Florida Senate - 2023 COMMITTEE AMENDMENT
Bill No. SB 136
Ì1966527Î196652
LEGISLATIVE ACTION
Senate . House
Comm: RCS .
03/07/2023 .
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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.