Stricken language would be deleted from and underlined language would be added to present law. *JMB567* 03/20/2025 12:06:46 PM JMB567 State of Arkansas 1 95th General Assembly A Bill 2 Regular Session, 2025 SENATE BILL 534 3 4 By: Senator G. Leding 5 By: Representative Eubanks 6 7 For An Act To Be Entitled 8 AN ACT TO ESTABLISH THE ARKANSAS KRATOM CONSUMER 9 PROTECTION ACT; TO REMOVE MITRAGYNINE AND 7 -10 HYDROXYMITRAGYNINE, ALSO KNOWN AS KRATOM, FROM THE 11 CONTROLLED SUBSTANCES LIST IN ARKANSAS; AND FOR OTHER 12 PURPOSES. 13 14 15 Subtitle 16 TO ESTABLISH THE ARKANSAS KRATOM 17 CONSUMER PROTECTION ACT; AND TO REMOVE 18 MITRAGYNINE AND 7-HYDROXYMITRAGYNINE, 19 ALSO KNOWN AS KRATOM, FROM THE 20 CONTROLLED SUBSTANCES LIST IN ARKANSAS. 21 22 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 23 24 SECTION 1. Arkansas Code Title 20, Chapter 56, is amended to add an 25 additional subchapter to read as follows: 26 Subchapter 5 — Arkansas Kratom Consumer Protection Act 27 28 20-56-501. Title. 29 This subchapter shall be known and may be cited as the “Arkansas Kratom 30 Consumer Protection Act”. 31 32 20-56-502. Legislative findings. 33 The General Assembly finds that: 34 (1) On February 1, 2016, the Department of Health added 35 mitragynine and 7-hydroxymitragynine, which are two (2) constituent compounds 36 SB534 2 03/20/2025 12:06:46 PM JMB567 of the kratom plant, as Schedule I substances; 1 (2) The Department of Health justified this action on the basis 2 that mitragynine and 7 -hydroxymitragynine induce opioid -like effects when 3 consumed and included kratom as a Schedule I substance since it has no 4 approved medical use by the United States Food and Drug Administration; 5 (3)(A) The United States Food and Drug Administration had 6 encouraged every state to ban kratom on the premise that it would be 7 scheduled by the United States Drug Enforcement Administration as a 8 controlled substance in 2016 and that Alabama, Wisconsin, Indiana, and 9 Vermont had already classified kratom as a Schedule I substance. 10 (B) Rhode Island also banned kratom in 2017 based on 11 information provided by the United State Food and Drug Administration; 12 (4) On October 13, 2016, the United States Drug Enforcement 13 Administration withdrew the United States Drug Enforcement Administration’s 14 scheduling recommendation for kratom, citing insufficient evidence to meet 15 the requirements for classifying mitragynine and 7 -hydroxymitragynine as 16 Schedule I substances; 17 (5) On August 16, 2018, the Assistant Secretary of Health of the 18 United States Department of Health and Human Services withdrew the United 19 States Food and Drug Administration’s second scheduling recommendation for 20 mitragynine and 7-hydroxymitragynine as Schedule I substances citing 21 “disappointingly poor evidence and data and a failure to consider overall 22 public health”; 23 (6) On December 1, 2021, the Expert Committee on Drug Dependence 24 at the United Nations Commission on Narcotic Drugs rejected the 25 recommendation for international scheduling of mitragynine and 7 -26 hydroxymitragynine citing insufficient evidence to support that action; 27 (7) On February 21, 2023, the Indiana House of Representatives, 28 on a vote of 53-40, passed a repeal of the kratom ban and replaced it with 29 the Kratom Consumer Protection Act; 30 (8)(A) On March 1, 2023, the Vermont Department of Health 31 accepted a petition by the American Kratom Association to remove the kratom 32 ban. 33 (B) Upon completion of the planned rulemaking of the 34 Vermont Department of Health, the number of states with a kratom ban has been 35 reduced to five (5) states; 36 SB534 3 03/20/2025 12:06:46 PM JMB567 (9) On March 10, 2023, the Wisconsin Controlled Substances Board 1 passed a motion affirming to the Wisconsin State Legislature that kratom does 2 not meet the statutorily -mandated eight factors established by the Controlled 3 Substances Act for scheduling despite their view kratom should not be removed 4 from scheduling until more research is