As mentioned in our last post, LegitScript has noticed a trend to market kratom as an opioid alternative and an opiate withdrawal aid. Today, we’re taking a closer look at this plant, which has been the subject of some recent alarming warnings by the FDA.
Kratom, also known as Mitragyna speciosa, is a tree that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. It has been identified as a Drug of Concern by the DEA, which notes that consumption of its leaves produces stimulant effects in low doses and sedative effects in high doses, and can lead to psychotic symptoms, and psychological and physiological dependence. We see it sold online frequently in the form of powders, tablets, capsules, extracts, and teas, with strains such as “Green Vein,” “Red Vein,” “Bali,” etc.
Despite the “Drug of Concern” label, kratom seemed to be riding high a year and a half ago. The DEA had announced an intent to schedule kratom as a Schedule I controlled substance, only to face intense opposition from proponents of the substance. (According to this report, the DEA received more than 2,000 phone calls on the matter, with most objecting to the scheduling.) The notice of intent to schedule kratom was withdrawn, with the DEA soliciting further public comment, as well as reiterating a request for a scientific and medical evaluation and scheduling recommendation from the FDA.
The fact that kratom is a plant seems to make it amenable to being marketed as “herbal” or “natural,” buzzwords that may create a perception that kratom is safe. In some circles, it gets promoted as a “legal high,” safer than controlled substances. In other circles, it gets promoted as an “herbal supplement” to treat diseases such as anxiety, depression, or opioid addiction.
Not so fast, the FDA says. Since the DEA’s request for a scientific and medical evaluation, the FDA has done its best to fight this perception. In November 2017, the FDA advised consumers that it was aware of reports of 36 deaths associated with the use of kratom, and warned that serious side effects from kratom use included seizures, liver damage, and withdrawal symptoms. It punctured the myth of kratom being a “legal high,” noting that kratom is already a controlled substance in 16 countries and is banned in several US states (e.g., Arkansas, Indiana, Tennessee, and Wisconsin). Speaking directly on the trend to market kratom for the treatment of opioid addiction, FDA Commissioner Scott Gottlieb said:
Given all these considerations, we must ask ourselves whether the use of kratom — for recreation, pain or other reasons — could expand the opioid epidemic. Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits.
I understand that there’s a lot of interest in the possibility for kratom to be used as a potential therapy for a range of disorders. But the FDA has a science-based obligation that supersedes popular trends and relies on evidence. [...] To date, no marketer has sought to properly develop a drug that includes kratom.
The FDA followed up in February by releasing the adverse event reports on the 36 deaths, and revising the number of reported deaths to 44. The FDA also detailed the results of its application of an advanced computational model to simulate how the compounds in kratom may behave inside the body and potentially affect the brain. Ironically, the FDA found that “kratom compounds are predicted to affect the body just like opioids”; in fact, the FDA stated, “we feel confident in calling compounds found in kratom, opioids.” This suggests that kratom offers not so much addiction treatment as an addiction alternative.
Since then, the FDA oversaw the destruction and recall of a large number of kratom-containing supplements and, along with the Centers for Disease Control and Prevention (CDC) and state and local officials, is investigating a multistate outbreak of Salmonella infections linked to products reportedly containing kratom. But Salmonella or no, the FDA continues to warn consumers “not to use any products labeled as containing the botanical substance kratom or its psychoactive compounds, mitragynine and 7-hydroxymitragynine.” Thinking that kratom is benign because it’s just a plant, says the FDA, is shortsighted and dangerous: “After all, heroin is an illegal, dangerous, and highly-addictive substance containing the opioid morphine, derived from the seed pod of the various opium poppy plants.”
It’s hard to imagine that these FDA actions have gone unnoticed by the DEA or kratom advocates. Only time will tell whether the former renews its intent to schedule, or the latter will produce the “clear, reliable evidence” of kratom’s benefits that the FDA is looking for.