Scientists Call on FDA to Regulate, Not Ban, Kratom

Four leading research scientists from the U.S. and Canada are calling on the U.S. Food and Drug Administration to stop attacking the coffee-like herb known as kratom, which they argue could be used to develop alternatives to opioid painkillers.

Instead, the scientists are urging the agency to start regulating the widely used botanical as a dietary supplement to protect the public from potentially dangerous contamination, such as the recent Salmonella outbreak reported by the Centers for Disease Control and Prevention in February.

Contrary to warnings from the FDA, kratom, which is sold as a powder ground from the leaves of a native Southeast Asian tree, is in no way similar to opioids with respect to addiction and death, the scientists said. Although kratom produces pain-relieving and mood-altering effects that are similar to opioids, it does not depress breathing, which is the cause of death in opioid overdoses.

According to Marc Swogger, associate professor of psychiatry at the University of Rochester Medical Center, four recent scientific surveys indicate “that many of the millions of people in the U.S. who use kratom rely on it as a lifeline away from potentially deadly opioids.”

Banning the substance, he warned, would likely result in a surge in opioid use at a time when more than a hundred Americans are dying every day from overdoses of the dangerous drugs. “There is no high-quality evidence to indicate that kratom is a serious public health threat, and much evidence to suggest that banning it would be,” he said.

The scientists cautioned that banning kratom would push consumers to seek illicit alternatives and stymie much needed scientific research on the risks and benefits of kratom.

In its most recent announcement, the FDA cited 44 reported deaths associated with kratom use as further evidence of its dangers.

According to Oliver Grundmann, a research professor at the University of Florida, the FDA’s report “cannot be supported by any reasonable scientific or medical standard.”

“Unlike overdose deaths that are rightly attributed to classical opioids, which reliably cause respiratory depression and death at high doses, the fatalities that the FDA lists as having been associated with kratom include deaths with a wide variety of apparent causes in people suffering from various diseases and/or taking other substances.”

In 2016, the Drug Enforcement Administration announced its intention to classify the herbal supplement as an illegal Schedule 1 drug, along with heroin, LSD and marijuana. But after public demonstrations, letters from Congress and a petition with more than 142,000 signatures, the agency put the proposal on hold and asked the FDA to investigate its potential benefits and dangers.

An estimated 3 million to 5 million Americans are using kratom to relieve pain, reduce anxiety and depression, and as an alternative to coffee and other stimulants. The herb is also widely used to stave off withdrawal symptoms and reduce cravings from opioid addiction.

Paula N. Brown, director of the British Columbia Institute of Technology, and Jack Henningfield, vice president at Pinney Associates and adjunct professor at Johns Hopkins, also expressed concerns about the public health dangers of banning rather than regulating kratom.