The U.S. Food and Drug Administration (FDA) has released preliminary findings from its first-ever pilot study on kratom, revealing that the botanical, in its natural leaf form, is “well tolerated” under controlled conditions. The study, presented in January 2025 at the University of Florida’s International Kratom Symposium, aimed to assess kratom’s safety and abuse potential.
Researchers conducted a single ascending dose (SAD) trial with 40 healthy participants, testing doses ranging from 1 to 12 grams. While higher doses caused mild side effects like nausea and vomiting, no significant adverse events were reported. Lead researcher Dr. Christopher McCurdy noted that these results pave the way for further research into kratom’s pharmacological effects.
The findings could influence regulatory discussions, with advocates urging the FDA to focus on regulating kratom products rather than banning them. For more details, visit SupplySide Supplement Journal.
