Subdivision 1. Definitions. (a) For the purposes of this section, the following terms have the meanings given.
(b) "Certified hemp" means hemp plants that have been tested and found to meet the requirements of chapter 18K and the rules adopted thereunder.
(c) "Edible cannabinoid product" means any product that is intended to be eaten or consumed as a beverage by humans, contains a cannabinoid in combination with food ingredients, and is not a drug.
(d) "Hemp" has the meaning given to "industrial hemp" in section 18K.02, subdivision 3.
(e) "Label" has the meaning given in section 151.01, subdivision 18.
(f) "Labeling" means all labels and other written, printed, or graphic matter that are:
(1) affixed to the immediate container in which a product regulated under this section is sold;
(2) provided, in any manner, with the immediate container, including but not limited to outer containers, wrappers, package inserts, brochures, or pamphlets; or
(3) provided on that portion of a manufacturer's website that is linked by a scannable barcode or matrix barcode.
(g) "Matrix barcode" means a code that stores data in a two-dimensional array of geometrically shaped dark and light cells capable of being read by the camera on a smartphone or other mobile device.
(h) "Nonintoxicating cannabinoid" means substances extracted from certified hemp plants that do not produce intoxicating effects when consumed by any route of administration.
Subd. 2. Scope. (a) This section applies to the sale of any product that contains cannabinoids extracted from hemp and that is an edible cannabinoid product or is intended for human or animal consumption by any route of administration.
(b) This section does not apply to any product dispensed by a registered medical cannabis manufacturer pursuant to sections 152.22 to 152.37.
(c) The board must have no authority over food products, as defined in section 34A.01, subdivision 4, that do not contain cannabinoids extracted or derived from hemp.
Subd. 3. Sale of cannabinoids derived from hemp. (a) Notwithstanding any other section of this chapter, a product containing nonintoxicating cannabinoids, including an edible cannabinoid product, may be sold for human or animal consumption only if all of the requirements of this section are met, provided that a product sold for human or animal consumption does not contain more than 0.3 percent of any tetrahydrocannabinol and an edible cannabinoid product does not contain an amount of any tetrahydrocannabinol that exceeds the limits established in subdivision 5a, paragraph (f).
(b) No other substance extracted or otherwise derived from hemp may be sold for human consumption if the substance is intended:
(1) for external or internal use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or
(2) to affect the structure or any function of the bodies of humans or other animals.
(c) No product containing any cannabinoid or tetrahydrocannabinol extracted or otherwise derived from hemp may be sold to any individual who is under the age of 21.
(d) Products that meet the requirements of this section are not controlled substances under section 152.02.
Subd. 4. Testing requirements. (a) A manufacturer of a product regulated under this section must submit representative samples of the product to an independent, accredited laboratory in order to certify that the product complies with the standards adopted by the board. Testing must be consistent with generally accepted industry standards for herbal and botanical substances, and, at a minimum, the testing must confirm that the product:
(1) contains the amount or percentage of cannabinoids that is stated on the label of the product;
(2) does not contain more than trace amounts of any mold, residual solvents, pesticides, fertilizers, or heavy metals; and
(3) does not contain more than 0.3 percent of any tetrahydrocannabinol.
(b) Upon the request of the board, the manufacturer of the product must provide the board with the results of the testing required in this section.
(c) Testing of the hemp from which the nonintoxicating cannabinoid was derived, or possession of a certificate of analysis for such hemp, does not meet the testing requirements of this section.
Subd. 5. Labeling requirements. (a) A product regulated under this section must bear a label that contains, at a minimum:
(1) the name, location, contact phone number, and website of the manufacturer of the product;
(2) the name and address of the independent, accredited laboratory used by the manufacturer to test the product; and
(3) an accurate statement of the amount or percentage of cannabinoids found in each unit of the product meant to be consumed.
(b) The information in paragraph (a) may be provided on an outer package if the immediate container that holds the product is too small to contain all of the information.
(c) The information required in paragraph (a) may be provided through the use of a scannable barcode or matrix barcode that links to a page on the manufacturer's website if that page contains all of the information required by this subdivision.
(d) The label must also include a statement stating that the product does not claim to diagnose, treat, cure, or prevent any disease and has not been evaluated or approved by the United States Food and Drug Administration (FDA) unless the product has been so approved.
(e) The information required by this subdivision must be prominently and conspicuously placed on the label or displayed on the website in terms that can be easily read and understood by the consumer.
(f) The labeling must not contain any claim that the product may be used or is effective for the prevention, treatment, or cure of a disease or that it may be used to alter the structure or function of human or animal bodies, unless the claim has been approved by the FDA.
Subd. 5a. Additional requirements for edible cannabinoid products. (a) In addition to the testing and labeling requirements under subdivisions 4 and 5, an edible cannabinoid must meet the requirements of this subdivision.
(b) An edible cannabinoid product must not:
(1) bear the likeness or contain cartoon-like characteristics of a real or fictional person, animal, or fruit that appeals to children;
(2) be modeled after a brand of products primarily consumed by or marketed to children;
(3) be made by applying an extracted or concentrated hemp-derived cannabinoid to a commercially available candy or snack food item;
(4) contain an ingredient, other than a hemp-derived cannabinoid, that is not approved by the United States Food and Drug Administration for use in food;
(5) be packaged in a way that resembles the trademarked, characteristic, or product-specialized packaging of any commercially available food product; or
(6) be packaged in a container that includes a statement, artwork, or design that could reasonably mislead any person to believe that the package contains anything other than an edible cannabinoid product.
