Kratom has been in the crosshairs of the Food and Drug Administration (FDA) for years. It has survived multiple attempts by the FDA to classify it as a Schedule I substance under the Controlled Substances Act (CSA), which would make it federally illegal. While widespread public and political support has helped play a role in avoiding such an action, the most important thing that kratom has on its side is simple: science.
In 2018, the U.S. Department of Health and Human Services (HHS) rescinded their prior recommendation to add kratom’s main alkaloids, mitragynine and 7-hydroxymitragynine, to the Schedule I list. A letter submitted to the Drug Enforcement Agency (DEA) by the Assistant Secretary for Health, Brett Giroir, MD, stated the following regarding the agency’s reversal:
“This decision is based on many factors, in part on new data, and in part on the relative lack of evidence, combined with an unknown and potentially substantial risk to public health if these chemicals were scheduled at this time.”
In other words, a ban is not backed by science and would actually do more harm than good.
Since 2018, more than 100 new peer-reviewed studies have been published by researchers about kratom. These studies have only bolstered kratom’s case further, proving through scientific research that kratom is safe, effective, and should remain legal.
According to a 2021 comprehensive review by Dr. Jack Henningfield and PinneyAssociates, all of these new kratom research studies concluded the following:
There are five categories of controlled substances established by the CSA, referred to as Schedules I-V. The categorization is based on different levels of abuse potential and medical usefulness. Schedule I is the most restrictive category and includes substances with a high potential for abuse and no accepted medical use.
The legal status of any substance is determined either by legislative or administrative scheduling. Legislative scheduling simply means that Congress passes legislation that places a substance under control, moves it to a different schedule, or removes it from control. Administrative scheduling decisions, on the other hand, are made by the DEA in participation with the HHS, FDA, and the public.
The DEA may initiate administrative scheduling on its own accord, at the request of the HHS, or on the petition of any interested party. They must first request a scientific and medical evaluation of the substance from the HHS, which has delegated this evaluation process to the FDA. Once the FDA submits their report, the DEA determines whether the substance should be scheduled, rescheduled, or removed. All decisions are subject to notice-and-comment rules, meaning the public has the opportunity to submit comments before the scheduling becomes final.
This is the point in the process where the FDA has failed in their attempts to make kratom a Schedule I substance. That is because their scientific justification has been significantly lacking. These agencies cannot schedule a substance simply because they want to. They must rely on scientific evidence.
In fact, there are eight factors that must be considered when making scheduling decisions. These factors are listed in Section 201 (c), [21 U.S.C. § 811 (c)] of the CSA.
When it comes to kratom, only factors 1-7 apply. This includes the following considerations:
Several studies have determined that mitragynine has a low abuse potential. For instance, a 2018 study published in Psychopharmacology by Kai Yue, Theresa Kopajtic, and Jonathan Katz concluded:
“These results suggest a limited abuse liability of mitragynine and potential for mitragynine treatment to specifically reduce opioid abuse. With the current prevalence of opioid abuse and misuse, it appears currently that mitragynine is deserving of more extensive exploration for its development or that of an analog as a medical treatment for opioid abuse.”
Also, a team of University of Florida researchers published the results of their 2020 study in Drug and Alcohol Dependence, stating:
“These initial findings indicate that mitragynine and 7-hydroxymitragynine are not rewarding in the ICSS procedure. The present results suggest that these kratom alkaloids do not have abuse potential.”
Many more similar studies reached the same conclusion, and Assistant Secretary Giroir relied on such data when he wrote the following in his formal decision to rescind the kratom scheduling request:
“One recently published peer reviewed animal study indicated that mitragynine does not have abuse potential and actually reduced morphine intake. As such, these new data suggest that mitragynine does not satisfy the first of the three statutory requisites for Schedule I, irrespective of broader considerations of public health.”
The effects of kratom are dependent on the dosage. As reported by Walter Prozialeck, Jateen Jivan, and Shridhar Andurkar in a 2012 study published in Journal of Osteopathic Medicine, these effects can be best summarized as follows:
The researchers also point out that kratom’s effects can vary greatly among individuals. Some users at low doses experience pleasant stimulant effects, while others may report an unpleasant sense of anxiety or agitation. Most who use kratom products for pain management, however, do find the stimulant effects to be more desirable than the sedative effects of opioids.
Also, at moderate to high doses, some individuals experience euphoric effects while others may feel more dysphoric. These effects are typically less intense than those of opioids.
Pharmacological research has advanced significantly since 2018, so even more has been learned about kratom’s effects and mechanisms of action than ever before. One example is a 2019 study published by a research team in ACS Central Science, which concluded:
“The major active alkaloid found in kratom, mitragynine, has been reported to have opioid agonist and analgesic activity in vitro and in animal models, consistent with the purported effects of kratom leaf in humans. However, preliminary research has provided some evidence that mitragynine and related compounds may act as atypical opioid agonists, inducing therapeutic effects such as analgesia, while limiting the negative side effects typical of classical opioids.”
The most important question to answer scientifically is whether kratom is safe. Lethal overdoses are obviously the top safety concern. Researchers have so far been unable to validate the lethal dosage level for humans or animals, and most human deaths when kratom was present were likely caused by other substances.
