Or. Admin. Code § 333-333-2400

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-333-2400 - Labeling for Sale to Client

(1) A label required by these rules must:

(a) Be printed or attached to client packaging containing psilocybin products.

(b) Contain all required information in a legible font at least eight points large.

(c) Be in English, though it may also be in other languages.

(d) Be unobstructed and clearly visible.

(2) A label may not:

(a) Display any untruthful or misleading statements including, but not limited to, a health claim that is not supported by the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner that is consistent with generally recognized scientific procedures and principles), and for which there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims; or

(b) Be attractive to minors, as that is defined in OAR 333-333-1010.

(3) Required Information. All client packaging must display:

(a) The manufacturer's business or trade name and license number.

(b) One of the following product type names: whole fungi, homogenized fungi, psilocybin extract, or edible psilocybin product.

(c) The net quantity of contents using the metric system of measurement and expressed in terms of fluid measure if the item is liquid, or in terms of weight if the item is solid, semi-solid, or viscous.

(d) The quantity of psilocybin analyte contained in the product, expressed in milligrams, and calculated using laboratory test results required by OAR 333-333-7040.

(e) A unique identification number as defined in OAR 333-333-1010.

(f) The "best by" date indicating the time that the manufacturer has determined that their product will retain its original quality.

(g) A statement that "Activation times for psilocybin products are variable and cannot be accurately predicted."

(h) A statement that "The risks, benefits, and drug interactions of psilocybin are not fully understood, and individual results may vary."

(4) Client packaging for edible psilocybin products must be consistent with applicable state food labeling requirements for the same type of food product or potable liquid when the food product or potable liquid does not contain psilocybin.

Or. Admin. Code § 333-333-2400

PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022; PH 58-2023, amend filed 12/21/2023, effective 1/1/2024

Statutory/Other Authority: ORS 475A.235 & ORS 475A.626

Statutes/Other Implemented: ORS 475A.626