2023 Colorado Revised Statutes › Title 25 - PUBLIC HEALTH AND ENVIRONMENT (§§ 25-1-101 — 25-59-106) › PRODUCTS CONTROL AND SAFETY (§§ 25-5-101 — 25-5.5-312) › Article 5 - PRODUCTS CONTROL AND SAFETY (§§ 25-5-101 — 25-5-1506) › Part 4 - PURE FOOD AND DRUG LAW (§§ 25-5-401 — 25-5-427) › Section 25-5-427 - Classes of hemp-derived compounds and cannabinoids - definitions - registration required - prohibitions - safe harbor - rules - repeal

(1)
Legislative declaration.
The general assembly finds, determines, and declares that the registration of hemp product and safe harbor hemp product manufacturers and the regulation of premises and places where hemp products and safe harbor hemp products are manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution in accordance with this part 4 and any rules promulgated under this part 4:
(a)
Are necessary to protect the public health;
(b)
Will benefit consumers by ensuring that hemp products are sold and distributed by safe sources;
(c)
Will assist retailers by ensuring that hemp products have not been adulterated during manufacturing, production, packaging, processing, preparing, treating, transporting, and storage; and
(d)
Will contribute to the economic health of the state by ensuring that Colorado hemp product and safe harbor hemp product manufacturers are permitted to ship their products in interstate commerce.
(2)
Definitions.
As used in this section, unless the context otherwise requires:
(a)
"Dietary supplement" has the meaning set forth in section
25-5-426 (2)(d)
.
(b)
"Hemp" has the meaning set forth in section
35-61-101 (7)
.
(c)
"Hemp manufacturer or storage facility" means a facility where hemp products are manufactured or stored.
(d)
"Hemp product" means a finished product that contains hemp and that:
(I)
Is a cosmetic, a dietary supplement, a food, a food additive, or an herb;
(II)
Is intended for human use or consumption;
(III)
Contains any part of the hemp plant, including naturally occurring cannabinoids, compounds, concentrates, extracts, isolates, or resins;
(IV)
Is produced from hemp;
(V)
Contains no more than one and three-fourths milligrams of THC per serving; and
(VI)
Contains a ratio of cannabidiol to THC of greater than or equal to fifteen to one.
(e)
"Intoxicating cannabinoid" means a cannabinoid that is classified as an intoxicating cannabinoid in this section or by rule of the department acting in coordination with the state licensing authority, in accordance with subsections (4)(g) and (4)(h) of this section.
(f)
"Manufacturing or processing", "manufacturing", "manufacture", "process", or "processing" has the same meaning as "manufacturing or processing", as set forth in section
25-5-426 (2)(h)
.
(g)
"Nonintoxicating cannabinoid" means a cannabinoid that is classified as a nonintoxicating cannabinoid in this section or by rule of the department acting in coordination with the state licensing authority, in accordance with subsections (4)(g) and (4)(h) of this section.
(h)
"Physical separation" means segregation of the operations of a regulated hemp facility, including:
(I)
The physical separation of hemp products and safe harbor hemp products during manufacture, production, storage, and distribution; and
(II)
The use of separate equipment for the manufacture or production of hemp products and safe harbor hemp products.
(i)
"Potentially intoxicating cannabinoid" has the meaning set forth in section
44-10-103
(48.5).
(j)
"Registrant" means a person registered under subsection (5) of this section.
(k)
"Regulated hemp facility" means:
(I)
A hemp manufacturer or storage facility; or
(II)
A safe harbor manufacturer or storage facility.
(l)
"Safe harbor hemp product" means a hemp-derived compound or cannabinoid, whether a finished product or in the process of being produced, that is permitted to be manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution in Colorado for export from Colorado but that is not permitted to be sold or distributed in Colorado.
(m)
"Safe harbor manufacturer or storage facility" or "safe harbor facility" means a facility that manufactures for distribution, produces for distribution, packages for distribution, processes for distribution, prepares for distribution, treats for distribution, transports for distribution, or holds for distribution a safe harbor hemp product.
(n)
"Semi-synthetic cannabinoid" has the meaning set forth in section
44-10-209 (2)(b)
.
