The Federal Drug Administration has issued a warning against the herbal, plant-based supplement Kratom and declares the drug is an opioid.
"And it's an opioid that's associated with novel risks". It is available at online portals and websites in the form of powder packaged within capsules or as tea.
Grundmann: At low concentrations, if you take it you get more of a stimulant effect; in higher concentrations you get more of an analgesic, opioid-like effect.
Those two uses are what Gottlieb appears to see as the most troubling. But how they interact with the opioid receptor is distinctly different from classical opioids.
In September 2014, U.S. Marshals, at the FDA's request, seized more than 25,000 pounds of raw kratom material worth more than $5 million from Rosefield Management, Inc.in Van Nuys, California. The scientific data and adverse event reports have "clearly revealed" that compounds in kratom render it more risky than "just a plant", he said.
The FDA says there are hundreds of kratom-related calls to poison control each year, increasing ten-fold from 2010 to 2015. The teenager who hanged himself for example tested positive for kratom, alcohol and several other prescription drugs. He said FDA now has data on 44 reported deaths associated with kratom, up from the 36 reported in a November advisory.
But those deaths are not as simple as they may seem. Other people who died after taking kratom tended to have mixed it with other drugs of various kinds. Gottlieb said that this case was being investigated and also that it was not an absolute proof that kratom could be causing these deaths alone.
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There's still a lot we don't know about kratom. Only one of the deaths was due to kratom alone states the FDA.
The American Kratom Association consumer group called the FDA's statement an "unprecedented abuse of science to create a new computer program that is clearly garbage in, garbage out avoiding the rules of the Controlled Substances Act and making unproven claims that have been proven to be untrue".
In 2016, the DEA proposed a ban on kratom but backtracked under pressure from some members of Congress and outcry from kratom advocates who said it could help treat opioid addiction.
But Gottlieb warned that claiming it's harmless because it's "just a plant" is shortsighted and unsafe.
Mixing kratom with over-the-counter drugs can intensify these effects, the FDA warned.
Kratom is far from the only risky ingredient that has shown up in supplements.
Evidence suggests the stimulants could be similar to ephedrine, a compound derived from ephedra, the risky and lethal weight-loss supplement that the FDA banned in 2004. In January 2016, U.S. Marshals, at the FDA's request, seized almost 90,000 bottles of dietary supplements labeled as containing kratom and worth more than $400,000, and in August 2016, they seized more than 100 cases of products labeled as containing kratom and worth more than $150,000.