By Pat Anson
A recent DEA decision to classify the designer drug O-DSMT (O-desmethyltramadol) as an illegal Schedule One controlled substance gives us some insight into how quickly the agency may do the same for concentrated forms of the kratom alkaloid 7-OH (7-hydroxymitragynine).
It also serves as a reminder of how misleading and inept the DEA and other federal agencies can be about their research and public statements about drugs and other substances.
O-DSMT is a natural metabolite made by the liver when you take the prescription opioid tramadol. Like 7-OH, O-DSMT can have opioid-like effects, and it is significantly more potent than tramadol itself. In recent years, illicit drug labs have been making synthetic versions of O-DSMT, which has led to abuse and overdoses.
The DEA published its first notice about scheduling O-DSMT on June 24. After a mandatory 30-day waiting period, the agency took another 19 days before officially classifying O-DSMT as a Schedule One substance on August 12.
The entire scheduling process took only 49 days for O-DSMT, which is quick work for the DEA.
Applying that same time frame to 7-OH, which the DEA first moved to schedule on July 6, means the DEA might officially classify concentrated 7-OH as an illegal drug on or about August 24.
The kratom alkaloid mitragynine pseudoindoxyl and synthetic alkaloids MGM-15 and MGM-16 could also be classified as Schedule One substances that day, putting them in the same category as LSD and heroin.
All of this is projection, since the DEA could schedule 7-OH at any time. In the past, the agency has waited several months or even years before scheduling a drug, but because this is an emergency scheduling based on an “imminent hazard to public health,” the DEA is unlikely to wait long.
The Trump administration appears eager to take concentrated 7-OH products off the market. President Trump has shown an interest in scheduling 7-OH, and Health and Human Services Secretary Robert. F Kennedy Jr. has called 7-OH manufacturers a “sinister industry” for their marketing efforts to children.
The FDA initially called for 7-OH to be banned over a year ago, but the DEA declined to take action until now.
‘FDA Fairytales’
Which brings us back to O-DSMT, which has an obscure but telling connection to kratom, the DEA and FDA.
In 2016, when the DEA first tried to schedule kratom’s alkaloids as Schedule One controlled substances, it claimed there were numerous deaths associated with kratom, including a “cluster of nine deaths in Sweden from use of the kratom product Krypton.”
“Krypton” is not a reference to the mythical home planet of Superman, but to an herbal powder that was being sold online as a legal high. Nine young people died in Sweden from respiratory depression after ingesting Krypton in 2010.
Krypton was then being marketed as a safe and natural kratom product, so the deaths were initially blamed on kratom. But toxicologists soon discovered that Krypton was laced with O-DSMT, which was detected in blood samples from the nine overdose victims. Based on that evidence, Swedish regulators quickly moved to ban O-DSMT as an illegal narcotic in 2011 — fifteen years before the DEA did.
“We believe that the addition of the potent mu-receptor agonist O-desmethyltramadol to powdered leaves from Kratom contributed to the unintentional death of the nine cases presented and conclude that intake of Krypton is not as harmless as it often is described on internet websites,” Swedish researchers reported.
Why was the DEA still blaming kratom for the Swedish deaths in 2016? Because that’s what it was told by the FDA, which continued to call the Krypton overdoses “kratom-associated deaths” long after the overdoses were linked to O-DSMT.
“The FDA misrepresented the nine Swedish deaths in its 3-Factor Analysis recommendation to the DEA in 2016 with the express purpose of triggering the emergency scheduling authority of DEA under the Controlled Substances Act (CSA) to schedule kratom as a Schedule I substance,” said Jane Banin, PhD, in a 2018 report sponsored by the the American Kratom Association.
The DEA wasn’t the only federal agency that was misled by the FDA. The CDC and National Institute on Drug Abuse (NIDA), as well as state and local health officials, also published warnings about kratom, based in part on what Babin called the “FDA’s fairytales.”
