1 | 1 | | Stricken language would be deleted from and underlined language would be added to present law. |
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2 | 2 | | *JMB567* 03/20/2025 12:06:46 PM JMB567 |
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3 | 3 | | State of Arkansas 1 |
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4 | 4 | | 95th General Assembly A Bill 2 |
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5 | 5 | | Regular Session, 2025 SENATE BILL 534 3 |
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6 | 6 | | 4 |
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7 | 7 | | By: Senator G. Leding 5 |
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8 | 8 | | By: Representative Eubanks 6 |
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9 | 9 | | 7 |
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10 | 10 | | For An Act To Be Entitled 8 |
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11 | 11 | | AN ACT TO ESTABLISH THE ARKANSAS KRATOM CONSUMER 9 |
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12 | 12 | | PROTECTION ACT; TO REMOVE MITRAGYNINE AND 7 -10 |
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13 | 13 | | HYDROXYMITRAGYNINE, ALSO KNOWN AS KRATOM, FROM THE 11 |
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14 | 14 | | CONTROLLED SUBSTANCES LIST IN ARKANSAS; AND FOR OTHER 12 |
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15 | 15 | | PURPOSES. 13 |
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16 | 16 | | 14 |
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17 | 17 | | 15 |
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18 | 18 | | Subtitle 16 |
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19 | 19 | | TO ESTABLISH THE ARKANSAS KRATOM 17 |
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20 | 20 | | CONSUMER PROTECTION ACT; AND TO REMOVE 18 |
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21 | 21 | | MITRAGYNINE AND 7-HYDROXYMITRAGYNINE, 19 |
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22 | 22 | | ALSO KNOWN AS KRATOM, FROM THE 20 |
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23 | 23 | | CONTROLLED SUBSTANCES LIST IN ARKANSAS. 21 |
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24 | 24 | | 22 |
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25 | 25 | | BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 23 |
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26 | 26 | | 24 |
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27 | 27 | | SECTION 1. Arkansas Code Title 20, Chapter 56, is amended to add an 25 |
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28 | 28 | | additional subchapter to read as follows: 26 |
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29 | 29 | | Subchapter 5 — Arkansas Kratom Consumer Protection Act 27 |
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30 | 30 | | 28 |
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31 | 31 | | 20-56-501. Title. 29 |
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32 | 32 | | This subchapter shall be known and may be cited as the “Arkansas Kratom 30 |
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33 | 33 | | Consumer Protection Act”. 31 |
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34 | 34 | | 32 |
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35 | 35 | | 20-56-502. Legislative findings. 33 |
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36 | 36 | | The General Assembly finds that: 34 |
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37 | 37 | | (1) On February 1, 2016, the Department of Health added 35 |
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38 | 38 | | mitragynine and 7-hydroxymitragynine, which are two (2) constituent compounds 36 SB534 |
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39 | 39 | | |
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41 | 41 | | of the kratom plant, as Schedule I substances; 1 |
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42 | 42 | | (2) The Department of Health justified this action on the basis 2 |
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43 | 43 | | that mitragynine and 7 -hydroxymitragynine induce opioid -like effects when 3 |
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44 | 44 | | consumed and included kratom as a Schedule I substance since it has no 4 |
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45 | 45 | | approved medical use by the United States Food and Drug Administration; 5 |
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46 | 46 | | (3)(A) The United States Food and Drug Administration had 6 |
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47 | 47 | | encouraged every state to ban kratom on the premise that it would be 7 |
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48 | 48 | | scheduled by the United States Drug Enforcement Administration as a 8 |
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49 | 49 | | controlled substance in 2016 and that Alabama, Wisconsin, Indiana, and 9 |
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50 | 50 | | Vermont had already classified kratom as a Schedule I substance. 10 |
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51 | 51 | | (B) Rhode Island also banned kratom in 2017 based on 11 |
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52 | 52 | | information provided by the United State Food and Drug Administration; 12 |
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53 | 53 | | (4) On October 13, 2016, the United States Drug Enforcement 13 |
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54 | 54 | | Administration withdrew the United States Drug Enforcement Administration’s 14 |
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55 | 55 | | scheduling recommendation for kratom, citing insufficient evidence to meet 15 |
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56 | 56 | | the requirements for classifying mitragynine and 7 -hydroxymitragynine as 16 |
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57 | 57 | | Schedule I substances; 17 |
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58 | 58 | | (5) On August 16, 2018, the Assistant Secretary of Health of the 18 |
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59 | 59 | | United States Department of Health and Human Services withdrew the United 19 |
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60 | 60 | | States Food and Drug Administration’s second scheduling recommendation for 20 |
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61 | 61 | | mitragynine and 7-hydroxymitragynine as Schedule I substances citing 21 |
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62 | 62 | | “disappointingly poor evidence and data and a failure to consider overall 22 |
