Kratom Consumer Advisory Council (KCAC) Refutes Misleading Safety Claims About Synthetic 7-OH Products

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Newly released position statement shares how poison control mortality data undercounts risks

Kratom Consumer Advisory Council (KCAC) released a position statement refuting misleading claims from the Holistic Alternative Recovery Trust (HART) that reported low mortality statistics on concentrated synthetic 7-hydroxymitragynine (7-OH) products in the Poison Control Center dataset proves safety and refutes FDA recommended scheduling.

There are numerous reasons why mortality statistics are grossly misleading:

• First responders, coroners, and clinicians were unaware that 7-OH products existed, greatly reducing the chances 7-OH would be tested for.
• People dying from unknown causes are not routinely tested for 7-OH concentrations. Many opioids, alcohol, and other drugs are routinely tested for post-mortem, so people dying after using 7-OH products in conjunction with another drug would be misattributed. 
• 7-OH products were marketed as “kratom,” so family members and caregivers would likely erroneously attribute deaths to “kratom” and not 7-OH products.
• 7-OH is unstable and degrades quickly in bodily fluids, so samples not taken shortly after death and analyzed expeditiously could fail to detect 7-OH. There are usually long delays analyzing post-mortem samples. 

“Instead of reflecting on the FDA’s well-founded concerns of serious potential health risk, HART continues to misrepresent the data, creating intentional disinformation,” stated KCAC Chair Dr. C. Michael White, Pharm.D., FCP, FCCP, FASHP, and Distinguished Professor of Pharmacy Practice at the University of Connecticut.

In an announcement on July 29, the FDA made clear that synthetic concentrated 7-hydroxymitragynine products, but not leaf kratom products, are dangerous and should be considered for scheduling under the U.S. Controlled Substances Act. 

KCAC emphasized that the FDA is right to act. Animal studies have shown that high dose 7-OH is as addictive and dangerous as regular opioids. Synthetic concentrated 7-OH products have been associated with severe addiction, rapid dosage escalation, and problems with breathing, agitation, seizures, and adverse heart effects in consumers. KCAC calls on regulators, lawmakers, and the media to take a clear-eyed view of the risks posed by synthetic 7-hydroxymitragynine (7-OH) products and urges a halt to the sale of these potent synthetic derivatives outside of research settings.

The full position statement, “Why Poison Control Center Mortality Data Cannot Accurately Reflect Synthetic Concentrated 7-OH Risk” is available here.

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SOURCE: Kratom Consumer Advisory Council (KCAC)

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