Florida Senate - 2023 COMMITTEE AMENDMENT Bill No. SB 136 Ì1966527Î196652 LEGISLATIVE ACTION Senate . House . . . . . ————————————————————————————————————————————————————————————————— ————————————————————————————————————————————————————————————————— The Committee on Commerce and Tourism (Gruters) recommended the following: 1 Senate Amendment (with title amendment) 2 3 Delete everything after the enacting clause 4 and insert: 5 Section 1. Section 501.9745, Florida Statutes, is created 6 to read: 7 501.9745 Kratom products; processor prohibitions; 8 registration; fines.— 9 (1) SHORT TITLE.—This section may be cited as the “Florida 10 Kratom Consumer Protection Act.” 11 (2) DEFINITIONS.—As used in this section, the term: 12 (a) “Kratom extract” means a food product or dietary 13 ingredient that contains any part of the leaf of the plant 14 Mitragyna speciosa which has been extracted and concentrated to 15 provide more standardized dosing. 16 (b) “Kratom product” means a food product, food ingredient, 17 dietary ingredient, dietary supplement, or beverage intended for 18 human consumption which contains any part of the leaf of the 19 plant Mitragyna speciosa or an extract of such plant and is 20 manufactured as a powder, capsule, pill, or beverage or any 21 other edible form. 22 (c) “Processor” means a person who sells, prepares, 23 manufactures, distributes, or maintains kratom products. 24 (3) PROHIBITIONS.— 25 (a) A processor may not sell, prepare, distribute, or 26 expose for sale: 27 1. A kratom product that: 28 a. Is adulterated with a dangerous non-kratom substance 29 that affects the quality or strength of the kratom product to 30 such a degree that it may injure a consumer. 31 b. Contains a poisonous or otherwise harmful non-kratom 32 ingredient, including, but not limited to, any substance listed 33 in s. 893.03. 34 c. Contains a level of 7-hydroxymitragynine in the alkaloid 35 fraction which is greater than 1 percent of the alkaloid 36 composition of the product. 37 d. Contains a synthetic alkaloid, including, but not 38 limited to, synthetic mitragynine, synthetic 7 39 hydroxymitragynine, or any other synthetically derived compound 40 of the plant Mitragyna speciosa. 41 e. Does not include directions for the safe and effective 42 use of the product, including, but not limited to, a suggested 43 serving size, on the product’s packaging or label. 44 f. Has a label that contains any claim that the product is 45 intended to diagnose, treat, cure, or prevent any medical 46 condition or disease. 47 2. Kratom extract that contains levels of residual solvents 48 higher than the standards set forth in USP-NF chapter 467. 49 (b) A processor may not sell, distribute, or expose for 50 sale a kratom product to an individual under 21 years of age. 51 (4) REGISTRATION.—A processor shall annually register with 52 the department any kratom product it intendeds to offer for sale 53 to an end consumer in this state which is in an approved kratom 54 delivery form. The registration must include a certificate of 55 analysis from an independent certified third-party laboratory 56 which shows that the kratom product is in compliance with the 57 requirements of this section for safe kratom products. 58 (5) REPORTING REQUIREMENTS.— 59 (a) If the department receives a report that any kratom 60 product offered for sale in this state is not in compliance with 61 the requirements of this section for safe kratom products, the 62 department must require the processor to produce an updated 63 certificate of analysis in a reasonable timeframe from an 64 independent certified third-party laboratory which shows that 65 the kratom product is in compliance with the requirements of 66 this section for safe kratom products. 67 (b) If a processor receives notice of an adverse event 68 related to its kratom product, the processor must submit via 69 certified mail to the department a copy of the adverse event 70 report required to be submitted to the United States Food and 71 Drug Administration under the Federal Food, Drug, and Cosmetic 72 Act, 21 U.S.C. s. 379aa-1(b)(1). 73 (c) If a processor fails to provide the department with an 74 updated certificate of analysis within the specified timeframe 75 or fails to report an adverse event to the department as 76 required by this subsection, the department may revoke the 77 processor’s kratom product registration. 78 (6) VIOLATIONS.— 79 (a) A processor who violates paragraph (3)(a), subsection 80 (4), or subsection (5) is subject to an administrative fine of 81 not more than $500 for the first offense and not more than 82 $1,000 for the second or subsequent offense. 83 (b) A processor that sells kratom products at retail does 84 not violate this section if it is shown by a preponderance of 85 the evidence that the processor relied in good faith upon the 86 representations of a manufacturer, processor, packer, or 87 distributor of food represented to be a kratom product. 88 (7) RULES.—The department shall adopt rules to administer 89 this section. 90 Section 2. This act shall take effect July 1, 2023. 91 92 ================= T I T L E A M E N D M E N T ================ 93 And the title is amended as follows: 94 Delete everything before the enacting clause 95 and insert: 96 A bill to be entitled 97 An act relating to the Florida Kratom Consumer 98 Protection Act; creating s. 501.9745, F.S.; providing 99 a short title; defining terms; prohibiting processors 100 from selling, preparing, distributing, or exposing for 101 sale certain kratom products; prohibiting processors 102 from distributing, selling, or exposing for sale a 103 kratom product to an individual under 21 years of age; 104 requiring processors to annually register kratom 105 products with the Department of Agriculture and 106 Consumer Services; providing requirements for such 107 registration; requiring processors to report certain 108 violations and adverse events to the department; 109 providing for the revocation of a processor’s kratom 110 product registration under certain circumstances; 111 providing civil penalties; providing an exception; 112 requiring the department to adopt rules; providing an 113 effective date.