“The FDA’s failure to provide accurate and critically relevant data biased the narrative on the alleged deaths associated with kratom, amounting to a viral event that infected wide ranging opinions, and produced deeply flawed public policy at federal, state, and local levels,” Babin wrote.
The FDA’s sloppy research on kratom was later called "embarrassingly poor evidence” by a top federal health official, when he informed the DEA in 2018 that the agency would no longer seek to have kratom scheduled as an illegal substance.
Flash forward eight years and the Trump administration is on the verge of banning concentrated forms of 7-OH, but not natural leaf kratom.
That distinction may be comforting to kratom advocates, but it sparks genuine fear in millions of 7-OH consumers, who have come to rely on 7-OH as a potent and effective pain reliever.
They can take cold comfort in the fact that the DEA is no longer spreading fairytales about what happened in Sweden. The DEA’s scheduling order for O-DSMT now correctly blames the nine overdoses in 2010 on “intoxication with O-DSMT.”
Deceptive and Misleading Evidence
That’s not likely to dispel fears the DEA is repeating the same mistakes again with 7-OH. A justified fear, as it turns out.
In its scheduling order for 7-OH, the DEA states that “fatal overdoses involving 7-hydroxymitragynine have been reported,” but briefly cites only one case: a 24-year old man who died in 2014 with a high concentration of 7-OH in his blood.
PNN discovered the DEA omitted some crucial information about the case and got one detail clearly wrong. For one, according to the researchers who investigated the overdose, the man was not 24-years old, he was middle-aged.
Unmentioned by the DEA is that the man had “a history of drug abuse and mental illness for several years.” In addition to 7-OH, he had a sedative, antidepressant, and anti-seizure medication in his blood and urine – clearly a case of polysubstance use.
Another key detail left out by the DEA is that the overdose happened in Norway – meaning the DEA was again invoking a drug death in Scandinavia and then getting basic facts about it wrong
But the strangest aspect is when the death occurred. High dose 7-OH products only came on the U.S. market in 2022, so citing a fatal overdose in Norway from 2014 doesn’t make much sense. I’ll go even further and say it’s deceptive.
In its campaign against 7-OH, the DEA mainly relies on anecdotal information from third-party sources, such as a growing number of calls to poison control centers about 7-OH and user-reported experiences posted online warning of 7-OH addiction and withdrawal.
“The National Drug Early Warning System (NDEWS) conducted web monitoring on reddit mentions of kratom and its derivates. In the report, information provided by reddit discussants surrounding kratom and 7-hydroxymitragynine shows that users often compare 7-hydroxymitragynine effects to prescription opioids, like oxycodone and hydrocodone, with users expressing worry on how such potent products are legally available at smoke shops,” DEA said.
The DEA’s failure to provide credible examples of 7-OH causing a fatal overdose is telling. So is its reliance on the guilt-by-association tactic of equating 7-OH with prescription opioids.
7-OH advocates say the DEA can’t provide evidence about an overdose on 7-OH alone, because the vast majority of reported deaths involve other substances — like the one in Norway.
“If you talk to medical toxicologists that do postmortems, they don't see it. The experts in the country don't believe that 7-OH is responsible for deaths. If you talk to emergency room physicians, if you talk to addiction scientists, if you talk to leading people at the National Poison Control Center, their data doesn't suggest that this is leading to great harm,” says Jeff Smith, Executive Director of the Holistic Alternative Recovery Trust (HART), an advocacy group funded by 7-OH manufacturers.
“The data doesn't appear to bear out that there is great harm occurring, or that this is any kind of emergency. If it were, they (DEA) wouldn't have waited a year for the initial recommendation.”
To be clear, concentrated formulations of 7-OH are potent analgesics that can lead to addiction and withdrawal. Even 7-OH advocates say the industry needs more regulation and accurate labeling, and that 7-OH products shouldn’t be marketed and sold to children.
All of this could be moot point though, because 7-OH products appear on the verge of being banned nationwide. Whether the evidence supports it or not.