(o)
"Serving" means the size or portion customarily consumed per eating occasion, expressed in a common household measure as established in table 2 of
21 CFR 101.12
.
(p)
"State licensing authority" has the meaning set forth in section
44-10-103 (69)
.
(q)
"Synthetic cannabinoid" has the meaning set forth in section
44-10-209 (2)(c)
.
(r)
"Tetrahydrocannabinol" or "THC" has the meaning set forth in section
44-10-209 (2)(d)
.
(s)
"Tincture" means a liquid hemp product that is packaged in a container of four fluid ounces or less, that is not a beverage or intended for drinking, and that consists of a solution:
(I)
Containing at least twenty-five percent nondenatured alcohol or a base of glycerin or plant-based oil;
(II)
Containing hemp, hemp concentrate, or hemp extract; and
(III)
Intended for human use.
(3)
Powers and duties of the department - rules.
The department has the power and duty to:
(a)
Grant or deny a registration issued under subsection (5) of this section and to grant or deny the annual renewal of a registration;
(b)
Suspend, deny, or revoke a registration under circumstances prescribed in this section or in rules promulgated under this section;
(c)
Review any records of a registrant that manufactures for distribution, produces for distribution, packages for distribution, processes for distribution, prepares for distribution, treats for distribution, transports for distribution, or holds for distribution products subject to this section as necessary to verify compliance with this section;
(d)
Promulgate rules necessary to authorize or prohibit chemical modification, conversion, or synthetic derivation of cannabinoids or other hemp-derived compounds, unless otherwise permitted by this part 4 or by any rules promulgated under this part 4;
(e)
(I)
Promulgate rules, in coordination with the state licensing authority, establishing the amount of any cannabinoid that makes the cannabinoid intoxicating;
(II)
Promulgate rules implementing subsection (8) of this section;
(III)
If necessary, promulgate rules creating a process to prevent cross contamination between hemp products and safe harbor hemp products and specifying a set of requirements for:
(A)
The co-location of the manufacture of, production of, storage of, and distribution of hemp products and safe harbor hemp products; and
(B)
The use of the same equipment for the production of safe harbor hemp products and hemp products;
(IV)
Promulgate rules prohibiting the export of a safe harbor hemp product to a state where the safe harbor hemp product is prohibited by state statute; and
(V)
Promulgate rules prohibiting the manufacture, production, or distribution of a safe harbor hemp product that is also a synthetic cannabinoid;
(f)
Promulgate rules governing testing and labeling, as provided in subsections (4)(c)(II) and (4)(d)(III) of this section. In promulgating the labeling for hemp products, the department shall consider:
(I)
The labeling rules promulgated by the state licensing authority governing products with THC;
(II)
How best to inform consumers of the ratio of cannabidiol to THC, including a differentiation between product labels based on the ratio of CBD to THC; and
(III)
Information on potential health effects of using hemp products and requirements for consumer notice as required in subsection (4)(f) of this section.
(g)
Promulgate rules authorizing, prohibiting, or regulating hemp-derived ingredients in hemp products that are compounds other than cannabinoids;
(h)
Promulgate any other rules that are necessary for the fair, impartial, and comprehensive administration of this part 4 with respect to hemp, hemp products, or safe harbor hemp products; and
(i)
Issue a cease-and-desist order or clean-up order to address violations of this section.
(4)
Classifications of hemp-derived compounds and cannabinoids - rules.
(a)
Hemp-derived compounds and cannabinoids are divided into three classifications:
(I)
Nonintoxicating cannabinoids;
(II)
Potentially intoxicating cannabinoids; and
(III)
Intoxicating cannabinoids.
(b)
(I)
Nonintoxicating cannabinoids include:
(A)
Full spectrum hemp extract that contains no more than one and three-fourths milligrams of THC per serving and contains a ratio of cannabidiol to THC of greater than or equal to fifteen to one;
(B)
Broad spectrum hemp extract;
(C)
Cannabidiol, also known as "CBD";
(D)
Tetrahydrocannabivarin, also known as "THCV";
(E)
Cannabichromene, also known as "CBC";
(F)
Cannabicitran, also known as "CBT";
(G)
Cannabicyclol, also known as "CBL";
(H)
Cannabielsoin, also known as "CBE";
(I)
Cannabigerol, also known as "CBG";
(J)
Cannabidivarin, also known as "CBDV"; and
(K)
Cannabinol, also known as "CBN".
