Source: Holistic Alternative Recovery Trust
Excerpt:
WASHINGTON, D.C. – The Holistic Alternative Recovery Trust (HART) today released the following statement in response to misleading and incomplete media reports surrounding a 7-hydroxymitragynine (7-OH):
“The misinformation circulating about 7-OH misrepresents both the science and the safety record of this compound,” Jeff Smith, PhD, National Policy Director for HART. “The only clinical study cited by the FDA comes from a researcher funded by the Global Kratom Coalition, a group actively fighting 7-OH products that have cut into their market share. That unreviewed, unpublished study sought to demonstrate harm by injecting 7-OH directly into mice’s bloodstream, even though humans consume it orally. Anything can be harmful if injected, eat a chocolate bar and you’re fine; inject it and you’ll die. The study was biased and misleading.”
Smith emphasized that responsible regulation, not prohibition, is the key to consumer safety.
“We have long supported sensible safeguards for botanical and alternative recovery compounds,” Smith continued. “That includes strict age restrictions, child-resistant packaging, third-party lab verification, and clear dosing guidance. Consumers deserve access to accurate information and responsibly made products, not fear-based narratives driven by competitors.”
The organization urged policymakers, public health officials, and journalists to seek out peer-reviewed science and balanced perspectives before issuing public warnings.
“Science should lead, not special interests. Out of the 47 reports of exposures to Kratom or 7-OH in the first nine months of 2025, the Missouri Department of Health and Human Services recorded only three cases involving 7-OH.” Smith added.
MYTH: 7-OH is described as a psychoactive compound that’s a synthetic derivative of the kratom plant.
FACT: 7-OH products marketed by HART members comply with FDA’s adulteration standard for dietary supplements; further, 7-OH is not lab-made or fully synthetic, it is naturally-derived from kratom, the same plant that all other kratom products come from, and undergoes a simple, one-step oxidation process, similar to how vitamin C is stabilized for supplements.
MYTH: Isolated 7-OH is far more potent – up to 13 times stronger than morphine at opioid receptors.
FACT: Potency does not equal danger. A compound can show strong activity in lab tests without causing strong effects in real life.
7-OH does bind strongly to the same receptors as conventional opioids, but it only partially activates them, which means 7-OH has a built-in “safety ceiling.” After a point, taking more does not create stronger opioid-like effects in the way traditional opioids do.
This is the key difference between 7-OH and drugs like morphine or fentanyl that fully activate those receptors and can cause dangerous respiratory depression and overdose. This is why there is no documented case of someone dying from 7-OH alone. If there were, it would be the first thing critics would point to, and they haven’t.
MYTH: 7-OH, not Kratom, is the problem.
FACT: According to the Food and Drug Administration’s (FDA) own Adverse Event Reporting System (FAERS), there have been under 40 adverse events, and ZERO deaths linked exclusively to 7-OH, despite well over a billion doses consumed nationwide.
Contrast that with raw kratom leaf, which the FDA itself has associated with nearly 200 confirmed deaths.
In the first nine months of 2025, the Missouri Department of Health and Human Services recorded 47 reports of exposures involving kratom or 7-OH, nearly double for the same time period in 2024. Three cases involved the synthetic isolation of 7-OH, with a patient requiring hospitalization in one case.
About the Holistic Alternative Recovery Trust (HART)
The Holistic Alternative Recovery Trust (HART) is a national nonprofit dedicated to promoting evidence-based, transparent policy around natural recovery compounds. HART supports responsible regulation that protects consumers while encouraging innovation in safe, science-driven alternatives to traditional pharmaceuticals.