First Industry-Sponsored Clinical Trial of Kratom Extract Reports No Severe Adverse Events Over 28 Days

Why it matters

This marks the first industry-funded clinical evaluation of a commercial kratom extract product, providing initial safety data that regulators and policymakers have long said was missing from the kratom market.

The big picture

Kratom has been sold as a supplement for over a decade in the U.S., yet virtually no controlled clinical safety studies existed for commercially available products. Regulatory agencies including the FDA have repeatedly cited the lack of clinical data as a barrier to legitimate status. This industry-sponsored study, presented at the University of Florida's Fifth Scientific Kratom Symposium, is a modest but notable first step toward a clinical evidence base for kratom extracts.

Key findings

• The 28-day study evaluated safety and tolerability of VIVAZEN® proprietary kratom extract in adult participants at low doses
• No severe adverse events were observed during the entire 28-day trial period
• The extract was described as well-tolerated for consecutive daily use
• No evidence of dependence or withdrawal was reported within the study window
• Findings were presented at the University of Florida Fifth Scientific Kratom Symposium on February 19, 2026
• The study was sponsored by VIVAZEN®, a commercial kratom product manufacturer; the results are a press release and have not yet been published in a peer-reviewed journal

What they say

"Policy should be informed by scientific evidence, not fear-based assumptions," said principal investigator Dr. Paula Brown, Director of Applied Research at the BC Institute of Technology. "Consumers rely on and deserve transparency and robust safety standards to make informed decisions about their wellness."

Bottom line

An industry-funded clinical study found no severe adverse events from a commercial kratom extract over 28 days — but the study's commercial sponsorship and absence of peer review require careful interpretation.