29.07.2025 20:16
The Food and Drug Administration (FDA) has issued a strong recommendation for a government ban on 7-hydroxymitragynine (7-OH), a concentrated kratom byproduct. The agency characterizes 7-OH as a significant public health threat, potentially fueling the next wave of opioid addiction. This potent substance, readily available over-the-counter in locations such as gas stations and vape shops, has raised serious concerns among health officials.
The FDA's proposal involves scheduling 7-OH as a Schedule I controlled substance, placing it alongside highly addictive and dangerous drugs like heroin and cocaine. This classification reflects the substance's known opioid receptor binding properties and its potential to cause severe respiratory depression, physiological dependence, and opioid-characteristic withdrawal symptoms. A Tuesday report from the FDA detailed these dangers, highlighting similarities to morphine, fentanyl, oxycodone, and hydrocodone.
Further fueling the FDA's concerns is the widespread availability and appealing presentation of 7-OH-containing products. The agency expressed specific worry about the presence of products formulated to attract children, including those marketed as fruit-flavored gummies or ice cream cones. This easy access and tempting packaging significantly escalate the risks associated with 7-OH.
The severity of the situation is underscored by prominent figures in the field. FDA Commissioner Dr. Marty Makary drew parallels between 7-OH and morphine, a comparison echoed by Christopher McCurdy, a leading kratom researcher at the University of Florida College of Pharmacy. McCurdy emphasized 7-OH’s pure opioid agonist nature and its exclusive interaction with opioid receptors, deeming its over-the-counter availability as reckless and irresponsible, analogous to selling morphine at a gas station.
The FDA's recommendation stems from a sharp increase in overdoses, poisonings, and emergency room visits linked to 7-OH products. Deputy Health and Human Services Commissioner James O’Neill, speaking to reporters on Tuesday, cited this alarming trend as the primary catalyst for the agency’s call for a ban. The readily accessible nature of this dangerous substance, coupled with its escalating negative impact, has prompted the FDA’s decisive action.
