Florida Senate - 2025 COMMITTEE AMENDMENT
Bill No. SB 1734
Ì406210_Î406210
LEGISLATIVE ACTION
Senate . House
Comm: RS .
03/25/2025 .
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The Committee on Commerce and Tourism (Collins) recommended the
following:
1 Senate Amendment (with title amendment)
2
3 Delete lines 77 - 189
4 and insert:
5 Mitragyna speciosa in any form.
6 (d) “Kratom beverage” means a prepackaged liquid kratom
7 product in the form of a tea, seltzer or tonic water, or
8 tincture.
9 (e) “Kratom food service establishment” means any public
10 food service establishment licensed as provided in chapter 509
11 which sells finished kratom products.
12 (f) “Kratom product” means a food product, food ingredient,
13 dietary ingredient, dietary supplement, or beverage intended for
14 human consumption which contains any part of the leaf of the
15 plant Mitragyna speciosa or an extract, synthetic alkaloid, or
16 synthetically derived compound of such plant and is manufactured
17 as a powder, capsule, pill, beverage, or other consumable edible
18 form.
19 (g) “Processor” means a person who manufactures, delivers,
20 offers for sale, distributes, or sells kratom products.
21 (3) PRODUCT REQUIREMENTS.—A processor may not manufacture,
22 deliver, offer for sale, distribute, or sell a finished kratom
23 product that:
24 (a) Is not one of the following approved delivery forms:
25 1. Dried leaf;
26 2. Kratom beverage;
27 3. Powder;
28 4. Pill;
29 5. Liquid dietary supplement;
30 6. Gummy or food that are not attractive to children; or
31 7. Capsule.
32 (b) Contains or is adulterated with synthesized or semi
33 synthesized kratom alkaloids or kratom constituents.
34 (c) Contains a level of 7-hydroxymitragynine in the
35 alkaloid fraction which is greater than 2 percent of the
36 alkaloid composition of the kratom product.
37 (d) Is not registered with the department pursuant to this
38 section.
39 (e) Does not have a certificate of analysis submitted to
40 the department as required by this section.
41 (f) Does not include directions for consumption of the
42 kratom product on the product’s label, including, but not
43 limited to:
44 1. Maximum dosage of 40 milligrams of mitragynine per
45 serving;
46 2. Number of servings per package;
47 3. Milligrams of 7-hydroxymitragynine and mitragynine per
48 serving;
49 4. A warning advising consumers of the number of servings
50 that may be safely consumed in a 24-hour period;
51 5. A warning prohibiting use by individuals who are under
52 21 years of age;
53 6. A warning advising against use by individuals who are
54 pregnant or breastfeeding;
55 7. A warning advising the consumer to consult a health care
56 professional before use, that the product may be habit-forming,
57 and that it may cause adverse health effects;
58 8. A warning stating the following: “These statements have
59 not been evaluated by the United States Food and Drug
60 Administration. This product is not intended to diagnose, treat,
61 cure, or prevent any disease.”;
62 9. The expiration date; and
63 10. The name and place of business of the registrant.
64 (g) Does not comply with the packaging and labeling
65 requirements set forth in this chapter and the rules adopted
66 pursuant thereto. Such kratom products are considered
67 misbranded.
68 (h) Is extracted using solvents other than water or Class 3
69 solvents set forth in USP-NF chapter 467.
70 (i) Contains levels of Class 3 solvents greater than the
71 limits set forth in USP-NF chapter 467.
72 (j) Is attractive to children.
73 (k) Is in a container that:
74 1. Is not suitable to contain products for human
75 consumption; or
76 2. Is not compliant with the United States Poison
77 Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
78 3. Does not contain a graduated measuring device, if
79 applicable.
80 (l) Is adulterated, including containing metals,
81 pesticides, or pathogens in excess of the limits set by this
82 section or department rule.
83 (4)(3) AGE RESTRICTION.—It is unlawful to sell, deliver,
84 barter, furnish, or give, directly or indirectly, any kratom
85 product to a person who is under 21 years of age.
86 (5) PERMIT AND FEDERAL REGISTRATION REQUIREMENTS FOR
87 PROCESSORS.—
88 (a) Kratom products may only be manufactured by, delivered
89 to, offered for sale by, distributed by, or sold by a processor
90 who holds a permit to operate as a food establishment as defined
91 in s. 500.03 or a convenience store or kava or kratom bar that
92 does not prepare, serve, or sell other food products besides
93 kratom products is not considered cottage food operations. A
94 processor may not operate as a cottage food operation pursuant
95 to s. 500.80 and is not exempt from food permit requirements
96 pursuant to s. 500.12(1)(a)1.
97 (b) A processor that manufactures, processes, packs, or
98 offers for sale kratom, kratom products, or finished kratom
99 products must be properly registered with the United States Food
100 and Drug Administration. Processors exclusively selling finished
101 kratom products at retail are not required to register with the
102 United States Food and Drug Administration.
103 (6) REGISTRATION.—
104 (a) A processor shall certify by sworn statement that any
105 finished kratom product it manufactures, delivers, offers for
106 sale, distributes, or sells in this state is registered with the
107 department and does not contain dangerous or harmful substances,
108 including, but not limited to, red-OH, synthetic 7-OH, synthetic
109 7-hydroxymitragynine, synthetic mitragynine, pseudoindoxyl,
110 super alkaloid, or any other synthetically derived compounds,
111 synthetic alkaloids, or controlled substances. Such registration
112 must be renewed annually.
113 (b) A processor shall assume all responsibility and
114 liability for its kratom, kratom product, or finished kratom
115 product.
116 (c) For each batch of a registered finished kratom product,
117 the processor shall retain and submit, upon request, a
118 certificate of analysis to the department from an accredited
119 laboratory affiliated with a university based in Florida. The
120 laboratory must be accredited under the International
121 Organization for Standardization (ISO)/International
122 Electrotechnical Commission (IEC) 17025:2017 General
123 Requirements for Competence of Testing and Calibration
124 Laboratories standard by an accreditation body that is a
125 signatory to the International Laboratory Accreditation
126 Cooperation Mutual Recognition Arrangement or a subsequent
127 arrangement. The processor may
128
129 ================= T I T L E A M E N D M E N T ================
130 And the title is amended as follows:
131 Delete line 20
132 and insert:
133 processor of a finished kratom product to retain and
134 submit a