The Food and Drug Administration (FDA) initiated a process to schedule 7-hydroxymitragynine (7-OH), a psychoactive compound derived from the kratom plant, as a controlled substance.

The details:

FDA is recommending that the Drug Enforcement Administration (DEA) add 7-OH to Schedule I, the most tightly regulated.
The move specifically targets products with elevated levels of 7-OH, which occurs naturally in kratom in trace amounts. FDA emphasized the enforcement action is not focused on “natural kratom leaf products.”
In effect, kratom itself will remain largely unregulated, but supplements containing elevated levels of 7-OH would be banned.

Why it’s important:

Officials said there has been a rise of overdoses and emergency department visits linked to products containing 7-OH.
The products are often sold online or in convenience stores with no quality control, dose limits, or warnings. Scheduling 7-OH would place restrictions on production, distribution, and possession.

The context: The government has considered restricting kratom products in the past but has not done so. This announcement comes weeks after FDA sent a series of warning letters to 7 companies warning against illegally marketing 7-OH tablets, gummies, and drink mixes.

What they’re saying: The administration cast the move as preventive, recalling the failure to prevent the spread of opioid painkillers.

But: Kratom is not a significant source of overdose deaths, and there is no recorded instance of a fatal overdose involving 7-OH without other substances.

Next steps: DEA plans to begin a rulemaking process to schedule 7-OH, which includes issuing a proposal for scheduling 7-OH and allowing for a public comment period.