During my tenure as CDC Director, I witnessed firsthand how quickly emerging substances can overwhelm our public health infrastructure. Today, I’m compelled to warn about a new threat hiding in plain sight: a potent synthetic opioid masquerading as natural kratom.
As a virologist who has spent decades studying how pathogens adapt and spread, I recognize the same pattern in how dangerous substances evolve to evade detection. What we’re seeing with the compound 7-hydroxymitragynine is a textbook case of how manufacturers exploit regulatory gaps to create products that are, in essence, unregulated pharmaceuticals.
Recent investigative testing by The Tampa Bay Times revealed kratom tablets containing 15 milligrams of 7-hydroxymitragynine each — concentrations that experts have characterized as equivalent to “legal morphine.” These are not trace amounts found naturally in kratom leaf. Laboratory analysis confirms that these levels can only result from chemical manipulation, where manufacturers convert the naturally occurring alkaloid mitragynine into its far more potent derivative.
To put this in perspective: natural kratom contains less than 0.01 percent 7-hydroxymitragynine. These synthetic products contain concentrations up to 150 times higher. This is not botanical kratom — this is pharmaceutical-grade opioid chemistry operating without oversight.
In 2024, the FDA completed a single ascending-dose clinical trial examining ground kratom leaf in experienced users. The results were illuminating: participants experienced no serious adverse events at doses up to 12 grams, with side effects limited to mild nausea and pupil constriction. Crucially, subjective “drug liking” scores never reached statistical significance compared to placebo, indicating low abuse potential for natural leaf.
This clinical evidence establishes a critical scientific baseline: natural kratom leaf, when used as it has been for centuries, presents a markedly different risk profile than the synthetic products flooding American markets.
Yet some manufacturers are cynically using this FDA safety data to justify products that bear no resemblance to what was actually studied. It’s a dangerous bait-and-switch that exploits both regulatory gaps and consumer trust.
We don’t need to reinvent the wheel. The bipartisan Kratom Consumer Protection and Safety Act of 2025 provides a science-based framework that addresses this crisis directly. The legislation caps 7-hydroxymitragynine at 0.1 percent of total alkaloids — levels consistent with natural kratom — while banning synthetic analogues entirely.
More importantly, the Department of Health and Human Services already possesses the authority to act immediately. Under existing Food, Drug and Cosmetic Act provisions, HHS can issue emergency import alerts targeting products exceeding natural alkaloid thresholds, classify isolated 7-hydroxymitragynine as an unapproved drug subject to seizure, and coordinate with DEA to schedule synthetic analogues.
Having led the CDC during the deadliest phase of our opioid epidemic, I’ve learned that early intervention is everything. The synthetic opioid crisis taught us that waiting for bodies to pile up before taking action is not just ineffective — it’s unconscionable.
The parallels are striking: unregulated synthesis, unknown potency, and products marketed to evade existing controls. If we allow 7-hydroxymitragynine to follow the fentanyl playbook, we will bear responsibility for the preventable deaths that follow.
This is not about banning kratom. Full spectrum kratom, used responsibly, appears to have acceptable safety margins based on FDA’s own clinical data. This is about preventing synthetic opioids from hiding behind botanical names.
I urge the FDA and HHS to act with the urgency this situation demands. Every day we delay, more Americans are exposed to substances that have undergone no safety testing and carry unknown risks.
The science is clear. The regulatory tools exist. The only question is whether we have the will to use them before emergency rooms nationwide confront another wave of synthetic opioid overdoses.
We cannot allow another generation of Americans to become casualties of regulatory inaction. The time to act is now.
Dr. Robert R. Redfield served as director of the Centers for Disease Control and Prevention from 2018 to 2021 and is a professor emeritus at the University of Maryland School of Medicine. He currently practices infectious disease medicine at Greater Baltimore Medical Center.
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