| 1 | 1 | | MISSISSIPPI LEGISLATURE 2025 Regular Session To: Business and Commerce By: Representative Bell (65th) House Bill 1076 AN ACT TO CREATE THE KRATOM CONSUMER PROTECTION ACT; TO DEFINE CERTAIN TERMS RELATING TO KRATOM PRODUCTS; TO PROVIDE CERTAIN PROHIBITIONS FOR KRATOM VENDORS; TO REQUIRE THAT KRATOM PRODUCTS BE ACCOMPANIED BY A LABEL BEARING CERTAIN INFORMATION PRIOR TO ITS SALE; TO REQUIRE VENDORS TO REGISTER EACH KRATOM PRODUCT INTENDED TO BE OFFERED FOR SALE WITH THE DEPARTMENT OF REVENUE; TO REQUIRE A PROCESSOR TO SUBMIT AN ADVERSE EVENT REPORT VIA CERTIFIED MAIL TO THE DEPARTMENT OF REVENUE AND THE UNITED STATES FOOD AND DRUG ADMINISTRATION UPON REPORT OF AN ADVERSE EVENT RELATED TO A REGISTERED KRATOM PRODUCT; AND FOR RELATED PURPOSES. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: SECTION 1. As used in this act, the following words and phrases have the meanings as defined in this section unless the context clearly indicates otherwise: (a) "Food" means a food, food product, food ingredient, dietary ingredient, dietary supplement or beverage for human consumption; (b) "Kratom leaf" means the leaf of the kratom plant, Mitragyna speciosa, in fresh or dehydrated or dried form that undergoes no post-harvest processing other than drying or size reduction by cutting, milling, or similar procedure, and may be cleaned or sterilized using standard treatments applied to food ingredients, such as heat, steam, pressurization, irradiation or other standard treatments applied to food ingredients. The total alkaloid content of kratom leaf material used in the kratom product shall not exceed three and one-half percent (3.5%) measured on a dried weight-to-weight basis; (c) "Kratom leaf extract" means the material obtained by extracting kratom using a solvent consisting of water, ethanol, or food-grade carbon dioxide (CO2). The extracted material shall contain mitragynine as the most abundant alkaloid, measured on a weight-to-weight basis, and at a level that is equal to or exceeds twice that of any other alkaloid present. The ratio of mitragynine to other alkaloids in the extract shall be equal to or greater than the ratio found in the starting material; (d) "Kratom product" means a food or dietary supplement that consists of or contains kratom leaf or kratom leaf extract that does not contain any synthesized kratom alkaloids, other kratom constituents, or synthesized metabolites of any kratom constituent in which the level of 7-hydroxymitragynine, on a percent weight basis, is not greater than one percent (1%) of the amount of total kratom alkaloids, as confirmed with a high-performance liquid chromatography testing method and not to exceed one (1) milligram per container. For purposes of this act, "synthesized" refers to substances produced using directed synthetic or biosynthetic chemistry, as opposed to traditional food preparation techniques such as heating or extracting; (e) "Total kratom alkaloids" means the sum of mitragynine, speciociliatine, speciogynine, paynantheine, and 7-hydroxymitragynine; and (f) "Vendor" means a person that sells, prepares or maintains kratom products or that advertises, represents or holds itself out as selling, preparing or maintaining kratom products and includes a manufacturer, wholesaler, store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, nursing home or food or drink company. SECTION 2. (1) A vendor shall not prepare, distribute, or sell any of the following: (a) A kratom product that does not meet the definition for a kratom product under Section 1 of this act; (b) A kratom product that is contaminated with a dangerous nonkratom substance. A kratom product is contaminated with a dangerous nonkratom substance if the kratom product contains a substance that is not safe for human consumption; (c) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than one percent (1%) of the alkaloid composition and not to exceed one-half (0.5) milligram per container of the product; (d) A kratom product containing any synthesized, or semi-synthesized, alkaloid including synthesized or semi-synthesized mitragynine, synthesized or semi-synthesized 7-hydroxymitragynine or any other synthesized or semi-synthesized compounds of the kratom plant; (e) A kratom product containing any controlled substance listed in the Uniform Controlled Substances Act, unless the product is compounded by a licensed pharmacist with the controlled substance dispensed in accordance with a valid prescription; (f) A kratom product containing a level of any residual solvent that was used in the manufacturing of the extract that exceeds the residual level specified for pharmaceutical products in the document "Q3C - Tables and List, Guidance for Industry, June 2017 ICH Revision 3" issued by the United States Department of Health and Human Services, Food and Drug Administration; or (g) A kratom product that is not registered by the Department of Revenue. (2) Kratom products shall be accompanied by a label bearing the following information prior to its sale in this state: (a) A list of the ingredients, which shall include the common or usual name of each ingredient used in the manufacture of the product, listed in descending order of predominance; (b) That