1. (1) A label required by these rules must:

   1. (a) Be printed or attached to client packaging containing psilocybin products.
   2. (b) Contain all required information in a legible font at least eight points large.
   3. (c) Be in English, though it may also be in other languages.
   4. (d) Be unobstructed and clearly visible.

2. (2) A label may not:

   1. (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
   2. (b) Be attractive to minors, as that is defined in OAR 333-333-1010.

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

   1. (a) The manufacturer’s business or trade name and license number.
   2. (b) One of the following product type names: whole fungi, homogenized fungi, psilocybin extract, or edible psilocybin product.
   3. (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.
   4. (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.
   5. (e) The psilocin content measured by quantity of psilocin analyte contained in the product, expressed in milligrams, and calculated using laboratory test results required by OAR 333-333-7040.
   6. (f) A unique identification number as defined in OAR 333-333-1010.
   7. (g) The “best by” date indicating the time that the manufacturer has determined that their product will retain its original quality.
   8. (h) A statement that “Activation times for psilocybin products are variable and cannot be accurately predicted.”
   9. (i) A statement that “The risks, benefits, and drug interactions of psilocybin are not fully understood, and individual results may vary.”
4. (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.
5. (5) In addition to the information required by section (3) of this rule, a manufacturer must include on a label any other values regarding available, potential or equivalent psilocin or psilocybin that are identified by the laboratory performing tests required by OAR 333-333-7040, including total potential psilocin as defined in OAR 333-064-0025. If the label includes other values related to psilocin or psilocybin, the product information document required by OAR 333-333-2410 must include an explanation of how those values were calculated, including any formulas and assumptions that were used to calculate the listed values.

Statutory/Other Authority

ORS 475A.235, ORS 475A.626 & Oregon Laws 2025, chapter 147

Statutes/Other Implemented

ORS 475A.626 & Oregon Laws 2025, chapter 147

History

PH 21-2025, amend filed 10/24/2025, effective 01/01/2026
PH 58-2023, amend filed 12/21/2023, effective 01/01/2024
PH 206-2022, adopt filed 12/27/2022, effective 12/27/2022