FDA declares kratom an opioid

Faith Castro
February 8, 2018

In withdrawing its plan, the agency asked the FDA to speed up a scientific and medical evaluation on kratom.

The PHASE model predicted that 22 of the 25 compounds found in kratom - including mitragynine - bind to and activate opioid receptors in the brain, the FDA said. FDA Commissioner Scott Gottlieb said the agency has been particularly concerned about the use of the botanical substance to treat opioid withdrawal symptoms, noting there is "no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist". Based on this definition, compounds in kratom are opioids, because they do act on opioid receptors, said Wes Hunter, director of pharmacy at UCHealth Yampa Valley Medical Center in Steamboat Springs, Colorado.

Gottlieb said the FDA documented 44 cases in which kratom was involved in a death; some were otherwise healthy young people.

"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", Gottlieb said.

Kratom is only banned in five states right now, and remains legal here in NY.

The FDA previously placed kratom products on import alert to prevent them from entering the country illegally and has seized several batches. But Hunter noted that some synthetic opioids, like fentanyl and methadone, don't look much like morphine in their structure either.

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Hunter added that some synthetic opioids are derived from materials found in coal tar. Many patients are drawn to the drug to help ease pain, depression or kick and opioid addiction. "It's not like you need an opium poppy to have opioid effects", he said.

Many people killed by kratom often mixed the drug with other substances, including inhaler chemicals and over-the-counter cold and flu medicine.

However, the American Kratom Association (AKA), a vocal advocate for the drug, calls the FDA's assessment "utterly and completely wrong", comparing it to a trick play to pressure the DEA into banning the substance.

The FDA is now saying that kratom contains opioid properties. It's sold online and in shops as powders and pills, among other formulations, and has been loosely regulated by the FDA. The scientific data and adverse event reports have "clearly revealed" that compounds in kratom render it more unsafe than "just a plant", he said.

Deaths linked to kratom were also taken into account. Federal agencies must move quickly to assess the abuse potential of newly identified designer street drugs for which limited or no pharmacological data are yet available.

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