1 Colo. Code Regs. § 212-3-3-3305

Current through Register Vol. 47, No. 20, October 25, 2024

Section 1 CCR 212-3-3-3305 - Packaging and Labeling Requirements

Basis and Purpose - 3305

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-203(1)(k), 44-50-203(2)(d), 44-50-203(2)(e), 44-50-203(2)(g), 44-50-203(2)(j), and 44-50-203(2)(k), C.R.S. The purpose of this rule is to define the requirements for packaging and labeling Regulated Natural Medicine and Regulated Natural Medicine Products between Natural Medicine Businesses or Facilitators. The following Rule, in conjunction with Rule 3505 - Licensee Marketing, seeks to implement measures to prevent diversion to individuals under 21 years of age, prevent accidental ingestion, and avoid the excessive commercialization of natural medicine and natural medicine services. Initially, this Rule seeks to minimize opportunities for packaging and labeling to misappropriate or exploit federally recognized American tribes, indigenous people, communities, and cultures by limiting the use of color and images on packages and labels. This rule does not limit the use of color or images in a Licensee's marketing materials, which could include branding - see Rule 3505 for additional information, requirements, and limitations on Licensee marketing.

A. Any transfer of Regulated Natural Medicine and Regulated Natural Medicine Product must be in a container and packaged and labeled in accordance with this Rule.

1.Servings of Regulated Natural Medicine and Regulated Natural Medicine Product.

a. A single Unit of Regulated Natural Medicine Product may contain no more than 10 milligrams of Total Psilocin.

b. A package of Regulated Natural Medicine Product may contain no more than 50 milligrams of Total Psilocin.

c. A package of Regulated Natural Medicine may contain no more than 5 grams of dried Fruiting Bodies.

2.Tincture Product Packaging. A Natural Medicine Products Manufacturer producing tincture products allowed under Rule 6005(C)(2)(a) must package the tincture product:

a. In a manner consistent with the requirements in subparagraph (1)(b) of this Rule; and

b. Affixing the package of tincture product with a measuring device that permits the Facilitator or Natural Medicine Handler Licensee to measure each serving.

3. A container or package may be reused as long as it is effectively sanitized and complies with the requirements of these Rules.

4. All labels must comply with the following:

a. The font on the label must be legible and at least 8-point font.

b. The date the Regulated Natural Medicine was harvested or the date the Regulated Natural Medicine Product was manufactured.

c. Natural Medicine Business name, License number, and Harvest Lot and/or Production Lot number.

d.Psilocybe cubensis strain type and net contents in either dried weight of the Fruiting Bodies or Total Psilocin of a manufactured product.

B.Prior to Transfer to a Natural Medicine Products Manufacturer.

1.Packaging. Prior to transfer to a Natural Medicine Products Manufacturer, Regulated Natural Medicine must have completed all required processing steps in accordance with the Licensee's standard operating procedures, including passing any required testing pursuant to Rule 4010.

2.Labeling Requirements. Prior to transfer to a Natural Medicine Products Manufacturer, the Natural Medicine Cultivation Facility must affix a label that complies with paragraph (A)(4) of this Rule.

C.Prior to Transfer to a Natural Medicine Testing Facility.

1. Prior to transfer to a Natural Medicine Testing Facility, a Sample of Regulated Natural Medicine or Regulated Natural Medicine Product must be in its final form and have completed all required processing or manufacturing steps in accordance with the Licensee's standard operating procedures.

2.Packaging. Samples of Regulated Natural Medicine and Regulated Natural Medicine Product must be placed into a transparent container that permits the Sample to be photographed by the Natural Medicine Testing Facility. The container must have at least 20% empty space.

3.Labeling Requirements. Prior to transfer to a Natural Medicine Testing Facility, the Natural Medicine Cultivation Facility or Natural Medicine Products Manufacturer must affix a label that:

a. Complies with paragraph (A)(4) of this Rule; and

b. If applicable, a list of all ingredients used to manufacture the Regulated Natural Medicine Product including identification of major allergens including milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

D.Prior to Transfer to a Healing Center or Facilitator.

1. Prior to transfer to a Healing Center or Facilitator, all Regulated Natural Medicine or Regulated Natural Medicine Product must be in its final form and have completed all required processing or manufacturing steps in accordance with the Licensee's standard operating procedures and have passed all required testing in accordance with Part 4 of these Rules.

2.Packaging.

a.Prior to transfer to a Licensed Facilitator. Regulated Natural Medicine and Regulated Natural Medicine Product transferred to a Facilitator for an Administration Session at an authorized location other than a Healing Center must be in a Child-Resistant container.

3.Labeling Requirements. Prior to transfer to a Healing Center or Facilitator, the container must be affixed with a label that:

a. Complies with paragraph (A)(4) of this Rule;

b. Includes the Total Psilocin content in milligrams, and the date the tryptamine content analysis test was performed; and

c. If applicable, a list of all ingredients used to manufacture the Regulated Natural Medicine Product including identification of major allergens including milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans.

4. The label may include, but is not required to include, the Natural Medicine Business's logo.

5.Supplemental Information. Prior to transfer to a Healing Center or Facilitator, the Natural Medicine Cultivation or Natural Medicine Product Manufacturer must provide the following information. This supplemental information may be included on the label, provided electronically, or provided in hard-copy documentation accompanying the package to the Healing Center:

a. If the Regulated Natural Medicine or Regulated Natural Medicine Product has been subject to shelf stability testing in accordance with Rules 5020(H)(3) or 6015(I)(3), the expiration date; or

b. If the Regulated Natural Medicine or Regulated Natural Medicine Product has not been subject to shelf stability testing to support an expiration date, the label must include the following statement:

"Tryptamine content must be retested every 9 months. Whoever is in possession of this product must submit it for tryptamine content analysis testing 9 months from the harvest or production date."; and

c. Include ideal storage conditions for the Regulated Natural Medicine or Regulated Natural Medicine Product; and

d.Drug Interaction Warning Statement: The label must include the following statement:

"Drug Interaction Warning: This product may interact with other prescription drugs, recreational drugs, alcohol, or other substances. Special care should be taken by anyone consuming natural medicine and other prescription or recreational drugs."

6.Labeling Restrictions.

a. A label on Regulated Natural Medicine or Regulated Natural Medicine Product shall not make any claims regarding health or physical benefits.

b. Labels must not be attractive to individuals under the age of 21. Colors, pictures, and cartoon images are not permitted on labels.

c. Labels must not use the word "candy" or "candies."

d. A Regulated Natural Medicine Product cannot be labeled or packaged in a manner that would cause confusion as to whether the product was a trademarked food product.

e. Regulated Natural Medicine and Regulated Natural Medicine Product shall not be labeled in a way that misappropriates or exploits the identity or cultural history of Federally Recognized American Tribes, as defined in section 12-170-104(7), C.R.S., and indigenous people, their community, cultures, or religions.

1 CCR 212-3-3-3305

47 CR 17, September 10, 2024, effective 10/1/2024