(II)
Nonintoxicating cannabinoids that are derived from hemp may be used as an ingredient in a hemp product or as a finished hemp product in accordance with this section and the rules promulgated under this part 4 or in accordance with article
10
of title
44
and the rules promulgated under article
10
of title
44
.
(c)
(I)
A person shall not:
(A)
Manufacture, produce, or distribute a potentially intoxicating cannabinoid within Colorado, as an ingredient in a hemp product or as a finished hemp product, unless the potentially intoxicating cannabinoid is a safe harbor hemp product that is exported from Colorado; or
(B)
Market or promote a hemp product as containing THC or any other potentially intoxicating cannabinoid.
(II)
A person that manufactures, produces, or distributes a product containing a potentially intoxicating cannabinoid shall label the product in accordance with the rules promulgated under this section.
(d)
(I)
Intoxicating cannabinoids include the following in an amount that exceeds the amount established by rule or, if no rule establishes the amount, in any amount:
(A)
Delta-10 THC and its isomers;
(B)
Delta-9 THC and its isomers;
(C)
Delta-8 THC and its isomers;
(D)
Delta-7 THC and its isomers;
(E)
Delta-6a, 10a THC and its isomers;
(F)
Exo-tetrahydrocannabinol;
(G)
Metabolites of THC, including 11-hydroxy-THC, 3-hydroxy-THC, or 7-hydroxy-THC;
(H)
Hydrogenated forms of THC, including hexahydrocannabinol, hexahydrocannabiphorol, and hexahydrocannabihexol;
(I)
Synthetic forms of THC, including dronabinol;
(J)
Ester forms of THC, including delta-8 THC-O-acetate, delta-9 THC-O-acetate, and hexahydrocannabinol-O-acetate;
(K)
Tetrahydrocannabivarins, including delta-8 tetrahydrocannabivarin but excluding delta-9 tetrahydrocannabivarin;
(L)
Analogues of tetrahydrocannabinols with an alkyl chain of four or more carbon atoms, including tetrahydrocannabiphorols, tetrahydrocannabioctyls, tetrahydrocannabihexols, or tetrahydrocannabutols; and
(M)
Any combination of the compounds, including hexahydrocannabiphorol-O-ester, listed in this subsection (4)(d)(I).
(II)
A person shall not:
(A)
Manufacture, produce, or distribute an intoxicating cannabinoid within Colorado, as an ingredient in a hemp product or as a finished hemp product, unless the intoxicating cannabinoid is a safe harbor hemp product that is exported from Colorado; or
(B)
Market or promote a safe harbor hemp product or hemp product as containing THC or any other intoxicating cannabinoid.
(III)
A person that manufactures, produces, or distributes a product containing an intoxicating cannabinoid shall label the product in accordance with the rules promulgated under this section.
(e)
(I)
A person shall not manufacture, produce, sell, or offer to sell a synthetic cannabinoid or a product containing a synthetic cannabinoid unless authorized by rule. If synthetic cannabinoids are permitted by rule, the department, in coordination with the state licensing authority, shall promulgate rules providing standards and requirements for the manufacture and production of synthetic cannabinoids in Colorado. The rules must include a labeling requirement for any hemp-derived product manufactured or produced in Colorado that contains a semi-synthetic or synthetic cannabinoid as an ingredient.
(II)
To be sold, offered for sale, or distributed, semi-synthetic cannabinoids must meet production, testing, and labeling requirements established in rules promulgated by the department under section
25-5-420
and subsection (4)(e)(I) of this section.
(f)
The department shall promulgate rules requiring a consumer notice statement if any hemp-derived products that are manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution in this state contain intoxicating cannabinoids or potentially intoxicating cannabinoids.
