The Food and Drug Administration is going after three marketers and distributors of products with the herbal drug Kratom, saying they are making false claims about the controversial pain drug.
The warnings announced Tuesday by the FDA are part of a larger crackdown on Kratom, which the agency said is not safe and there are no FDA-approved uses for it. The companies made false claims that Kratom can help people recover from opioid addiction and treat pain, cancer and lower blood pressure, FDA says.
“Despite our warnings that no Kratom product is safe, we continue to find companies selling Kratom and doing so with deceptive medical claims for which there’s no reliable scientific proof to support their use,” said FDA Commissioner Scott Gottlieb in a release.
The FDA said it is concerned that Kratom “appears to have properties that expose users to the risks of addiction, abuse and dependence.”
In February, the agency told manufacturers that they should take Kratom products off the market because “extensive scientific data” conclude that it has addictive effects similar to opioids.
But some experts have pushed back on the notion that Kratom isn’t safe or contributes to the opioid epidemic.
A group of 44 scientists warned the Trump administration in February that banning Kratom would result in more opioid deaths. Federal data show that more than 42,000 people died in 2016 from an opioid overdose.
[Also read: FDA declares kratom an opioid as scheduling remains in limbo]
The crackdown comes as the Centers for Disease Control and Prevention has linked Kratom to more than 100 illnesses from salmonella.
The agency cited Front Range Kratom, Kratom Spot and Revibe for illegally selling Kratom products. If the companies do not cease marketing and selling the products, they could be seized by the federal government and the companies charged with massive fines.
