Kratom Consumer Advisory Council (KCAC) today released a comprehensive white paper challenging recent claims that products containing isolated 7-hydroxymitragynine (also known as “7”) are safe for widespread, uncontrolled consumer use. The white paper, "Have '7' Products with 7-Hydroxymitragynine (7-OH) Been Proven to Be Safe?" directly refutes assertions made in a July 7 press release by the Holistic Alternative Recovery Trust (HART), which KCAC says misrepresented findings from a report HART itself commissioned from healthcare consulting firm Marwood Group.
KCAC Chair Dr. C. Michael White, Pharm.D., FCP, FCCP, FASHP, and Distinguished Professor of Pharmacy Practice at the University of Connecticut, issued a stark warning:
“It is dangerously misleading to suggest that 7 products are safe for public sale without medical oversight. Marwood Group’s own report, despite being commissioned by HART, clearly concludes that synthetic 7-hydroxymitragynine is a potent opioid agonist with high abuse potential, rapid tolerance development, and physical dependence in animal models. HART’s attempt to erase key parts of the report after publication, including these risk statements, is an alarming act of public deception that endangers consumers.”
The KCAC white paper cites the following key concerns from the Marwood Group report that HART initially published and then quietly removed:
- Synthetic 7-hydroxymitragynine is over 10 times more potent than morphine and acts on the same opioid receptors known to cause euphoria, addiction, and respiratory depression.
- Repeated use leads to rapid tolerance, dependence, and withdrawal symptoms, none of which are seen with the kratom leaf’s main alkaloid, mitragynine.
- No clinical trials exist demonstrating the safety or efficacy of synthetic 7-hydroxymitragynine products for any medical condition.
- Marwood’s disclaimer clearly states that synthetic 7-hydroxymitragynine should not be used to self-treat or self-diagnose, directly contradicting HART’s public promotion of these products.
The KCAC paper refutes Marwood Group’s assertion that 7-hydroxymitragynine has a lower risk of respiratory depression. They used a surrogate marker called beta-arrestin recruitment to say the risk was lower without looking at actual animal studies where breathing was assessed and shown to be depressed, just like with morphine. It also provides a balanced perspective on anecdotal experiences with 7 products where consumers report widespread recreational use for euphoria and suffering from severe addiction.
“We’ve seen this playbook before, downplaying the risks of potent opioids while encouraging unregulated use. The opioid crisis of the 2000s began with similar false assurances,” said Dr. White. “We must not repeat history with synthetic 7-hydroxymitragynine. These products must be evaluated through rigorous clinical trials and carefully controlled, not sold like candy at gas stations.”
The white paper also highlights KCAC’s support for the FDA’s July 15 warning letters against firms illegally marketing synthetic 7-hydroxymitragynine products and making unsubstantiated medical claims.
KCAC calls on regulators, lawmakers, and the media to take a clear-eyed view of the risks posed by synthetic 7-hydroxymitragynine products and urges a halt to the sale of these potent synthetic derivatives outside of clinical or research settings.
The full white paper, “Have ‘7’ Products with 7-Hydroxymitragynine (7-OH) Been Proven to Be Safe?” is available here.
