Florida Senate - 2025 CS for SB 1734
By the Committee on Commerce and Tourism; and Senators Collins
and Calatayud
577-02803-25 20251734c1
1 A bill to be entitled
2 An act relating to the Florida Kratom Consumer
3 Protection Act; amending s. 500.92, F.S.; defining
4 terms; revising the definition of the term “kratom
5 product”; prohibiting processors from manufacturing,
6 delivering, offering for sale, distributing, or
7 selling finished kratom products that do not meet
8 specified requirements; requiring that kratom products
9 be manufactured by, delivered to, offered for sale by,
10 distributed by, or sold by a processor who holds a
11 certain permit; prohibiting specified operations;
12 prohibiting exemption from certain requirements;
13 requiring such processors to be registered with the
14 United States Food and Drug Administration; providing
15 an exception; requiring processors to make a certain
16 certification regarding their finished kratom
17 products; requiring a processor to assume
18 responsibility and liability for its kratom, kratom
19 product, and finished kratom product; requiring a
20 processor of a finished kratom product to retain and
21 submit a certificate of analysis from a certain
22 laboratory to the Department of Agriculture and
23 Consumer Services for each batch of finished kratom
24 product; specifying requirements for such laboratory;
25 prohibiting the processor from having any financial or
26 economic interest in such laboratory or the body
27 accrediting such laboratory; requiring the processor
28 to maintain its certificates of analysis for a
29 specified amount of time after the finished kratom
30 product’s expiration date; requiring that the
31 certificate of analysis demonstrate that the finished
32 kratom product is in compliance with statutory and
33 rule concentration limits for specified substances;
34 requiring that certain finished kratom products comply
35 with product registration and testing requirements;
36 providing an exception; prohibiting the serving of
37 kratom beverages combined with alcohol, drugs, or
38 other kratom products; requiring a processor or the
39 department to submit a certain report to the United
40 States Food and Drug Administration if a processor or
41 the department receives a certain notice; authorizing
42 the department to conduct an independent third-party
43 test of a kratom product if probable cause exists that
44 the product is adulterated; requiring the processor to
45 pay the testing cost; authorizing the department to
46 revoke the processor’s product registration if the
47 processor fails to pay for such test within a
48 specified timeframe; providing criminal penalties;
49 providing that certain kratom products are subject to
50 a stop-sale order; authorizing the department to
51 revoke a processor’s finished kratom product
52 registration under certain circumstances; providing
53 that a processor whose kratom product contains a
54 controlled substance or other prohibited substances is
55 in violation of this act; providing an administrative
56 fine; providing an appropriation; providing an
57 effective date.
58
59 Be It Enacted by the Legislature of the State of Florida:
60
61 Section 1. Section 500.92, Florida Statutes, is amended to
62 read:
63 500.92 Florida Kratom Consumer Protection Act.—
64 (1) SHORT TITLE.—This section may be cited as the “Florida
65 Kratom Consumer Protection Act.”
66 (2) DEFINITIONS.—As used in this section, the term:
67 (a) “Attractive to children” means a product manufactured:
68 1. In a shape that resembles a human, a cartoon character,
69 or an animal;
70 2. In a form that resembles an existing candy product that
71 is a widely distributed, branded food item; or
72 3. Using any color additives.
73 (b) “Finished kratom product” means a kratom product that
74 is ready for sale to the end user. For purposes of registration,
75 a finished kratom product is differentiated by its ingredients,
76 not by its weight, volume, or size.
77 (c) “Kratom” means the plant or any part of the plant
78 Mitragyna speciosa in any form.
79 (d) “Kratom beverage” means a prepackaged liquid kratom
80 product in the form of a tea, seltzer or tonic water, or
81 tincture.
82 (e) “Kratom food service establishment” means any public
83 food service establishment licensed as provided in chapter 509
84 which sells finished kratom products.
85 (f) “Kratom product” means a food product, food ingredient,
86 dietary ingredient, dietary supplement, or beverage intended for
87 human consumption which contains any part of the leaf of the
88 plant Mitragyna speciosa or an extract, synthetic alkaloid, or
89 synthetically derived compound of such plant and is manufactured
90 as a powder, capsule, pill, beverage, or other consumable edible
91 form.
92 (g) “Processor” means a person who manufactures, delivers,
93 offers for sale, distributes, or sells kratom products.
