Opioid Crisis

Opioid crisis: How a synthetic opioid is exploiting America’s kratom debate

Opioids Crisis can really be a very bad issue for any emerging nation or community . During my tenure as CDC Director, directly I experienced from close proximity and how quickly emerging substances such as Opioids can overwhelm our public health infrastructure. Today, I’m compelled to educate about a new threat hiding in plain sight: a potent synthetic opioid crisis if not controlled or when abused as natural kratom.

 

As a virologist who has dedicated his life works into understanding how pathogens adapt and spread, there were very noticeable similar pattern in how dangerous substances evolve to evade detection when not regulated or controlled . 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 — levels that science has proven to be same as  “legal morphine.” It is important to note that these are not quantities found naturally in kratom leaf. Scientific research and data analysis confirms that these degree of Hydroxymitragynine can only result from chemical manipulation, where manufacturers understand the need and demand from patients with Pain 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 Laboratory manufactured products contain concentrations up to 150 times higher. This is not botanical kratom — this is pharmaceutical-grade opioid chemistry operating without oversight. (Opioid Crisis)

Opioid Crisis

Opioid Crisis

 

In 2024, the FDA conducted a single ascending-dose clinical trial to evaluate the safety and effects of ground kratom leaf in individuals who were already familiar with its use. The findings were insightful: participants tolerated doses up to 12 grams without experiencing any serious adverse events. Reported side effects were mild and included nausea and pupil constriction. Importantly, when participants rated how much they “liked” the effects of the kratom leaf—a measure often used to assess the potential for abuse—the scores did not differ significantly from those given to a placebo. This suggests that natural kratom leaf has a low potential for abuse under the conditions studied and when consumed in controlled amounts .

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 and less prone to abuse than the Laboratory manufactured products flooding American markets.

Yet some scientists trying to make money 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 as well as desperation from those who genuinely need this .

There’s no need to start from scratch. The bipartisan Kratom Consumer Protection and Safety Act of 2025 offers a scientifically grounded approach to tackling the current challenges. It sets a strict limit on 7-hydroxymitragynine, allowing no more than 0.1% of total alkaloid content—levels that align with what naturally occurs in kratom. Additionally, the bill completely prohibits the use of synthetic kratom-like compounds.

Even more critically, the Department of Health and Human Services already has the legal tools to take swift action. Under the current Food, Drug, and Cosmetic Act, HHS can immediately issue import alerts for products that contain alkaloid levels above those found naturally, treat isolated 7-hydroxymitragynine as an unapproved drug eligible for seizure, and work with the DEA to classify synthetic kratom analogues as controlled substances and therefore punishable except regulated .

Having overseen the CDC during the most lethal period of the opioid epidemic, I know firsthand that acting early can save lives. The synthetic opioid crisis showed us that delaying action until tragedy strikes is not only ineffective—it’s morally indefensible.

The warning signs are familiar: unregulated chemical production, unpredictable strength, and products designed to skirt existing regulations. If we let 7-hydroxymitragynine follow the same path as fentanyl, the resulting deaths will be on our watch—and entirely avoidable.

This isn’t a call to outlaw kratom. When used in its natural, full-spectrum form, kratom appears to have a reasonable safety profile, as the FDA’s own clinical research suggests. The real issue is stopping synthetic opioids from masquerading as natural plant products .

I strongly encourage the FDA and HHS to respond with the speed and seriousness this issue requires. With each passing day, more people are exposed to untested substances with unpredictable and potentially dangerous effects.

The evidence is undeniable. The necessary regulatory mechanisms are already in place. What remains to be seen is whether we are prepared to use them—before hospitals across the country face yet another surge in synthetic opioid overdoses.

We can’t afford to let inaction lead to another lost generation. The moment to intervene 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.

Posted in Pain.