Bill Text: FL S1734 | 2025 | Regular Session | Introduced
Bill Title: Florida Kratom Consumer Protection Act
Spectrum: Partisan Bill (Republican 1-0)
Status: (Introduced) 2025-02-28 - Filed [S1734 Detail]
Download: Florida-2025-S1734-Introduced.html
Florida Senate - 2025 SB 1734
By Senator Collins
14-00600B-25 20251734__
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 submit a
21 certificate of analysis from a certain laboratory to
22 the Department of Agriculture and Consumer Services
23 for each batch of finished kratom product; specifying
24 requirements for such laboratory; prohibiting the
25 processor from having any financial or economic
26 interest in such laboratory or the body accrediting
27 such laboratory; requiring the processor to maintain
28 its certificates of analysis for a specified amount of
29 time after the finished kratom product’s expiration
30 date; requiring that the certificate of analysis
31 demonstrate that the finished kratom product is in
32 compliance with statutory and rule concentration
33 limits for specified substances; requiring that
34 certain finished kratom products comply with product
35 registration and testing requirements; providing an
36 exception; prohibiting the serving of kratom beverages
37 combined with alcohol, drugs, or other kratom
38 products; requiring a processor or the department to
39 submit a certain report to the United States Food and
40 Drug Administration if a processor or the department
41 receives a certain notice; authorizing the department
42 to conduct an independent third-party test of a kratom
43 product if probable cause exists that the product is
44 adulterated; requiring the processor to pay the
45 testing cost; authorizing the department to revoke the
46 processor’s product registration if the processor
47 fails to pay for such test within a specified
48 timeframe; providing criminal penalties; providing
49 that certain kratom products are subject to a stop
50 sale order; authorizing the department to revoke a
51 processor’s finished kratom product registration under
52 certain circumstances; providing that a processor
53 whose kratom product contains a controlled substance
54 or other prohibited substances is in violation of this
55 act; providing an administrative fine; providing an
56 appropriation; providing an effective date.
57
58 Be It Enacted by the Legislature of the State of Florida:
59
60 Section 1. Section 500.92, Florida Statutes, is amended to
61 read:
62 500.92 Florida Kratom Consumer Protection Act.—
63 (1) SHORT TITLE.—This section may be cited as the “Florida
64 Kratom Consumer Protection Act.”
65 (2) DEFINITIONS.—As used in this section, the term:
66 (a) “Attractive to children” means a product manufactured:
67 1. In a shape that resembles a human, a cartoon character,
68 or an animal;
69 2. In a form that resembles an existing candy product that
70 is a widely distributed, branded food item; or
71 3. Using any color additives.
72 (b) “Finished kratom product” means a kratom product that
73 is ready for sale to the end user. For purposes of registration,
74 a finished kratom product is differentiated by its ingredients,
75 not by its weight, volume, or size.
76 (c) “Kratom” means the plant or any part of the plant
77 Mitragyna speciosa.
78 (d) “Kratom beverage” means a prepackaged liquid kratom
79 product in the form of a tea, seltzer or tonic water, or
80 tincture.
81 (e) “Kratom food service establishment” means any public
82 food service establishment licensed as provided in chapter 509
83 which sells finished kratom products.
84 (f) “Kratom product” means a food product, food ingredient,
85 dietary ingredient, dietary supplement, or beverage intended for
86 human consumption which contains any part of the leaf of the
87 plant Mitragyna speciosa or an extract, synthetic alkaloid, or
88 synthetically derived compound of such plant and is manufactured
89 as a powder, capsule, pill, beverage, or other edible form.
90 (g) “Processor” means a person who manufactures, delivers,
91 or offers for sale, distributes, or sells kratom products.
92 (3) PRODUCT REQUIREMENTS.—A processor may not manufacture,
93 deliver, offer for sale, distribute, or sell a finished kratom
94 product that:
95 (a) Is not one of the following approved delivery forms:
96 1. Dried leaf;
97 2. Kratom beverage;
98 3. Powder;
99 4. Pill; or
100 5. Capsule.
101 (b) Contains a level of synthetic 7-hydroxymitragynine in
102 the alkaloid fraction which is greater than 2 percent of the
103 alkaloid composition of the kratom product.