available; 5 (10) The Rhode Island Legislature is proceeding with the Kratom 6 Consumer Protection Act after the Interim Director of the Rhode Island 7 Department of Health acknowledged kratom does not meet the criteria for 8 scheduling; 9 (11) At this time, nine (9) states, including Utah, Georgia, 10 Arizona, Nevada, Oregon, Colorado, Oklahoma, West Virginia, and Virginia, 11 have passed versions of the Kratom Consumer Protection Act; 12 (12) On March 16, 2022, United States Department of Health and 13 Human Services Secretary Becerra, in a letter to Senator Mike Lee and 14 Representative Mark Pocan, acknowledged “knowledge gaps” on kratom and that 15 “kratom-involved overdose deaths have occurred after use of adulterated 16 kratom products or taking kratom with other substances”; 17 (13) On December 29, 2022, President Joe Biden signed the FY23 18 Omnibus with kratom report language commending the National Institute on Drug 19 Abuse for funding studies on kratom that “may provide help for some Americans 20 struggling with addictions, given its analgesic and less addictive properties 21 as compared to opioids”; 22 (14)(A) Data from the Department of Health shows that fatal 23 opioid overdoses have been on the rise in recent years. 24 (B) In 2021, the Department of Health reported there were 25 six hundred twenty-eight (628) drug overdose deaths in Arkansas; and 26 (15)(A) On May 17, 2022, the Director of the National Institute 27 on Drug Abuse, Dr. Nora Volkow, testified regarding the drug overdose crisis 28 at a hearing of the United States Senate Appropriations Subcommittee on 29 Labor, Health and Human Services, Education, and Related Agencies. 30 (B) When asked about overdose prevention strategies, Dr. 31 Volkow stated: “There’s also interest in the community to test other products 32 that may serve as harm reduction. For example, the use of kratom, which is 33 sold as tea and that contains a drug molecule that has effects that are 34 similar to a dose of buprenorphine but could be utilized also for decreasing 35 withdrawal or depression.” 36 SB534 4 03/20/2025 12:06:46 PM JMB567 1 20-56-503. Definitions. 2 As used in this subchapter: 3 (1) "Food" means a food, food product, food ingredient, dietary 4 ingredient, dietary supplement, or beverage for human consumption; 5 (2)(A) "Kratom product" means a food containing any part of the 6 leaf of the plant Mitragyna speciosa or an extract of the plant mitragyna 7 speciosa. 8 (B) A "kratom product" may be manufactured as a powder, 9 capsule, pill, beverage, extract, or other edible form; 10 (3) “Kratom extract” means a food containing any part of the 11 leaf of the plant Mitragyna speciosa that has been extracted in order to 12 provide more standardized dosing; 13 (4) "Processor" means a person who sells, prepares, 14 manufactures, distributes, or maintains kratom products or advertises, 15 represents, or holds itself out as selling, preparing, or maintaining kratom 16 products; and 17 (5) “Retailer” means a person that sells, distributes, 18 advertises, represents, or holds itself out as selling or maintaining kratom 19 products. 20 21 20-56-504. Kratom product limitations. 22 A processor shall not prepare, distribute, sell, or expose for sale any 23 of the following: 24 (1) A kratom product that: 25 (A)(i) Is adulterated with a dangerous non -kratom 26 substance. 27 (ii) A kratom product is adulterated with a 28 dangerous non-kratom substance if the kratom product is mixed or packed with 29 a non-kratom substance and that substance affects the quality or strength of 30 the kratom product to such a degree as to render the kratom product injurious 31 to a consumer; 32 (B)(i) Is contaminated with a dangerous non -kratom 33 substance. 