NIH Greenlights First Kratom Clinical Trial While California Takes Legal Action Against Manufacturer

Why it matters

The FDA and NIH simultaneously pursuing clinical research on kratom as an opioid use disorder treatment while California prosecutes a kratom manufacturer reflects the central paradox of U.S. kratom policy: the same compound may be both a public health risk and a potential therapeutic tool.

The big picture

Kratom occupies an unusual regulatory space: no FDA-approved uses exist, yet millions of Americans self-medicate with it for pain, anxiety, and opioid withdrawal. On June 1, 2026, NIH announced FDA clearance for the first human clinical trial of mitragynine — kratom's primary alkaloid — as an opioid use disorder treatment. Days later, the California Department of Public Health and state Attorney General filed a civil complaint against a manufacturer accused of continuing to produce and ship kratom products after multiple enforcement actions.

Key findings

• NIH and University of Florida researchers received FDA clearance (Investigational New Drug status) on June 1, 2026, to begin Phase 1 clinical trials of mitragynine for opioid use disorder treatment
• Kratom-related calls to U.S. poison control centers rose 1,200% over a decade; California's poison control center reports similar trends
• More than 5 million Americans have used kratom; use rose between 2021-2024 despite state bans, with 1.9% of people aged 12+ reporting use in 2024
• California has seized over $5 million worth of kratom and 7-OH products; the state filed a lawsuit against Ashlynn Marketing Group Inc. of Santee after multiple facility inspections found continued manufacturing
• Los Angeles County linked 6 deaths to 7-OH combined with other substances in 2024, prompting a county-wide ban
• A 2020 Johns Hopkins survey found 91% of kratom users took it for chronic pain, 67% for anxiety, and 41% for opioid dependence

What they say

"This is a major step toward expanding treatment options for the millions of Americans struggling with opioid use disorder, which has contributed to historically high overdose mortality rates." — Dr. Nora Volkow, Director, NIH National Institute on Drug Abuse

Bottom line

The federal government is simultaneously funding research into kratom as a potential opioid treatment and taking enforcement actions against its sale, illustrating why kratom policy remains one of the most contested public health questions in the U.S.