Read "A Sensible, Evidence-Based Proposal for Kratom Reform"- from Bill of Health by the Petrie-Flom Center at Harvard Law School
The FDA's war on kratom relies on the Agency's naked power, and its penchant for abusing that power, rather than on any evidenced-based science. A recent commentary by Dustin Marlan, an Assistant Professor of Law at the University of Massachusetts School of Law, is worth a read.
In May 2021, the U.S. Food and Drug Administration (FDA) announced the seizure of 37,500 tons of adulterated kratom in Florida, worth an estimated $1.3 million.
But rather than focusing on the fact that the seized substance was adulterated, FDA Commissioner Janet Woodcock emphasized the alleged toxicity of kratom. This telling choice falls in line with recent efforts by the FDA to end U.S. kratom sales, distribution, and use, including a failed 2016 attempt to have kratom placed into Schedule I of the Controlled Substances Act, along with other federally prohibited drugs such as cannabis, psilocybin, and heroin.
This reactionary prohibitionism is likely to do more harm than good. Moreover, it does not reflect the state of the science, which remains unsettled as to kratom’s risks and benefits.
Kratom is an herb derived from Mitragyna speciosa, a tree native to Southeast Asia related to the coffee plant. It is estimated that between ten and fifteen million people in the U.S. use kratom, which is commonly sold as a powder or in capsules. While some states have banned kratom, in most it remains an unregulated dietary supplement, and is becoming increasingly popular. The primary effects and safety profile of its two main psychoactive compounds—mitragynine and 7-hydroxymitragynine — are controversial and the subject of intense debate.
The American Kratom Association (AKA) and other kratom advocates, including many physicians, legislators, and public health experts, view Mitragyna speciosa as a relatively benign natural resource effective in assisting with opioid addiction and withdrawal.
Its effects, when taken at relatively low doses, are like a mild stimulant. To the extent serious medical issues do arise with kratom use, they are, according to advocates, due to severe misuse, the combined presence of other drugs, such as alcohol or benzodiazepines, or impurities. Unlike other substances exhibiting opioid-receptor mediated effects, kratom rarely, if ever, causes respiratory depression. And while kratom may cause symptoms of withdrawal in some users, such symptoms are rarely life-threatening. Advocates generally believe the plant should be appropriately researched and regulated to assure that kratom products are pure and consumed responsibly by adults.
On the other side are kratom’s critics. Critics claim that, at higher doses, psychoactive compounds in kratom create an addictive, morphine-like euphoria, rather than a stimulant effect.
Former FDA commissioner Scott Gottlieb recently tweeted that he “is convinced [kratom is] fueling the opioid crisis.” Based on innovative — if somewhat dystopian — technology, the FDA simulated how kratom acts as an opioid in the body and brain. Gottlieb and other critics point out that the plant has been linked to adverse medical conditions and even, occasionally, death.
Thus, because “no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist,” the FDA currently believes kratom should be classified as a Schedule I substance.
But attempting once again to prohibit kratom would be a mistake, regardless of whether it is harmless or prone to misuse.
If it is a safe and helpful plant medicine, like caffeine, which is derived from kratom’s relative, the coffee bean, there is no reason to schedule it. But even if kratom is a dangerous, opioid-like substance, banning it would exacerbate, rather than relieve, the overdose crisis.
Because millions in the U.S. depend on kratom for pain relief, and especially if it causes dependence and addiction, if prohibited, individuals would be forced to turn to a heavily-adulterated illicit market, either for kratom, or more potent pain killers, like fentanyl. Forcing those who have found relief in kratom to do so is cruel and unusual, and would likely result in significant pain, suffering, and death.
Moreover, if the FDA tried and again failed in its misguided quest to prohibit kratom, it would be an enormous setback for the agency and further erode consumer confidence. The FDA’s previous attempt to encourage the Drug Enforcement Agency to schedule kratom failed due to “embarrassingly poor evidence [and] data.” And more recent scientific research has found that kratom is “relatively safe” and can assist in reducing problematic opioid use.
Instead of fueling the long-failed War on Drugs by repressing kratom, the FDA should strengthen consumer confidence by creating uniform federal regulations for kratom, similar to state-level legislative efforts that have been passed already. Those involved in the kratom supply chain should not be able to sell or distribute adulterated versions of the substance — impure kratom has been linked to problems including salmonella, and nickel and lead poisoning. Labeling guidelines should exist so that users are able to accurately track the amount of kratom they are consuming. Kratom brands should not be able to tout unproven claims about health benefits. Minors under the age of 18 should not be allowed to purchase kratom without a parent or guardian present.
It is through these sorts of sensible regulations that both advocates and critics can come to a non-dualistic understanding of kratom reform, which accounts for potential risks without introducing needlessly punitive measures.
Dustin Marlan is an Assistant Professor of Law at the University of Massachusetts School of Law.