94 (3) PRODUCT REQUIREMENTS.—A processor may not manufacture,
95 deliver, offer for sale, distribute, or sell a finished kratom
96 product that:
97 (a) Is not one of the following approved delivery forms:
98 1. Dried leaf;
99 2. Kratom beverage;
100 3. Powder;
101 4. Pill;
102 5. Liquid dietary supplement;
103 6. Gummy or food that are not attractive to children; or
104 7. Capsule.
105 (b) Contains or is adulterated with synthesized or semi
106 synthesized kratom alkaloids or kratom constituents.
107 (c) Contains a level of 7-hydroxymitragynine in the
108 alkaloid fraction which is greater than 2 percent of the
109 alkaloid composition of the kratom product.
110 (d) Is not registered with the department pursuant to this
111 section.
112 (e) Does not have a certificate of analysis submitted to
113 the department as required by this section.
114 (f) Does not include directions for consumption of the
115 kratom product on the product’s label, including, but not
116 limited to:
117 1. Maximum dosage of 40 milligrams of mitragynine per
118 serving;
119 2. Number of servings per package;
120 3. Milligrams of 7-hydroxymitragynine and mitragynine per
121 serving;
122 4. A warning advising consumers of the number of servings
123 that may be safely consumed in a 24-hour period;
124 5. A warning prohibiting use by individuals who are under
125 21 years of age;
126 6. A warning advising against use by individuals who are
127 pregnant or breastfeeding;
128 7. A warning advising the consumer to consult a health care
129 professional before use, that the product may be habit-forming,
130 and that it may cause adverse health effects;
131 8. A warning stating the following: “These statements have
132 not been evaluated by the United States Food and Drug
133 Administration. This product is not intended to diagnose, treat,
134 cure, or prevent any disease.”;
135 9. The expiration date; and
136 10. The name and place of business of the registrant.
137 (g) Does not comply with the packaging and labeling
138 requirements set forth in this chapter and the rules adopted
139 pursuant thereto. Such kratom products are considered
140 misbranded.
141 (h) Is attractive to children.
142 (i) Is in a container that:
143 1. Is not suitable to contain products for human
144 consumption;
145 2. Is not compliant with the United States Poison
146 Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.; or
147 3. Does not contain a graduated measuring device, if
148 applicable.
149 (j) Is adulterated, including containing metals,
150 pesticides, or pathogens in excess of the limits set by this
151 section or department rule.
152 (4)(3) AGE RESTRICTION.—It is unlawful to sell, deliver,
153 barter, furnish, or give, directly or indirectly, any kratom
154 product to a person who is under 21 years of age.
155 (5) PERMIT AND FEDERAL REGISTRATION REQUIREMENTS FOR
156 PROCESSORS.—
157 (a) Kratom products may only be manufactured by, delivered
158 to, offered for sale by, distributed by, or sold by a processor
159 who holds a permit to operate as a food establishment as defined
160 in s. 500.03 or as a convenience store or kava or kratom bar
161 that does not prepare, serve, or sell other food products
162 besides kratom products and is not considered a cottage food
163 operation. A processor may not operate as a cottage food
164 operation pursuant to s. 500.80 and is not exempt from food
165 permit requirements pursuant to s. 500.12(1)(a)1.
166 (b) A processor that manufactures, processes, packs, or
167 offers for sale kratom, kratom products, or finished kratom
168 products must be properly registered with the United States Food
169 and Drug Administration. Processors exclusively selling finished
170 kratom products at retail are not required to register with the
171 United States Food and Drug Administration.
172 (6) REGISTRATION.—
173 (a) A processor shall certify by sworn statement that any
174 finished kratom product it manufactures, delivers, offers for
175 sale, distributes, or sells in this state is registered with the
176 department and does not contain dangerous or harmful substances,
177 including, but not limited to, red-OH, synthetic 7-OH, synthetic
178 7-hydroxymitragynine, synthetic mitragynine, pseudoindoxyl,
179 super alkaloid, or any other synthetically derived compounds,
180 synthetic alkaloids, or controlled substances. Such registration
181 must be renewed annually.
182 (b) A processor shall assume all responsibility and
183 liability for its kratom, kratom product, or finished kratom
184 product.
