| 104 | 90 | | sterilized using standard treatments applied to food ingredients, |
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| 105 | 91 | | such as heat, steam, pressurization, or irradiation or other |
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| 106 | 92 | | standard treatments applied to food ingredients. The total alkaloid |
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| 107 | 93 | | content of kratom leaf material used in the kratom product shall not |
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| 108 | 94 | | exceed three and one -half percent (3.5%) measured on a dried weight - |
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| 109 | 95 | | to-weight basis; |
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| 110 | 96 | | 3. “Kratom leaf extract” means the material obtained by |
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| 111 | 97 | | extracting kratom using a solvent consisting of: |
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| 112 | 98 | | a. water, ethanol, or food -grade carbon dioxide (CO 2), or |
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| 113 | 99 | | b. any other solvent allowed by federal or state |
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| 114 | 100 | | regulation for use in manufacturing a food ingredient. |
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| 115 | 101 | | The extracted material shall contain mitragynine as the most |
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| 116 | 102 | | abundant alkaloid, measured on a weight -to-weight basis, and at a |
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| 117 | 103 | | level that is equal to or exceeds twice that of any other alka loid |
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| 118 | 104 | | present. The ratio of mitragynine to other alkaloids in the extract |
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| 119 | 105 | | shall be equal to or greater than the ratio found in the starting |
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| 120 | 106 | | material; |
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| 155 | 140 | | chromatography testing method. For purposes of this paragraph, |
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| 156 | 141 | | “synthesized” refers to substances produced using directed synthetic |
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| 157 | 142 | | or biosynthetic chemistry, as opposed to traditional food |
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| 158 | 143 | | preparation techniques such as heating or ex tracting; |
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| 159 | 144 | | 5. “Total kratom alkaloids ” means the sum of mitragynine, |
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| 160 | 145 | | speciociliatine, speciogynine, paynantheine, and 7 - |
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| 161 | 146 | | hydroxymitragynine; and |
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| 162 | 147 | | 6. “Vendor” means a person or entity that sells, prepares or |
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| 163 | 148 | | maintains kratom products or that advertises, repr esents or holds |
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| 164 | 149 | | himself, herself, or itself out as selling, preparing or maintaining |
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| 165 | 150 | | kratom products and includes a manufacturer, wholesaler, store, |
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| 166 | 151 | | restaurant, hotel, catering facility, camp, bakery, delicatessen, |
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| 167 | 152 | | supermarket, grocery store, convenience s tore, nursing home or food |
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| 168 | 153 | | or drink company. |
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| 199 | | - | Section 1-1432.4. A. A vendor shall not prepare, distribute, |
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| 200 | | - | sell or expose for sale any of the following: |
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| 201 | | - | 1. A kratom product that does not meet the definition for a |
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| 202 | | - | kratom product pursuant to Section 1 -1432.2 of this title; |
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| 203 | | - | 2. A kratom product that is contaminated with a dangerous |
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| 204 | | - | nonkratom substance. A kratom product is contamina ted with a |
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| 205 | | - | dangerous nonkratom substance if the kratom product contains a |
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| 206 | | - | substance that is not safe for human consumption; |
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| 207 | | - | 3. A kratom product containing a level of 7 -hydroxymitragynine |
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| 208 | | - | in the alkaloid fraction t hat is greater than one percent (1%) of |
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| 209 | | - | the alkaloid composition of the product; |
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| 210 | | - | 4. A kratom product containing any synthesized alkaloid |
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| 211 | | - | including synthesized mitragynine, synthesized 7 -hydroxymitragynine |
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| 212 | | - | or any other synthesized compounds of the kratom p lant; |
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| 213 | | - | 5. A kratom product containing any controlled substance listed |
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| 214 | | - | in the Uniform Controlled Dangerous Substances Act, unless the |
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| 215 | | - | product is compounded by a licensed pharmacist with the controlled |
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| 216 | | - | substance dispensed in accordance with a valid prescrip tion; or |
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| 217 | | - | 6. A kratom product containing a level of any residual solvent |
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| 218 | | - | that was used in the manufacturing of the extract that exceeds the |
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| 219 | | - | residual level specified for pharmaceutical products in the document |
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| 220 | | - | "Q3C - Tables and List, Guidance for Industry, [June 2017] ICH |
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| 221 | | - | Revision 3" issued by the United States Department of Health and |
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| 222 | | - | Human Services, Food and Drug Administration. |
