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 products 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 processors 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 processors 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: 63 500.92Florida 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 products 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 products 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 processors 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 departments 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 processors 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.