DEA moves to place some strong kratom products under strict federal drug controls

• The DEA proposal sets a threshold of 0.050% 7-OH by dry weight for kratom plant material, or 1 milligram of 7-OH in certain products, to determine Schedule I classification
• Regulators warn that companies are selling pills, gummies, powders, and liquid shots with much higher amounts of 7-OH than occurs naturally in the Southeast Asian kratom plant
• The DEA is also moving to temporarily control three lab-made 7-OH-related synthetic substances: mitragynine pseudoindoxyl, dihydro-7-hydroxymitragynine, and MGM-16

Summary

Key Development: The U.S. Drug Enforcement Administration (DEA) announced Wednesday it will temporarily classify certain high-potency kratom products under Schedule I federal drug controls, the strictest category under U.S. drug law, citing opioid-like properties and consumer safety concerns.

Target Products: The action specifically targets products containing elevated levels of 7-hydroxymitragynine (7-OH), a compound naturally occurring in trace amounts in kratom, a Southeast Asian plant. Companies are currently selling pills, gummies, powders, and liquid shots with significantly higher concentrations than found naturally.

Regulatory Thresholds: The DEA proposal, set for Federal Register publication on July 6, would place kratom products exceeding 0.050% 7-OH by dry weight, or containing more than 1 milligram of 7-OH, into Schedule I classification. Three synthetic lab-made substances related to 7-OH—mitragynine pseudoindoxyl, dihydro-7-hydroxymitragynine, and MGM-16—will also face temporary controls.

Agency Support: Both the Department of Health and Human Services and the Food and Drug Administration backed the move. The FDA previously identified the 7-OH compound as requiring controlled substance designation due to its opioid properties.

Market Implications: The regulatory action distinguishes between concentrated/synthetic kratom products and natural kratom leaf without enhanced 7-OH levels, suggesting natural kratom products may remain unaffected. Companies producing or selling high-potency kratom supplements will face significant restrictions, potentially impacting the dietary supplement and alternative wellness sectors.

This enforcement action reflects growing federal scrutiny of kratom products amid rising concerns about their potency and potential health risks, particularly regarding opioid-like effects.