The powers in this part 4 vested in the department are declared to be cumulative and in addition to and not in exclusion nor derogation nor limitation of the powers vested by law in the department, or in any other department of this state, or in any board or commission established by law, or in any law enforcement authority of this state.
Source: L. 57: p. 441, � 24. CRS 53: � 66-22-24. C.R.S. 1963: � 66-20-24.
25-5-426. Wholesale food manufacturing and storage - definitions - legislative declaration - registration - fees - cash fund. (1) The general assembly hereby finds, determines, and declares that the registration of wholesale food manufacturers and the regulation of premises or places wherein manufactured foods are produced, manufactured, packed, processed, prepared, treated, packaged, transported, or held for distribution in accordance with the Colorado Food and Drug Act, the Shellfish Dealer Certification Act, and the sanitary regulations administered by the department pursuant to part 1 of article 4 of this title and any rules promulgated thereunder:
(a) Is necessary to protect the public health;
(b) Will benefit consumers by ensuring that the sale and distribution of manufactured food is from safe sources;
(c) Will assist retailers by ensuring that manufactured foods have not been adulterated during manufacturing, packing, processing, preparing, treating, packaging, transporting, and storage; and
(d) Will contribute to the economic health of the state by assuring that Colorado wholesale food manufacturers are permitted to ship their product in interstate commerce.
(2) As used in this section, unless the context otherwise requires:
(a) Brew pub has the same meaning as set forth in section 44-3-103 (5).
(b) Brewery has the same meaning as set forth in section 44-3-103 (6).
(c) Dietary ingredient means one or any combination of a vitamin, mineral, herb or other botanical, amino acid, and a substance such as an enzyme, organ tissue, glandular, or metabolite.
(d) Dietary supplement means a product taken by mouth that contains a dietary ingredient or a new dietary ingredient intended to supplement the diet.
(e) Distillery or distiller has the same meaning as set forth in section 44-3-103 (13).
(f) Grain means a small hard fruit or seed produced by a cereal grass and the seeds of such plants as a whole.
(g) Grain storage facility means any establishment, structure, or structures under one management at one general physical location that holds grain without further manufacturing or processing after harvest.
(g.3) and (g.5) Repealed.
(h) Manufacturing or processing means making food from one or more ingredients, or synthesizing, preparing, treating, modifying, or manipulating food, including food crops or ingredients. Examples include: Cutting, peeling, trimming, washing, waxing, eviscerating, rendering, cooking, baking, freezing, cooling, pasteurizing, homogenizing, mixing, formulating, bottling, milling, grinding, extracting juices, distilling, labeling, or packaging.
(i) New dietary ingredient means a dietary ingredient that was not sold in the United States as a dietary supplement before October 15, 1994.
(j) Nonprofit facility means a charitable entity that provides food to the public, including food banks and nonprofit food facilities. To qualify as a nonprofit facility, the entity shall be exempt from paying federal income tax under the federal internal revenue code.
(k) Spirituous liquors has the same meaning as set forth in section 44-3-103 (54).
(l) Wholesale food manufacturer and storage facility mean a facility that manufactures, produces, packs, processes, treats, packages, transports, or holds human food, including dietary supplements. These terms include, without limitation, any repacker, reshipper, shell stock shipper, and shucker-packer, as defined in section 25-4-1803 (8), (9), (12), and (13), respectively.
(m) Winery has the same meaning as set forth in section 44-3-103 (61).
(3) The department has the following powers and duties:
(a) To grant or refuse to grant registration pursuant to subsection (4) of this section and to grant or refuse to grant the annual renewal of a registration;
(b) To deny, suspend, or revoke a registration;
(c) To issue a certificate of free sale; and
(d) To review any records of a wholesale food manufacturer or storage facility necessary to verify compliance with the provisions of this section.
(4) (a) Beginning July 1, 2003, and on or before July 1 of each year thereafter, the owner of any wholesale food manufacturer or storage facility shall submit an application to the department. Each wholesale food manufacturer or storage facility shall pay an annual application fee of one hundred dollars, plus any additional registration fee specified in subsection (4)(b) of this section; except that an application fee is not required for a nonprofit facility. The application for registration is valid for one year or for the portion of the fiscal year that remains if an application is submitted after July 1 of any fiscal year. If an application is valid for only a portion of a fiscal year, an application fee reduction is not required by this section. Each application expires on June 30 of the state fiscal year in which the application is submitted.
