Changes are coming to Oregon’s artificially derived CBN product regulations for products sold through the OLCC licensed system, effective July 1st 2023.
On April 20, 2023, OLCC amended OAR 845-025-1310, allowing artificially derived CBN products an additional 18 months to meet the same requirements as other artificially derived cannabinoids, with differences regarding when the products were made. These updates do not change the current hemp labeling requirements under OAR 845-025-7145 and label application materials under OAR 845-025-7160.
Artificially Derived CBN Products Made Before July 1st, 2023
CBN products made before July 1st, the effective date of the new regulations, may continue to be sold as long as they complied with OLCC rules prior to the amendments. Products must have been manufactured by an OLCC-licensed processor or an ODA-licensed hemp handler at a facility with an ODA food safety license, and must not be intended for inhalation. These products may continue to be sold until January 2nd, 2025, after which the products must meet the requirements under OAR 845-025-1310(1).
Artificially Derived CBN Products Made On or After July 1st, 2023
For CBN products made on or after July 1st, 2023, manufacturers and retailers can only manufacture and/or sell artificially derived CBN products if:
The product is not intended for inhalation;
The product was manufactured under either an OLCC processor license or/and ODA hemp handler license, in a facility with an ODA food safety license;
The manufacturer of the CBN product has written approval from OLCC.
Products that meet these requirements may continue to be sold until January 2, 2025, after which, the products must meet the general requirements for artificially derived cannabinoids under OAR 845-025-1310(1). CBN manufacturers must submit a request for written approval from OLCC. In order to obtain written approval, CBN manufacturer must:
Affirm they have taken “substantial steps” to meet other standards required for artificially derived cannabinoids, in particular, receiving GRAS status from the FDA or receiving an acknowledgement with no objection from the FDA in response to submitting a new dietary ingredient notification;
Provide OLCC with a copy of their hazard analysis, as described for food products under 21 CFR 117.130;
Provide OLCC with copies of any preventive controls, as required under 21 CFR 117.135.
Have questions about how these rules will affect your business? Having trouble figuring out how you should meet these requirements? Contact our office to schedule a consultation at email@example.com