the sale or transfer of kratom to a person under twenty-one (21) years of age is prohibited; (c) The amount of total kratom alkaloids, mitragynine, and 7-hydroxymitragynine contained in the product; (d) The name and the principal street address of the vendor or the person responsible for distributing the product; (e) Any federal food allergen labeling requirements, if applicable, and clear and adequate directions for the consumption and safe and effective use of such product, including the recommended serving size, the number of servings in the container, and the number of servings that can be safely consumed in a day. Liquid kratom products shall be packaged in a retail container that has clear serving size markings. (f) Any precautionary statements as to the safety and effectiveness of the product, including a warning that a consumer should consult a health care professional on questions about the use of kratom, that the product may be habit-forming, and a statement that the kratom product is not intended to "diagnose, treat, cure, or prevent any disease"; and (g) A statement that a kratom product label is prohibited from making any therapeutic claims unless approved by the United States Food and Drug Administration. (3) A vendor may not distribute or sell a kratom product to an individual under twenty-one (21) years of age. (4) Upon request by the Department of Revenue, the vendor shall provide test results from a United States-based testing facility to confirm the items listed on the product label. SECTION 3. (1) A vendor shall register with the Department of Revenue each kratom product intended to be offered for sale. A kratom product registration is valid for one (1) year. A vendor shall pay a registration fee, adjusted annually, to cover all administrative costs for processing and administering the registration program. A vendor shall submit to the department a certificate of analysis for a product from a United States-based testing facility to confirm the items listed on the product label, which must conform to this act. If the kratom product does not comply with the requirements of this subsection (a), it shall not be registered. (2) Upon report of an adverse event related to a registered kratom product, a processor shall submit an adverse event report via certified mail to the Department of Revenue and the United States Food and Drug Administration in accordance with federal law. A failure to report an adverse event to the Department of Revenue shall authorize the commissioner to revoke a product's registration. SECTION 4. This act shall take effect and be in force from and after July 1, 2025. |
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| 2 | 2 | | |
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| 3 | 3 | | MISSISSIPPI LEGISLATURE |
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| 4 | 4 | | |
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| 5 | 5 | | 2025 Regular Session |
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| 6 | 6 | | |
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| 7 | 7 | | To: Business and Commerce |
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| 8 | 8 | | |
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| 9 | 9 | | By: Representative Bell (65th) |
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| 10 | 10 | | |
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| 11 | 11 | | # House Bill 1076 |
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| 12 | 12 | | |
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| 13 | 13 | | AN ACT TO CREATE THE KRATOM CONSUMER PROTECTION ACT; TO DEFINE CERTAIN TERMS RELATING TO KRATOM PRODUCTS; TO PROVIDE CERTAIN PROHIBITIONS FOR KRATOM VENDORS; TO REQUIRE THAT KRATOM PRODUCTS BE ACCOMPANIED BY A LABEL BEARING CERTAIN INFORMATION PRIOR TO ITS SALE; TO REQUIRE VENDORS TO REGISTER EACH KRATOM PRODUCT INTENDED TO BE OFFERED FOR SALE WITH THE DEPARTMENT OF REVENUE; TO REQUIRE A PROCESSOR TO SUBMIT AN ADVERSE EVENT REPORT VIA CERTIFIED MAIL TO THE DEPARTMENT OF REVENUE AND THE UNITED STATES FOOD AND DRUG ADMINISTRATION UPON REPORT OF AN ADVERSE EVENT RELATED TO A REGISTERED KRATOM PRODUCT; AND FOR RELATED PURPOSES. |
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| 14 | 14 | | |
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| 15 | 15 | | BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: |
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| 16 | 16 | | |
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| 17 | 17 | | SECTION 1. As used in this act, the following words and phrases have the meanings as defined in this section unless the context clearly indicates otherwise: |
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| 18 | 18 | | |
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| 19 | 19 | | (a) "Food" means a food, food product, food ingredient, dietary ingredient, dietary supplement or beverage for human consumption; |
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| 20 | 20 | | |