(b) In addition to the application fee a facility is required to pay pursuant to subsection (4)(a) of this section, the schedule for annual registration fees for wholesale food manufacturers or storage facilities is as follows:
(I) A registration fee is not required for a nonprofit facility, grain storage facility, brewery, brew pub, winery, or a distiller of spirituous liquors.
(II) A wholesale food manufacturer or storage facility with gross annual sales of less than one hundred fifty thousand dollars shall pay the department a registration fee of sixty dollars.
(III) A wholesale food manufacturer or storage facility with gross annual sales of one hundred fifty thousand dollars or more shall pay the department a registration fee of three hundred dollars.
(IV) Repealed.
(c) Upon issuing a certificate of free sale, the department shall collect a fee of one hundred fifty dollars.
(d) and (e) Repealed.
(5) Fees collected by the department pursuant to subsection (4) of this section shall be transmitted to the state treasurer, who shall credit such fees to the wholesale food manufacturing and storage protection cash fund, which is hereby created in the state treasury. The general assembly shall annually appropriate the moneys in such fund to the department for the payment of expenses necessary for the administration of this section. Any unexpended and unencumbered moneys remaining in the fund at the end of any fiscal year shall remain in the fund and shall not revert to the general fund or any other fund.
(6) and (7) Repealed.
Source: L. 2003: Entire section added, p. 1460, � 1, effective May 1. L. 2004: (2), (4)(a), and (4)(b) amended and (6) added, p. 628, � 1, effective April 23. L. 2007: (6) amended, p. 1576, � 1, effective May 31. L. 2008: (4)(b) amended, p. 1000, � 1, effective July 1. L. 2017: (2) R&RE, (4) amended, and (6) repealed, (HB 17-1079), ch. 396, p. 2069, � 1, effective June 6. L. 2018: (2)(g.3), (2)(g.5), and (4)(d) added, (HB 18-1295), ch. 341, p. 2032, � 2, effective August 8. L. 2019: (4)(b)(II) and (4)(b)(III) amended and (4)(b)(IV) and (7) added, (SB 19-240), ch. 351, p. 3243, � 1, effective May 29. L. 2022: (4)(e) added, (SB 22-205), ch. 278, p. 2000, � 1, effective May 31. L. 2023: (2)(g.3), (2)(g.5), (4)(b)(IV), (4)(d), and (4)(e) repealed and (4)(b)(II) and (4)(b)(III) amended, (SB 23-271), ch. 444, p. 2596, � 1, effective June 7.
Editor's note: (1) Subsection (4)(c) was originally numbered as subsection (4)(b)(IV) in the 2016 Colorado Revised Statutes and was renumbered as subsection (4)(c) in HB 17-1079, but the change was inadvertently not shown in the bill. (See L. 2017, p. 2069.)
(2) Subsection (7)(b)(III) provided for the repeal of subsection (7), effective September 1, 2021. (See L. 2019, p. 3243.)
25-5-427. Classes of hemp-derived compounds and cannabinoids - definitions - registration required - prohibitions - safe harbor - rules. (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) Repealed.
(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.
(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.
Source: L. 2023: Entire section added, (SB 23-271), ch. 444, p. 2597, � 2, effective June 7.
Editor's note: Subsection (5)(f)(II) provided for the repeal of subsection (5)(f), effective July 1, 2025. (See L. 2023, p. 2597.)
25-5-428. Misbranding of cell-cultivated meat as meat product prohibited - labeling of cell-cultivated meat required - definitions - inspections - stop orders - embargo orders - enforcement - rules. (1) As used in this section, unless the context otherwise requires:
(a) Agricultural food animal means:
(I) A domesticated animal belonging to the bovine, caprine, ovine, or porcine species; or
(II) A live domestic chicken or turkey.
(b) Cell-cultivated meat means food having one or more sensory attributes that resembles a type of tissue originating from an agricultural food animal but that, in lieu of being derived from meat processing, is derived from manufacturing cells, in which one or more stem cells are initially isolated from an agricultural food animal, are grown in vitro, and may be manipulated as part of a manufacturing operation.
(c) Food processing plant means a commercial operation that manufactures, packages, labels, or stores food for human consumption and does not provide food directly to a consumer.
