Kratom, a herbal supplement used to relieve pain, has been labeled an opioid in a recent statement made by the U.S. Food and Drug Administration (FDA).
An increase in adverse events, alongside growing popularity among patients with chronic pain, prompted the FDA to conduct scientific research on kratom. The agency determined the substance possesses opioid-like properties, released a public health advisory and began detaining kratom imports.
Proponents of kratom, however, believe it can be used as an alternative to prescription painkillers. With the FDA focused on regulatory safety, and kratom users fighting for access to the alternative medicine, the question of whether or not kratom is an opioid becomes even more significant.
What is Kratom?
In Southeast Asia, kratom has been used for recreational and medicinal purposes for centuries. Kratom is a herbal substance derived from the leaves of the Mitragyna speciosa tree. Originally growing in Thailand, Malaysia and Indonesia, the pain reliever belongs to the Rubiaceae family, which is the same as the coffee plant.
Dried, ground and processed, kratom is imported and purchased at smoke shops in tea or capsules. Though there are no therapeutic uses approved by the FDA, kratom has become well-known for its healing properties.
Kratom is primarily used to manage chronic pain, though it may also be used as a treatment for depression and anxiety. Some argue kratom could be used to treat opioid withdrawal, which is a concerning possibility for the FDA.
Thailand and Malaysia, two of its origin countries, treat kratom like a controlled substance. It is also a considered a controlled substance in 14 other countries, including Australia, Sweden and Germany.
In the U.S., kratom has been made illegal in Alabama, Arkansas, Indiana, Tennessee and Wisconsin, though kratom remains legal under federal law.
FDA Research on Kratom
As kratom gains notoriety, the U.S. Drug Enforcement Administration (DEA) and the FDA have started to get involved. In August 2016, the DEA attempted to make kratom a Schedule I drug.
The DEA experienced backlash from the public and some members of Congress, prompting the FDA to conduct research to determine more information about the compounds in kratom. In Nov. 2017, the FDA released its first statement on kratom.
Kratom has two active ingredients, mitragynine and 7-hydroxymitragynine. The agency studied the compounds and found that bind to the brain’s mu-opioid receptors and share structural characteristics that are comparable to opioids.
“As the scientific data and adverse event reports have clearly revealed, compounds in kratom make it so it isn’t just a plant — it’s an opioid,” FDA Commissioner Scott Gottlieb, M.D., wrote.
In the recent safety announcement, the FDA released some adverse event data on kratom:
- Calls to U.S. poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year.
- The number of deaths associated kratom rose from 36 people in Nov. 2017 to 44 people in Feb. 2018.
- The FDA doesn’t know how kratom interacts with other drugs.
- There have been reports of kratom being laced with other opioids like hydrocodone.
- The use of kratom is also associated with serious side effects like seizures, liver damage and withdrawal symptoms.
Kratom is not safe purely because it is a plant-based substance, according to the FDA. The conditions it is being used to treat are considered serious, warranting diagnosis, treatment and supervision from a licensed physician.
“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.”