The regulatory history of kratom and its alkaloids is a complex and still-evolving story that spans multiple jurisdictions, involves several federal agencies, and has produced significant legal uncertainty for researchers, manufacturers, and consumers alike. Understanding this regulatory landscape, factually and without advocacy, is an important context for anyone engaging with kratom alkaloid science.
This article provides a factual chronological overview of key regulatory developments, focusing on the United States but noting significant international developments. It does not advocate for any particular regulatory outcome.
Traditional Regulation in Southeast Asia
Regulatory action on kratom predates Western scientific attention by decades. In Thailand, Mitragyna speciosa was first regulated under the Kratom Act of 1943, which prohibited cultivation and possession. Historians have noted that the 1943 prohibition coincided with periods of high opium taxation, with some scholarly accounts suggesting economic motivations related to opium revenue may have contributed to the regulatory action, in addition to public health considerations.
Malaysia's Poisons Act categorised kratom as a scheduled substance in 2004. In both countries, regulatory status has evolved over subsequent decades. Thailand decriminalised kratom for certain traditional and medicinal uses in 2021 as part of broader drug policy reform, though commercial sale remains regulated. Indonesia, which is one of the world's largest kratom-producing countries, has faced ongoing regulatory debate about the plant's status.
Early Regulatory Attention in the United States
Kratom first appeared on the radar of US regulatory agencies in the mid-2000s as importation increased. The Drug Enforcement Administration (DEA) added kratom to its ‘drugs and chemicals of concern’ list in 2012, and the FDA began issuing import alerts.
In 2016, the DEA announced its intent to place mitragynine and 7-hydroxymitragynine in Schedule I of the Controlled Substances Act on an emergency basis, the same schedule as heroin and lysergic acid diethylamide (LSD). This action would have made research, possession, and distribution of these compounds illegal without DEA Schedule I research registration. The announcement generated significant public comment, including from the scientific and medical communities, raising concerns about the impact on research and on individuals who had been using kratom as a substitute for prescription opioids. The DEA withdrew the emergency scheduling notice in October 2016, stating it would seek additional public comment and FDA input.
FDA's Position and Enforcement Actions
While the DEA's emergency scheduling attempt was withdrawn, the FDA has maintained a consistently critical posture toward kratom products. The FDA's regulatory concern has operated through several distinct mechanisms:
Import Alerts
The FDA has maintained import alerts that allow detention without physical examination of kratom-containing products at the US border. Import Alert 54-15, first issued in 2012, covers kratom products. These import alerts do not require proof that a specific shipment is adulterated or misbranded; they allow detention based on the agency's prior findings regarding the product category.
Warning Letters
The FDA has issued warning letters to kratom product vendors making explicit health claims, particularly therapeutic or medical claims. Warning letters have cited violations of the Federal Food, Drug, and Cosmetic Act for marketing kratom products as intended to diagnose, treat, cure, or prevent diseases, which would classify them as unapproved new drugs. Warning letters have specifically named 7-hydroxymitragynine as an unapproved new drug ingredient in some cases.
Public Health Advisories
The FDA has issued multiple public statements characterising kratom as a substance of concern, citing adverse event reports including deaths (though most reported deaths involved polypharmacy, simultaneous use of multiple substances, complicating causation analysis), and describing its opioid-like pharmacological properties.
Salmonella-Related Enforcement
In 2018, the FDA coordinated a voluntary recall of kratom products associated with a Salmonella outbreak, and subsequently requested that the CDC investigate kratom-related Salmonella cases. This episode highlighted food safety concerns distinct from the pharmacological debate.
The Kratom Policy Reform Movement and American Kratom Association
In response to federal regulatory pressure, an advocacy and lobbying infrastructure developed around kratom. The American Kratom Association (AKA) has been the primary advocacy organisation, lobbying against federal scheduling and promoting state-level legislation.
The AKA developed and has advocated for the Kratom Consumer Protection Act (KCPA), a model state legislation framework that would not legalise kratom per se but would establish quality and labelling standards, age restrictions (typically 21+), and prohibit adulteration. As of 2024, versions of the KCPA had been enacted in a number of US states including Utah, Georgia, Arizona, and Nevada, while other states have moved in the opposite direction by scheduling kratom.
State-Level Regulation: A Patchwork Landscape
In the absence of federal scheduling, US regulation of kratom has devolved to the state level, producing a highly inconsistent legal landscape:
- States with kratom scheduled as a controlled substance (prohibiting possession and sale): Alabama, Arkansas, Indiana, Rhode Island, Vermont, Wisconsin
- States with age-restriction laws or consumer protection frameworks under KCPA-derived legislation: Utah, Georgia, Arizona, Nevada, Colorado, Oregon (among others, with ongoing legislative activity)
- States where kratom remains unscheduled with no specific regulations: the majority of states, where kratom products are sold as botanical supplements
This patchwork creates significant legal complexity for interstate commerce and for individuals who use kratom and travel across state lines.
The NIH Research Investment
In parallel with enforcement activity, federal research agencies have invested in kratom alkaloid science. The National Institute on Drug Abuse (NIDA) and the National Center for Complementary and Integrative Health (NCCIH) have both funded kratom research. NIDA's investment has been framed primarily around understanding addiction potential and developing safer opioid analgesics. NCCIH's framing has acknowledged the need for rigorous scientific study to understand how kratom is actually being used and what its risk-benefit profile is.
This simultaneous enforcement-and-research posture by federal agencies reflects the genuine scientific uncertainty that characterises the field. The regulatory agencies have acknowledged they do not have sufficient clinical data to make fully evidence-based scheduling decisions, while the research enterprise works to generate that data.
International Regulatory Developments
Internationally, kratom's regulatory status is similarly varied. The World Health Organisation's Expert Committee on Drug Dependence (ECDD) reviewed kratom in 2021 and recommended against international scheduling under the UN drug conventions, citing insufficient evidence of significant public health harm to justify the restrictive consequences of international scheduling. This recommendation represented a significant divergence from the FDA's domestic posture.
In the UK, kratom is not controlled under the Misuse of Drugs Act but is regulated under the Psychoactive Substances Act 2016, which prohibits supply of psychoactive substances not otherwise exempted. In Canada, kratom products are regulated as food under the Food and Drugs Act, with no approved therapeutic claims permitted. Australia has listed mitragynine and related alkaloids in Schedule 9 (prohibited substances).