or a notification that your product is approved for sales/distribution in the Commonwealth.
Frequently Asked Questions for Manufacturers and Processors
A Processor converts the actual hemp plant material into an isolate product. A Manufacturer uses the isolate to produce an oil, vape, gummy, drink, food product, or any edible product.
No. If a product contains 2.5 mg or less of adult-use cannabinoids, such as THC, per serving and has a 15:1 ratio or greater of non-intoxicating cannabinoids to adult-use cannabinoids it can be sold to the general public. Cosmetic products are not considered adult-use products.
Yes, a person 18 years of age or older can work in manufacturing if they are under the supervision of a person who is at least 21 years of age.
If your firm's total sales of all products are over $1 million per year you will need to have a written plan that includes Hazard Analysis, Process Controls, Food Allergen Controls, Sanitation Controls, Supply Chain Program, and a Recall Plan. More information can be found at: Key Facts about Preventive Controls for Human Food (fda.gov)
Processing facilities must conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific report, and other information known, or reasonably foreseeable hazards associated with each type of cannabinoid product produced by extraction, conversion, catalyzation, or distillation, hydrogenation, or other refinement processes, and shall include processing reagents or catalysis, processing by-products or compounds, and tentatively identified compounds.
The hazard analysis shall include an evaluation of the hazards identified to assess the severity of illness or injury from the hazard and the probability that the hazard will occur in the absence of preventive controls.
A processing facility shall identify and implement preventive controls to provide assurances that any hazards requiring a preventive control shall be significantly minimized or prevented, and the hemp-derived cannabinoid product is not adulterated.
Each batch or process lot is required to be tested. Tests must be run for cannabinoids, microbial impurities, mycotoxins, residual pesticides, heavy metals, and residual solvents if applicable. If an infused product was made with a cannabinoid that was already tested, then a second test for microbial impurities, mycotoxins, residual pesticides, heavy metals, or residual solvents is not required. However, the cannabinoid level in the finished product is still required to be tested. Both the cannabinoid isolate's certificate of analysis (COA) and the cannabinoid level COA must be presented on the product label via a website link, QR code, or other acceptable method.
Reserve samples are samples of the finished product that have been packaged and labeled the same as if the product were being distributed. The samples must be retained for the shelf-life of the product, or for two years from the date of distribution. The samples must consist of at least twice the quantity necessary for all tests to determine if the product meets specifications.
Testing must be done by an independent third-party laboratory accredited to the standard established by ISO - 17025 — Testing and calibration laboratories by an International Laboratory Accreditation body. The third-party laboratory must comply with all required analytes standards for the relevant test methods.
Testing must be performed using a cannabinoid quantification technique with a high enough specificity and sensitivity to differentiate between cannabinoids and isomers of cannabinoids.
No. Mixed products shall be considered adulterated, regardless of the defect level of the final product.
A Master Formulation Record provides information needed to formulate the product, describe the production, and ensure its repeatability. The record shall be prepared and maintained for each unique hemp-derived cannabinoid product. Please refer to 902 KAR 45:021E for details of the information required in a master formulation record.
A record of process controls, deviations from the Master Formulation Record, any problems or errors experienced during the manufacturing process and corrective actions must be kept for each batch or process lot. Refer to 902 KAR 45:021E for details of the information required to be recorded.
If the receiving state or jurisdiction does not have testing and labeling requirements, then the Kentucky regulation must be followed. However, if the receiving state has testing and labeling requirements, then the receiving state's regulations regarding testing and labeling may be followed for the product going to that state. All other requirements of Kentucky's regulation beyond testing and labeling must still be followed. Products intended for out-of-state sale must be stored separately from products intended for in-state sale.
All adult-use cannabinoid products offered for sale in Kentucky must be registered and listed on the Cabinet for Health and Family Services product registry. The cannabinoid product registry can be found on the Kentucky Food Safety Branch website or by visiting this link: Hemp-derived Cannabinoid Product Registry (ky.gov)
You must notify the Cabinet for Health and Family Services within 24 hours by emailing food.safety@ky.gov or calling (502) 564-7181.
Cannabinoid Food Labeling Guidance
Incorrect and Correct Cannabinoid-Containing Ingestible Product Label
Ingestible and Cosmetic Cannabinoid Labeling Guidance
Warehouses and Distributors
All persons engaged in warehousing or distributing hemp-derived cannabinoid products in the state of Kentucky shall submit an annual registration to the Cabinet for Health and Family Services' Kentucky Department for Public Health. 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.