FDA Commissioner Scott Gottlieb, M.D., issued a statement Tuesday indicating that the agency is “concerned about harmful unapproved products that have been crossing our borders in increasing numbers,” and that “kratom has raised significant concerns given its increasing prevalence and potential safety risks.”

Kratom, or Mitragyna speciosa, is a tropical tree native to Southeast Asia that produces leaves which have been used for hundreds of years to relieve pain. The leaves can be eaten raw, but are most often crushed and brewed as tea, or turned into capsules, tablets and liquids.

Part of the problem with kratom, according to the FDA, is that it features inverse properties at different dosages. In low doses, kratom acts as a stimulant, whereas at high doses it has sedative properties. FDA also said the supplement can lead to psychotic symptoms and psychological addiction.

“Evidence shows that kratom has similar effects to narcotics like opioids, and carries similar risks of abuse, addiction and in some cases, death,” Gottlieb said. “Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.”

From 2010-2015, calls about kratom to U.S. poison control centers jumped 10-fold from 26 to 263, according to the Centers for Disease Control and Prevention (CDC).

Since the FDA put kratom on “import alert” in 2012, it says there have been at least 36 deaths associated with its products. Kratom can cause serious side effects including seizures, liver damage, and withdrawal symptoms. Certain batches of the supplement have been found to be contaminated with other opioids like hydrocodone.

“As a physician and FDA Commissioner, I stand committed to doing my part to prevent illegal substances that pose a threat to public health from taking their grip on Americans,” 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.”

Source: U.S. Food & Drug Administration (FDA)

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