HLS 25RS-163 ORIGINAL 2025 Regular Session HOUSE BILL NO. 253 BY REPRESENTATIVE BOYER Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. DRUGS: Provides relative to kratom 1 AN ACT 2To enact Chapter 9 of Title 26 of the Louisiana Revised Statutes of 1950, to be comprised 3 of R.S. 26:941 through 944, relative to kratom products; to provide for definitions; 4 to prohibit sale or distribution of kratom to persons under twenty-one years of age 5 and under other circumstances; to provide labeling requirements for kratom 6 products; to provide for approval and registration of kratom products; and to provide 7 for related matters. 8Be it enacted by the Legislature of Louisiana: 9 Section 1. Chapter 9 of Title 26 of the Louisiana Revised Statutes of 1950, 10comprised of R.S. 26:941 through 944, is hereby enacted to read as follows: 11 CHAPTER 9. KRATOM CONSUMER PROTECTI ON ACT 12 §941. Short title 13 This Chapter shall be known and may be cited as the "Kratom Consumer 14 Protection Act". 15 §942. Definitions 16 As used in this Chapter, the following terms have the following meanings: 17 (1) "Artificial" means produced using directed synthetic, semi-synthetic, or 18 biosynthetic chemistry, as opposed to traditional food preparation techniques such 19 as heating or extracting. Page 1 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-163 ORIGINAL HB NO. 253 1 (2) "Food" means a food, food product, food ingredient, dietary ingredient, 2 dietary supplement, or beverage for human consumption. 3 (3) "Kratom leaf" means the leaf of the kratom plant, Mitragyna speciosa, 4 in fresh or dehydrated or dried form that undergoes no post-harvest processing other 5 than drying or size reduction by cutting, milling, or similar procedure, and may be 6 cleaned or sterilized using standard treatments applied to food ingredients, such as 7 heat, steam, pressurization, or irradiation or other standard treatments applied to food 8 ingredients. 9 (4) "Kratom leaf extract" means the material obtained by extracting kratom 10 using a solvent consisting of water, ethanol, or food-grade solvent. 11 (5) "Kratom product" means a food or dietary supplement that consists of or 12 contains kratom leaf or kratom leaf extract. 13 (6) "Total kratom alkaloids" means the sum amount of mitragynine, 14 speciociliatine, speciogynine, paynantheine, and 7-hydroxymitragynine. 15 (7) "Vendor" means a person that sells, prepares, or maintains kratom 16 products or that advertises, represents, or holds itself out as selling, preparing, or 17 maintaining kratom products and includes a manufacturer, wholesaler, store, 18 restaurant, or any business that provides kratom to its customers or clients. 19 §943. Kratom products criteria 20 A. A vendor shall not prepare, manufacture, process, distribute, or sell any 21 of the following: 22 (1) A kratom product that does not meet the definition for a kratom product 23 pursuant to R.S. 26:942. 24 (2) A kratom product that contains a substance that is not safe for human 25 consumption. 26 (3) A kratom product containing a level of 7-hydroxymitragynine in the 27 alkaloid fraction that is greater than one percent of the alkaloid composition and 28 exceeding one-half milligram per container of the product. Page 2 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-163 ORIGINAL HB NO. 253 1 (4) A kratom product containing any artificial alkaloid, including 2 mitragynine, 7-hydroxymitragynine, or any other artificial compounds or metabolites 3 of the kratom plant. 4 (5) A kratom product containing a level of any residual solvent that was used 5 in the manufacturing of the kratom product and exceeds the residual level specified 6 for pharmaceutical products by the United States Department of Health and Human 7 Services, Food and Drug Administration. 8 (6) A kratom product in which the total alkaloid content of kratom leaf 9 material used exceeds three and one-half percent measured on a dry weight basis. 10 (7) A kratom product that contains a level of 7-hydroxymitragynine, on a 11 percent weight basis, that is greater than one percent of the amount of total kratom 12 alkaloids, as confirmed with a high-performance liquid chromatography testing 13 method and exceeds one milligram per container. 14 (8) A kratom product in which the amount of mitragynine is not twice that 15 of any other alkaloid present. The ratio of mitragynine to other alkaloids in the 16 product shall be equal to or greater than the ratio found in the starting material. 17 (9) A liquid kratom product that is not packaged in a retail container clearly 18 identifying the serving size. 19 (10) A kratom product that is not registered by the Louisiana Department of 20 Health. 21 B. Kratom products shall be accompanied by a label bearing the following 22 information prior to its sale in this state: 23 (1) A list of the ingredients, which shall include the common or usual name 24 of each ingredient used in the manufacture of the product, listed in descending order 25 of predominance. 