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| 21 | 21 | | (b) "Kratom leaf" means the leaf of the kratom plant, Mitragyna speciosa, in fresh or dehydrated or dried form that undergoes no post-harvest processing other than drying or size reduction by cutting, milling, or similar procedure, and may be cleaned or sterilized using standard treatments applied to food ingredients, such as heat, steam, pressurization, irradiation or other standard treatments applied to food ingredients. The total alkaloid content of kratom leaf material used in the kratom product shall not exceed three and one-half percent (3.5%) measured on a dried weight-to-weight basis; |
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| 22 | 22 | | |
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| 23 | 23 | | (c) "Kratom leaf extract" means the material obtained by extracting kratom using a solvent consisting of water, ethanol, or food-grade carbon dioxide (CO2). The extracted material shall contain mitragynine as the most abundant alkaloid, measured on a weight-to-weight basis, and at a level that is equal to or exceeds twice that of any other alkaloid present. The ratio of mitragynine to other alkaloids in the extract shall be equal to or greater than the ratio found in the starting material; |
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| 24 | 24 | | |
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| 25 | 25 | | (d) "Kratom product" means a food or dietary supplement that consists of or contains kratom leaf or kratom leaf extract that does not contain any synthesized kratom alkaloids, other kratom constituents, or synthesized metabolites of any kratom constituent in which the level of 7-hydroxymitragynine, on a percent weight basis, is not greater than one percent (1%) of the amount of total kratom alkaloids, as confirmed with a high-performance liquid chromatography testing method and not to exceed one (1) milligram per container. For purposes of this act, "synthesized" refers to substances produced using directed synthetic or biosynthetic chemistry, as opposed to traditional food preparation techniques such as heating or extracting; |
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| 26 | 26 | | |
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| 27 | 27 | | (e) "Total kratom alkaloids" means the sum of mitragynine, speciociliatine, speciogynine, paynantheine, and |
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| 28 | 28 | | |
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| 29 | 29 | | 7-hydroxymitragynine; and |
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| 30 | 30 | | |
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| 31 | 31 | | (f) "Vendor" means a person that sells, prepares or maintains kratom products or that advertises, represents or holds itself out as selling, preparing or maintaining kratom products and includes a manufacturer, wholesaler, store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, nursing home or food or drink company. |
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| 32 | 32 | | |
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| 33 | 33 | | SECTION 2. (1) A vendor shall not prepare, distribute, or sell any of the following: |
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| 34 | 34 | | |
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| 35 | 35 | | (a) A kratom product that does not meet the definition for a kratom product under Section 1 of this act; |
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| 36 | 36 | | |
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| 37 | 37 | | (b) A kratom product that is contaminated with a dangerous nonkratom substance. A kratom product is contaminated with a dangerous nonkratom substance if the kratom product contains a substance that is not safe for human consumption; |
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| 38 | 38 | | |
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| 39 | 39 | | (c) A kratom product containing a level of 7-hydroxymitragynine in the alkaloid fraction that is greater than one percent (1%) of the alkaloid composition and not to exceed |
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| 40 | 40 | | |
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| 41 | 41 | | one-half (0.5) milligram per container of the product; |
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| 42 | 42 | | |
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| 43 | 43 | | (d) A kratom product containing any synthesized, or semi-synthesized, alkaloid including synthesized or semi-synthesized mitragynine, synthesized or semi-synthesized 7-hydroxymitragynine or any other synthesized or semi-synthesized compounds of the kratom plant; |
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| 44 | 44 | | |
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| 45 | 45 | | (e) A kratom product containing any controlled substance listed in the Uniform Controlled Substances Act, unless the product is compounded by a licensed pharmacist with the controlled substance dispensed in accordance with a valid prescription; |
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| 46 | 46 | | |