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| 223 | | - | |
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| 224 | | - | SB891 HFLR Page 5 |
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| 225 | | - | BOLD FACE denotes Committee Amendments. 1 |
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| 226 | | - | 2 |
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| 249 | | - | |
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| 250 | | - | B. Kratom products shall be accompanied by a label bearing the |
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| 251 | | - | following information prior to its sale in this state: |
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| 252 | | - | 1. A list of the ingredients, which shall include the common or |
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| 253 | | - | usual name of each ingredient used in the manufacture of the |
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| 254 | | - | product, listed in descending order of predominance; |
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| 255 | | - | 2. That the sale or transfer of kratom to a person under |
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| 256 | | - | eighteen (18) years of age is prohibited; |
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| 257 | | - | 3. The amount of total krato m alkaloids, mitragynine, and 7 - |
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| 258 | | - | hydroxymitragynine contained in the product; |
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| 259 | | - | 4. The amount of total kratom alkaloids, mitragynine, and 7 - |
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| 260 | | - | hydroxymitragynine contained in packaging for the product; |
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| 261 | | - | 5. The name and the principal street address of the vendor or |
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| 262 | | - | the person responsible for distributing the product; |
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| 263 | | - | 6. Any federal food allergen labeling requirements, if |
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| 264 | | - | applicable, and clear and adequate directions for the consumption |
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| 265 | | - | and safe and effective use of such product, including the |
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| 266 | | - | recommended serving size, the number of servings in the container, |
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| 267 | | - | and the number of servings that can be safely consumed in a day. |
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| 268 | | - | Provided, liquid kratom products shall be packaged in a retail |
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| 269 | | - | container that has clear serving size markings and be subject to the |
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| 270 | | - | following requirements: |
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| 271 | | - | a. products of less than eight (8) fluid ounces which |
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| 272 | | - | contain more than three servings shall be accompanied |
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| 273 | | - | by a calibrated measuring device, and |
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| 274 | | - | |
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| 275 | | - | SB891 HFLR Page 6 |
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| 276 | | - | BOLD FACE denotes Committee Amendments. 1 |
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| 277 | | - | 2 |
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| 278 | | - | 3 |
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| 300 | | - | |
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| 301 | | - | b. if such a product contains more than the eight (8) |
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| 302 | | - | fluid ounces, the requirements specified in |
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| 303 | | - | subparagraph a of this paragraph do not apply. |
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| 304 | | - | Provided further, packaging for powdered kratom products not in |
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| 305 | | - | capsule form shall have a calibrated measuring device included in |
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| 306 | | - | the container; |
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| 307 | | - | 7. Any precautionary statements as to the safety and |
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| 308 | | - | effectiveness of the product, including a warning that a consumer |
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| 309 | | - | should consult a health care professional on questions about the use |
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| 310 | | - | of kratom, that the product may be habit -forming, and a statement |
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| 311 | | - | that the kratom product is not intended to "diagnose, treat, cure, |
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| 312 | | - | or prevent any disease" ; and |
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| 313 | | - | 8. A statement that a kratom product label is prohibited from |
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| 314 | | - | making any therapeutic claims unless approved by the United States |
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| 315 | | - | Food and Drug Administration says “These statemen ts have not been |
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| 316 | | - | evaluated by the United States Food and Drug Administration. This |
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| 317 | | - | product is not intended to diagnose, treat, cure, or prevent any |
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| 318 | | - | disease”. |
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| 319 | | - | C. A vendor may not distribute, sell or expose for sale a |
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| 320 | | - | kratom product to an individual under eighteen (18) years of age. |
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| 321 | | - | D. Upon request by the State Department of Health, the vendor |
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| 322 | | - | shall provide test results from a United States -based testing |
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| 323 | | - | facility to confirm the items listed on the product label. |
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| 181 | + | Passed the Senate the 17th day of February, 2025. |
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