(g)
The department, in coordination with the state licensing authority, may promulgate rules to:
(I)
Classify a hemp-derived compound or cannabinoid that is not classified in this subsection (4);
(II)
Reclassify a hemp-derived compound or cannabinoid classified in this subsection (4) if:
(A)
The state has adopted or federal law has established a process to review and approve hemp-derived compounds or cannabinoids;
(B)
The review and approval process described in subsection (4)(g)(II)(A) of this section evaluates the intoxicating potential of the hemp-derived compound or cannabinoid; and
(C)
The reclassification is based on the findings of the process and evaluation described in subsections (4)(g)(II)(A) and (4)(g)(II)(B) of this section.
(h)
To reclassify a hemp-derived compound or cannabinoid, under subsection (4)(g) of this section, the reclassification must:
(I)
Be supported by peer-reviewed research or clinical trials establishing to a reasonable degree of scientific certainty that the hemp-derived compound or cannabinoid or a product containing a hemp-derived compound or cannabinoid should be reclassified; or
(II)
Be based on a threat to human health, including substantial reports of intoxication or adverse health event reports.
(5)
Registration required - regulated hemp facilities - application - fees - repeal.
(a)
Beginning July 1, 2023, and on or before July 1 of each year thereafter, the owner of a regulated hemp facility shall submit a registration application to the department. To submit an application, each hemp manufacturer or storage facility and each safe harbor manufacturer or storage facility must pay an annual application fee of one hundred dollars plus any additional registration fee specified in subsection (5)(b) of this section. Each registration expires on June 30 of the year for which the registration is issued, regardless of whether the registration was issued after July 1 for the year. Notwithstanding that a registration is valid for only a portion of a fiscal year, the application and registration fee do not change.
(b)
In addition to the application fee imposed in subsection (5)(a) of this section, the annual registration fee for a regulated hemp facility is one thousand five hundred dollars.
(c)
(I)
To be registered under subsection (5)(a) of this section, a safe harbor manufacturer or storage facility must demonstrate compliance with the federal current good manufacturing practices for food or dietary supplements before registering or within twelve months after the previous registration by submitting to the department:
(A)
An attestation form, as provided by the department, within thirty days after June 7, 2023, and each year thereafter; and
(B)
Evidence of obtaining an inspection from an approved third-party auditor by July 1, 2024, and by July 1 of each year thereafter.
(II)
The department shall not register a person as a safe harbor manufacturer or storage facility under this subsection (5) if the person is registered as a hemp manufacturer or storage facility or as a wholesale food manufacturing and storage facility, unless each safe harbor hemp product:
(A)
Is physically separated from hemp products during the manufacture of, production of, storage of, and distribution of the safe harbor hemp product;
(B)
Is manufactured, produced, stored, and distributed in accordance with procedures that are approved by the department and that ensure no cross contamination between hemp products and safe harbor hemp products; or
(C)
Is manufactured, produced, stored, and distributed in accordance with rules of the department promulgated in accordance with subsection (3)(e)(III) of this section.
(III)
To be exported for sale or distribution, each safe harbor hemp product must be tested and labeled in accordance with rules promulgated under section
25-5-420
and subsection (4)(e) of this section.
(d)
A registration issued under this subsection (5) is subject to suspension or revocation, in accordance with article
4
of title
24
, if the registrant violates this part 4 or rules promulgated under this part 4.
(e)
A registrant who violates this section is subject to the civil penalties established in subsection (9) of this section.
(f)
(I)
A regulated hemp facility may continue manufacturing, producing, and distributing hemp products and safe harbor hemp products until the department promulgates rules implementing this subsection (5) if the regulated hemp facility complies with the currently applicable statutes and rules.
(II)
This subsection (5)(f) is repealed, effective July 1, 2025.
(6)
Hemp products not adulterated.
A product containing hemp produced by a registrant is not deemed adulterated, as defined in sections
25-5-410
and
25-5-416
, unless the product meets one or more of the criteria for adulteration set forth in section
25-5-410
or
25-5-416
.
(7)
Fees deposited in fund.
The department shall transmit fees collected in accordance with subsection (5) of this section to the state treasurer, who shall credit the fees to the wholesale food manufacturing and storage protection cash fund established in section
25-5-426 (5)
.