26 (2) That the sale or transfer of kratom to a person under twenty-one years of 27 age is prohibited. 28 (3) The amount of total kratom alkaloids, mitragynine, and 7- 29 hydroxymitragynine contained in the product or in each serving. 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HLS 25RS-163 ORIGINAL HB NO. 253 1 (4) The name and the principal street address of the vendor or the person 2 responsible for distributing the product. 3 (5) Any federal food allergen labeling requirements, if applicable, and clear 4 and adequate directions for the consumption and safe and effective use of such 5 product, including the recommended serving size, the number of servings in the 6 container, and the number of servings that can be safely consumed in a day. 7 (6) A warning that a consumer should consult a healthcare professional on 8 questions about the use of kratom, that the product may be habit-forming, and a 9 statement that the kratom product is not intended to "diagnose, treat, cure, or prevent 10 any disease". 11 (7) A statement that a kratom product label is prohibited from making any 12 therapeutic claims unless approved by the United States Food and Drug 13 Administration. 14 C. Upon request by the Louisiana Department of Health, the vendor shall 15 provide test results from a United States-based testing facility to confirm the items 16 listed on the product label. 17 §944. Registration and reporting 18 A.(1) A manufacturer shall register with the Louisiana Department of Health 19 each kratom product intended to be offered for sale to an end consumer. Each 20 kratom product registration is valid for one year. 21 (2) A manufacturer shall pay to the Louisiana Department of Health a 22 registration fee, adjusted annually, to cover all administrative costs for processing 23 and administering the registration program. 24 (3)(a) Upon payment of the registration fee, a manufacturer shall submit a 25 certificate of analysis for a product from a United States-based testing facility to 26 confirm the items listed on the product label, which must conform to this Chapter. 27 (b) If the kratom product does not comply with the requirements of this 28 Subsection, the department shall not register the product. Page 4 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-163 ORIGINAL HB NO. 253 1 B.(1) Upon learning of an adverse event related to a registered kratom 2 product, a processor shall submit an adverse event report via certified mail to the 3 Louisiana Department of Health and the United States Food and Drug 4 Administration in accordance with federal law. 5 (2) A failure to report an adverse event to the department shall authorize the 6 secretary to revoke a product's registration. DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 253 Original 2025 Regular Session Boyer Abstract: Prohibits the sale of kratom products that do not meet certain chemical makeup and packaging requirements. Requires kratom manufacturers to register products with the La. Dept. of Health (LDH) and submit a certificate of analysis verifying the product's contents. Proposed law provides definitions regarding kratom products. Proposed law prohibits vendors and manufacturers from producing or selling kratom products: (1)That contain dangerous substances. (2)That contain more than 1% of 7-hydroxymitragynine. (3)That contain levels of residual solvents in amounts higher than that specified by the FDA. (4)That contain levels of alkaloids higher than 3.5%. (5)In which the amount of mitragynine is less than the starting material. (6)That are liquid products which do not clearly identify the serving size. (7)That are not registered by the La. Dept. of Health. Proposed law states that labels for kratom products shall: (1)List all ingredients. (2)State that the sale of kratom to a person under 21 is prohibited. (3)List the amount of total kratom alkaloids. (4)Identify the name and address of the vendor. (5)List any food allergens. Page 5 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 25RS-163 ORIGINAL HB NO. 253 (6)Provide a warning that the consumer should consult a healthcare professional for questions. (7)Provide a statement that the label is prohibited from making any therapeutic. claims unless approved by the FDA. Proposed law requires a vendor to provide kratom test results upon request by LDH. Proposed law requires manufacturers to register kratom products with LDH annually and pay a registration fee to LDH. Proposed law requires manufacturers to submit a certificate of analysis from a testing facility. Proposed law provides that LDH shall not register products that do not comply with registration requirements. Proposed law requires processors to submit adverse event reports to LDH upon discovery of adverse events. Proposed law provides that a failure to report an adverse event shall authorize the secretary to revoke a product's registration. (Adds R.S. 26:941-944) Page 6 of 6 CODING: Words in struck through type are deletions from existing law; words underscored are additions.