The federal government is targeting 7-OH without presenting the evidence

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The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced their intent to initiate scheduling of 7-hydroxymitragynine (7-OH), a kratom-derived compound, under the Controlled Substances Act. On July 29, officials suggested placing 7-OH in Schedule I, a classification traditionally reserved for substances with a high potential for abuse, no currently accepted medical use, and no established safety margin.

Such a move would have sweeping consequences for clinical research, product regulation, and patient access. Yet no evidence was presented to support it.

Jeff Smith, PhD

Introducing kratom and 7-OH

Kratom (Mitragyna speciosa) is a tropical plant native to Southeast Asia, traditionally used to relieve pain and combat fatigue. Its primary alkaloid, mitragynine, is metabolized in the body into 7-OH, a more potent compound thought to play a significant role in kratom’s analgesic effects. Today, 7-OH is also sold directly in isolated, low-dose form in several states. Though not yet FDA approved, many of these products are voluntarily tested by third-party labs and subject to quality standards under current Good Manufacturing Practices. According to estimates from the Marwood Group, 7-OH has been used by Americans hundreds of millions of times.

At the HHS press conference, officials raised general concerns about addiction and unregulated substances but did not cite any study, data set or adverse event report specific to 7-OH. When asked whether even a single death could be attributed to 7-OH, they declined to answer. The featured consumer advocate warned against the compound but acknowledged she had never used it and was relying on secondhand reports from a vape store clerk who said he had heard things from others.

This raises serious questions about the evidentiary basis for such a significant regulatory action.

What is the danger?

According to the FDA’s own Adverse Event Reporting System (FAERS), there have been no confirmed deaths from 7-OH used in isolation. Only three serious adverse events are recorded, two of which occurred before current standardized products were widely available. While FAERS data are limited, there is neither a toxicological nor a general public health signal indicating widespread harm associated with 7-OH. If there were, it would likely be reflected in clinical literature and media reporting. In short, emergency rooms would be filled with people who consumed 7-OH products, and the nightly news would feature public health authorities clamoring for a ban. None of it is happening.

By contrast, FAERS includes more than 200 deaths linked to kratom leaf products and 48 serious adverse events in the first quarter of 2025 alone. If the public were presented with two substances, one associated with over 200 deaths and the other with zero confirmed fatalities, most would identify the greater risk. This makes the decision to target 7-OH over raw kratom difficult to understand.

One possible explanation may lie in industry dynamics. Certain trade associations representing kratom manufacturers have lobbied against 7-OH products in state legislatures across the country. These same organizations promote their own unstandardized offerings, including high-mitragynine products that appear frequently in FDA safety data. A paid protest against 7-OH at a Las Vegas industry event in July was reportedly funded by one such trade group. The opposition may stem less from clinical concerns than from commercial competition, as the consistency and efficacy of 7-OH presents a threat to less regulated kratom products.

Early findings

Meanwhile, emerging preclinical research is beginning to define 7-OH’s pharmacological characteristics. An in vitro study tested 7-OH and mitragynine on human cell lines from pulmonary, renal and hematologic systems. The researchers observed no cytotoxic effects from 7-OH, even at high concentrations, and found fewer disruptions to cardiovascular and renal markers than those caused by mitragynine. In 2025, a pilot safety study conducted in beagle dogs found that 7-OH was well tolerated at therapeutic doses, with no serious adverse events and only mild gastrointestinal symptoms observed at higher levels.

These findings are early stage and not a substitute for clinical trials. More research is needed to fully assess 7-OH’s risks, including its potential for misuse, dependence or drug-drug interactions. But they do not support the claim that 7-OH is an imminent threat to public health.

To be clear, 7-OH is a potent compound. But potency alone does not justify prohibition. Alcohol, benzodiazepines and prescription opioids are far more dangerous and remain legally available under strict regulation. The proper response to uncertainty is research and oversight: not bans.

Speculation or science?

Schedule I classification is intended for substances with no medical value, high abuse potential and no margin of safety. It imposes the highest regulatory burden under U.S. law, makes further research difficult, and criminalizes access to the substance entirely. Applying that label to 7-OH at this stage would cut off regulated production, force use into unmonitored markets, and potentially push patients back toward more dangerous options, including opioids like heroin and fentanyl that have killed nearly 100,000 annually for years.

This is not a decision that should be made without rigorous public evidence and broad expert input. Physicians, toxicologists, addiction researchers and pharmacologists deserve a role in shaping policy on emerging compounds like 7-OH. Premature scheduling risks setting public health back by substituting speculation for science.

This issue is especially relevant for primary care physicians, many of whom may not be familiar with 7-OH. That knowledge gap matters. In past decades, physicians were too often misled about the risks of prescription opioids, contributing, through no fault of their own, to the crisis we now face. Today, doctors deserve clear, evidence-based guidance on emerging compounds like 7-OH, including how they interact with other medications, how patients use them, and what warning signs to look for. Frontline providers need accurate information to give informed advice and build trust with patients.

That’s why the stakes of this decision are so high. If HHS and FDA have data to support the claim that 7-OH poses an imminent danger, they should release them. If they do not, they should pause and allow for a transparent scientific dialogue before taking irreversible action.

Jeff Smith, PhD, is the national policy director for the Holistic Alternative Recovery Trust. He also leads J.R. Smith Policy Solutions, advising nonprofits focused on public safety and criminal justice reform. A former Missouri state senator, he previously taught public policy at The New School in New York and holds a PhD in political science from Washington University. His writing has appeared in The New York Times, The Atlantic, CNN and Politico.