FDA Analysis Shows Kratom Not "Just a Plant"

No evidence to indicate kratom safe or effective for any medical use
No evidence to indicate kratom safe or effective for any medical use

A scientific analysis conducted by the Food and Drug Administration (FDA) on the botanical substance kratom further supports the Agency's concerns about its potential for abuse, addiction, and serious health consequences. 

To better understand the pharmacological properties of kratom, the FDA used the Public Health Assessment via Structural Evaluation (PHASE) methodology, a 3-D computer simulation that analyzes the molecular structure of a chemical substance to predict how it may function within the body. 

An investigation of the 25 most prevalent compounds in kratom showed that these compounds share structural similarities with controlled opioid analgesics, such as morphine derivatives. According to the model, 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors; this finding along with previous data, confirm that 2 of the top 5 most prevalent compounds in kratom are opioid agonists. 

In addition, the model predicted that some of these compounds may bind to receptors in the brain that may contribute to stress responses that impact cardiovascular and neurologic function. In previous communications, the FDA had noted potentially serious adverse effects associated with kratom, including seizures and respiratory depression. 

To date, 44 reported deaths have been associated with the use of kratom. In a statement, FDA Commissioner Scott Gottlieb, MD warned that kratom should not be used to treat medical conditions or be used as an alternative to prescription opioids. 

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"The data from the PHASE model shows us that kratom compounds are predicted to affect the body just like opioids. Based on the scientific information in the literature and further supported by our computational modeling and the reports of its adverse effects in humans, we feel confident in calling compounds found in kratom, opioids," said Gottlieb.

For more information visit FDA.gov.