A naturally occurring plant in Southeast Asia and some Pacific Islands, kratom has been marketed as a “safe” alternative to opioids, sold over the counter in “head shops.” But after 36 deaths from the drug, on November 14, 2017, the U.S. Food and Drug Administration (FDA) issued a warning of the dangers associated with kratom.
Previously, on August 30, 2016, the DEA announced its intention to outlaw kratom, but after facing criticism from the pro-kratom community, the plans to do this were stalled. Meanwhile, it has become popular with teens looking to get a legal high.
What is Kratom?
Kratom is an opioid-containing leaf that is often sold in powder or liquid form.
Kratom (Mitragyna speciosa) is a native plant in Myanmar, Thailand, Indonesia, and Papua New Guinea. Its traditional use has included chewing the leaves for pain relief and increased energy, and has also been used in religious ceremonies.
Just like the coca leaf, kratom used in the traditional form has only mild effects. However, the products seen for sale in the U.S. have been subjected to chemical processes to extract stronger chemicals for a more euphoric, and dangerous, high.
Kratom for Detox?
In the midst of a nationwide opioid crisis in the U.S., some have advocated for kratom to be used to detox from opioids such as heroin, oxycodone, or hydromorphone. However, there have been no clinical studies to examine the safety or effectiveness of kratom for opioid detoxification. In response to this idea, FDA Commissioner Scott Gottlieb, M.D. remarked, “It’s very troubling to the FDA that patients believe they can use kratom to treat opioid withdrawal symptoms.”
“ There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder.” - Scott Gottlieb, M.D., FDA Commissioner
As a physician who treats addiction, I have treated patients addicted to kratom. In fact, they have required opioid detoxification just like people dependent on heroin or other opioids. My anecdotal experience is that kratom isn’t much different from other opioids when it comes to developing drug dependence.
Is Kratom Really Dangerous?
Kratom is being sold in smoke shops in various forms, including capsules and e-liquid for vaping (if you’re older than 40, google it). It is the last form, the liquid for vaporizing, that is especially concerning.
To understand why, please indulge me with a brief lesson in the physiology of drug use. When a drug is taken by mouth, there is a slower absorption of the substance. Most drugs need to go all the way to the small intestine before they can be absorbed into the blood stream. That is why it takes at least 20 minutes for Tylenol to make your headache away. When a drug is smoked, it only needs to pass the ultrathin tissues in the lung to enter the blood stream, giving the user effects within seconds. (Lung tissue needs to be thin because we absorb oxygen from the air straight into our blood.) Smoked kratom “hits a person faster,” leading to a more intense effect.
It is this rapid effect of smoked kratom that presents a threat for overdose. Just like other opioids, kratom can slow down a person’s automatic breathing rate. If breathing becomes too slow to provide the brain’s oxygen needs, it can cause death. This effect of opioids causes all the overdoses we hear about on the news.
Does that mean kratom pills are safer than the smoked version? Yes and (mostly) No. Taking kratom capsules can also produce the same effect on breathing that all opioids do. Taking the drug by mouth slows down the effect, but it can still be fatal. Also, you never know what is inside of unregulated drugs; one person who died from kratom was reportedly taking a product mixed with Tramadol, another painkiller (click here for the scientific article).
So, Kratom can be Dangerous… but why is the FDA involved?
When natural supplements are sold over-the-counter, they are regulated by the FDA as “food additives.” The restrictions really just focus on marketing: there cannot be a “medical claim” made. But there is a loophole in this nutraceutical law: there is no requirement to demonstrate that a supplement is “safe.” So until now, kratom fell under this category. Selling kratom for “opioid detoxification” was always illegal, but when labeled as a “dietary supplement” it was legal.
Reflecting the second letter in FDA, the agency approves and regulates drugs (as in “prescription drugs,” not “street drugs”). Dr. Gottlieb stated, “The FDA has exercised jurisdiction over kratom as an unapproved drug (emphasis added), and has also taken action against kratom-containing dietary supplements.” As an unapproved drug, there is completely different regulation. Gottlieb said, “…we are working to actively prevent shipments of kratom from entering the U.S. At international mail facilities, the FDA has detained hundreds of shipments of kratom.”
When developing my own product, ALCOVITE, I had to pay close attention to the FDA nutritional supplement regulations. Even though it is just a vitamin product, there are strict regulations around what claims are made (or not made). My supplement contains vitamins as part of nutritional support for those who drink alcohol regularly, but it does not make a medical claim. To make a claim of treating vitamin deficiencies from alcohol use, it has different requirements. An example of the FDA disclaimer for this product can be seen here. But back to kratom…
Should Kratom be Illegal?
The DEA intends to list two of the chemicals in kratom as Schedule I, alongside its cousin, heroin. In case you haven’t figured it out, Schedule I drugs are illegal in the United States. Drugs of abuse are placed in Schedule I-V, with the higher-numbered schedules containing drugs with lower abuse potential. Schedule II-V drugs are medications available by prescription. Schedule I drugs cannot be prescribed like medicine, but may be used in highly regulated research settings.
If Kratom is so Dangerous, it should made Schedule I, right?
Placing recreational drugs in Schedule I presents problems for researchers, as they cannot be given like a normal prescription. The less-restrictive Schedule II contains drugs of abuse like methamphetamine and cocaine, but mainly houses more commonly prescribed drugs with abuse potential, like hydrocodone, oxycodone, fentanyl, and amphetamines. So performing research on methamphetamine or cocaine is less restrictive than heroin research.
For that reason, while I applaud the FDA’s move to make kratom an unregulated drug, I would also encourage the DEA to “outlaw” kratom as a schedule II drug, rather than an “illegal” Schedule I. This would allow more research on the drug and perhaps lead to the discovery of a new painkiller or treatment for opioid use disorder.