Florida Senate - 2023 CS for CS for SB 136 By the Appropriations Committee on Agriculture, Environment, and General Government; the Committee on Commerce and Tourism; and Senators Gruters, Stewart, and Perry 601-03765-23 2023136c2 1 A bill to be entitled 2 An act relating to the Florida Kratom Consumer 3 Protection Act; creating s. 501.9745, F.S.; providing 4 a short title; defining terms; prohibiting processors 5 from selling, preparing, distributing, or exposing for 6 sale certain kratom products; prohibiting processors 7 from distributing, selling, or exposing for sale a 8 kratom product to an individual under 21 years of age; 9 requiring processors to annually register kratom 10 products with the Department of Agriculture and 11 Consumer Services; providing requirements for such 12 registration; requiring processors to report certain 13 violations and adverse events to the department; 14 providing for the revocation of a processor’s kratom 15 product registration under certain circumstances; 16 providing criminal penalties; providing an exception; 17 requiring the department to adopt rules; providing an 18 effective date. 19 20 Be It Enacted by the Legislature of the State of Florida: 21 22 Section 1. Section 501.9745, Florida Statutes, is created 23 to read: 24 501.9745 Kratom products; processor prohibitions; 25 registration; fines.— 26 (1) SHORT TITLE.—This section may be cited as the “Florida 27 Kratom Consumer Protection Act.” 28 (2) DEFINITIONS.—As used in this section, the term: 29 (a) “Kratom extract” means a food product or dietary 30 ingredient that contains any part of the leaf of the plant 31 Mitragyna speciosa which has been extracted and concentrated to 32 provide more standardized dosing. 33 (b) “Kratom product” means a food product, food ingredient, 34 dietary ingredient, dietary supplement, or beverage intended for 35 human consumption which contains any part of the leaf of the 36 plant Mitragyna speciosa or an extract of such plant and is 37 manufactured as a powder, capsule, pill, or beverage or any 38 other edible form. 39 (c) “Processor” means a person who sells, prepares, 40 manufactures, distributes, or maintains kratom products. 41 (3) PROHIBITIONS.— 42 (a) A processor may not sell, prepare, distribute, or 43 expose for sale: 44 1. A kratom product that: 45 a. Is adulterated with a dangerous non-kratom substance 46 that affects the quality or strength of the kratom product to 47 such a degree that it may injure a consumer. 48 b. Contains a poisonous or otherwise harmful non-kratom 49 ingredient, including, but not limited to, any substance listed 50 in s. 893.03. 51 c. Contains a level of 7-hydroxymitragynine in the alkaloid 52 fraction which is greater than 1 percent of the alkaloid 53 composition of the product. 54 d. Contains a synthetic alkaloid, including, but not 55 limited to, synthetic mitragynine, synthetic 7 56 hydroxymitragynine, or any other synthetically derived compound 57 of the plant Mitragyna speciosa. 58 e. Does not include directions for the safe and effective 59 use of the product, including, but not limited to, a suggested 60 serving size, on the product’s packaging or label. 61 f. Has a label that contains any claim that the product is 62 intended to diagnose, treat, cure, or prevent any medical 63 condition or disease. 64 2. Kratom extract that contains levels of residual solvents 65 higher than the standards set forth in USP-NF chapter 467. 66 (b) A processor may not sell, distribute, or expose for 67 sale a kratom product to an individual under 21 years of age. 68 (4) REGISTRATION.—A processor shall annually register with 69 the department any kratom product it intendeds to offer for sale 70 to an end consumer in this state which is in an approved kratom 71 delivery form. The registration must include a certificate of 72 analysis from an independent certified third-party laboratory 73 which shows that the kratom product is in compliance with the 74 requirements of this section for safe kratom products. 75 (5) REPORTING REQUIREMENTS.— 76 (a) If the department receives a report that any kratom 77 product offered for sale in this state is not in compliance with 78 the requirements of this section for safe kratom products, the 79 department must require the processor to produce an updated 80 certificate of analysis in a reasonable timeframe from an 81 independent certified third-party laboratory which shows that 82 the kratom product is in compliance with the requirements of 83 this section for safe kratom products. 84 (b) If a processor receives notice of an adverse event 85 related to its kratom product, the processor must submit via 86 certified mail to the department a copy of the adverse event 87 report required to be submitted to the United States Food and 88 Drug Administration under the Federal Food, Drug, and Cosmetic 89 Act, 21 U.S.C. s. 379aa-1(b)(1). 90 (c) If a processor fails to provide the department with an 91 updated certificate of analysis within the specified timeframe 92 or fails to report an adverse event to the department as 93 required by this subsection, the department may revoke the 94 processor’s kratom product registration. 95 (6) VIOLATIONS.— 96 (a) A person who violates this section commits a 97 misdemeanor of the second degree, punishable as provided in s. 98 775.082 or s. 775.083. 99 (b) A processor that sells kratom products at retail does 100 not violate this section if it is shown by a preponderance of 101 the evidence that the processor relied in good faith upon the 102 representations of a manufacturer, processor, packer, or 103 distributor of food represented to be a kratom product. 104 (7) RULES.—The department shall adopt rules to administer 105 this section. 106 Section 2. This act shall take effect July 1, 2023.