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63 | 63 | | public health”; 23 |
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64 | 64 | | (6) On December 1, 2021, the Expert Committee on Drug Dependence 24 |
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65 | 65 | | at the United Nations Commission on Narcotic Drugs rejected the 25 |
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66 | 66 | | recommendation for international scheduling of mitragynine and 7 -26 |
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67 | 67 | | hydroxymitragynine citing insufficient evidence to support that action; 27 |
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68 | 68 | | (7) On February 21, 2023, the Indiana House of Representatives, 28 |
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69 | 69 | | on a vote of 53-40, passed a repeal of the kratom ban and replaced it with 29 |
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70 | 70 | | the Kratom Consumer Protection Act; 30 |
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71 | 71 | | (8)(A) On March 1, 2023, the Vermont Department of Health 31 |
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72 | 72 | | accepted a petition by the American Kratom Association to remove the kratom 32 |
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73 | 73 | | ban. 33 |
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74 | 74 | | (B) Upon completion of the planned rulemaking of the 34 |
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75 | 75 | | Vermont Department of Health, the number of states with a kratom ban has been 35 |
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76 | 76 | | reduced to five (5) states; 36 SB534 |
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77 | 77 | | |
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79 | 79 | | (9) On March 10, 2023, the Wisconsin Controlled Substances Board 1 |
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80 | 80 | | passed a motion affirming to the Wisconsin State Legislature that kratom does 2 |
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81 | 81 | | not meet the statutorily -mandated eight factors established by the Controlled 3 |
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82 | 82 | | Substances Act for scheduling despite their view kratom should not be removed 4 |
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83 | 83 | | from scheduling until more research is available; 5 |
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84 | 84 | | (10) The Rhode Island Legislature is proceeding with the Kratom 6 |
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85 | 85 | | Consumer Protection Act after the Interim Director of the Rhode Island 7 |
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86 | 86 | | Department of Health acknowledged kratom does not meet the criteria for 8 |
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87 | 87 | | scheduling; 9 |
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88 | 88 | | (11) At this time, nine (9) states, including Utah, Georgia, 10 |
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89 | 89 | | Arizona, Nevada, Oregon, Colorado, Oklahoma, West Virginia, and Virginia, 11 |
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90 | 90 | | have passed versions of the Kratom Consumer Protection Act; 12 |
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91 | 91 | | (12) On March 16, 2022, United States Department of Health and 13 |
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92 | 92 | | Human Services Secretary Becerra, in a letter to Senator Mike Lee and 14 |
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93 | 93 | | Representative Mark Pocan, acknowledged “knowledge gaps” on kratom and that 15 |
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94 | 94 | | “kratom-involved overdose deaths have occurred after use of adulterated 16 |
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95 | 95 | | kratom products or taking kratom with other substances”; 17 |
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96 | 96 | | (13) On December 29, 2022, President Joe Biden signed the FY23 18 |
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97 | 97 | | Omnibus with kratom report language commending the National Institute on Drug 19 |
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98 | 98 | | Abuse for funding studies on kratom that “may provide help for some Americans 20 |
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99 | 99 | | struggling with addictions, given its analgesic and less addictive properties 21 |
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100 | 100 | | as compared to opioids”; 22 |
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101 | 101 | | (14)(A) Data from the Department of Health shows that fatal 23 |
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102 | 102 | | opioid overdoses have been on the rise in recent years. 24 |
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103 | 103 | | (B) In 2021, the Department of Health reported there were 25 |
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104 | 104 | | six hundred twenty-eight (628) drug overdose deaths in Arkansas; and 26 |
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105 | 105 | | (15)(A) On May 17, 2022, the Director of the National Institute 27 |
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106 | 106 | | on Drug Abuse, Dr. Nora Volkow, testified regarding the drug overdose crisis 28 |
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107 | 107 | | at a hearing of the United States Senate Appropriations Subcommittee on 29 |
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108 | 108 | | Labor, Health and Human Services, Education, and Related Agencies. 30 |
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109 | 109 | | (B) When asked about overdose prevention strategies, Dr. 31 |
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110 | 110 | | Volkow stated: “There’s also interest in the community to test other products 32 |
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111 | 111 | | that may serve as harm reduction. For example, the use of kratom, which is 33 |
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112 | 112 | | sold as tea and that contains a drug molecule that has effects that are 34 |
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113 | 113 | | similar to a dose of buprenorphine but could be utilized also for decreasing 35 |
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114 | 114 | | withdrawal or depression.” 36 SB534 |
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115 | 115 | | |
