The Global Kratom Coalition (GKC) expresses deep concern over the increasing presence of nefarious actors who are selling unapproved drugs under the guise of labeling them as dietary supplements.
Matthew Lowe, Executive Director of the Global Kratom Coalition, voiced his concerns about these developments:
“We have seen this in the past through the sale of illegally marketed misbranded dietary supplements that contain drugs like Tianeptine and Phenibut. We are now seeing the same thing through the marketing and proliferation of synthesized isolate 7-hydroxymitragynine (7OH) products that are misbranded as kratom and misbranded as dietary supplements. I want to be clear, 7OH products are not kratom, they are pure opioids masquerading as dietary supplements. These products should be controlled substances.”
7OH isolate products contain novel substances that are not found anywhere in nature. The 7OH found in these products is chemically different from the scant amount of 7OH that is found in dried kratom leaf. There are several novel substances in these products for which there is no history of use, nor is the GKC aware of any scientific data that supports their safety. Therefore, these products should be subject to the FDA’s New Drug Application (NDA) process. The GKC is not aware of any approved, let alone filed, NDAs for this substance.
Significantly, leading scientists have repeatedly warned that it is extremely likely that these novel compounds are physically and psychologically addictive with a high potential for abuse, and should be controlled substances.
The Kratom Consumer Protection Act, in many cases, prohibits or limits the sale of these synthetic 7OH products, yet they remain widely available. The Global Kratom Coalition believes policymakers and regulators must not be coerced into treating 7OH products as synonymous with kratom. Nor should they provide a pathway for these products to be sold as dietary ingredients.
The GKC remains committed to working with all stakeholders to ensure that kratom is regulated responsibly and that dangerous synthetic products are kept off the market.
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.
