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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.
Read more: HHS warns kratom derivative has opioid-like effects; Trump administration moves to ban concentrated 7-OH, kratom-related synthetic; Feds launch crackdown on kratom byproduct
Published
August 2025