In a significant development in the world of alternative medicine, the Global Kratom Coalition (GKC) has publicly expressed its support for the U.S. Food and Drug Administration’s (FDA) current clinical research efforts on kratom. This move marks a pivotal moment for kratom, a tropical evergreen tree native to Southeast Asia, whose leaves have been used for centuries as a mood booster and energy enhancer.
Under the new leadership of James “Jim” Jones, the first-ever Deputy Commissioner of the Human Foods Program, the FDA is making strides toward enhancing consumer access to accurate information. Jones, who previously contributed to the Reagan-Udall Foundation’s Expert Panel, brings a wealth of knowledge on food safety and regulatory affairs to the table. The GKC lauds this appointment as a step forward in ensuring that kratom research is conducted with the utmost rigor and transparency.
Matthew Lowe, Executive Director of the GKC, emphasized the significance of the FDA’s research, stating that it has the potential to bring clarity to the ongoing debates surrounding kratom’s safety and efficacy. The research aims to guide regulatory oversight and could potentially revolutionize the industry by providing consumers with reliable information on kratom’s risk profile.
Kratom (Mitragyna speciosa) has been a subject of contention in various countries, including the U.S., due to concerns about its safety and regulatory status. Despite its traditional use in Southeast Asia, the absence of comprehensive scientific data has led to a fragmented regulatory landscape. The FDA’s commitment, as highlighted in a February 2024 Food Navigator article, to pursuing transparent and science-based decision-making is a promising development for kratom stakeholders.
The FDA’s research encompasses two critical studies: the Single Ascending Dose (SAD) study and the upcoming Human Abuse Potential (HAP) study. The SAD study is designed to assess the safety, pharmacokinetics, and pharmacodynamics of leaf kratom, aiming to identify the optimal dose range for further clinical development. This study is a cornerstone in understanding kratom’s safety profiles and will inform dose selection for future clinical trials. Initial results are expected to be released in late 2024.
Furthermore, the FDA has called for proposals for HAP research to evaluate kratom’s addictive properties and abuse liability through controlled laboratory studies and observational research. This research is crucial for informing regulatory decisions on how kratom should be adequately regulated in the U.S., ensuring consumer safety while maintaining access to this traditional botanical.
The GKC, representing advocates for kratom, supports the advancement of scientific research and sensible regulation. The coalition operates on principles of access, education, advocacy, community, and responsibility, striving to empower individuals with access to safe and responsibly sourced kratom products. The GKC’s mission aligns with the broader goal of ensuring that consumers are informed and protected, while also advocating for fair and sensible regulations that prioritize consumer safety and freedom of information.
As the FDA continues its research on kratom, the outcomes of these studies are eagerly anticipated by both proponents and critics of the botanical. The GKC’s support for the FDA’s efforts underscores the importance of evidence-based policymaking in the realm of alternative medicine. By advancing scientific understanding and fostering an environment of transparency and accountability, the FDA and GKC are working together to ensure that kratom’s potential benefits are realized in a safe and regulated manner.
For more information on the Global Kratom Coalition and their efforts, visit their official website.