Updated: Jul 17, 2019
Published on KevinMD.com
What is it? Kratom is a powdered herbal supplement derived from the leaves of a tropical evergreen tree that is native to Southeast Asia and is usually taken orally but can also be brewed into teas.
It is commonly used by consumers as an alternative medicine to self-treat opioid addiction and chronic pain. The leaves contain two compounds, mitragynine and 7-a-hydroxymitragyine, which interact withvarious receptors in the brain.
At low doses the drug acts similar to a stimulant; however, at higher doses more like an opioid.
What’s the FDA’s view?
There are no FDA-approved uses for kratom and the agency has received concerning reports about the safety of kratom.
On February 6, 2018, FDA Commissioner Scott Gottlieb M.D. released a statement citing the agency’s scientific analysis and review of the 25 most prevalent compounds in kratom. “From this analysis, theagency concluded that all of the compounds share the most structural similarities with controlled opioidanalgesics, such as morphine derivatives.”
In the same statement, Dr. Gottlieb stated that the FDA had linked 44 deaths associated with kratom use and that there was “no reliable evidence to support the use of kratom as a treatment for opioid use disorder” and “Kratom should not be used to treat medical conditions, nor should it be used as an alternative to prescription opioids. There is no evidence to indicate that kratom is safe or effective for any medical use.”
And in May of this year the FDA issued warning letters to several kratom distributors for illegally selling kratom containing products with unproven claims about their ability to treat opioid addiction and withdrawal, pain, blood pressure, and cancer.
What About the CDC?
On February 20, 2018, the CDC issued a nationwide public warning advising consumers to avoid kratom due to a multi-state outbreak of Salmonella linked to the herbal supplement. The outbreak ultimately affected 199 people in 41 states. And in 2016, the CDC reported that between January 2010 and December 2015, U.S. poison centers received 660 calls related to kratom exposure.
How about the DEA? On August 31, 2016, the DEA published a “notice of intent” in the Federal Register “to temporarily schedule the opioids mitragynine and 7-hydroxymitragynine, which are the main active constituents of the plant Kratom, into schedule I pursuant to the temporary scheduling provisions of the Controlled Substances Act based on a finding by the DEA that the placement of these opioids into schedule I of the Controlled Substances Act is necessary to avoid an imminent hazard to the public safety."
In support of their position, the DEA cited an increasing number of poison centers calls related to kratom, significant and increasing law enforcement seizures of the drug and numerous direct and indirect deaths relating to the substance.
Both the FDA and NIDA had no objection to DEA’s proposed action.
However, two months later DEA withdrew its “notice of intent” action against kratom after 51 U.S.Representatives asked DEA to delay its action to “provide ample time for public comment” while referring to the plant substance as an “internationally recognized herbal supplement.” Eleven U.S.Senators wrote DEA a few days later and also asked for a delay “given the long reported history of kratom use, coupled with the public sentiments that it is a safe alternative to prescription opioids.”
Is it legal?
Kratom is legal under federal law but illegal in the states of Alabama, Arkansas, Indiana, Vermont,Wisconsin and the District of Columbia.
It is also illegal in Thailand, Australia, Malaysia, and several European countries.
Standard dosage unit?
There are currently no established standards for safely producing kratom, no standard dosage unit or composition, and limited, if any clinical research along with hundreds of unknown foreign and Internet providers of the drug.
While the FDA continues to release red flag warnings about the drug, those that are self-medicating with kratom are risking their health and possibly their lives.
Dennis Wichern is a retired DEA Agent who now works to mitigate controlled substance risk for providers and hospital organizations worldwide.