Based on our review of the available literature, we conclude that regulation of M. speciosa in Wisconsin as a schedule-I substance is not justified at this time. We base this conclusion, in part, on the scientific evidence demonstrating that M. speciosa and its chemical constituents have lower potential for overdose and abuse relative to other agents that are not scheduled in this way. We believe that controlling M. speciosa and its chemical constituents under schedule-I harms public health and stifles much-needed research into its therapeutic and toxic properties.

Abstract

Rationale Kratom derives from Mitragyna speciosa (Korth.), a tropical tree in the genus Mitragyna (Rubiaceae) that also includes the coffee tree. Kratom leaf powders, tea-like decoctions, and commercial extracts are taken orally, primarily for health and well-being by millions of people globally. Others take kratom to eliminate opioid use for analgesia and manage opioid withdrawal and use disorder. There is debate over the possible respiratory depressant overdose risk of the primary active alkaloid, mitragynine, a partial μ-opioid receptor agonist, that does not signal through ß-arrestin, the primary opioid respiratory depressant pathway.

Preface

Kratom science has been increasing almost exponentially over the past decade with more than 100 new published studies addressing kratom safety, benefits, and abuse potential since early 2018. The science provides evidence to guide consumer safety leading to kratom regulations now passed into law in seven states, with many more states considering such laws. As discussed below, these new scientific findings also led the United States Department of Health and Human Services (US DHHS) to reverse its position on Controlled Substances Act (CSA) scheduling and, in August 2018, to rescind its earlier scheduling recommendation to the Drug Enforcement Administration (DEA). More recently, and with still more evidence, in 2021, the World Health Organization Expert Committee on Drug Dependence (WHO ECDD), reviewed the evidence for international scheduling and concluded that there was not sufficient evidence to recommend scheduling, meaning the available data did not show public health risks of kratom warranting international restrictions.

What is clearly needed is balanced regulation to ensure that kratom products purchased by consumers are pure and unadulterated, in other words meeting the same types of standards that apply to other food products, and even bottled water. Steps toward such standards were taken in states that passed their own versions of kratom consumer protection act laws. Ultimately, the Food and Drug Administration (FDA) needs to develop national performance standards for kratom as it does for other products. Such standards will help ensure access to kratom products that are appropriately marketed and are without contaminants and adulterants that might pose safety risks.