104 (c) Is not registered with the department pursuant to this
105 section.
106 (d) Does not have a certificate of analysis submitted to
107 the department as required by this section.
108 (e) Does not include directions for consumption of the
109 kratom product on the product’s label, including, but not
110 limited to:
111 1. Maximum dosage of 40 milligrams of mitragynine per
112 serving;
113 2. Number of servings per package;
114 3. Milligrams of 7-hydroxymitragynine and mitragynine per
115 serving;
116 4. A warning advising consumers of the number of servings
117 that may be safely consumed in a 24-hour period;
118 5. A warning prohibiting use by individuals who are under
119 21 years of age;
120 6. A warning advising against use by individuals who are
121 pregnant or breastfeeding;
122 7. A warning advising the consumer to consult a health care
123 professional before use, that the product may be habit-forming,
124 and that it may cause adverse health effects;
125 8. A warning stating the following: “These statements have
126 not been evaluated by the United States Food and Drug
127 Administration. This product is not intended to diagnose, treat,
128 cure, or prevent any disease.”;
129 9. The expiration date; and
130 10. The name and place of business of the registrant.
131 (f) Does not comply with the packaging and labeling
132 requirements set forth in this chapter and the rules adopted
133 pursuant thereto. Such kratom products are considered
134 misbranded.
135 (g) Is extracted using solvents other than water or Class 3
136 solvents set forth in USP-NF chapter 467.
137 (h) Contains levels of Class 3 solvents greater than the
138 limits set forth in USP-NF chapter 467.
139 (i) Is attractive to children.
140 (j) Is in a container that:
141 1. Is not suitable to contain products for human
142 consumption; or
143 2. Is not compliant with the United States Poison
144 Prevention Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
145 3. Does not contain a graduated measuring device, if
146 applicable.
147 (k) Is adulterated, including containing metals,
148 pesticides, or pathogens in excess of the limits set by this
149 section or department rule.
150 (4)(3) AGE RESTRICTION.—It is unlawful to sell, deliver,
151 barter, furnish, or give, directly or indirectly, any kratom
152 product to a person who is under 21 years of age.
153 (5) PERMIT AND FEDERAL REGISTRATION REQUIREMENTS FOR
154 PROCESSORS.—
155 (a) Kratom products may only be manufactured by, delivered
156 to, offered for sale by, distributed by, or sold by a processor
157 who holds a permit to operate as a food establishment as defined
158 in s. 500.03. A processor may not operate as a cottage food
159 operation pursuant to s. 500.80 and is not exempt from food
160 permit requirements pursuant to s. 500.12(1)(a)1.
161 (b) A processor that manufactures, processes, packs, or
162 offers for sale kratom, kratom products, or finished kratom
163 products must be properly registered with the United States Food
164 and Drug Administration. Processors exclusively selling finished
165 kratom products at retail are not required to register with the
166 United States Food and Drug Administration.
167 (6) REGISTRATION.—
168 (a) A processor shall certify by sworn statement that any
169 finished kratom product it manufactures, delivers, offers for
170 sale, distributes, or sells in this state is registered with the
171 department and does not contain dangerous or harmful substances,
172 including, but not limited to, red-OH, synthetic 7-OH, synthetic
173 7-hydroxymitragynine, synthetic mitragynine, pseudoindoxyl,
174 super alkaloid, or any other synthetically derived compounds,
175 synthetic alkaloids, or controlled substances. Such registration
176 must be renewed annually.
177 (b) A processor shall assume all responsibility and
178 liability for its kratom, kratom product, or finished kratom
179 product.
180 (c) For each batch of a registered finished kratom product,
181 the processor shall submit a certificate of analysis to the
182 department from an independent, third-party, accredited
183 laboratory. The laboratory must be accredited under the
184 International Organization for Standardization
185 (ISO)/International Electrotechnical Commission (IEC) 17025:2017
186 General Requirements for Competence of Testing and Calibration
187 Laboratories standard by an accreditation body that is a
188 signatory to the International Laboratory Accreditation
189 Cooperation Mutual Recognition Arrangement. The processor may
190 not have any direct or indirect financial or economic interest
191 in the laboratory or accrediting body. The processor shall
192 maintain the certificates of analysis for a minimum of 1 year
193 after the finished kratom product’s expiration date. The
194 certificate of analysis must demonstrate that the finished
195 kratom product is in compliance with the statutory and rule
196 concentration limits for:
197 1. Alkaloid and alkaloid metabolites;
198 2. Residual solvents;
199 3. Heavy metals, including cadmium, arsenic, mercury, and
200 lead; and
201 4. Pesticides and any substance limited by department rule.
