(TMU Opinion) — Despite the fact that it’s been used by indigenous people for generations, kratom (Mitragyna speciosa) was relatively unknown to a critical mass of Americans until 2016, when suddenly the Drug Enforcement Agency (DEA) and the Food and Drug Administration (FDA) took an aggressive interest in making the Southeast Asian plant a scheduled drug.
Led by then-Commissioner Scott Gottlieb, the FDA took up the mantle and attempted to restrict kratom via aggressive regulations. While the federal government continues to misrepresent the science behind kratom research, the DEA is not likely to recommend criminal scheduling on kratom until newly commissioned studies are completed, which will likely be several years from now.
The federal push to make kratom a Schedule 1 Drug (which would have put it in the same category as heroin and cocaine) was predicated on a series of reports dating back to 2009 and later that called into question whether kratom was a public health threat.
The FDA claimed that kratom was associated with 44 deaths. However, independent, peer-reviewed analysis—later corroborated by the National Institute on Drug Abuse (NIDA)—showed that virtually all of these cases involved either adulterated kratom (meaning it was mixed with something else), or poly-drug use, with some of the decedents having O-desmethyltramadol in their systems.
Over a phone call, Legislative Director of the American Kratom Association (AKA), Mac Haddow, said that despite the fact that the government’s claims were roundly debunked, the FDA continues to deliberately mislead the public and the DEA by referencing these deaths.
The AKA, which has fought the DEA and FDA every step of the way, commissioned their own 8-factor analysis, which concluded that NIDA’s report was correct and that any harm reduction that may result from taking kratom off the market (which is negligible) would be completely offset by kratom users turning to the black market or opioids.
Haddow explained the three main criteria for a scheduling decision: 1) the safety hazard to the public, 2) the addiction level and 3) absence of approved medical uses.
He believes the FDA used the false claim that kratom is associated with 44 deaths in order to justify the safety hazard. With regard to the second piece of criteria, Haddow says that kratom is not an opioid. Its alkaloids affect the brain’s mu-opioid receptors in a similar way but they do not have the same pharmacologic effects and, more importantly, do not slow down the respiratory system, which is what causes so many people to die after overdosing on opioids. The FDA’s claims that kratom is an opioid is another example of their misleading and outright lying to the public.
Kratom’s addiction potential was also addressed by two NIDA studies, which concluded that while kratom can cause psychological dependence just like caffeine, there is no liability for dangerous physical addiction.
As far as criteria #3, while many people all across the world take kratom for relief from pain, anxiety and depression, “kratom is a dietary ingredient from a natural plant and is not, in its natural form, a candidate for the filing of a new drug application.” In other words, the “Controlled Substances Act does not apply to kratom in its common use as a dietary ingredient.”
Haddow says he personally knows of substantive reports attributed to Congressional staffers with close connections to the DEA which suggest that the agency will not recommend scheduling until they see the results of new comprehensive studies funded by the NIDA. The results of these studies will not be available for 2-5 years.
Haddow is confident kratom will not be criminalized before then. He told the Mind Unleashed:
“While it is possible the DEA could issue a Federal Register Notice to schedule at any time. It is my understanding they want to get the decision right and that will be informed by the results of the NIDA studies that are now funded and underway.”
Meanwhile, conspiracies abound about Big Pharma colluding with the government to have kratom banned. While there is no direct evidence for this, aside from the fact that there has been interest in patenting mitragynine alkaloids, a representative for at least one major pharmaceutical company denied lobbying against kratom.
Yet, the perception that Big Pharma is pressuring the government to eliminate an unregulated competitor that is eating into their opioid cash cows remains. Haddow believes the FDA has a “natural inclination to protect their monopoly on the drug approval process.”
The perception of corruption is continually reinforced by the revolving door between government agencies and corporate boardrooms. Just recently, former FDA head Scott Gottlieb was appointed to the Pfizer board, a move that presidential candidate Elizabeth Warren condemned as “smack[ing] of corruption.”
In the last few years, Kratom advocates have accomplished the rare feat of forcing the DEA to reexamine, suspend, and potentially abandon a highly aggressive and propagandized campaign. Haddow says this is unprecedented.
However, while he and the AKA are confident that kratom is safe from near-term federal criminalization, the war is far from over. The newest specter in the war on kratom is the possibility of the federal government attacking kratom at its source in order to cut off supply. The country of Indonesia, which supplies the majority of U.S. kratom, may soon crack down on kratom production. It’s a sudden move for a country where kratom is one of the most profitable exports, causing many to suspect the FDA is applying pressure on them to intercede.
Mac Haddow told Inverse that the Indonesian Health Ministry had admitted that the “top FDA official” was “encourag[ing] the Minister of Health to help the United States by banning the exportation of kratom.”
The FDA has denied any involvement.
Haddow told the Mind Unleashed that the Indonesian ban represents an existential threat to U.S. kratom use, since the country produces 95% of the world’s supply, saying:
“If the regulation issued by the Ministry of Health remains in place, it will have the same effect as scheduling would have here in the U.S.” and that “it will lead to more deaths in our current opioid crisis.”
Out of the frying pan and into the fire. For kratom users, the success of advocacy against the DEA and FDA may subsequently cause the federal government to try new devious methods to cut off their supply.
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