Florida Senate - 2026 SB 994
By Senator Gruters
22-00574B-26 2026994__
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”; requiring that finished kratom products sold
6 to consumers at certain establishments meet certain
7 requirements; requiring that kratom products be
8 manufactured only by a processor who holds a certain
9 permit issued by the Department of Agriculture and
10 Consumer Services; prohibiting specified operations;
11 prohibiting exemptions from certain requirements;
12 requiring certain processors to be properly registered
13 with the United States Food and Drug Administration;
14 requiring processors to comply with certain
15 regulations; requiring processors to maintain product
16 liability insurance with a specified occurrence limit;
17 requiring processors of a finished kratom product to
18 retain and submit a certificate of analysis from an
19 accredited laboratory to the Department of Agriculture
20 and Consumer Services for each batch of finished
21 kratom product; specifying requirements for such
22 laboratory; prohibiting processors from having any
23 financial or economic interest in such laboratory or
24 the body accrediting such laboratory; requiring
25 processors to maintain their certificates of analysis
26 for a specified amount of time after the finished
27 kratom product’s expiration date; requiring that the
28 certificate of analysis demonstrate that the finished
29 kratom product is in compliance with statutory and
30 rule concentration limits for specified substances;
31 requiring that certain finished kratom products comply
32 with product registration and testing requirements;
33 providing an exception; providing nonapplicability;
34 providing requirements for finished kratom products
35 produced in this state and subsequently shipped or
36 transported out of this state for sale outside of this
37 state; requiring a processor or the department to
38 submit a certain report to the United States Food and
39 Drug Administration if a processor or the department
40 receives a certain notice; authorizing the department
41 to conduct an independent third-party test of a kratom
42 product if probable cause exists that the product is
43 adulterated; requiring the processor to pay the
44 testing cost; authorizing the department to revoke the
45 processor’s product registration if the processor
46 fails to pay for such test within a specified
47 timeframe; providing prohibitions; providing criminal
48 penalties; providing that certain kratom products are
49 subject to a stop-sale order; authorizing the
50 department to revoke a processor’s finished kratom
51 product registration under certain circumstances;
52 providing that a processor whose kratom product
53 contains a controlled substance or other prohibited
54 substances is in violation of the act; authorizing the
55 levying of administrative fines for laboratories that
56 fail to comply with certain requirements; providing an
57 appropriation; providing an 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; or
70 2. In a form that resembles an existing candy product that
71 is widely distributed or branded.
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 in any form.
78 (d) “Kratom beverage” means a prepackaged liquid kratom
79 product in the form of a tea, a seltzer or tonic water, or a
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 consumable edible
90 form.
91 (g) “Processor” means an entity that:
92 1. Refines kratom into input ingredients for the purpose of
93 manufacturing a finished kratom product;
94 2. Manufactures finished kratom products; or
95 3. Packages finished kratom products for resale.
96 (3) KRATOM PRODUCT RETAIL SALE REQUIREMENTS.—Finished
97 kratom products sold to consumers at retail establishments,
98 including a food establishment as defined in s. 500.03(1), a
99 convenience store, or a kava or kratom bar:
100 (a) Must be in one of the following delivery forms:
101 1. Dried leaf;
102 2. Kratom beverage;
103 3. Powder;
104 4. Pill;
105 5. Liquid dietary supplement;
106 6. Gummy or food; or
107 7. Capsule.
108 (b) Must possess a certificate of analysis, which must be
109 submitted to the department pursuant to paragraph (4)(e).
110 (c) Must be registered with the department pursuant to this
111 section.
112 (d) Must include directions for consumption of the kratom
113 product on the product’s label, including, but not limited to:
114 1. Maximum dosage of 100 milligrams of kratom alkaloids per
115 serving;
116 2. Number of servings per package;
117 3. Milligrams of mitragynine and 7-hydroxymitragynine per
118 serving;
119 4. A warning advising consumers of the number of servings
120 that may be safely consumed in a 24-hour period;
121 5. A warning prohibiting use by individuals who are under
122 21 years of age;
123 6. A warning advising against use by individuals who are
124 pregnant or breastfeeding;
125 7. A warning advising the consumer to consult a health care
126 professional before use, that the product may be habit-forming,
127 and that it may cause adverse health effects;
128 8. A warning stating the following: “These statements have
129 not been evaluated by the United States Food and Drug
130 Administration. This product is not intended to diagnose, treat,
131 cure, or prevent any disease.”;
132 9. The expiration date; and
133 10. The name and place of business of the registrant.
134 (e) Must comply with the packaging and labeling
135 requirements set forth in this chapter and with the rules
136 adopted pursuant thereto.
137 (f) May not be attractive to children.
138 (g) Must be packaged in a container that:
139 1. Is suitable to contain products for human consumption.
140 2. Is compliant with the United States Poison Prevention
141 Packaging Act of 1970, 15 U.S.C. ss. 1471 et seq.
142 3. Contains a graduated measuring device, if applicable.
143 (h) May not be adulterated, including containing metals,
144 pesticides, or pathogens in excess of the limits set by this
145 section or department rule.
146 (i) May be sold only in establishments that restrict entry
147 to persons who are 21 years of age or older and require age
148 verification.
149 (j) May not be served in a form that combines or mixes
150 finished kratom products with psychoactive substances that
151 impact the central nervous system, including, but not limited
152 to, alcohol, caffeine, kava, cannabinoids, and nicotine.
