The U.S. Food and Drug Administration warned of serious safety risks of herbal supplement kratom, a plant native to Southeast Asia, saying Tuesday that the substance has effects similar to opioids' and that regulators know of at least 36 deaths linked to it.
Kratom, a plant grown naturally in countries including Thailand and Malaysia, is widely sold in smoke shops and other locations as a powder that can be used in tea to slow the effects of opioid withdrawal. Because it produces symptoms, such as euphoria, similar to opiates, it is also used recreationally. According to Bloomberg Businessweek, the American Kratom Association-yes, it exists-has lobbied to have kratom recognized as "a safe alternative to legal and illegal opioids".
The drug is kratom, and despite failing to gain FDA approval, it continued to be available for sale online and in stores - including inside a vending machine in Arizona. And 36 deaths have been linked to kratom-containing products.
"Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product's dangers, potential side effects or interactions with other drugs", he wrote.
People are taking the unapproved supplement to treat conditions like pain, anxiety and depression - without medical supervision, FDA Commissioner Dr. Scott Gottlieb said in a statement.
"At a time when we have hit a critical point in the opioid epidemic, the increasing use of kratom as an alternative or adjunct to opioid use is extremely concerning". "Kratom is also banned in several states, specifically Alabama, Arkansas, Indiana, Tennessee, and Wisconsin and several others have pending legislation to ban it", Gottlieb stated.
The DEA almost made it a Schedule 1 drug in 2016, which would have put it in the same category as heroin, marijuana and LSD, but ultimately scrapped the plan. The agency has already detained hundreds of packages at worldwide mail facilities.
Gottlieb said he was sympathetic but said distributors have to show that kratom does work as advertised.
"While we remain open to the potential medicinal uses of kratom, those uses must be backed by sound-science and weighted appropriately against the potential for abuse", he wrote. "In the meantime, based on the weight of the evidence, the FDA will continue to take action on these products in order to protect public health", Gottlieb said in the statement.
"They must be put through a proper evaluative process that involves the DEA and the FDA".