FDA Tries Again To Ban Kratom

Last year, I wrote about the Food and Drug Administration’s campaign to ban the Asian herb Kratom, a non-opiate option for those with chronic pain, anxiety, and drug dependency issues.

As someone interested in medical strategies for disaster or remote settings, I was considering the herb as an option in circumstances when modern medicine isn’t available. The FDA, however, set a date for late 2016 to rule Kratom a Schedule I drug (the same category as heroin) and eliminate its access to the average citizen.

Then an extraordinary thing happened: A public outcry from tens of thousands of citizens that also included dozens of members of Congress. In response to the pressure, the proposed ban was cancelled. Now, a persistent FDA is once again pushing to prevent the sale and use of Kratom in the U.S.

Kratom (scientific name Mitragyna speciosa) has long been used in Southeast Asia for various medicinal purposes, including pain, anxiety, and depression. The chemical compounds in Kratom, (scientific name Mitragyna speciosa) are mitragynine and 7-hydroxymitragynine. These substances act on opioid receptors in the brain, just like heroin and morphine do, to eliminate pain. Despite this, Kratom is not an opioid; It’s actually a member of the coffee family. Therefore, using it doesn’t cause respiratory depression, which is how most opioid overdoses die.

A non-opioid alternative to Heroin? Sounds like a reasonable option to pursue, but FDA commissioner Scott Gottlieb says: “At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning.”

I can understand not wanting it to be an adjunct (medical-speak for adding Kratom to your drug intake), but not even as an alternative to Heroin? I think almost anything would be a welcome substitute for Heroin or prescription opioid abuse.

In the U.S., Kratom has received many testimonials as to its success in helping those addicted to opioids “kick the habit”.  On the other side of the coin, however, FDA commissioner Scott Gottlieb claims there is no hard data for Kratom’s effectiveness and that there is a “deadly risk” to using the herb. Indeed, some states, and even some countries, have outlawed its sale or export.

The FDA uses several hundred reported cases of Kratom “poisoning” and 36 deaths “involving” Kratom over the past few years as reason enough to deny access to it. But Kratom is rarely the only drug found in the systems of these cases; some mix it with OxyContin and other drugs. In the meantime, the number of deaths from Heroin overdose in 2015 alone was more than 13,000, with 15,000 prescription opioid deaths in the same year.

Given those numbers, you would think that the government would want to do further research on Kratom before dismissing it as Heroin-class dangerous. Some of the research, reported in Scientific American as well as by Columbia and other universities, favors further evaluation before placing Kratom on the list with the bad-guy drugs.

Columbia University pharmacologist Andrew Kruegel says keeping Kratom legal may help develop better pain meds: “Those compounds alone may already be superior to codeine and oxycodone. At a minimum, if you can get rid of respiratory [problems] then you can save thousands of lives…if the research were able to legally continue.”

However, the FDA was stung by the pressure to reverse its decision last year, so it persists in its mission. Is it so certain, however, that it won’t drive Kratom users to more clearly dangerous drugs by banning it? Perhaps the devil you know (Heroin, prescription opioids) is better than the devil you don’t (Kratom), but in this case, I doubt it. Don’t act hastily to prohibit Kratom.

Joe Alton MD

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