(c) An edible cannabinoid product must be prepackaged in packaging or a container that is child-resistant, tamper-evident, and opaque or placed in packaging or a container that is child-resistant, tamper-evident, and opaque at the final point of sale to a customer. The requirement that packaging be child-resistant does not apply to an edible cannabinoid product that is intended to be consumed as a beverage and which contains no more than a trace amount of any tetrahydrocannabinol.
(d) If an edible cannabinoid product is intended for more than a single use or contains multiple servings, each serving must be indicated by scoring, wrapping, or other indicators designating the individual serving size.
(e) A label containing at least the following information must be affixed to the packaging or container of all edible cannabinoid products sold to consumers:
(1) the serving size;
(2) the cannabinoid profile per serving and in total;
(3) a list of ingredients, including identification of any major food allergens declared by name; and
(4) the following statement: "Keep this product out of reach of children."
(f) An edible cannabinoid product must not contain more than five milligrams of any tetrahydrocannabinol in a single serving, or more than a total of 50 milligrams of any tetrahydrocannabinol per package.
Subd. 6. Enforcement. (a) A product regulated under this section, including an edible cannabinoid product, shall be considered an adulterated drug if:
(1) it consists, in whole or in part, of any filthy, putrid, or decomposed substance;
(2) it has been produced, prepared, packed, or held under unsanitary conditions where it may have been rendered injurious to health, or where it may have been contaminated with filth;
(3) its container is composed, in whole or in part, of any poisonous or deleterious substance that may render the contents injurious to health;
(4) it contains any food additives, color additives, or excipients that have been found by the FDA to be unsafe for human or animal consumption;
(5) it contains an amount or percentage of nonintoxicating cannabinoids that is different than the amount or percentage stated on the label;
(6) it contains more than 0.3 percent of any tetrahydrocannabinol or, if the product is an edible cannabinoid product, an amount of tetrahydrocannabinol that exceeds the limits established in subdivision 5a, paragraph (f); or
(7) it contains more than trace amounts of mold, residual solvents, pesticides, fertilizers, or heavy metals.
(b) A product regulated under this section shall be considered a misbranded drug if the product's labeling is false or misleading in any manner or in violation of the requirements of this section.
(c) The board's authority to issue cease and desist orders under section 151.06; to embargo adulterated and misbranded drugs under section 151.38; and to seek injunctive relief under section 214.11, extends to any violation of this section.
1Sp2019 c 9 art 11 s 76; 2021 c 30 art 3 s 27; 2022 c 98 art 13 s 3-9
Structure Minnesota Statutes
Chapter 151 — Pharmacy Practice And Wholesale Distribution Act
Section 151.02 — State Board Of Pharmacy.
Section 151.04 — Recommended Names.
Section 151.05 — Election Of Officers.
Section 151.06 — Powers And Duties.
Section 151.061 — Unfair Price Discrimination.
Section 151.065 — Fee Amounts.
Section 151.066 — Opiate Product Registration Fee.
Section 151.07 — Meetings; Examination Fee.
Section 151.071 — Disciplinary Action.
Section 151.072 — Reporting Obligations.
Section 151.074 — Licensee Or Registrant Cooperation.
Section 151.075 — Disciplinary Record On Judicial Review.
Section 151.095 — Inactive Status License.
Section 151.10 — Qualifications Of Applicants.
Section 151.102 — Pharmacy Technician.
Section 151.12 — Reciprocity; Licensure.
Section 151.13 — Renewal Fee; Continuing Education.
Section 151.14 — Reinstatements.
Section 151.15 — Compounding Drugs Unlawful Under Certain Conditions.
Section 151.16 — Violation A Gross Misdemeanor.
Section 151.17 — Unlawful Use Of "pharmacist."
Section 151.18 — Unlawful To Use Misleading Name.
Section 151.19 — Registration; Fees.
Section 151.191 — Licensing Medical Gas Facilities; Fees; Prohibitions.
Section 151.21 — Substitution.
Section 151.211 — Records Of Prescriptions.
Section 151.212 — Label Of Prescription Drug Containers.
Section 151.213 — Copies Of Prescriptions.
Section 151.214 — Payment Disclosure.
Section 151.215 — Certification.
Section 151.22 — Liability For Quality Of Drugs.
Section 151.23 — Poisons Must Be Labeled.
Section 151.24 — Sale Of Poisons Must Be Recorded.
Section 151.252 — Licensing Of Drug Manufacturers; Fees; Prohibitions.
Section 151.253 — Compounding.
Section 151.29 — Violation A Misdemeanor.
Section 151.30 — County Attorney To Prosecute.
Section 151.301 — Reports To Commissioner Of Health.
Section 151.33 — Careless Distribution Of Drugs.
Section 151.335 — Delivery Through Common Carrier; Compliance With Temperature Requirements.
Section 151.34 — Prohibited Acts.
Section 151.35 — Drugs, Adulteration.
Section 151.36 — Drugs, Misbranding.
Section 151.361 — Manufacturer Disclosure.
Section 151.37 — Legend Drugs; Who May Prescribe, Possess.
Section 151.375 — Investigational Drug Use.
Section 151.39 — Distressed Drugs.
Section 151.40 — Possession And Sale Of Hypodermic Syringes And Needles.
Section 151.415 — Long-term Care Resident Access To Pharmaceuticals Act.
Section 151.441 — Definitions.
Section 151.46 — Prohibited Drug Purchases Or Receipt.
Section 151.461 — Gifts To Practitioners Prohibited.
Section 151.47 — Wholesale Drug Distributor Licensing Requirements.
Section 151.471 — Third-party Logistics Provider Requirements.
Section 151.555 — Prescription Drug Repository Program.
Section 151.56 — County Return Of Unused Drugs Or Medical Devices.
Section 151.58 — Automated Drug Distribution Systems.