There have been 36 deaths linked to the use of kratom-containing products, the FDA said, adding that the substance is also being laced with other opioids like hydrocodone for marketing purposes. "Before it can be legally marketed for therapeutic uses in the USA, kratom's risks and benefits must be evaluated as part of the regulatory process for drugs that Congress has entrusted the FDA with". In his statement, he wrote that calls to United States poison control centers regarding kratom have increased 10-fold from 2010 to 2015, with hundreds of calls made each year.
Kratom is a naturally growing plant in Thailand, Malaysia, Indonesia and Papua New Guinea, and is being marketed as a "safe" treatment option for certain diseases, including opioid addiction, the FDA said.
These two uses are what Gottlieb appears to see as the most troubling. "Alternatively, if proponents are right and kratom can be used to help treat opioid addiction, patients deserve to have clear, reliable evidence of these benefits". "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".
"Given all these considerations, we must ask ourselves whether the use of kratom-for recreation, pain or other reasons-could expand the opioid epidemic". Finally, the use of kratom is associated with serious side effects like seizures, liver damage and withdrawal symptoms, he wrote.
On Nov. 14, 2017, FDA Commissioner Scott Gottlieb, MD, issued a statement regarding the risk of using kratom. The DEA will review the FDA's assessment and make a determination, says DEA spokesperson Wade Sparks.
Kratom is banned in Australia, Malaysia, Myanmar, and Thailand and in several U.S. states - Alabama, Arkansas, Indiana, Tennessee, and Wisconsin.
The FDA public health advisory on kratom follows the Drug Enforcement Administration's reversal or at least delay of plans to classify kratom as a controlled substance on the same level as heroin and LSD.
More than 340 million shipments of kratom reach the US each year, even though the FDA has seized hundreds more.
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 weighed appropriately against the potential for abuse", Gottlieb 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.