Portland, Oregon — The Oregon Liquor and Cannabis Commission (OLCC) has issued a significant regulatory update impacting the sale of certain cannabinoid products, announcing a strict deadline of July 1, 2025, for products containing artificially derived cannabinol (CBN) to meet rigorous federal standards.
According to Compliance Education Bulletin CE2025-05, distributed by the OLCC, effective on the stipulated date, products incorporating artificially derived CBN will be prohibited from sale within Oregon unless the substance’s manufacturer has successfully navigated specific regulatory pathways established by the U.S. Food and Drug Administration (FDA).
Understanding the New Regulation
The core of the new mandate centers on ensuring the safety and regulatory compliance of cannabinoids produced through artificial means, as opposed to those naturally extracted from cannabis or hemp plants. While naturally occurring CBN exists, a significant portion of the CBN used in commercial products, particularly in the hemp market, is synthesized or otherwise chemically derived. The OLCC’s bulletin targets this category, specifically products labeled with “artificially derived cannabinoid.”
To remain compliant post-July 1, 2025, manufacturers of this artificially derived CBN must either obtain a “Generally Recognized as Safe” (GRAS) determination from the FDA – a designation indicating a substance’s safety for its intended use based on scientific consensus – or submit a New Dietary Ingredient Notification (NDIN) to the FDA and receive a “no objections” response. These processes are complex and require substantial scientific evidence demonstrating safety.
Scope and Impact on Retailers
The regulatory shift is far-reaching, affecting not only businesses licensed directly by the OLCC but also general market hemp retailers across the state. This dual impact means dispensaries, cannabis processors, and also shops selling hemp-derived products like tinctures, edibles, and topicals containing artificially derived CBN must ensure their inventory complies with the new rule.
OLCC licensees have been explicitly instructed regarding existing stock. By the July 1, 2025, deadline, any products containing artificially derived CBN that do not meet the newly enforced FDA standards must be removed from sale. Licensees are directed to return or dispose of this affected inventory in accordance with OLCC regulations.
The bulletin’s implications extend beyond current stock, necessitating a review of supply chains and product formulations for future sales within the state.
The Current Regulatory Landscape
A critical detail highlighted in the bulletin and subsequent reports is the current status of manufacturers meeting these stringent FDA requirements for artificially derived CBN. As of the issuance of CE2025-05 and surrounding communications, the OLCC stated it was not aware of any manufacturers currently meeting either the GRAS determination or having received a “no objections” response to an NDIN for artificially derived CBN.
This lack of known compliant sources presents a significant challenge for retailers and manufacturers operating in or supplying the Oregon market, suggesting that a substantial portion of currently available artificially derived CBN products may become unsaleable come the deadline.
Preparing for the Deadline
The OLCC’s bulletin serves as a clear warning and provides businesses with a definitive timeline to adjust. Retailers are urged to identify products in their inventory containing artificially derived CBN and communicate with their suppliers to ascertain the regulatory status of the cannabinoid used. Given the current lack of known compliant manufacturers, businesses must prepare for the likelihood that many existing artificially derived CBN products will need to be phased out or reformulated.
The regulatory action underscores a broader trend towards increased scrutiny of cannabinoid products, particularly those derived or processed through methods outside of traditional cultivation and extraction. By aligning with FDA standards, Oregon is emphasizing a focus on product safety and consumer protection, pushing the industry towards more robust manufacturing and validation practices for synthesized or chemically modified cannabinoids.
The approach taken by the OLCC, requiring FDA-level safety substantiation, sets a high bar for the continued legality of artificially derived CBN products in the state. The coming months will be crucial for manufacturers to pursue the necessary FDA pathways or for the Oregon market to adapt to products utilizing naturally derived CBN or other compliant ingredients.