Despite Thailand’s recent legalization of kratom—swiftly following the country’s decriminalization earlier this year—international kratom advocacy’s momentum is facing stern resistance from the United States Food and Drug Administration.
The FDA has made no secret of its attitude to the plant, following numerous attempts to schedule it as a federally illegal substance in recent years. Dr. Scott Gottlieb, the agency’s former commissioner, even groundlessly blamed kratom for “fueling the opioid addiction crisis” this past spring. While the failures of attempts at federal scheduling have represented victories for kratom advocacy, it doesn’t mean the FDA is slowing down.
In late July, the FDA publicly announced that it will be gathering feedback from the US public as part of an effort to compile data on kratom. This has been done in preparation for a major meeting that the World Health Organization (WHO) is holding this October, where the FDA’s data will help inform the US stance on kratom.
“It came as a bit of a shock to all of us, both the FDA pressure and the fact that the peer-review appeared on the agenda.”
Delegates from the WHO’s Expert Committee on Drug Dependence (ECDD) will be convening for a peer-review session, in order to combine data and reach a conclusion on how kratom should be classified internationally. News of this was an abrupt and concerning development for kratom advocates across the globe.
“It came as a bit of a shock to all of us, both the FDA pressure and the fact that the peer-review appeared on the agenda for the October ECDD meeting,” said Martin Jelsma, director of the Drugs and Democracy program at the Transnational Institute in Amsterdam and a key figure in the International Drug Policy Consortium. “So there is now a big question mark surrounding what the procedure is. I did get confirmation from the ECDD that what triggered the peer-review has to do with the Early Warning Advisory.”
The Early Warning Advisory (EWA) is an ongoing series of reports made on behalf of the United Nations Office on Drugs and Crime (UNODC) in order to monitor New Psychoactive Substances (NPS). They document drug-related fatalities, toxicology reports and the scientific process of their findings on a regular basis.
While the reports do not target kratom directly, they’re not afraid to make grim and highly dubious implications about the plant, which has mild opioid- and stimulant-like properties and is said by many people to help with chronic pain and withdrawal from opioids.
“There is a graph in the report that shows a very irresponsible representation from the UNODC, where it says something like ‘46 percent of these [overdose] cases involve kratom,’” Jelsma told Filter. “So that gives the image that among all the new psychoactive substances it’s the most dangerous…”
“It’s absolutely inflated,” he continued. “All of these recorded cases involved other substances like oxycontin or oxycodone, so none of these cases had kratom as a direct [cause] of an overdose.”
As a result of the combined EWA reports, kratom was put under “surveillance” by the WHO—a sort of regulatory limbo where no official scheduling is reached.
However, this is only the first step in a lengthy process. The impending peer review this October will be the second step. The final step (if reached) will be a critical review.
The October meeting will be the defining factor in what happens next.
“Critical reviews can only be triggered directly; so if a member-state asks for it, let’s say the US or Malaysia, they would have made a request and it could have gone directly to that step,” Jelsma explained.
The fact that the US hasn’t yet done this, despite the FDA’s record, could be a hopeful sign. However, this does not mean the possibility of a critical review is off the table, as the October meeting will be the defining factor in what happens next.
Some kratom advocates believe the FDA’s anti-kratom fires were stoked by rising kratom acceptance in South East Asia combined with the FDA’s failed attempts at federal criminalization—and essentially amount to an attempt to circumvent domestic obstacles by pushing for an international ban. Not all international advocates subscribe to this cause-and-effect narrative, however.
“I’m still not fully convinced that this is a byproduct of the FDA’s failed attempts to schedule it nationally—that’s a theory put forward by the American Kratom Association,” Jelsma said. “The only thing that is clear is that the FDA has definitely increased domestic pressure on kratom.”
US Efforts to Push Back Against the FDA
The American Kratom Association (AKA) has watched the FDA attempt every play in the book in order to criminalize kratom. Mac Haddow, the AKA’s senior fellow on public policy, has been on the frontlines of this particular regulatory skirmish for some time. Having formerly served as the chief of staff for the Department of Health and Human Services, under whose umbrella the FDA falls, he has substantial insight into how the agency operates.
“We have to take this fight on, both in the US and now that they [the FDA] have opened the international stage with their efforts,” Haddow told Filter. “It’s absurd and we all know it; this is a battle that I’ve been preparing for decades and we’re going to continue to fight and push back at the FDA with every opportunity.”
“The FDA is so wrong about the public policy they’re trying to enact, it’s not even funny.”
The AKA is as open about its conflict with the FDA as the FDA is about its desire to schedule kratom. The main page of the AKA website even displays a counter showing how long it has been since the FDA ignored the organization’s meeting request (1,113 days at publication time.)
“If you have a non-addictive substance that can be used by people who are suffering from acute chronic pain, why the hell wouldn’t we do it?” Haddow said regarding legal regulation. “The FDA is so wrong about the public policy they’re trying to enact, it’s not even funny—and that is why we’re successfully convincing members of state legislatures to pass the Consumer Protection Act.”
This legislation, according to Haddow, generates the same kind of consumer protections that would be in effect if the FDA weren’t so determined to criminalize kratom. These include manufacturing standards to ensure that products are monitored, not altered or contaminated with dangerous substances, properly labelled and marketed strictly to adults.
“Utah, Georgia, Arizona and Oklahoma have passed it in the past,” Haddow said. “It did pass in Oregon but the governor vetoed it only because she believed—due to FDA pressure—that the Department of Agriculture was the wrong regulatory body.”
Texas and Missouri are among other states that have been favourably inclined toward this legislation, only to have their attempts thwarted by red tape and obstruction, according to Haddow.
So how does the state-by-state battle between the AKA and the FDA translate to the impending international summit with the WHO?
“If they do go to critical review, then we’re going to fight tooth-and-nail to make sure that science prevails.”
Recently, the FDA’s requests for feedback, the AKA opened a channel for people with pro-kratom views to share their opinions with the FDA ahead of the summit. At publication time, almost 64,000 people had submitted comments, according to the AKA website.
Haddow is optimistic that this volume of US voices can effectively push back against the FDA’s apparent international intentions.
“If the ECDD looks at the science and applies the standards as doctors then we’re going to be able to successfully get them to put this in the right category, which is a substance that should be under surveillance but not one that should be regulated on an international level,” he said. “If they do go to critical review, then we’re going to fight tooth-and-nail to make sure that science prevails, rather than this nonsense.”