The Global Kratom Coalition objects to the position put forward by American Kratom Association and the Holistic Alternative Recovery Trust (HART) that 7-hydroxymitragynine (7OH) products be regulated in the same way as kratom.
In an AKA/HART press event, all panel members stated that 7OH products are for pain relief and opioid use disorder. Unapproved new drug claims of this kind are already being made by HART members as seen in the recent Kratom Advocacy Podcast. GKC emphasizes that such claims cause 7OH products to be drugs as defined by the FDA and therefore unlawful to sell without prior FDA drug approval.
Global Kratom Coalition (GKC) Executive Director Matthew Lowe responded to the AKA’s announcement: "The GKC believes that 7OH products should be treated as controlled substances. These semi-synthetic products, that are more potent than morphine, pose significant potential public health risks and are being marketed as drugs. Rebranding does not mitigate the danger of selling a pure opioid without restriction. 7OH isolates should be regulated as any other drug product would be. It is my opinion that today’s announcement is a clear effort to create a loophole in existing state laws to open the flood gates to unregulated 7OH products to be sold freely in smoke shops."
"Our position remains that 7OH products should be deemed controlled substances. If 7OH producers, represented under the banner of HART and AKA, want to be regulated, they should first seek new drug approval from FDA, as federal law requires."
Dr Chris McCurdy, a leading kratom scientist, testified in recent Kratom Congressional Hearing (28:43 to 31:21) that the 7OH found in 7OH isolate products is distinctly different from the scant amount of 7OH that is found in dried kratom leaf. He identified several unknown compounds in these products stating that “we have no idea what they are. Meaning we have no idea what the harm could be or the risk…which is concerning for all of us as scientists”. As such, the GKC agrees that these products are not kratom. They are novel substances that have not been seen before and are being administered in humans for the first time. Dr McCurdy also recently called for these products to be controlled substances, which the GKC also agrees with.
GKC urges policymakers to respect the differences between the dietary ingredient kratom, which has a long history of safe use, and unapproved drugs like 7OH. Proper regulation and enforcement are necessary to ensure the public’s safety and to prevent bad actors from marketing untested and dangerous substances.
About the Global Kratom Coalition
The Global Kratom Coalition is an alliance of kratom consumers, experts, and industry leaders dedicated to protecting access to kratom while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers.
