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Tuesday, September 27, 2022

Oregon Hemp: New Rules (Part III)

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The end of 2021 was marked by a great deal organizational changes Adopted by the Oregon Liquor and Hemp Commission ( OLCC), including the new rules for cannabis and cannabis. Today I will be covering a few of the big changes affecting synthetically derived hemp, including CBN and Delta-8 THC.

In the big picture, Oregon stakeholders knew new regulations would be adopted in December 2021, but most hoped for less stringent eventual rules. Unfortunately for the industry, the OLCC has decided to go ahead with the adoption of fairly strict regulations, including onerous rules that affect the manufacture and sale of finished cannabis products sold in the state.

Two of the most noteworthy changes affecting these products include:

  1. Prohibition of the sale and distribution of “adult cannabis substances” to minors as well as restrictions on the ability to sell these products outside the entertainment market, which Covered last week; And
  2. Onerous requirements imposed on “artificial cannabinoids”, including the popular and profitable cannabinoids: Cannabinol (CBN), which is a topic posted today.
Reason for synthetically derived cannabis rules

Back in March 2021, the OLCC released a file public statement The agency has expressed increasing concern about the general availability – including for children – of unregulated products and cannabis-derived liqueur. Delta-8 THC was a prime example. to address this public health threat, OLCC began the rule-making process for Delta-8 THC and the other psychoactive ingredients of cannabis which then fell out of the OLCC market. also adopted emergency rules In July, it banned the sale of this “synthetically derived hemp” to minors under the age of 21.

However, in the month following the enactment of these emergency rules, the OLCC broadened the definition of the term “synthetically-derived cannabis” to include “semi-synthetic cannabinoids resulting from chemical reactions with substances derived from cannabis,” including non-psychoactive cannabinoids such as CBN.

Authorized industrial hemp-related activities

The new OLCC rules distinguish between intoxicating and non-intoxicating synthetically derived cannabinoids by imposing different sales restrictions on these products. specially:

  • Starting July 1, 2022, the sale of synthetically derived hemp will not be permitted if it is sold outside the OLCC recreational market; And
  • After the July 1 deadlineIn fact, the sale of synthetic intoxicating cannabis, such as Delta-8-THC, will be strictly prohibited both on and off the OLCC market.

It should be noted that the moratorium on the sale of a CBN product has been extended to July 1, 2023. Until then, OLCC licensees may continue to transfer, sell, transfer, buy, accept, return or receive CBN and products containing artificially derived CBN for as long as:

  1. The CBN product is manufactured in a facility with an Oregon Department of Agriculture (ODA) Food Safety Authorization by an OLCC processor or an ODA cannabis processor;
  2. CBN product is not intended for human inhalation;
  3. The CBN product will be sold at an OLCC authorized retailer; And
  4. CBN product meets labeling requirements in . format paddle 845-025-7145.

After the deadline of July 1, 2023, OLCC Licensees will be able to transfer, sell, transfer, buy, accept, return or receive Synthetically Derived Narcotic Substances and Products containing Synthetically Derived Narcotics, including CBN Products, provided that the following conditions are met:

  1. Synthetically derived hemp is not diluted or intoxicating;
  2. Synthetically-derived cannabis or product not intended for human inhalation;
  3. Synthetically derived cannabinoids are manufactured in a facility with an ODA Food Safety License by an OLCC Processor or an ODA Hemp Processor;
  4. The synthetically derived product meets the labeling requirements in paddle 845-025-7145;
  5. Synthetically derived hemp has been reported as a natural component in the plant of the Cannabaceae plant family Cannabaceae in at least three peer-reviewed publications; And
  6. The synthetically derived cannabis manufacturer provides OLCC with a “generally recognized as safe” (GRAS) designation for synthetic hemp.

Why do new rules hurt

Most of all, Requirement #6 above is very onerous. This is because: (1) that Food and Drug Administration has not yet established a federal regulatory framework for cannabis-derived products (also, Agency has not yet approved any pre-marketing approval provided by cannabis companies), and (ii) this pre-approval process is lengthy and cumbersome.

Many in the Oregon cannabis industry see the OLCC’s decision to impose a GRAS limitation requirement on industrially-derived hemp as arbitrary and unfair. In fact, the OLCC does not impose such a GRAS limitation on naturally derived hemp sold in the state. But no matter where cannabis companies that manufacture and sell synthetically derived hemp products stand on this issue, everyone will be required to make the necessary changes to comply with the new OLCC rules.

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