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117 | 117 | | 1 |
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118 | 118 | | 20-56-503. Definitions. 2 |
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119 | 119 | | As used in this subchapter: 3 |
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120 | 120 | | (1) "Food" means a food, food product, food ingredient, dietary 4 |
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121 | 121 | | ingredient, dietary supplement, or beverage for human consumption; 5 |
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122 | 122 | | (2)(A) "Kratom product" means a food containing any part of the 6 |
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123 | 123 | | leaf of the plant Mitragyna speciosa or an extract of the plant mitragyna 7 |
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124 | 124 | | speciosa. 8 |
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125 | 125 | | (B) A "kratom product" may be manufactured as a powder, 9 |
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126 | 126 | | capsule, pill, beverage, extract, or other edible form; 10 |
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127 | 127 | | (3) “Kratom extract” means a food containing any part of the 11 |
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128 | 128 | | leaf of the plant Mitragyna speciosa that has been extracted in order to 12 |
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129 | 129 | | provide more standardized dosing; 13 |
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130 | 130 | | (4) "Processor" means a person who sells, prepares, 14 |
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131 | 131 | | manufactures, distributes, or maintains kratom products or advertises, 15 |
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132 | 132 | | represents, or holds itself out as selling, preparing, or maintaining kratom 16 |
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133 | 133 | | products; and 17 |
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134 | 134 | | (5) “Retailer” means a person that sells, distributes, 18 |
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135 | 135 | | advertises, represents, or holds itself out as selling or maintaining kratom 19 |
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136 | 136 | | products. 20 |
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137 | 137 | | 21 |
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138 | 138 | | 20-56-504. Kratom product limitations. 22 |
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139 | 139 | | A processor shall not prepare, distribute, sell, or expose for sale any 23 |
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140 | 140 | | of the following: 24 |
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141 | 141 | | (1) A kratom product that: 25 |
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142 | 142 | | (A)(i) Is adulterated with a dangerous non -kratom 26 |
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143 | 143 | | substance. 27 |
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144 | 144 | | (ii) A kratom product is adulterated with a 28 |
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145 | 145 | | dangerous non-kratom substance if the kratom product is mixed or packed with 29 |
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146 | 146 | | a non-kratom substance and that substance affects the quality or strength of 30 |
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147 | 147 | | the kratom product to such a degree as to render the kratom product injurious 31 |
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148 | 148 | | to a consumer; 32 |
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149 | 149 | | (B)(i) Is contaminated with a dangerous non -kratom 33 |
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150 | 150 | | substance. 34 |
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151 | 151 | | (ii) A kratom product is contaminated with a 35 |
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152 | 152 | | dangerous non-kratom substance if the kratom product contains a poisonous or 36 SB534 |
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153 | 153 | | |
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155 | 155 | | otherwise deleterious non -kratom ingredient, including without limitation the 1 |
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156 | 156 | | substances listed in the state’s controlled substances list; 2 |
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157 | 157 | | (C) Contains: 3 |
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158 | 158 | | (i) A level of 7-hydroxymitragynine in the alkaloid 4 |
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159 | 159 | | fraction that is greater than one percent (1%) of the overall alkaloid 5 |
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160 | 160 | | composition of the product; or 6 |
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161 | 161 | | (ii) Any synthetic alkaloids including synthetic 7 |
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162 | 162 | | mitragynine, synthetic 7 -hydroxymitragynine, or any other synthetically 8 |
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163 | 163 | | derived compounds of the kratom plant; 9 |
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164 | 164 | | (2) A kratom extract that contains levels of residual solvents 10 |
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165 | 165 | | higher than is allowed in the U.S. Pharmacopeia Chapter 467; or 11 |
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166 | 166 | | (3) A kratom product or kratom extract that does not provide 12 |
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167 | 167 | | adequate labeling directions necessary for safe use by consumers, including a 13 |
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168 | 168 | | recommended serving size, the recommended number of servings per day, and the 14 |
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169 | 169 | | number of servings in the package that is sold. 15 |
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170 | 170 | | 16 |
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171 | 171 | | 20-56-505. Age limits. 17 |
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172 | 172 | | A processor or retailer shall not distribute, sell, or expose for sale 18 |
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173 | 173 | | a kratom product to an individual under eighteen (18) years of age. 19 |
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174 | 174 | | 20 |
