Florida Senate - 2021 SB 1978 By Senator Powell 30-01251-21 20211978__ Page 1 of 4 CODING: Words stricken are deletions; words underlined are additions. A bill to be entitled 1

An act relating to the Florida Kratom Consumer 2 Protection Act; creating s. 501.9745, F.S.; providing 3 a

short title; defining the terms “department,” 4 “kratom product,” and “processor”; requiring a 5 processor to register with the Department of 6 Agricultural and Consumer Services to sell kratom 7 products at retail; prohibiting processors from 8 selling certain kratom products; prohibiting 9 processors from distributing, selling, or exposing for 10 sale a kratom product to an individual under 21 years 11 of age; providing civil penalties; providing an 12 exception; requiring the department to adopt rules; 13 providing an effective date. 14 15 Be It Enacted by the Legislature of the State of Florida: 16 17

Section

Section 501.9745, Florida Statutes, is created 18 to read: 19 501.9745 Florida Kratom Consumer Protection Act.— 20

(1) This

section may be cited as the “Florida Kratom 21 Consumer Protection Act.” 22

(2) As used in this section, the term: 23 (a) ”Department” means the Department of Agricultural and 24 Consumer Services. 25 (b) ”Kratom product” means a food product, food ingredient, 26 dietary ingredient, dietary supplement, or beverage that is 27 intended for human consumption, that contains any part of the 28 leaf of the plant Mitragyna speciosa or an extract of such 29 Florida Senate - 2021 SB 1978 30-01251-21 20211978__ Page 2 of 4 CODING: Words stricken are deletions; words underlined are additions. plant, and that is manufactured as a powder, capsule, pill, 30 beverage, or other edible form. 31 (c) “Processor” means a person that sells, prepares, 32 manufactures, distributes, or maintains kratom products. 33

(3) A processor must be registered with the department to 34 sell kratom products at retail. 35

(4) A processor may not sell, prepare, distribute, or 36 expose for sale a kratom product that: 37 (

a) Is adulterated with a dangerous non-kratom substance 38 that affects the quality or strength of the kratom product to 39 such a degree that it may injure a consumer. 40 (

b) Contains a poisonous or otherwise harmful non-kratom 41 ingredient, including, but not limited to, any substance listed 42 in s. 893.03. 43 (

c) Contains a level of 7-hydroxymitragynine in the 44 alkaloid fraction which is greater than 2 percent of the 45 alkaloid composition of the product. 46 (

d) Contains a synthetic alkaloid, including, but not 47 limited to, synthetic mitragynine, synthetic 7-48 hydroxymitragynine, or any other synthetically derived compound 49 of the kratom plant. 50 (

e) Does not include directions for the safe and effective 51 use of the product, including, but not limited to, a suggested 52 serving size, on the product’s packaging or label. 53 (

f) Has a label that contains any claim that the product is 54 intended to diagnose, treat, cure, or prevent any medical 55 condition or disease. 56

(5) A processor may not distribute, sell, or expose for 57 sale a kratom product to an individual under 21 years of age. 58 Florida Senate - 2021 SB 1978 30-01251-21 20211978__ Page 3 of 4 CODING: Words stricken are deletions; words underlined are additions.

(6) A processor that violates subsection (4) is subject to 59 an administrative fine of not more than $500 for the first 60 offense and not more than $1,000 for the second or subsequent 61 offense. A processor selling kratom products at retail does not 62 violate subsection (4) if it is shown by a preponderance of the 63 evidence that the processor relied in good faith upon the 64 representations of a manufacturer, processor, packer, or 65 distributor of a kratom product. 66

(7) The department shall adopt rules for the administration 67 and enforcement of this act, including, but not limited to, 68 rules that: 69 (

a) Establish a procedure for a processor to register with 70 the department to sell kratom products at retail; and 71 (

b) Require processors to provide the department, upon 72 request, with information for each kratom product that the 73 processor sells, prepares, manufactures, distributes, or 74 maintains, including, but not limited to: 75 1. The name and address of the processor and the name and 76 address of the person whose name appears on the label, if other 77 than the processor; 78 2. The names of each kratom product included in the 79 registration; 80 3. The type of kratom product and the product’s recommended 81 usage, including directions for use and the recommended serving 82 size; 83 4.

The recommended method of consumption for the kratom 84 product; 85 5. The weights or volumes, as appropriate, of the kratom 86 products for sale; 87 Florida Senate - 2021 SB 1978 30-01251-21 20211978__ Page 4 of 4 CODING: Words stricken are deletions; words underlined are additions. 6. A copy of the kratom product’s label; 88 7. A written certification that the kratom product complies 89 with subsection (4); and 90 8.

A certificate of analysis for the kratom product from an 91 independent third-party laboratory that is accredited as a 92 competent testing laboratory pursuant to ISO/IEC 17025:2017 of 93 the International Organization for Standardization. 94

Section 2. This act shall take effect July 1, 2021. 95