The Global Kratom Coalition Applauds FDA Clinical Research on Kratom

The Global Kratom Coalition (GKC) announced today their support of the U.S. Food and Drug Administration (FDA) as they undertake clinical research on kratom. Clinical research is necessary to expand understanding of kratom consumer safety, guide regulatory decision-making, and impact global health. The GKC is expressing support for an efficient research timeline that produces findings for real-life applications.

The GKC also applauded the FDA for the appointment of James “Jim” Jones, the first-ever Deputy Commissioner of the Human Foods Program. Jones comes to the FDA with intimate knowledge of the food program having served on the Reagan-Udall Foundation’s Expert Panel that reviewed and made recommendations for the program in 2022.

"The FDA is in a position to produce robust scientific data that evaluates the efficacy and safety of kratom, which can help guide regulatory oversight," said Matthew Lowe, Executive Director of the GKC. "When this research is made public, it will bring much greater certainty to the question marks that the FDA has had in relation to kratom's risk profile. These findings could be an industry and consumer game changer." 

In a positive demonstration of its commitment to risk-prioritization strategy and policy, the FDA last year appointed Jones. He will oversee areas involving human foods for the FDA. Overall, according to food and beverage market trade Food Navigator, the FDA will "pursue access to accurate information that is easy to understand and transparency into how FDA evaluates food safety." The February 2024 article also quoted Kimberlee Trzeciak, FDA Commissioner for Policy, Legislation and International Affairs: "FDA are doing as much as we can to be more transparent and to provide sufficient assurance that the decisions we are making are science-based."

Kratom (Mitragyna speciosa) is a tropical evergreen tree native to Southeast Asia, where its leaves have long been used as a mood booster and energy enhancer. Despite being used traditionally in Southeast Asia in global form for centuries, kratom's regulatory status and safety are debated in countries around the world, including the U.S., where it is now available in various forms such as ground leaf, extracts, and isolates.

As noted at the recent 3rd Kratom Symposium, the scientific community strongly encourages further research on the various forms of kratom to help firmly establish, clarify, or dispel inaccuracies. The FDA’s recent leaf kratom Single Ascending Dose (SAD) study and upcoming Human Abuse Potential (HAP) are critical components of the clinical research needed in this space.

The SAD study aims to learn about the safety, pharmacokinetics (what the body does to the substance), and pharmacodynamics (what the substance does to the body) of leaf Kratom.1 This SAD research will help determine the optimal dose range for further clinical development by identifying the maximum tolerated serving and assessing kratom's effect at various serving levels. Additionally, the single ascending dose data will provide valuable data on leaf kratom’s safety profiles, guiding subsequent dose selection for further clinical trials and public statements on kratom. Initial SAD results are expected to be released in late 2024.

The FDA has also released a request for proposal for Human Abuse Potential (HAP) research. The HAP research will evaluate kratom through controlled laboratory studies and observational research, which can provide critical insights into its addictive properties and abuse liability, informing regulatory decisions on how kratom should be adequately regulated in the U.S.

"By conducting robust research in these areas, the FDA can contribute to a more evidence-based understanding of the various forms of kratom's risks and benefits," said Lowe. "Altogether, clinical data will facilitate informed policymaking and regulatory oversight, which we believe will benefit kratom consumers across the country."

The Global Kratom Coalition (GKC) exists to protect and expand access to leaf-based kratom around the world. The organization represents the interests of advocates committed to positive change benefiting consumers. The organization supports education and the development of kratom science, which is central to the GKC’s mission—to empower individuals worldwide with access to safe and responsibly sourced kratom products by advancing scientific research and sensible regulation.

The GKC operates on five key values:

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Media Contact

Matthew Lowe
mlowe@globalkratomcoalition.org