FDA advises against use of kratom

Kratom, a Southeast Asian plant in the coffee family, is currently under investigation by the Food and Drug Administration after the Drug Enforcement Agency considered reclassifying it as a Schedule I drug. (Enterprise photo — Aaron Cerbone)

The federal Food and Drug Administration issued an advisory Tuesday morning warning consumers about the potential health risks of kratom.

This advisory comes in the midst of the administration’s eight-factor analysis of the Southeast Asian plant, which the Drug Enforcement Agency commissioned to review the leaf that many use for pain relief, recreation or recovering from heroin addiction.

The DEA has previously expressed a desire to make kratom as a Schedule I drug, alongside heroin, cocaine and LSD. However, after fierce opposition from kratom users , it pulled its notice and requested the FDA take a closer look at the plant.

The FDA’s research has so far concluded that, though many use the leaf medicinally without fear of overdosing or addiction, kratom poses health risks of abuse, addiction and death similar to opioids.

“There are currently no FDA-approved therapeutic uses of kratom,” FDA Commissioner Scott Gottlieb wrote in a statement on the advisory. “Moreover, the FDA has evidence to show that there are significant safety issues associated with its use.”

Gottlieb cites 36 deaths and hundreds of calls to U.S. poison control centers regarding kratom, which have increased 10-fold from 2010 to 2015. This figure raises the previous alleged kratom-related death count from 15. The Enterprise has submitted a FOIL request for the 21 additional cases.

The actual research has not been made public yet but will be released with the DEA’s statement to reclassify or not, according to Meyer. There is no deadline set for the DEA to make this decision.

Gottlieb also writes in his statement that the administration is working to actively prevent shipments of kratom from entering the U.S.

“Regulatory enforcement actions could be anything from product seizures, to detaining them to warning letters, injunctions, criminal investigations,” said Lyndsay Meyer, the press officer for the FDA.

Gottlieb says the FDA has a process for evaluating botanical drug products. Parties seeking to make therapeutic claims can submit an investigatory new drug application through a team of medical reviewers in the FDA’s Center for Drug Evaluation and Research specialized in the proper development of drug applications for botanicals.

“To date, no marketer has sought to properly develop a drug that includes kratom,” Gottlieb wrote.