Similar to the packaging and labeling requirements for cannabis products, Oregon’s psilocybin manufacturers have to comply with strict packaging and labeling rules for their psilocybin products.
Psilocybin remains a Schedule 1 Controlled Substance at the Federal level, and the packaging and labeling regulations ensure that minors and other unintended persons don’t access psilocybin products.
However, unlike the adult-use cannabis industry, which allows direct-to-consumer sales from licensed cannabis retail outlets, psilocybin products are manufactured for sale only to licensed psilocybin service centers. In addition, clients can only access and consume the psilocybin products during an administration session with an authorized facilitator present for the entire session. As such, some packaging requirements for psilocybin products, like child-safe packaging, are not as stringent as are the requirements for cannabis products.
What does “Attractive to Minors” Mean In the Context of Psilocybin Regulations
As discussed previously, in the article on Advertising regulations, the proposed* Section 6, Rule 333-333-1010, defines “attractive to minors” as:
- Including cartoons. The definitions in the proposed* psilocybin regulations define cartoons (Section 12, Rule 333-333-1010) to mean any drawing or other depiction of an object, person, animal, creature, or any similar caricature which may feature:
- The use of comically exaggerated features;
- The attribution of human characteristics to animals, plants, or other objects, or the similar use of this anthropomorphic technique; or
- The attribution of unnatural or extra-human abilities, such as imperviousness to pain or injury, X-ray vision, tunneling at very high speeds or transformation.
- A design, brand, or name that resembles a non-psilocybin consumer product of the type that is typically marketed to minors;
- Symbols or celebrities that are commonly used to market products to minors;
- Images of minors; or
- Words that refer to products that are commonly associated with minors or marketed to people under 21 years of age.
Examples of Package and Label Designs That Would Be Considered “Attractive to Minors”
It is wise to steer clear of designs that can be considered “attractive to minors” when designing brand assets (logo, etc.), packaging, and labeling for psilocybin products. As logos and brand names are undeniably always a part of the product label, creating non-compliant brand assets can be a significant waste of time and money further down the line.
Client Packaging Rules for Psilocybin Products
The proposed* packaging rules primarily focus on keeping psilocybin products safe till clients can consume them at licensed service centers and out of the hands of minors and other unintended parties. Per the rules, all psilocybin products must be transferred to a service center in sealed client packaging for ultimate sale to a client. The client packaging rules for psilocybin products addressed in Proposed* Rule 333-333-2300 (Packaging for Sale to Client) can be separated into two categories:
Ensuring Product Integrity
According to the rules, the sealed psilocybin client packaging must:
- Protect the packaged psilocybin product from contamination and excessive moisture.
- Not impart any toxic or harmful substance to the packaged item.
Ensuring Client Safety
Psilocybin products for ultimate sale to a client must:
- Not be packaged or labeled in a manner that is attractive to minors.
- Comply with serving size requirements. Per Proposed* Rule 333-333-2300 (Packaging and Serving Size) a serving of a psilocybin product may not contain more than 25 mg of psilocybin analyte.
- Be properly labeled accurately (see requirements below).
- Not display any untruthful or misleading content.
Labeling Requirements for Psilocybin Products
A compliant label that meets the requirements defined under Proposed* Rule 333-333-2400 (Labeling for Sale to Client) is an essential component of the sealed psilocybin client packaging. The labeling requirements for psilocybin products can be separated into two categories:
Physical and Technical Requirements
- Compliant psilocybin labels must:
- Be printed or attached to client packaging containing psilocybin products.
- Contain all required information in a legible font at least eight points large.
- Be in English, though it may also be in other languages.
- Be unobstructed and clearly visible.
- Psilocybin packaging labels may not:
- Display false or misleading statements, including health claims even if they are backed by reliable and respected studies.
- Be attractive to minors, as discussed above.
Compliant psilocybin client packaging must display the following:
- The manufacturer’s business or trade name and license number.
- One of the following product type names:
- Whole fungi
- homogenized fungi
- psilocybin extract or
- edible psilocybin product.
- 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.
- The quantity of psilocybin analyte contained in the product expressed in milligrams and calculated using laboratory test results.
- A unique identification number (UIN).
- A “best by” date which indicates the time that the manufacturer has determined that their product will retain its original quality.
Product Information Document
In addition to the sealed packaging, a Product Information Document is included when psilocybin products in sealed client packaging are transferred from a licensed manufacturer to a licensed service center for ultimate sale to a client per Rule 333-333-2410 (Product Information Document).
Licensed psilocybin facilitators must provide clients a Product Information Document for all psilocybin products that may be consumed during the client’s psilocybin administration session during a client’s preparation session. Clients have an opportunity to discuss the document with the facilitator during the preparation session. During the client’s administration session, licensed facilitators of a service center transfer psilocybin products to clients in sealed client packaging. (Proposed* Rule 333-333-5170 Sale and Transfer of Psilocybin Products to Clients)
Conclusion: Don’t Overlook Routine Compliance
As you build and grow your psilocybin businesses, don’t forget to comply with the labeling and packaging restrictions listed in the proposed* regulations.
Rogoway Law’s Outside General Counsel Program allows small-to-medium-sized businesses the ability to harness a full suite of legal capabilities, including packaging and labeling review, in a cost-effective manner. As participating clients only pay a set fee, their businesses can budget for and keep up with critical legal needs before they become costly problems.
If you have questions about how the proposed* psilocybin regulations will affect your psilocybin license application and business, please get in touch with us. The psychedelic law attorneys at Rogoway Law are ready to help you with your Oregon psilocybin service center, manufacturer, and/or testing laboratory queries and concerns.
* This post is based on rules still in draft form. The final regulations, in their entirety, are expected to be adopted by December 30, 2022.
We will update this post with any pertinent information as the rules are finalized and adopted.