Mississippi 2025 Regular Session

Mississippi House Bill HB1464 Compare Versions

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11 MISSISSIPPI LEGISLATURE 2025 Regular Session To: Business and Commerce By: Representative Bell (65th) House Bill 1464 AN ACT TO CREATE THE "KRATOM CONSUMER PROTECTION ACT"; TO DEFINE CERTAIN TERMS RELATING TO KRATOM PRODUCTS; TO PROVIDE CERTAIN PROHIBITIONS FOR KRATOM RETAILERS, WHOLESALERS, JOBBERS, DISTRIBUTORS AND MANUFACTURERS; TO REQUIRE KRATOM PRODUCTS TO BE ACCOMPANIED BY A LABEL BEARING CERTAIN INFORMATION PRIOR TO SALE; TO REQUIRE RETAILERS, MANUFACTURERS AND WHOLESALERS 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. (1) This act shall be known and my be cited as the "Kratom Consumer Protection Act". (2) As used in this act, the following words and phrases have the meanings ascribed in this subsection 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. (f) "Retailer" means a person that sells or maintains kratom products or that advertises, represents or holds itself out as selling, preparing or maintaining kratom products and includes a store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, or food or drink company. (g) "Wholesaler," "jobber" or "distributor" means a person doing a regularly organized wholesale or jobbing business, known to the trade as such, and selling kratom products to licensed retail dealers or other wholesalers for resale in the regular course of business. (h) "Manufacturer" means a person that produces, prepares, compounds or processes kratom products. This includes a person packaging, repackaging, labeling or relabeling of kratom products. (i) "Person" has the same meaning as ascribed in Section 1-3-39. SECTION 2. (1) A retailer, wholesaler, jobber, distributor or manufacturer may 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 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 manufacturer 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) A retailer, manufacturer or wholesaler may not distribute or sell a kratom product to an individual under twenty-one (21) years of age. (b) Kratom products offered for sell must be placed behind the retailer's counter. (c) A person engaged in the business of selling kratom products at retail shall notify each individual employed by that person as a retail sales clerk that state law: (i) Prohibits the sale or distribution of kratom products, including samples, to a person under twenty-one (21) years of age and the purchase or receipt of kratom products by a person under twenty-one (21) years of age; and (ii) Requires that proof of age be demanded from a prospective purchaser or recipient if the prospective purchaser or recipient is under the age of twenty-one (21) years. Every person employed by a person engaged in the business of selling kratom products at retail shall sign an agreement with the person's employer in substantially the following or similar form: "I understand that state law prohibits the sale or distribution of kratom products to persons under the age of twenty-one (21) years and requires that proof of age be demanded from a prospective purchaser or recipient under twenty-one (21) years of age if the individual is not known to the seller, barterer, deliverer or giver of the kratom product to be over the age of twenty-one (21) years. I promise, as a condition of my employment, to observe this law." (d) A person violating this section must be penalized by a fine of not less than Fifty Dollars ($50.00) nor more than One Hundred Dollars ($100.00). (e) A retailer who instructs the retailer's employees as required in this section is not liable for a violation committed by those employees. (4) Upon request by the Department of Revenue, the retailer, manufacturer and wholesaler shall provide test results from a United States-based testing facility to confirm the items listed on the product label. SECTION 3. (1) A retailer, manufacturer and wholesaler shall register with the Department of Revenue each kratom product intended to be offered for sale to an end consumer. 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 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 act, it may 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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33 MISSISSIPPI LEGISLATURE
44
55 2025 Regular Session
66
77 To: Business and Commerce
88
99 By: Representative Bell (65th)
1010
1111 # House Bill 1464
1212
1313 AN ACT TO CREATE THE "KRATOM CONSUMER PROTECTION ACT"; TO DEFINE CERTAIN TERMS RELATING TO KRATOM PRODUCTS; TO PROVIDE CERTAIN PROHIBITIONS FOR KRATOM RETAILERS, WHOLESALERS, JOBBERS, DISTRIBUTORS AND MANUFACTURERS; TO REQUIRE KRATOM PRODUCTS TO BE ACCOMPANIED BY A LABEL BEARING CERTAIN INFORMATION PRIOR TO SALE; TO REQUIRE RETAILERS, MANUFACTURERS AND WHOLESALERS 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.