(d) Identifying meat term means any word or phrase that states, indicates, suggests, or describes a meat product, regardless of whether the word or phrase is used individually, as a portmanteau, or as a compound word. Identifying meat term includes:
(I) A common name for the species of the agricultural food animal subject to slaughter and processing, including a calf or cow, a chicken, a goat or kid, a hog or pig, poultry, a lamb or sheep, or a turkey;
(II) A common name for a characteristic of a species of the agricultural food animal subject to slaughter and processing based on age, breed, or sex;
(III) Beef or veal; broiler, fryer, poulet, or yearling; cabrito or chevon; lamb or mutton; or pork;
(IV) A common name used to describe a major cut of the meat of an agricultural food animal slaughtered and processed, including a major meat cut specified in 9 CFR 317.344;
(V) A poultry product such as breast, drumstick, giblet, thigh, or wing;
(VI) The common name of an organ or offal, including gizzard, heart, liver, kidney, or tongue; and
(VII) Any other common name that a reasonable purchaser would immediately and exclusively associate with a meat product prepared for sale in normal commercial channels, such as bacon, baloney, bologna, bone, brat or bratwurst, brisket, burger or hamburger, butt, chop, chuck, cold cut, cutlet, filet, flat iron, frank or frankfurter, ham, hock, hot dog, jerky, liverwurst, loin, London broil, lunch meat, New York strip, pepperoni, porterhouse, ribeye, roast, rib or sparerib, salami, sausage, shank, sirloin, tenderloin, or a comparable word or phrase the department adopts by rule.
(e) Meat processing means the handling, preparation, and slaughter of an agricultural food animal; the dressing of its carcass; or the cutting, storage, and packaging of its tissue or other parts as food.
(f) Meat product means food derived from meat processing.
(g) (I) Misbranded as a meat product means that cell-cultivated meat or a food containing cell-cultivated meat:
(A) Is sold or offered for sale by a food processing plant; and
(B) Bears a label that includes an identifying meat term.
(II) Notwithstanding subsection (1)(g)(I) of this section, cell-cultivated meat or a food containing cell-cultivated meat is not misbranded as a meat product if:
(A) The label includes a conspicuous and prominent qualifying term in close proximity to the identifying meat term; or
(B) The product contains no more than a trace amount of cell-cultivated meat, as determined by the department.
(h) Qualifying term means a word, compound word, or phrase that would clearly disclose to a reasonable purchaser of meat products from a food processing plant that a food is not a meat product. Qualifying term includes cell-cultivated, cell-cultured, grown in a lab, imitation, lab-created, lab-grown, meat free, meatless, and a comparable word or phrase adopted by the department by rule.
(2) A food processing plant shall not sell or offer for sale cell-cultivated meat that is misbranded as a meat product.
(3) A food processing plant that sells or offers for sale cell-cultivated meat shall ensure that each unit of the cell-cultivated meat bears a label that describes the product as cell-cultivated meat in clear, legible type.
(4) The department shall inspect an inventory of food offered for sale or sold at a food processing plant pursuant to section 25-5-421 if the department has reasonable cause to believe that:
(a) Cell-cultivated meat sold or offered for sale by the food processing plant is misbranded as a meat product; or
(b) The food processing plant is failing to label cell-cultivated meat as required by subsection (3) of this section.
(5) (a) If, after an inspection, the department has reasonable cause to believe that a food processing plant is selling or offering for sale cell-cultivated meat that is misbranded as a meat product, or is failing to label cell-cultivated meat as cell-cultivated meat, the department may issue a stop order. After receiving the stop order, the food processing plant shall not sell the product or offer it for sale until the department determines whether the food is misbranded as a meat product or improperly unlabeled. The department may require the food processing plant to hold the product and secure it from purchase.
(b) If the department determines that cell-cultivated meat sold or offered for sale by a food processing plant is misbranded as a meat product, or that a food processing plant has failed to label cell-cultivated meat as required by subsection (3) of this section, the department may issue an embargo order requiring the food processing plant to dispose of the cell-cultivated meat by means other than by sale to purchasers in Colorado.
(c) The department, the attorney general, or the district attorney in the district where cell-cultivated meat is being offered for sale or sold may petition the district court to enforce a stop order issued pursuant to subsection (5)(a) of this section or an embargo order issued pursuant to subsection (5)(b) of this section.
(6) The department may adopt rules as necessary to implement this section.
Source: L. 2025: Entire section added, (HB 25-1203), ch. 83, p. 344, � 3, effective August 6.
Editor's note: Section 4(2) of chapter 83 (HB 25-1203), Session Laws of Colorado 2025, provides that the act adding this section applies to food labeled or packaged on or after August 6, 2025.
Cross references: For the legislative declaration in HB 25-1203, see section 1 of chapter 83, Session Laws of Colorado 2025.