Kratom is an almost-indefinable substance. It is a leaf from a Southeast Asian tree. The tree belongs to “the coffee family,” but the leaf itself contains multiple substances, including an alkaloid that could lead to drug addiction. With the lack of an easy definition, kratom falls into a legal gray area—with its proponents pointing out that it has been used in Southeast Asia for millennia, while its detractors note that it is not FDA-approved for medical use and has been linked to deaths in the United States and abroad.
Kratom’s regulatory complexity is further complicated by the dose-dependent nature of its pharmacological effects. At “low doses” from “1 to 5 g[rams]” it acts as a stimulant, but “beyond 5 g[rams],” it’s a sedative and acts as an opioid. This is because kratom contains two separate substances, and research is likely to show that it has others. The stimulant is mitragynine, traditionally used as a “household remedy” and to “combat fatigue.” The opioid is 7-hydroxymitragynine (7-OH), and in the small amounts present in the leaf or tea form, comes at too low of a dose to do much besides decrease anxiety or to help “relax and sociali[ze.]” But because the 7-OH can be extracted and made more potent via synthetic manipulation, kratom consumption can become dangerous, including possible liver toxicity, seizures, and even substance use disorder. The fact remains that kratom leaf has “addictive qualities” because of that opioid-like substance.
In addition to that, there is no standardized level of substance or drug in the leaf when it occurs in its natural form. It depends on the subtype of the tree, and therefore “certificates” are not useful when it comes to “guarantees” of quality or quantity. Another challenge is that some users, scientists, and professionals support some form of kratom (not an outright ban) on the market because it can be very useful to “get off of strong prescription opioids[,]” making it a safer down-rap from possible addiction. But that merely circles back around to the fact that kratom itself can be addictive. In fact, dealing with kratom withdrawals can be more challenging because users are not only withdrawing from the opioid-like mitragynine, but also the other substances in the leaf—and that “just treating the opioid effect is . . . not enough[.]”
Currently in the United States, kratom is not approved by the FDA for medical use and is not subject to a clear federal regulatory framework. Instead of formal regulation, the FDA has issued warnings and advisories expressing safety concerns and pointing to the lack of reliable research.
There have been a multitude of proposals for how to manage the increasing consumption of this plant. The Child Mind Institute proposes placing kratom in the same regulatory class as drugs like oxycodone and Adderall, so that it isn’t fully banned, but can be safely prescribed by a physicians. The Drug Enforcement Administration merely lists kratom as a “Chemical of Concern.” The Mayo Clinic does not explicitly propose any type of regulation, but strongly advises against using kratom, citing to a dearth of research and urging people to seek alternative treatments.
Because of Kratom’s traditional use, like coffee, it may not be appropriate to schedule this drug under federal law. Moreover, the plant’s multi-substance nature and variable effects make it difficult to create neatly drawn regulatory boxes designed for single-compound pharmaceuticals. But it is undeniable that kratom leaf (not to mention the stronger compounds that can be drawn from it) can have strong effects, ranging from the substances themselves to behavioral tendencies to self-medicate. And even in some countries of Southeast Asia, where kratom consumption originated as a household cure-all tea for illness or a social relaxant, governments have cracked down on its usage. Some scientists urge caution with regulation given such a long history of mild traditional use.
It is clear that the best action to take is not nothing, but that scientific research is desperately needed to better understand kratom’s pharmacology, risks, and potential therapeutic uses. That research will probably lead to complex regulations, given the multi-substance nature of the leaf, but will better reflect the reality of consumption. The leaf is chemically complicated, which is why regulation will be challenging—and simultaneously, why regulation is desperately needed. This will ultimately make kratom consumption safer without either taking no action (despite knowing the increased questions kratom is posing) or a total ban (which neither users nor health professionals advocate for).