FEB 7 2018, 10:35 AM ET

FDA declares popular alt-medicine kratom an opioid

by MAGGIE FOX

The Food and Drug Administration declared the popular herbal product kratom to be an opioid on Tuesday, opening a new front in its battle to get people to stop using it.

New research shows kratom acts in the brain just as opioids do, FDA Commissioner Dr. Scott Gottlieb said in a statement. And he said the agency has documented 44 cases in which kratom at least helped kill people — often otherwise healthy young people.

“Taken in total, the scientific evidence we’ve evaluated about kratom provides a clear picture of the biologic effect of this substance,” Gottlieb wrote.

Kratom is used by some as a home remedy for opioid addiction — and by others just for fun. It has a passionate following.

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Additional adverse events associated with kratom use identified

For Immediate Release
February 6, 2018

Summary
FDA releases adverse events and scientific analysis providing even stronger evidence of kratom compounds’ opioid properties.

Statement
Over the past several months, there have been many questions raised about the botanical substance known as kratom. Our concerns related to this product, and the actions we’ve taken, are rooted in sound science and are in the interest of protecting public health. However, we recognize that there is still much that is unknown about kratom, which is why we’ve taken some significant steps to advance the scientific understanding of this product and how it works in the body. Today, we’re providing details of some of the important scientific tools, data and research that have contributed to the FDA’s concerns about kratom’s potential for abuse, addiction, and serious health consequences; including death.

Notably, we recently conducted a novel scientific analysis using a computational model developed by agency scientists, which provided even stronger evidence of kratom compounds’ opioid properties. These kinds of models have become an advanced, common and reliable tool for understanding the behavior of drugs in the body. We also have learned more about deaths that involved kratom use, and have identified additional adverse events related to this product. This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom.

We have been especially concerned about the use of kratom to treat opioid withdrawal symptoms, as there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist. We recognize the need and desire for alternative treatments for both the treatment of opioid addiction, as well as the treatment of chronic pain. The FDA stands ready to evaluate evidence that could demonstrate a medicinal purpose for kratom. However, to date, we have received no such submissions and are not aware of any evidence that would meet the agency’s standard for approval.

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