Certificate of Analysis

Certificate of analysis2019 Minnesota Statutes


Subdivision 1.Definitions.

 (a) For the purposes of this section, the following terms have the meanings given.

(b) "Hemp" has the meaning given to "industrial hemp" in section 18K.02, subdivision 3.

(c) "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; or

(2) provided, in any manner, with the immediate container, including but not limited to outer containers, wrappers, package inserts, brochures, or pamphlets.

Subd. 2.Scope.

 (a) This section applies to the sale of any product that contains nonintoxicating cannabinoids extracted from hemp other than food that 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.

Subd. 3.Sale of cannabinoids derived from hemp.

 Notwithstanding any other section of this chapter, a product containing nonintoxicating cannabinoids may be sold for human or animal consumption if all of the requirements of this section are met.

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 pesticides, fertilizers, or heavy metals; and

(3) does not contain a delta-9 tetrahydrocannabinol concentration that exceeds the concentration permitted for industrial hemp as defined in section 18K.02, subdivision 3.

(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.

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;

(3) an accurate statement of the amount or percentage of cannabinoids found in each unit of the product meant to be consumed; and

(4) a statement stating that this 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.

(b) The information required to be on the label must be prominently and conspicuously placed and in terms that can be easily read and understood by the consumer.

(c) The label 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. 6.Enforcement.

 (a) A product sold under this section 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 color additives or excipients that have been found by the FDA to be unsafe for human or animal consumption; or

(5) it contains an amount or percentage of cannabinoids that is different than the amount or percentage stated on the label.

(b) A product sold 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