1414
1515 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:
1616
1717 SECTION 1. (1) This act shall be known and my be cited as the "Kratom Consumer Protection Act".
1818
1919 (2) As used in this act, the following words and phrases have the meanings ascribed in this subsection unless the context clearly indicates otherwise:
2020
2121 (a) "Food" means a food, food product, food ingredient, dietary ingredient, dietary supplement or beverage for human consumption.
2222
2323 (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.
2424
2525 (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.
2626
2727 (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.
2828
2929 (e) "Total kratom alkaloids" means the sum of mitragynine, speciociliatine, speciogynine, paynantheine, and
3030
3131 7-hydroxymitragynine.
3232
3333 (f) "Retailer" means a person that sells or maintains kratom products or that advertises, represents or holds itself out as selling, preparing or maintaining kratom products and includes a store, restaurant, hotel, catering facility, camp, bakery, delicatessen, supermarket, grocery store, convenience store, or food or drink company.
3434
3535 (g) "Wholesaler," "jobber" or "distributor" means a person doing a regularly organized wholesale or jobbing business, known to the trade as such, and selling kratom products to licensed retail dealers or other wholesalers for resale in the regular course of business.
3636
3737 (h) "Manufacturer" means a person that produces, prepares, compounds or processes kratom products. This includes a person packaging, repackaging, labeling or relabeling of kratom products.
3838
3939 (i) "Person" has the same meaning as ascribed in Section 1-3-39.
4040
4141 SECTION 2. (1) A retailer, wholesaler, jobber, distributor or manufacturer may not prepare, distribute, or sell any of the following:
4242
4343 (a) A kratom product that does not meet the definition for a kratom product under Section 1 of this act;
4444
4545 (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;
4646
4747 (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
4848
4949 one-half (0.5) milligram per container of the product;
5050
5151 (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;
5252
5353 (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;
5454
5555 (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
5656
5757 (g) A kratom product that is not registered by the Department of Revenue.
5858
5959 (2) Kratom products shall be accompanied by a label bearing the following information prior to sale in this state:
6060
6161 (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;
6262
6363 (b) That the sale or transfer of kratom to a person under twenty-one (21) years of age is prohibited;
6464
6565 (c) The amount of total kratom alkaloids, mitragynine, and 7-hydroxymitragynine contained in the product;
6666
6767 (d) The name and the principal street address of the manufacturer or the person responsible for distributing the product;
6868
6969 (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.
7070
7171 (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
7272
7373 (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.
7474
7575 (3) (a) A retailer, manufacturer or wholesaler may not distribute or sell a kratom product to an individual under twenty-one (21) years of age.
7676
7777 (b) Kratom products offered for sell must be placed behind the retailer's counter.
7878
7979 (c) A person engaged in the business of selling kratom products at retail shall notify each individual employed by that person as a retail sales clerk that state law:
8080
8181 (i) Prohibits the sale or distribution of kratom products, including samples, to a person under twenty-one (21) years of age and the purchase or receipt of kratom products by a person under twenty-one (21) years of age; and
8282
8383 (ii) Requires that proof of age be demanded from a prospective purchaser or recipient if the prospective purchaser or recipient is under the age of twenty-one (21) years. Every person employed by a person engaged in the business of selling kratom products at retail shall sign an agreement with the person's employer in substantially the following or similar form:
8484
8585 "I understand that state law prohibits the sale or distribution of kratom products to persons under the age of twenty-one (21) years and requires that proof of age be demanded from a prospective purchaser or recipient under twenty-one (21) years of age if the individual is not known to the seller, barterer, deliverer or giver of the kratom product to be over the age of twenty-one (21) years. I promise, as a condition of my employment, to observe this law."
8686
8787 (d) A person violating this section must be penalized by a fine of not less than Fifty Dollars ($50.00) nor more than One Hundred Dollars ($100.00).
8888
8989 (e) A retailer who instructs the retailer's employees as required in this section is not liable for a violation committed by those employees.
9090
9191 (4) Upon request by the Department of Revenue, the retailer, manufacturer and wholesaler shall provide test results from a United States-based testing facility to confirm the items listed on the product label.
9292
9393 SECTION 3. (1) A retailer, manufacturer and wholesaler shall register with the Department of Revenue each kratom product intended to be offered for sale to an end consumer. 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 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 act, it may not be registered.
9494
9595 (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.
9696
9797 SECTION 4. This act shall take effect and be in force from and after July 1, 2025.