DEA Files Notice to Place 7-OH Above Threshold in Schedule I, Targets Three Synthetic Derivatives

Why it matters

The DEA's notice of intent marks the most significant federal regulatory action on kratom-related compounds to date, directly affecting hundreds of products sold in retail stores nationwide. A 30-day public comment period will shape the final threshold and implementation.

The big picture

The DEA's move follows a formal recommendation from HHS and FDA in 2025 to classify 7-OH as Schedule I due to its opioid-like pharmacology. The action deliberately separates concentrated and synthetic 7-OH from natural botanical kratom, which remains unscheduled. The federal notice will be published in the Federal Register on July 6 and triggers a public comment period before a temporary two-year order can take effect.

Key findings

• The DEA notice targets products with more than 0.050% 7-OH by dry weight or more than 1 milligram of 7-OH per product
• Three lab-made 7-OH derivatives are also flagged: mitragynine pseudoindoxyl (MP), dihydro-7-hydroxymitragynine (MGM-15), and the 9-fluoro derivative MGM-16
• HHS and FDA supported the action, characterizing it as targeting concentrated and synthetic products rather than natural kratom leaf
• Once finalized, the temporary scheduling order would be effective for two years with an option to extend for a third
• Laboratory testing by the DEA found commercial products frequently contain far higher 7-OH concentrations than naturally occurring kratom leaf

What they say

The FDA "recommended scheduling the 7-OH compound as a controlled substance due to its opioid properties," according to Reuters reporting on the DEA-HHS-FDA coordination.

Bottom line

The DEA's threshold-based approach creates the first federal bright line between natural kratom and high-potency synthetic 7-OH products — with a 30-day public comment window still to come.