Current through Register Vol. 47, No. 17, September 10, 2024
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.