185 (c) For each batch of a registered finished kratom product,
186 the processor shall retain and submit, upon request, a
187 certificate of analysis to the department from an accredited
188 laboratory affiliated with a university based in Florida. The
189 laboratory must be accredited under the International
190 Organization for Standardization (ISO)/International
191 Electrotechnical Commission (IEC) 17025:2017 General
192 Requirements for Competence of Testing and Calibration
193 Laboratories standard by an accreditation body that is a
194 signatory to the International Laboratory Accreditation
195 Cooperation Mutual Recognition Arrangement or a subsequent
196 arrangement. The processor may not have any direct or indirect
197 financial or economic interest in the laboratory or accrediting
198 body. The processor shall maintain the certificates of analysis
199 for a minimum of 1 year after the finished kratom product’s
200 expiration date. The certificate of analysis must demonstrate
201 that the finished kratom product is in compliance with the
202 statutory and rule concentration limits for:
203 1. Alkaloid and alkaloid metabolites;
204 2. Residual solvents;
205 3. Heavy metals, including cadmium, arsenic, mercury, and
206 lead; and
207 4. Pesticides and any substance limited by department rule.
208 (d) A finished kratom product served by a kratom food
209 service establishment must comply with the requirements of this
210 section; however, a separate registration under this subsection
211 is not required when a kratom beverage is combined with another
212 food or beverage by the kratom food service establishment for
213 consumption on premises. Serving kratom beverages combined with
214 alcohol, drugs, or other kratom products is prohibited.
215 (7) REPORTING AND TESTING.—
216 (a) If a processor or the department receives notice of any
217 adverse health event suspected to be related to the processor’s
218 kratom product, the processor or the department must submit an
219 adverse event report as set out in chapter IX of the Federal
220 Food, Drug, and Cosmetic Act, 21 U.S.C. s. 379aa-1(b)(1) to the
221 United States Food and Drug Administration.
222 (b) If probable cause exists that a kratom product may be
223 adulterated, the department may require an independent third
224 party test of the kratom product by a laboratory of the
225 department’s choice, and the processor must pay the cost of the
226 test. If the processor does not make such payment to the
227 department within 30 days after receiving the invoice for the
228 testing fee, the department must revoke the registration for
229 that product.
230 (8)(4) VIOLATIONS.—
231 (a) A violation of subsection (4) (3) is a misdemeanor of
232 the second degree, punishable as provided in s. 775.082 or s.
233 775.083.
234 (b) A processor that manufactures, delivers, or offers for
235 sale, distributes, or sells a finished kratom product that
236 violates paragraph (3)(b) or paragraph (3)(c) commits a felony
237 of the third degree, punishable as provided in s. 775.082 or s.
238 775.083.
239 (c) Kratom products possessed, manufactured, delivered,
240 offered for sale, distributed, or sold in violation of this
241 section by an entity regulated under this chapter are subject to
242 s. 500.172 and an immediate stop-sale order, and the entity is
243 subject to penalties as provided in s. 500.121. The department
244 may not grant permission to remove or use, except for disposal,
245 finished kratom products subject to a stop-sale order which are
246 attractive to children until the finished kratom products comply
247 with this section.
248 (d) If a processor fails to provide the department with a
249 certificate of analysis within 2 days after receiving a request
250 from the department or fails to immediately report an adverse
251 health event to the department as required by this section, the
252 department may revoke the processor’s finished kratom product
253 registration.
254 (e) A processor that manufactures, delivers, offers for
255 sale, distributes, or sells a kratom product that contains any
256 controlled substance listed in s. 893.03 or an alkaloid not
257 naturally present in kratom, contains a synthetic alkaloid or a
258 synthetic alkaloid metabolite, including, but not limited to,
259 red-OH, synthetic 7-OH, synthetic 7-hydroxymitragynine,
260 synthetic mitragynine, pseudoindoxyl, super alkaloid, or any
261 other synthetically derived compounds of the plant Mitragyna
262 speciosa, or contains a level of 7-hydroxymitragynine in the
263 alkaloid fraction which is greater than 2 percent, is in
264 violation of this section.
265 (f) A laboratory that fails to ensure the accuracy of its
266 certificates of analysis issued pursuant to this section is
267 subject to an administrative fine as provided by department
268 rule.
269 (9)(5) RULES.—The department shall adopt rules to
270 administer this section.
271 Section 2. For the 2025-2026 fiscal year, the sums of
272 $1,920,141.22 in recurring funds and $1,791,608 in nonrecurring
273 funds from the General Inspection Trust Fund are appropriated to
274 the Department of Agriculture and Consumer Services, and 24
275 full-time equivalent positions with associated salary rate of
276 1,508,152.18 are authorized, for the purpose of implementing
277 this act.
278 Section 3. This act shall take effect July 1, 2025.