The Food and Drug Administration (FDA)’s Commissioner Scott Gottlieb, MD, has issued a statement regarding the deadly risks associated with the botanical substance, kratom. 

Kratom has grown in popularity in the U.S., with circulating claims of it being a safe treatment with a range of healing properties. The FDA is aware that individuals have been using kratom to treat pain, anxiety, and depression, as well as for recreational purposes for its euphoric effects. 

The herbal product has been shown to exert similar effects as opioids, carrying with it similar risks of abuse and addiction. Kratom is categorized as a controlled substance in 16 countries and is banned in multiple states including Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.

In a press release, Dr. Gottlieb highlighted the FDA’s concern for patients who believe they can use kratom to treat opioid withdrawal symptoms. He stated, “There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder. Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed healthcare provider about the product’s dangers, potential side effects or interactions with other drugs.”

The health risks associated with kratom have also been clearly established as seen with a 10-fold increase (from 2010 to 2015) in calls to U.S. poison control centers regarding its use. To date, the FDA has noted 36 deaths associated with kratom-containing products; there have also been reports of kratom laced with other opioids (eg, hydrocodone). Seizures, liver damage, and withdrawal symptoms have all been associated with kratom use. 

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At this time, there are no FDA-approved therapeutic uses of kratom; its risks and benefits must be assessed under the FDA regulatory process before it can be legally marketed for therapy. 

As kratom is an unapproved drug, the FDA is actively working to prevent illegal kratom imports from entering the U.S. In addition, in response to a request from the Drug Enforcement Agency (DEA), the FDA has conducted a scientific and medical evaluation of two compounds found in kratom.

Dr. Gottlieb concluded, “While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighed appropriately against the potential for abuse […] In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health.”

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