(8)
Offenses.
It is unlawful to engage in or knowingly cause a person to engage in any of the following acts:
(a)
Manufacturing, selling, or delivering or holding or offering for sale any products containing hemp and intoxicating cannabinoids or potentially intoxicating cannabinoids in excess of limits established by rules promulgated under subsection (3)(e) of this section or section
25-5-420
;
(b)
Manufacturing a product containing hemp that is not a cosmetic, a dietary supplement, a food, a food additive, or an herb;
(c)
Manufacturing, producing, selling, distributing, or holding for sale or distribution a hemp product without registering with the department under this section;
(d)
Manufacturing, producing, selling, distributing, or holding for sale or distribution a safe harbor hemp product without registering with the department under this section;
(e)
(I)
Selling a hemp product to an individual who is under twenty-one years of age if the hemp product:
(A)
Has more than one and one-fourth milligrams of THC per serving; or
(B)
Has a ratio of cannabidiol to THC of less than twenty to one.
(II)
This subsection (8)(e) does not apply to:
(A)
Products with no THC;
(B)
Tinctures;
(C)
Cosmetics; or
(D)
A hemp product that the United States food and drug administration has determined is generally recognized as safe under the "Federal Food, Drug, and Cosmetic Act",
21 U.S.C. sec. 301
et seq.
(f)
(I)
Selling a hemp product in a package with more than five servings if the hemp product:
(A)
Has more than one and one-fourth milligrams of THC per serving; and
(B)
Has a ratio of cannabidiol to THC of less than twenty to one.
(II)
This subsection (8)(f) does not apply to:
(A)
Products with no THC;
(B)
Tinctures;
(C)
Cosmetics; or
(D)
A hemp product that the United States food and drug administration has determined is generally recognized as safe under the "Federal Food, Drug, and Cosmetic Act",
21 U.S.C. sec. 301
et seq.; or
(g)
(I)
Selling a hemp product in a package with more than thirty servings if the hemp product:
(A)
Has more than one and one-fourth milligrams of THC per serving; and
(B)
Has a ratio of cannabidiol to THC of twenty to one or more.
(II)
This subsection (8)(g) does not apply to:
(A)
Products with no THC;
(B)
Tinctures;
(C)
Cosmetics; or
(D)
A hemp product that the United States food and drug administration has determined is generally recognized as safe under the "Federal Food, Drug, and Cosmetic Act",
21 U.S.C. sec. 301
et seq.
(9)
Penalties.
A person who violates this section, the rules promulgated under this section, or a final cease-and-desist order or clean-up order under subsection (3)(i) of this section is subject to a civil penalty of not more than ten thousand dollars per day per violation. The department or the court shall transmit each civil penalty collected under this subsection (9) to the state treasurer, who shall credit the penalty to the wholesale food manufacturing and storage protection cash fund established in section
25-5-426 (5)
. In determining the amount of a civil penalty under this subsection (9), the department or the court shall consider the following factors:
(a)
The actual or potential damage from the violation;
(b)
The violator's compliance history;
(c)
Whether the violation was intentional, reckless, or negligent;
(d)
The effect upon or threat posed to the public health or environment as a result of the violation;
(e)
The duration of the violation; and
(f)
Any economic benefit realized by the violator as a result of the violation.
(10)
Inspections and monitoring - rules.
(a)
For the purpose of enforcement of this section, the department may conduct inspections of regulated hemp facilities in accordance with section
25-5-421
.
(b)
Unless the department approves, a county, a district created under article
1
of title
32
, a municipality, or a city and county shall not perform a food safety inspection at a premises or place where hemp products or safe harbor hemp products are manufactured for distribution, produced for distribution, packaged for distribution, processed for distribution, prepared for distribution, treated for distribution, transported for distribution, or held for distribution.
(c)
The department may promulgate rules establishing monitoring requirements for safe harbor hemp products in accordance with good manufacturing practices. The rules may include inventory tracking, surveillance, and record-keeping requirements.
Added by 2023 Ch. 444,§ 2, eff. 6/7/2023.