A combination of data from the FDA and two independent studies prompted a group of scientists to speak out on conversations surrounding 7-hydroxymitragynine (7-OH) and its parent plant, kratom. The science confirms the strong safety profile of 7-OH and slams the door closed on continued efforts by industry competitors to push 7-OH out of the marketplace with public smears, unfounded science, and government overreach.
The Marwood Group recently completed an independent analysis of data from the FDA, CDC and other federal agencies that confirms 7-OH’s strong real-world safety profile. According to the FDA’s Adverse Event Reporting System (FAERS), there have been no confirmed deaths from 7-OH alone despite more than half a billion estimated doses consumed nationwide. Only five serious adverse events have been reported. Marwood’s review similarly found that while 7-OH was present in two deaths involving numerous other substances, neither death was attributed to it. In contrast, more than 200 deaths were linked to kratom-related products. The analysis of data available suggests that 7-OH has a significantly lower risk profile and is being used more safely than many other natural compounds currently on the market.
“Businesses, consumers and regulatory decision makers deserve credible and accurate information about 7‑OH,” said Dr. Michele Ross, neuroscientist and addiction researcher. “As someone who is both a scientist and a chronic pain patient, I’ve seen firsthand how misinformation harms people looking for natural alternatives. The evidence we have so far, from both the independent studies and the FDA’s two databases, shows that 7‑OH has a very strong safety profile.”
Adding to the body of evidence, a new 2025 pilot study by East Tennessee Clinical Research gave dogs extremely high doses of 7-OH (up to 10 times the typical human dose). The results:
- No cardiac, neurological, or behavioral harm
- The only observed effect was mild, temporary drooling, even at the highest dose
- All animals fully recovered with no lasting impact
In addition to the K-9 study, scientists also tested 7-OH and a related compound called MGP on different types of human cells, from the lungs, kidneys, and blood. Here’s what they found:
- 7-OH was not toxic to the cells, even at high doses.
- It caused fewer problems with important systems in the body, like the heart and kidneys, compared to regular kratom (mitragynine).
Laboratory researchers have also taken note of 7-OH’s unusually wide therapeutic window. In controlled studies, it showed minimal toxicity even at doses far exceeding typical human use. Unlike many natural compounds, 7-OH maintained a strong safety profile, with no signs of cellular damage, cardiovascular issues, or DNA disruption. These findings support the call for evidence-based regulation that ensures safe access while encouraging continued research.
All 7-OH producers who are members of the Holistic Alternative Recovery Trust (HART) are also taking proactive steps to protect consumers by following Good Manufacturing Practices (GMP), conducting third-party lab testing, and using child-resistant packaging with clear instructions. Independent testing confirms that these products consistently meet or exceed purity and labeling standards. As access to 7-OH has grown, national drug overdose deaths have begun to decline for the first time in years—a trend that researchers say may reflect shifting consumer behavior toward safer, plant-based wellness options.
Retailers report that consumer interest in 7-OH continues to grow, with many describing it as a reliable and trusted wellness supplement. Shoppers consistently return for the product, citing its effectiveness and clean sourcing. These buying patterns reflect growing public trust and satisfaction.
“The current data suggests that 7-OH has a strong safety profile and low toxicity in both lab and animal studies,” said Leonard Pickard, chemist and drug policy expert. “It shows promise as a well-tolerated, plant-derived compound. Rather than banning it, we should pursue thoughtful regulation that protects consumers while allowing continued research and access.”
“The science is clear, but some groups are trying to use fear and politics to take away an option that’s working. That’s not right,” said Jeff Smith, national policy director for HART. “Let’s be clear: that isn’t about safety—it’s about market control. We have years of real-world data, we have independent studies, and we have federal agency reports that combine to show 7-OH is being unfairly targeted because it threatens powerful interests.”
“This conversation should be about regulation, not prohibition,” Smith added. “We’re not asking regulators to trust us—we’re asking them to trust the data. The public deserves science-based oversight, not corporate cronyism in the form of a ban designed to create a kratom monopoly.”
