Beware: Synthetic kratom 7-OH powers a new opioid crisis
It's concentrated 7-OH, a synthetic byproduct of the kratom plant that binds strongly to the body's opioid receptors — making it up to 13 times more potent than morphine.
This addictive compound is ubiquitous, it's being pushed deceptively to consumers, and its use is quietly growing.
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In previous waves of the opioid crisis — prescription opioids, heroin and fentanyl — the Food and Drug Administration realized too late that a public health crisis was raging, and got caught flat-footed.
Let's not make that mistake again.
On Tuesday, in collaboration with the Drug Enforcement Administration, the FDA began the process of reviewing whether products with unusually high levels of 7-OH should be classified as controlled substances.
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To be clear, the kratom plant leaf, which contains trace amounts of 7-OH and has been consumed for centuries, is not our focus at the FDA.
Rather, we are seeking to remove a dangerous synthetic opioid from retail shelves nationwide.
As a part of this effort, the FDA issued seven warning letters earlier this month to prominent firms illegally marketing 7-OH products. Already a number of companies have stopped sales, another is recalling its products, and one company's website disappeared entirely.
But a DEA classification and warning letters alone won't solve this problem. We must also educate the public to be vigilant about this threat.
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Americans should know that synthetic, concentrated 7-OH products can be marketed as 7-hydroxymitragynine, 7-OH-mitragynine, 7-OHMG, 7-Hydroxy, 7-HMG or 7 — and all these compounds pose significant health risks.
The potency of 7-OH greatly increases the risk of overdose and dependence. A 2025 National Institute on Drug Abuse study found that 7-OH resulted in respiratory depression at a magnitude three times more severe than morphine.
Given how 7-OH interacts with the brain, we're hearing more and more stories of severe addiction in young people — and of major withdrawal symptoms, including insomnia, anxiety, body aches and sweats.
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We don't have precise statistics about the use of 7-OH. Because it's unregulated, sales data and adverse-event reporting are close to nonexistent.
But instead of waiting for a crisis before we respond, we're reading the signs and acting proactively.
Despite the critical differences between natural leaf kratom and synthetic 7-OH, many of these opioid products are marketed as 'kratom extract' or 'enhanced kratom' and sold on the same shelves as kratom.
Many 7-OH products do not even state how much of the substance the product contains.
And since the vast majority of these products come from uninspected manufacturing facilities in India, users may consume inconsistent doses and unknown contaminants.
Perhaps most alarming is that 7-OH products are often disguised as attractive candies, gummies and even ice cream cones that parents might never see as a risk.
But let's be clear: No FDA-approved drug, food or supplement product contains 7-OH, and none of the health claims made about these products have been federally substantiated.
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Public safety is a priority for President Trump and his administration. To support the FDA's broader actions on 7-OH, the National Institutes of Health will be initiating studies to better understand the substance's effects.
While some 7-OH products claim to provide pain relief, clinicians and people struggling with addiction should not view this synthetic opioid as a safer alternative — and store owners, too, should be aware that 7-OH is not just another harmless product.
A special FDA resource page, 'Hiding in Plain Sight,' provides more about the risks of 7-OH and how to avoid them.
Historically, the medical establishment has been slow to understand and respond to new products as they come to market.
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From cigarettes to social media, it often takes decades before we recognize pervasive harms.
But as with tobacco, we know that public awareness can drive behavior change — and massive public health improvements can follow.
Even better than rolling back a public health crisis would be never having one in the first place. Let's not allow 7-OH to drive the next wave of the US opioid epidemic.
Dr. Marty Makary is the commissioner of the Food and Drug Administration.
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