BALTIMORE — Kratom derivatives are now temporarily scheduled as opioids, prompting both alarm and approval within the sprawling kratom industry after federal officials moved to ban three related compounds while signaling limited enforcement for trace amounts in traditional products.
Attorney General Todd Blanche announced the temporary scheduling of mitragynine pseudoindoxyl, also known as MGPI, along with MGM-15 and MGM-16. He said the Department of Justice acted to address deliberately manufactured and concentrated opioid products linked to the kratom plant, not what he described as traditional botanical kratom.
In a statement, Blanche said published research has not established MGPI as a naturally occurring alkaloid in kratom, though questions remain about whether incidental trace levels might appear in botanical products due to processing, storage, or analytical conditions. He added that the department would exercise enforcement discretion only in cases where incidental trace amounts of MGPI are detected in products otherwise considered botanical kratom. The designation as a controlled substance remains in effect.
Kratom is a Southeast Asian tree whose leaves are consumed or brewed as tea for mild psychoactive effects. Supporters say it can help manage pain and ease opioid withdrawal symptoms. The plant, however, has drawn scrutiny for reports of dependence, seizures, and deaths associated with heavy use. The industry, which says it serves more than 15 million users, faces a wave of wrongful death lawsuits as researchers examine the plant’s pharmacology. MGPI has been reported to be up to 20 times stronger than morphine.
Importation of kratom has been banned since 2017, but the product is legal to sell and use in most states once inside the country. Industry advocates have lobbied the Food and Drug Administration to regulate kratom as a food. More recently, the sector has split between backers of so-called pure leaf products, including liquid tinctures they describe as natural, and companies promoting chemically refined or altered offerings that are stronger and often more palatable. Those products often contain one or more of the newly scheduled substances and sometimes 7-hydroxymitragynine, or 7-OH, a potent analogue that exists naturally in kratom at low levels.
Proponents of the higher potency alkaloids have argued to keep them legal. The 7-HOPE Alliance, which supports 7-hydroxymitragynine, held an online meeting on Aug. 26 urging supporters to submit comments to the FDA in favor of 7-OH amid concerns it could also be scheduled.
Traditional leaf advocates, including Mac Haddow of the American Kratom Association, have criticized the market for stronger, altered products. Haddow welcomed the Justice Department’s action and its emphasis on leaving natural leaf kratom products untouched. He said the distinction aligns with the group’s effort to highlight risks from chemically manipulated products marketed as kratom.
A Texas wrongful death case has complicated that distinction. Attorney Talis Abolins of Mctlaw, who has pursued multiple kratom-related cases, said testing tied to a lawsuit involving the death of Texas hotel clerk Dustin Hernandez found MGPI in kratom taken from a bag linked to the incident. The defendants are companies associated with OPMS, also known as Optimized Plant Mediated Solutions, a major supporter of the American Kratom Association and an early signer of the group’s good manufacturing pledge. According to court filings, a defense expert said selling a bag with that level of pseudoindoxyl would be fraud. The defendants argued the bag had been tampered with, but Abolins said subsequent testing of other OPMS pure leaf products also detected MGPI.
Industry figures responded in court with new studies asserting that MGPI can occur naturally and may be present in ground leaf products, similar to 7-OH. That position is not universally shared among researchers. Abhisheak Sharma, a kratom researcher at the University of Florida, said his team has not observed mitragynine pseudoindoxyl in leaf-based powder or capsule products, though traces have appeared in liquid kratom. He suggested that acids used for flavor in liquid formulations could drive conversion.
As the debate over how powerful opioids enter kratom products continues, so do lobbying efforts to keep 7-OH off Schedule I. In an Aug. 26 livestream, 7-HOPE Alliance executive director Jackie Subic lauded supporters for submitting more than 30,000 comments to the FDA, telling them, “We killed it.”
Federal move targets kratom derivatives while signaling discretion
For now, the Justice Department’s policy focuses on the three scheduled kratom derivatives while allowing for enforcement discretion in cases of incidental trace MGPI in botanical kratom. The department emphasized that MGPI remains a controlled substance despite that discretion.
The industry’s evolving legal landscape has unfolded alongside a broader surge in federal criminal cases and civil litigation, from wrongful death suits to high-profile conspiracy trials such as the one that led to a 764 extremist group member gets 77-year federal sentence. As kratom stakeholders await further regulatory moves, lawyers, manufacturers, and consumer advocates are bracing for more courtroom battles over where to draw the line between traditional leaf products and newly scheduled compounds.