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175 | 175 | | 20-56-506. Processor registration. 21 |
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176 | 176 | | (a)(1) A processor shall register annually with the Department of 22 |
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177 | 177 | | Agriculture any kratom product or kratom extract intended to be offered for 23 |
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178 | 178 | | sale to an end consumer that is in an approved kratom delivery form and pay a 24 |
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179 | 179 | | fee that is adjusted annually to cover all administrative costs for 25 |
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180 | 180 | | processing and administering the registrations. 26 |
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181 | 181 | | (2) The registration shall include a certificate of analysis 27 |
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182 | 182 | | from a certified independent third -party laboratory showing compliance with 28 |
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183 | 183 | | the requirements for kratom products or kratom extracts in this subchapter. 29 |
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184 | 184 | | (b)(1) Upon receipt of a credible report of noncompliance with this 30 |
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185 | 185 | | subchapter on a kratom product or kratom extract offered for sale, the 31 |
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186 | 186 | | department shall require the processor to produce an updated and current 32 |
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187 | 187 | | certificate of analysis in a reasonable time frame from a certified 33 |
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188 | 188 | | independent third-party laboratory showing compliance with the requirements 34 |
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189 | 189 | | of this subchapter for safe kratom products or kratom extracts. 35 |
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190 | 190 | | (2) If the processor does not provide the certificate of 36 SB534 |
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191 | 191 | | |
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193 | 193 | | analysis in subdivision (b)(1) of this section in the specified time frame, 1 |
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194 | 194 | | the registration for that kratom product or kratom extract shall be revoked. 2 |
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195 | 195 | | (c)(1) Upon receipt of any adverse event related to a registered 3 |
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196 | 196 | | kratom product or kratom extract, the processor shall submit a copy of the 4 |
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197 | 197 | | adverse event report via certified mail to the department that is required to 5 |
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198 | 198 | | be submitted to the United States Food and Drug Administration under Section 6 |
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199 | 199 | | 761 of the Federal Food, Drug, and Cosmetic Act. 7 |
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200 | 200 | | (2) The department may revoke the kratom product’s or kratom 8 |
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201 | 201 | | extract's registration for any documented failure to report an adverse event 9 |
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202 | 202 | | to the department. 10 |
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203 | 203 | | (d)(1) If the department has a reasonable basis to require an 11 |
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204 | 204 | | independent third-party test of a registered kratom product or kratom extract 12 |
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205 | 205 | | by a laboratory of the department’s choice, the processor shall be required 13 |
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206 | 206 | | to submit payment for the test within a reasonable time frame. 14 |
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207 | 207 | | (2) If the processor does not tender payment to the department 15 |
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208 | 208 | | within a set time period upon receipt of the invoice for the testing, the 16 |
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209 | 209 | | department shall revoke the registration for that kratom product or kratom 17 |
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210 | 210 | | extract. 18 |
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211 | 211 | | 19 |
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212 | 212 | | 20-56-507. Violations. 20 |
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213 | 213 | | (a)(1) A processor that violates this subchapter is subject to an 21 |
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214 | 214 | | administrative fine of not more than five hundred dollars ($500) for the 22 |
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215 | 215 | | first offense and not more than one thousand dollars ($1,000) for a second or 23 |
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216 | 216 | | subsequent offense. 24 |
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217 | 217 | | (2) Upon the request of a person to whom an administrative fine 25 |
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218 | 218 | | is issued, the Secretary of the Department of Agriculture shall conduct a 26 |
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219 | 219 | | hearing in accordance with the Arkansas Administrative Procedure Act, § 25 -27 |
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220 | 220 | | 15-201 et seq. 28 |
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221 | 221 | | (b) A retailer does not violate this subchapter if it is shown by a 29 |
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222 | 222 | | preponderance of the evidence that the retailer relied in good faith upon the 30 |
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223 | 223 | | representations of a processor of food represented to be a kratom product or 31 |
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224 | 224 | | kratom extract. 32 |
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225 | 225 | | 33 |
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226 | 226 | | 34 |
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227 | 227 | | 35 |
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228 | 228 | | 36 |
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