As one team stated in their 2019 study in Preventative Medicine: An International Journal Devoted to Practice and Theory:
“Most such deaths have been ascribed to fentanyl, heroin, benzodiazepines, prescription opioids, cocaine and other causes (e.g., homicide, suicide and various preexisting diseases)…By any of our assessments, it appears that the risk of overdose death is > 1000 times greater for opioids than for kratom.”
Another group of researchers in 2019 could not find any instances of fatalities that could be attributed to kratom alone. As they reported in the International Journal of Drug Policy:
“In fact, while the contribution of kratom to death in some cases cannot be ruled out, there has yet to be an overdose death from kratom alone in either the US or Southeast Asia where heavy kratom use is common.”
Aside from fatal overdoses, another main area of concern is whether kratom causes long-term adverse effects. A 2018 study examined the impact of kratom use on brain function among chronic users. These findings were published in the Malaysian Journal of Medicine and Health Sciences, where the researchers wrote:
“This preliminary study showed long-term consumption of kratom decoction is not significantly associated with altered brain structures in regular kratom users in traditional settings. However, further study is needed to establish more data for kratom use and its effects.”
And in 2020, a different research team studied the lipid profiles and liver functions of chronic kratom users versus nonusers. According to their paper published in PLoS One:
“The liver parameters of the study participants were within normal range. The serum total cholesterol and LDL of kratom users were significantly lower than those of healthy subjects who do not use kratom. There were no significant differences in the serum triglyceride and HDL levels.”
While no serious adverse consequences were found in the multitude of studies, researchers were all in agreement that additional studies are required. The results certainly are very promising, but more comprehensive research must be done before definitive conclusions can be made regarding adverse effects of kratom.
These two factors are closely related as they both deal with recreational use and abuse of kratom. Many scientific surveys have been conducted in an effort to shed light on these topics.
For instance, the following 2020 survey results were published in the journal Drug and Alcohol Dependence and are representative of many other similar surveys conducted by other researchers:
“This study supports the results of previous studies by suggesting that kratom has a relatively benign risk profile compared to typical opioids, with only a minority of respondents endorsing kratom related adverse effects, withdrawal symptoms, or problematic use. Adverse effects reported here were most commonly rated as mild and lasted ≤1 day, and less than 1% of the total sample found the effects of kratom to be severe enough to seek medical treatment.”
This same study also concluded:
“Kratom is used among White, middle-aged Americans for symptoms of pain, anxiety, depression, and opioid withdrawal. Although regular use was typical, kratom-related substance use disorder (SUD) and serious adverse effects were uncommon.”
While individual risks are certainly important, the main reason for a substance to be scheduled is because it poses a significant risk to overall public health. This simply is not the case when it comes to kratom.
In a 2018 policy report for the American Kratom Association, Jane Babin, Ph.D., Esq. conducted a study of all deaths claimed by the FDA to be related to kratom. The very title of this paper says it all: “The FDA Kratom Death Data: Exaggerated Claims, Discredited Research, and Distorted Data Fail to Meet the Evidentiary Standard for Placing Kratom as a Schedule I Controlled Substance.”
Babin concluded the following in this report:
“None of the case reports released to date support the evidentiary standard required by the CSA to prove there is a risk to the public health that relies primarily on the FDA claim of numerous deaths associated with kratom. In fact, the data show only that a relatively small number of individuals died from a variety of actual causes related to underlying health issues, abuse of prescription or illicit drugs either at toxic doses or taken in combination when contraindicated. The use of kratom by these individuals has no medical or statistical significance in assessing the safety signal required for scheduling.”
As mentioned previously, Assistant Secretary Giroir even indicated that the public health risk would actually come from scheduling kratom, not from keeping it legal. In his letter to the DEA, Giroir wrote:
“Furthermore, there is a significant risk of immediate adverse public health consequences for potentially millions of users if kratom or its components are included in Schedule I, such as:
Suffering with intractable pain;
Kratom users switching to highly lethal opioids, including potent and deadly prescription opioids, heroin, and/or fentanyl, risking thousands of deaths from overdoses and infectious diseases associated with IV drug use;
Inhibition of patients discussing kratom use with their primary care physicians leading to more harm, and enhancement of stigma thereby decreasing desire for treatment, because of individual users now being guilty of a crime by virtue of their possession or use of kratom;
The stifling effect of classification in Schedule I on critical research needed on the complex and potentially useful chemistry of components of kratom.”
Marc Swogger and Zach Walsh systematically reviewed all studies on kratom and mental health published between January 1960 through July 2017. Their work was extremely thorough and comprehensive, and in the end, they determined the following:
“In conclusion, kratom use appears to have several important mental health benefits that warrant further study. Kratom dependence is a risk for some people, though the dependence syndrome appears to be mild in its psychosocial and physiological effects relative to that of opioids.”
The volume of recent scientific evidence that demonstrates the safety and effectiveness of kratom is astounding. The examples listed in this article only scratch the surface of what has already been discovered about kratom’s many benefits. Even more studies are on the way as funding continues to increase due to the potential that researchers recognize in kratom.
Don’t just take our word for it, though. Anyone interested in learning more about the science behind kratom should check out all the available studies for themselves. Take some time to research the research, and find out what those in Southeast Asia have already known for centuries about kratom’s remarkable ability to manage their health and well-being.