Regulatory Update: FDA Takes Action on Concentrated Kratom-Derivative Products

On July 29, 2025, the U.S. Food and Drug Administration (FDA) announced its recommendation to schedule 7-hydroxymitragynine (7-OH)—a concentrated byproduct of the kratom plant—under the Controlled Substances Act (CSA). 

This move follows the agency’s comprehensive medical and scientific review and is part of the FDA’s broader efforts to address the risks associated with opioid-like substances.

What Happened? 

The FDA recommended that 7-OH be scheduled under the CSA. This means that products containing 7-OH products could be subject to strict federal oversight over their manufacture, distribution, and sale. Based on this recommendation, the Drug Enforcement Administration (DEA) is considering whether to add 7-OH to the schedules of controlled substances. In making this determination, the DEA considers 7-OH's accepted medical use and its potential for dependance and abuse. 

What is 7-OH?

The FDA considers 7-OH a substance with a high potential for abuse due to its strong binding affinity to opioid receptors, asserting that 7-OH has potency that can exceed morphine. The FDA took care to distinguish concentrated 7-OH products from natural kratom leaf products. The agency is particularly concerned with concentrated 7-OH due to its opioid-like effects and proliferation in the marketplace in forms such as gummies, drink mixes, and vape products—often marketed in ways that appeal to youth.

Recent FDA scientific analysis asserts that 7-OH is present only in trace amounts in natural kratom leaves, but many commercial products contain unnaturally high, often synthetically derived, concentrations of 7-OH. The FDA pointed to surveillance data from poison centers and law enforcement indicating a sharp increase in serious adverse events and overdoses linked to these concentrated 7-OH products, underscoring the urgent need for regulatory intervention.

In response to these findings, FDA officials have emphasized the need for regulatory oversight and public awareness. As FDA Commissioner Dr. Marty Makary stated: “We need regulation and public education to prevent another wave of the opioid epidemic.” 

What’s Next?

The DEA is now reviewing the FDA’s recommendation. A public comment period is anticipated before any scheduling action is finalized. 

Separately, the FDA has issued warning letters to several companies for illegally distributing 7-OH products. The agency is actively educating both health care professionals and consumers about the risks posed by 7-OH products. In its warning letters, the agency stated that 7-OH is not a lawful dietary supplement, food additive, or ingredient in any approved drug, and that products containing 7-OH are considered adulterated or misbranded under federal law. The FDA emphasized that some products were being sold with unproven claims, such as pain relief or anxiety management, which classifies them as unapproved new drugs.