Current through Register Vol. 63, No. 9, September 1, 2024
(1) A licensee may
transfer, sell, transport, purchase, possess, accept, return, or receive an
artificially derived cannabinoid, including an artificially derived cannabinoid
created by a refinement process using a reactive material such as bleaching
clay, or a marijuana or hemp item that contains an artificially derived
cannabinoid if:
(a) The artificially derived
cannabinoid:
(A) Is not a controlled
substance under OAR chapter 855, division 80;
(B) Was manufactured in compliance with
applicable laws relating to food safety;
(C) In the Commission's judgment, is not
impairing or intoxicating; and
(D)
Has been reported as a naturally-occurring component of the plant Cannabis
family Cannabaceae in at least three peer-reviewed publications.
(b) The item is not intended for
human inhalation; and
(c) The
manufacturer of the artificially derived cannabinoid:
(A) Has made a "Generally Recognized as Safe"
(GRAS) determination for the artificial cannabinoid and supplied a copy of that
determination to the Commission;
(B) Has provided to the Commission a Food and
Drug Administration (FDA) letter responding to a "Generally Recognized as Safe"
(GRAS) notice for the artificially derived cannabinoid manufactured by the same
method that the manufacturer uses, affirming that FDA has no questions about
the notice; or
(C) Has provided to
the Commission an FDA letter of acknowledgement with no objections in response
to a New Dietary Ingredient notification for the artificially derived
cannabinoid manufactured by the same method that the manufacturer
uses.
(2) The
Commission will notify the licensee of acceptance of documentation received
under paragraph (1)(c)(A), (B) or (C) of this rule and may apply additional
labeling and concentration limit rules.
(3) Until January 2, 2025, a licensee may
transfer, sell, transport, purchase, possess, accept, return, or receive any
marijuana or hemp item manufactured before July 1, 2023 containing the
artificially derived cannabinoid cannabinol (CBN) if:
(a) The item is not intended for human
inhalation; and
(b) The CBN:
(A) Is not a controlled substance under OAR
chapter 855, division 80; and
(B)
Was manufactured in compliance with applicable laws relating to food
safety.
(4)
Until January 2, 2025, a licensee may transfer, sell, transport, purchase,
possess, accept, return, or receive any marijuana or hemp item manufactured on
or after July 1, 2023 containing the artificially derived cannabinoid
cannabinol (CBN) if:
(a) The item is not
intended for human inhalation; and
(b) The CBN:
(A) Is not a controlled substance under OAR
chapter 855, division 80;
(B) Was
manufactured in compliance with applicable laws relating to food safety;
and
(C) Was manufactured by a
person with written approval from the Commission affirming that the
manufacturer:
(i) Has taken substantial steps
towards meeting the requirements described in subsection (1)(c) of this rule,
including but not limited to initiating or contracting to initiate safety
studies;
(ii) Has conducted a
hazard analysis as described in
21 CFR
117.130 to identify foreseeable hazards in
the process of manufacturing the CBN and provided the Commission with a copy of
the analysis; and
(iii) Has
provided the Commission with copies of any preventative controls, as described
in 21 CFR
117.135 that minimize or prevent any hazards
requiring a preventive control.
(5) A manufacturer may request written
approval as described in paragraph (4)(b)(C) of this rule in a form and manner
prescribed by the Commission. The Commission:
(a) Shall publish a list of manufacturers who
obtain this written approval.
(b)
May revoke this approval if the manufacturer no longer meets the requirements
described in subsection (4)(b) of this rule. If the Commission revokes
approval, the manufacturer has the right to a hearing under the procedures in
ORS chapter 183.
(c) May consult
with the Oregon Department of Agriculture for the purposes of reviewing the
request.
(6) If the
Commission requires a manufacturer to submit or produce documents to the
Commission that the manufacturer believes falls within the definition of a
trade secret as defined in ORS
192.501, the manufacturer must
mark each document "confidential" or "trade secret."
(7) A licensee may not transfer, sell,
transport, purchase, possess, accept, return, or receive an artificially
derived cannabinoid or a marijuana or hemp item that contains an artificially
derived cannabinoid other than as provided in this rule.
(8) The Commission may reevaluate the
regulation of artificially derived cannabinoids on an annual basis, including
establishing purity standards.
Statutory/Other Authority: ORS
475C.017
Statutes/Other Implemented: ORS
475C.017
