The Food and Drug Administration has released an agency analysis that could put additional pressure on drug enforcement agencies to effectively ban an herbal supplement taken by people who suffer from pain, depression, and addiction.
The product in question is a Southeast Asian tree leaf known as kratom, which is currently legal under federal law. The FDA's latest analysis, released Tuesday, included details about deaths associated with kratom and a conclusion by the agency that kratom contains some of the same components as opioids, which have caused tens of thousands of U.S. deaths annually.
Scott Gottlieb, commissioner at the FDA, said in a statement that his agency was concerned about reports that people had been using kratom to wean themselves off of opioids, saying "there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist." He has warned in the past that kratom can cause seizures and liver damage.
The Drug Enforcement Administration has not said whether it intends to take action given the latest analyses and recommendations by the FDA, and does not have a specific deadline. The agency said in October 2016, during the Obama administration, that it would hold off on banning kratom as a Schedule I substance like heroin, marijuana, or LSD, as it waited for additional public comment as well as FDA recommendations.
For the latest analysis, the FDA used 3-D computer technology to detect how the brain reacts when it is met with kratom. The findings, the FDA, said, provide evidence that kratom has "opioid properties."
But Andrew Kruegel, an associate research scientist at Columbia University, said this wasn't a new conclusion. The compounds in kratom turn on the same receptors in the brain that opioids do, something outside researchers had already discovered.
"They said these compounds are predicted to turn on those opioid receptors; that's already known," Kruegel said. "I don't understand what that's contributing to the field ... It's almost like going back to an earlier stage of scientific discovery."
He warned that classifying the drug as a Schedule 1 substance would result in scientists being unable to research whether kratom is in fact effective in alleviating pain or in helping to wean people off opioids. People sip it in tea or take it in pill form, and have said that it helped them with various medical difficulties.
The American Kratom Association consumer group slammed the FDA's statement about the product, calling it an "unprecedented abuse of science to create a new computer program that is clearly garbage in, garbage out" and "making unproven claims that have been proven to be untrue."
"Our scientists will review the statement, but there are clear mistakes based on pre-existing confirmation bias on the part of the FDA," the group wrote.
The FDA's study suggested that 44 deaths had been associated with kratom since 2011, and provided accounts of 36 of those deaths. In some cases, people were using other drugs in combination with kratom.
"This new data adds to our body of substantial scientific evidence supporting our concerns about the safety and abuse potential of kratom," Gottlieb said.
One death occurred in a patient who had a history of abuse to heroin but hadn't used in one or two years. The document goes on to say, "However, the patient could not speak for themselves and the husband's information of the patient was not consistent throughout the hospital stay."
Kruegel said he disagreed with the FDA's conclusions.
"We know so little about the circumstances of those death reports that it's very hard to know whether kratom was involved or how kratom was involved."
Preliminary research and anecdotal accounts has suggested that kratom can result in some dependency among users, both physical and psychological, Kruegel said. Still, he pointed out, deaths tied to opioids, some of which are legal, has been much higher.
The latest-available federal data show that 42,249 people died from an opioid overdose in 2016, whether from heroin, fentanyl, or prescription painkillers. Of the deaths, 3,373 were caused by methadone, a medication often prescribed for people with addictions to opioids.