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| 47 | 47 | | (f) A kratom product containing a level of any residual solvent that was used in the manufacturing of the extract that exceeds the residual level specified for pharmaceutical products in the document "Q3C - Tables and List, Guidance for Industry, June 2017 ICH Revision 3" issued by the United States Department of Health and Human Services, Food and Drug Administration; or |
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| 48 | 48 | | |
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| 49 | 49 | | (g) A kratom product that is not registered by the Department of Revenue. |
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| 50 | 50 | | |
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| 51 | 51 | | (2) Kratom products shall be accompanied by a label bearing the following information prior to its sale in this state: |
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| 52 | 52 | | |
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| 53 | 53 | | (a) A list of the ingredients, which shall include the common or usual name of each ingredient used in the manufacture of the product, listed in descending order of predominance; |
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| 54 | 54 | | |
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| 55 | 55 | | (b) That the sale or transfer of kratom to a person under twenty-one (21) years of age is prohibited; |
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| 56 | 56 | | |
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| 57 | 57 | | (c) The amount of total kratom alkaloids, mitragynine, and 7-hydroxymitragynine contained in the product; |
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| 58 | 58 | | |
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| 59 | 59 | | (d) The name and the principal street address of the vendor or the person responsible for distributing the product; |
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| 60 | 60 | | |
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| 61 | 61 | | (e) Any federal food allergen labeling requirements, if applicable, and clear and adequate directions for the consumption and safe and effective use of such product, including the recommended serving size, the number of servings in the container, and the number of servings that can be safely consumed in a day. Liquid kratom products shall be packaged in a retail container that has clear serving size markings. |
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| 62 | 62 | | |
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| 63 | 63 | | (f) Any precautionary statements as to the safety and effectiveness of the product, including a warning that a consumer should consult a health care professional on questions about the use of kratom, that the product may be habit-forming, and a statement that the kratom product is not intended to "diagnose, treat, cure, or prevent any disease"; and |
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| 64 | 64 | | |
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| 65 | 65 | | (g) A statement that a kratom product label is prohibited from making any therapeutic claims unless approved by the United States Food and Drug Administration. |
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| 66 | 66 | | |
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| 67 | 67 | | (3) A vendor may not distribute or sell a kratom product to an individual under twenty-one (21) years of age. |
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| 68 | 68 | | |
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| 69 | 69 | | (4) Upon request by the Department of Revenue, the vendor shall provide test results from a United States-based testing facility to confirm the items listed on the product label. |
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| 70 | 70 | | |
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| 71 | 71 | | SECTION 3. (1) A vendor shall register with the Department of Revenue each kratom product intended to be offered for sale. A kratom product registration is valid for one (1) year. A vendor shall pay a registration fee, adjusted annually, to cover all administrative costs for processing and administering the registration program. A vendor shall submit to the department a certificate of analysis for a product from a United States-based testing facility to confirm the items listed on the product label, which must conform to this act. If the kratom product does not comply with the requirements of this subsection (a), it shall not be registered. |
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| 72 | 72 | | |
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| 73 | 73 | | (2) Upon report of an adverse event related to a registered kratom product, a processor shall submit an adverse event report via certified mail to the Department of Revenue and the United States Food and Drug Administration in accordance with federal law. A failure to report an adverse event to the Department of Revenue shall authorize the commissioner to revoke a product's registration. |
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| 74 | 74 | | |
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| 75 | 75 | | SECTION 4. This act shall take effect and be in force from and after July 1, 2025. |
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