Senate Floor Amendment

sch2414a-2 sch2414a-2

1.1Senator Bigham moved to amend H.F. No. 2414, as amended pursuant to Rule 45,
1.2adopted by the Senate April 29, 2019, as follows:
1.3(The text of the amended House File is identical to S.F. No. 2452.)
1.4Page 325, after line 12, insert:

1.6    Subdivision 1. Definitions. (a) For the purposes of this subdivision, the following terms
1.7have the meanings given.
1.8(b) "Hemp" has the meaning given to "industrial hemp" in section 18K.02, subdivision
1.10(c) "Labeling" means all labels and other written, printed, or graphic matter that are:
1.11(1) affixed to the immediate container in which a product regulated under this section
1.12is sold; or
1.13(2) provided, in any manner, with the immediate container, including but not limited to
1.14outer containers, wrappers, package inserts, brochures, or pamphlets.
1.15    Subd. 2. Sale of cannabinoids derived from hemp. (a) This section applies to the sale
1.16of any products, other than food, intended for human or animal consumption by any route
1.17of administration, that contain cannabinoids extracted from hemp. This section does not
1.18apply to any products dispensed by a registered medical cannabis manufacturer pursuant
1.19to sections 152.22 to 125.37.
1.20(b) Notwithstanding any other section of this chapter, a product containing cannabinoids
1.21may be sold for human or animal consumption if all of the requirements of this section are
1.23(c) A product regulated under this section must be tested by an independent, accredited,
1.24third-party analytical laboratory to confirm that the product:
1.25(1) contains the amount or percentage of cannabidiol that is stated on the label of the
1.27(2) does not contain more than trace amounts of any pesticides, fertilizers, or heavy
1.28metals; and
1.29(3) does not contain tetrahydrocannabinol that exceeds the concentration permitted for
1.30industrial hemp as defined in section 18K.02, subdivision 3.
1.31(d) A product regulated under this section must bear a label that contains, at a minimum:
2.1(1) the name, location, contact phone number, and website of the manufacturer of the
2.3(2) the name and address of the independent, accredited third-party analytical laboratory
2.4that has tested the product;
2.5(3) an accurate statement of the amount or percentage of cannabidiol found in each unit
2.6of the product meant to be consumed; and
2.7(4) the statement "This product has not been approved by the U.S. Food and Drug
2.8Administration for the prevention, treatment, or cure of any disease, or to alter the structure
2.9or function of human or animal bodies, or for use as a dietary supplement," unless the
2.10product has been so approved.
2.11(e) A product sold under this section is considered an adulterated drug if:
2.12(1) it consists, in whole or in part, of any filthy, putrid, or decomposed substance;
2.13(2) it has been produced, prepared, packed, or held under unsanitary conditions where
2.14it may have been rendered injurious to health, or where it may have been contaminated with
2.16(3) its container is composed, in whole or in part, of any poisonous or deleterious
2.17substance that may render the contents injurious to health;
2.18(4) it contains any color additives or excipients that have been found by the United States
2.19Food and Drug Administration to be unsafe for human or animal consumption; or
2.20(5) it contains an amount or percentage of cannabidiol that is different than the amount
2.21or percentage stated on the label.
2.22(f) A product sold under this section is a misbranded drug if:
2.23(1) its labeling is false or misleading in any manner;
2.24(2) any word, statement, or other information required by this section to appear on the
2.25labeling is not prominently placed on the labeling with such conspicuousness, as compared
2.26with other words, statements, designs, or devices, in the labeling, and in such terms as to
2.27render it to be read and understood by the ordinary individual under customary conditions
2.28of purchase and use; or
2.29(3) its labeling makes any claim that the product may be used or is effective for the
2.30prevention, treatment, or cure of a disease or that it may be used to alter the structure or
2.31function of human or animal bodies, unless the claim has been approved by the United
2.32States Food and Drug Administration.
3.1(g) No person who sells a product regulated under this section may make a false,
3.2misleading, or unsubstantiated claim concerning the health benefits of the product.
3.3(h) The authority of the Board of Pharmacy to issue cease and desist orders under section
3.4151.06, to embargo misbranded and adulterated drugs under section 151.38, and to seek
3.5injunctive relief under section 214.11, extends to violations of this section."
3.6Renumber the sections in sequence and correct the internal references
3.7Amend the title accordingly
3.8The motion prevailed. #did not prevail. So the amendment was #not adopted.