153 (4) PERMIT FOR PROCESSING FINISHED KRATOM PRODUCTS AND
154 FEDERAL AND STATE REGISTRATION REQUIREMENTS FOR PROCESSORS.—
155 (a) Kratom products may be manufactured or distributed in
156 this state only by a processor who holds a permit issued by the
157 department to operate as a food establishment as defined in s.
158 500.03(1). 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.
165 (c) A processor shall comply with 21 C.F.R. part 210.
166 (d) A processor shall maintain product liability insurance
167 with an occurrence limit of $3 million.
168 (e) For each batch of a registered, finished kratom
169 product, the processor shall retain and, upon request, submit a
170 certificate of analysis to the department from an accredited
171 laboratory. The laboratory must be accredited under the
172 International Organization for Standardization
173 (ISO)/International Electrotechnical Commission (IEC) 17025:2017
174 general requirements for competence of testing and calibration
175 laboratories standard by an accreditation body that is a
176 signatory to the International Laboratory Accreditation
177 Cooperation Mutual Recognition Arrangement or a subsequent
178 arrangement. The processor may not have any direct or indirect
179 financial or economic interest in the laboratory or accrediting
180 body. The processor shall maintain the certificates of analysis
181 for a minimum of 1 year after the finished kratom product’s
182 expiration date. The certificate of analysis must demonstrate
183 that the finished kratom product is in compliance with the
184 statutory and rule concentration limits for:
185 1. Alkaloid and alkaloid metabolites;
186 2. Residual solvents;
187 3. Heavy metals, including cadmium, arsenic, mercury, and
188 lead; and
189 4. Pesticides and any substance limited by department rule.
190 (f) A finished kratom product served by a kratom food
191 service establishment must comply with the requirements of this
192 section; however, a separate registration under this subsection
193 is not required when a kratom beverage is combined with another
194 food or beverage by the kratom food service establishment for
195 consumption on premises.
196 (g) Subsection (3) does not apply to finished kratom
197 products processed or manufactured in this state and
198 subsequently shipped or transported out of this state for sale
199 or use outside of this state.
200 (h) Finished kratom products produced in this state and
201 subsequently shipped or transported out of this state for sale
202 outside of this state:
203 1. May not be sold, shipped, or transported to a consumer
204 in this state, a retail establishment in this state, or to a
205 person who intends to sell such products to a consumer in this
206 state;
207 2. Must be in a package marked “NOT FOR USE OR RETAIL SALE
208 IN FLORIDA” in a bold font size of at least 36 points; and
209 3. Must be physically separated from finished kratom
210 products that are, or are intended to be, sold or used in this
211 state.
212 (5) REPORTING AND TESTING.—
213 (a) If a processor or the department receives notice of any
214 adverse health event suspected to be related to the processor’s
215 kratom product, the processor or the department must submit an
216 adverse event report as set out in chapter 9 of the Federal
217 Food, Drug, and Cosmetic Act, 21 U.S.C. s. 379aa-1(b)(1) to the
218 United States Food and Drug Administration.
219 (b) If probable cause exists that a kratom product may be
220 adulterated, the department may require an independent third
221 party test of the kratom product by a laboratory of the
222 department’s choice, and the processor must pay the cost of the
223 test. If the processor does not make such payment to the
224 department within 30 days after receiving the invoice for the
225 testing fee, the department must revoke the registration for
226 that product.
227 (6) PROHIBITIONS.—
228 (a) It is unlawful to serve kratom beverages combined with
229 alcohol, drugs, or other kratom products.
230 (b) It is unlawful to sell, deliver, barter, furnish, or
231 give, directly or indirectly, any kratom product to a person who
232 is under 21 years of age.
233 (7)(4) VIOLATIONS.—
234 (a) A violation of subsection (4) (3) is a misdemeanor of
235 the second degree, punishable as provided in s. 775.082 or s.
236 775.083.
237 (b) A processor that manufactures, delivers, offers for
238 sale, distributes, or sells a finished kratom product that
239 violates paragraph (3)(b) or paragraph (3)(c) commits a
240 misdemeanor of the second degree, punishable as provided in s.
241 775.082 or s. 775.083.
242 (c) Kratom products possessed, manufactured, delivered,
243 offered for sale, distributed, or sold in violation of this
244 section by an entity regulated under this chapter are subject to
245 s. 500.172 and an immediate stop-sale order, and the entity is
246 subject to penalties as provided in s. 500.121. The department
247 may not grant permission to remove or use, except for disposal,
248 finished kratom products subject to a stop-sale order which are
249 attractive to children until the finished kratom products comply
250 with this section.
251 (d) If a processor fails to provide the department with a
252 certificate of analysis within 7 days after receiving a request
253 from the department or fails to immediately report an adverse
254 health event to the department as required by this section, the
255 department may revoke the processor’s finished kratom product
256 registration.
257 (e) A processor that manufactures, delivers, offers for
258 sale, distributes, or sells a kratom product that contains any
259 controlled substance or adulterants is in violation of this
260 section.
261 (f) A laboratory that fails to ensure the accuracy of its
262 certificates of analysis issued pursuant to this section is
263 subject to an administrative fine as provided by department
264 rule.
265 (8)(5) RULES.—The department shall adopt rules to
266 administer this section.
267 Section 2. For the 2026-2027 fiscal year, the sums of
268 $1,920,141.22 in recurring funds and $1,791,608 in nonrecurring
269 funds from the General Inspection Trust Fund are appropriated to
270 the Department of Agriculture and Consumer Services, and 24
271 full-time equivalent positions with associated salary rate of
272 $1,508,152.18 are authorized, for the purpose of implementing
273 this act.
274 Section 3. This act shall take effect October 1, 2026.