34 (ii) A kratom product is contaminated with a 35 dangerous non-kratom substance if the kratom product contains a poisonous or 36 SB534 5 03/20/2025 12:06:46 PM JMB567 otherwise deleterious non -kratom ingredient, including without limitation the 1 substances listed in the state’s controlled substances list; 2 (C) Contains: 3 (i) A level of 7-hydroxymitragynine in the alkaloid 4 fraction that is greater than one percent (1%) of the overall alkaloid 5 composition of the product; or 6 (ii) Any synthetic alkaloids including synthetic 7 mitragynine, synthetic 7 -hydroxymitragynine, or any other synthetically 8 derived compounds of the kratom plant; 9 (2) A kratom extract that contains levels of residual solvents 10 higher than is allowed in the U.S. Pharmacopeia Chapter 467; or 11 (3) A kratom product or kratom extract that does not provide 12 adequate labeling directions necessary for safe use by consumers, including a 13 recommended serving size, the recommended number of servings per day, and the 14 number of servings in the package that is sold. 15 16 20-56-505. Age limits. 17 A processor or retailer shall not distribute, sell, or expose for sale 18 a kratom product to an individual under eighteen (18) years of age. 19 20 20-56-506. Processor registration. 21 (a)(1) A processor shall register annually with the Department of 22 Agriculture any kratom product or kratom extract intended to be offered for 23 sale to an end consumer that is in an approved kratom delivery form and pay a 24 fee that is adjusted annually to cover all administrative costs for 25 processing and administering the registrations. 26 (2) The registration shall include a certificate of analysis 27 from a certified independent third -party laboratory showing compliance with 28 the requirements for kratom products or kratom extracts in this subchapter. 29 (b)(1) Upon receipt of a credible report of noncompliance with this 30 subchapter on a kratom product or kratom extract offered for sale, the 31 department shall require the processor to produce an updated and current 32 certificate of analysis in a reasonable time frame from a certified 33 independent third-party laboratory showing compliance with the requirements 34 of this subchapter for safe kratom products or kratom extracts. 35 (2) If the processor does not provide the certificate of 36 SB534 6 03/20/2025 12:06:46 PM JMB567 analysis in subdivision (b)(1) of this section in the specified time frame, 1 the registration for that kratom product or kratom extract shall be revoked. 2 (c)(1) Upon receipt of any adverse event related to a registered 3 kratom product or kratom extract, the processor shall submit a copy of the 4 adverse event report via certified mail to the department that is required to 5 be submitted to the United States Food and Drug Administration under Section 6 761 of the Federal Food, Drug, and Cosmetic Act. 7 (2) The department may revoke the kratom product’s or kratom 8 extract's registration for any documented failure to report an adverse event 9 to the department. 10 (d)(1) If the department has a reasonable basis to require an 11 independent third-party test of a registered kratom product or kratom extract 12 by a laboratory of the department’s choice, the processor shall be required 13 to submit payment for the test within a reasonable time frame. 14 (2) If the processor does not tender payment to the department 15 within a set time period upon receipt of the invoice for the testing, the 16 department shall revoke the registration for that kratom product or kratom 17 extract. 18 19 20-56-507. Violations. 20 (a)(1) A processor that violates this subchapter is subject to an 21 administrative fine of not more than five hundred dollars ($500) for the 22 first offense and not more than one thousand dollars ($1,000) for a second or 23 subsequent offense. 24 (2) Upon the request of a person to whom an administrative fine 25 is issued, the Secretary of the Department of Agriculture shall conduct a 26 hearing in accordance with the Arkansas Administrative Procedure Act, § 25 -27 15-201 et seq. 28 (b) A retailer does not violate this subchapter if it is shown by a 29 preponderance of the evidence that the retailer relied in good faith upon the 30 representations of a processor of food represented to be a kratom product or 31 kratom extract. 32 33 34 35 36