Leading Kratom Scientists Call on FDA, DEA to Keep Kratom Legal

In a recent article published in International Journal of Drug Policy, leading kratom researchers called on the FDA, DEA, and legislators to keep kratom legal, as placing kratom on Schedule 1 would impede research and cause damaging public health consequences. Authors included Chris McCurdy, Andrew Kruegal, Jack Henningfield, and the late Bonnie Avery (who passed away of cancer in March, and to whom the paper is dedicated).

The article entitled “Kratom policy: The challenge of balancing therapeutic potential with public safety” is available online for free. I encourage anyone interested in kratom science to read not only this article, but the source material as well.

This is great source material for commenting on negative news and in other online forums. Let’s highlight some of the main points that contradict the FDA and mainstream media narrative.

Point 1: Scheduling kratom would push many consumers into a newly created black market

Clearly, scheduling kratom would create a situation where kratom consumers would either have to buy it on the black market, or turn to illegally acquired opioids or heroin to manage chronic pain or withdrawal, causing significant public health and social problems. We’ve seen prohibition and the War on Drugs fail over and over again. Banning substances clearly does not work. By scheduling, policymakers, purposefully or ignorantly, will be creating an illegal, dangerous market for kratom. From the article:

First, such a classification would likely foster a significant “black market” for kratom products. Many thousands of individuals in the US have been using kratom as a means of avoiding use of more dangerous classical opioids and are terrified of losing what they view as a life-line to sobriety (Anson, 2016; DEA, 2016c; FDA, 2018c; Henningfield et al., 2018). It is reasonable to conclude that under Schedule 1 restrictions, a subset of kratom users would turn to or return to prescription or illicit opioids, resulting in an increase in unintended negative public health consequences, including higher incidence of OUD, incarceration, and overdose death.

Point 2: Scheduling kratom would impede necessary research

The paper outlines exactly how a Schedule 1 ban on kratom would essentially block the science necessary to understand kratom. American politics has a long, shameful tradition of stopping the progress of science. Research into the benefits of cannabis and psychedelics have been virtually halted because of reactionary prohibition laws, passed purposefully to make criminals out of citizens undesirable to figures like Harry Anslinger and Richard Nixon.

…a move of kratom or its constituents to Schedule I will make it much more difficult for researchers to conduct necessary research exploring kratom’s medicinal potential (Chen, 2016). In this regard, the legal milieu surrounding kratom is comparable to what has happened with “medical marijuana” and psychedelic-assisted therapies, where federal policies, including classification as a Schedule I substance, have impeded hypothesis-driven research investigations (Belouin & Henningfield, 2018; Stith & Vigil, 2016). Many institutions and government agencies are reluctant to fund research on Schedule I substances because such work involves infrastructure and resources that many institutions lack (Belouin & Henningfield, 2018).

While research is scarce and concerns about how kratom interacts with other drugs are valid, Schedule 1 will keep scientists ignorant about how kratom interacts with other drugs. For most consumers, kratom is relatively benign, a mild stimulant and at larger doses, a mild painkiller. Deaths from pure leaf kratom have never been reported in hundreds of years of use in Southeast Asia, and as we’ve discussed here many times, deaths reported in the West are the result of adulteration or a mixture with other drugs that can kill on their own, usually fentanyl.

Finally, almost nothing is known about how kratom might interact with other drugs or herbal agents that subjects may be using. Unfortunately, future control as a Schedule I substance would erect substantial barriers to this necessary research. Furthermore, the source of funding for such work is unclear, given the limited commercial opportunity provided by unpatentable natural products.

Point 3: FDA-approved options for chronic pain are not available to millions of Americans

The paper also points out that the FDA’s statements that chronic pain patients should seek out FDA-approved treatments are not applicable to many, now that doctors have been legally required to under-prescribe opiates as a response to the drug company manufactured opioid addiction crisis. Statements from politicians regarding individual health decisions, such as Harry Sanders from Lowndes County, MS suggesting chronic pain sufferers should turn to Tylenol, are arrogant and ignorant.

The FDA’s position is that kratom use can cause deleterious health risks and that kratom users should turn to approved treatments (FDA, 2018c), despite the reality that many such users have commented to the DEA and FDA that such treatments were not available or acceptable, whereas kratom was accessible and helpful.

Point 4: Kratom Stories Matter

While scientists studying kratom struggle to acquire funding for clinical trials on humans, thousands of online accounts of kratom use, as well as positive outcomes in countries where pure unadulterated kratom has been used traditionally should be taken into consideration as a first step to build hypotheses and further research. The article uses the FDA’s own rationale, pointing to internet forums such as r/kratom, for using “Real World Evidence” and “Real World Data” to prove this point:

Thus, even though we do not make the claim that kratom should be viewed as a medically proven effective and safe therapy for [Opioid Use Disorder], we believe it is warranted to take seriously the extensive user reports and analytical surveillance indicating that many people are self-managing their OUD using kratom. Such information may be considered a form of Real-World Evidence that is taken seriously by users and many scientists and should not be ignored by the FDA which has stated that “Real world data (RWD) and real world evidence (RWE) are playing an increasing role in health care decisions” and is used to make “regulatory” decisions.

Point 5: Stories about deaths caused by “kratom alone” are unfounded

Week after week we see sensationalist news reports about this “deadly drug” causing “91 deaths“. In reality the deceased were taking multiple drugs. No research exists to explain exactly how kratom would lead to a death, and local medical examiners, going on the Reefer Madness-style pronouncements from the FDA, are irresponsibly listing “mitragynine toxicity” as a cause of death.

In the majority of these case reports associating kratom with lethal outcomes, patients have had confounding health conditions, have been using other drugs along with kratom, or both (Galbis-Reig, 2016; Gershman et al., 2019; Prozialeck et al., 2012; Singh et al., 2015, 2016; Wing, 2018). Moreover, in the absence of evidence for a defined mechanism by which kratom would lead to death (e.g. respiratory depression), these anecdotal reports involve considerable speculation and do little to establish a scientific backing for the proposition that kratom is potentially deadly.

These are only a few of the points made in this paper. As always, we encourage our readers to #followthescience !