202 (d) A finished kratom product served by a kratom food
203 service establishment must comply with the requirements of this
204 section; however, a separate registration under this subsection
205 is not required when a kratom beverage is combined with another
206 food or beverage by the kratom food service establishment for
207 consumption on premises. Serving kratom beverages combined with
208 alcohol, drugs, or other kratom products is prohibited.
209 (7) REPORTING AND TESTING.—
210 (a) If a processor or the department receives notice of any
211 adverse health event suspected to be related to the processor’s
212 kratom product, the processor or the department must submit an
213 adverse event report as set out in chapter IX of the Federal
214 Food, Drug, and Cosmetic Act, 21 U.S.C. s. 379aa-1(b)(1) to the
215 United States Food and Drug Administration.
216 (b) If probable cause exists that a kratom product may be
217 adulterated, the department may require an independent third
218 party test of the kratom product by a laboratory of the
219 department’s choice, and the processor must pay the cost of the
220 test. If the processor does not make such payment to the
221 department within 30 days after receiving the invoice for the
222 testing fee, the department must revoke the registration for
223 that product.
224 (8)(4) VIOLATIONS.—
225 (a) A violation of subsection (4) (3) is a misdemeanor of
226 the second degree, punishable as provided in s. 775.082 or s.
227 775.083.
228 (b) A processor that manufactures, delivers, or offers for
229 sale, distributes, or sells a finished kratom product that
230 violates paragraph (3)(b) or paragraph (3)(c) commits a felony
231 of the third degree, punishable as provided in s. 775.082 or s.
232 775.083.
233 (c) Kratom products possessed, manufactured, delivered,
234 offered for sale, distributed, or sold in violation of this
235 section by an entity regulated under this chapter are subject to
236 s. 500.172 and an immediate stop-sale order, and the entity is
237 subject to penalties as provided in s. 500.121. The department
238 may not grant permission to remove or use, except for disposal,
239 finished kratom products subject to a stop-sale order which are
240 attractive to children until the finished kratom products comply
241 with this section.
242 (d) If a processor fails to provide the department with a
243 certificate of analysis within 2 days after receiving a request
244 from the department or fails to immediately report an adverse
245 health event to the department as required by this section, the
246 department may revoke the processor’s finished kratom product
247 registration.
248 (e) A processor that manufactures, delivers, offers for
249 sale, distributes, or sells a kratom product that contains any
250 controlled substance listed in s. 893.03 or an alkaloid not
251 naturally present in kratom, contains a synthetic alkaloid or a
252 synthetic alkaloid metabolite, including, but not limited to,
253 red-OH, synthetic 7-OH, synthetic 7-hydroxymitragynine,
254 synthetic mitragynine, pseudoindoxyl, super alkaloid, or any
255 other synthetically derived compounds of the plant Mitragyna
256 speciosa, or contains a level of 7-hydroxymitragynine in the
257 alkaloid fraction which is greater than 2 percent, is in
258 violation of this section.
259 (f) A laboratory that fails to ensure the accuracy of its
260 certificates of analysis issued pursuant to this section is
261 subject to an administrative fine as provided by department
262 rule.
263 (9)(5) RULES.—The department shall adopt rules to
264 administer this section.
265 Section 2. For the 2025-2026 fiscal year, the sums of
266 $1,920,141.22 in recurring funds and $1,791,608 in nonrecurring
267 funds from the General Inspection Trust Fund are appropriated to
268 the Department of Agriculture and Consumer Services, and 24
269 full-time equivalent positions with associated salary rate of
270 1,508,152.18 are authorized, for the purpose of implementing
271 this act.
272 Section 3. This act shall take effect July 1, 2025.
