SPRINGFIELD, VIRGINIA — The order imposes regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances on persons who handle or propose to handle these substances. This temporary order remains effective until August 26, 2028.

The scheduling action covers not only the base compounds but also their chemical derivatives. The temporary scheduling order includes isomers, esters, ethers, salts, and salts of isomers, esters, and ethers of mitragynine pseudoindoxyl, MGM-15, and MGM-16 whenever their existence is possible.

Mitragynine pseudoindoxyl is chemically identified as Methyl (E)-2-((1′S,6′S,7′S)-6′-ethyl-4-methoxy-3-oxo-3′,5′,6′,7′,8′,8a′-hexahydro2′H-spiro[indoline-2,1′-indolizine]-7′-yl)-3-methoxyacrylate. MGM-15 is chemically identified as Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-7a-hydroxy-8-methoxy1,2,3,4,6,7,7a,12,12a,12b-decahydroindolo[2,3-a]quinolizin-2-yl)-3methoxyacrylate and is also known as dihydro-7-hydroxymitragynine.

MGM-16 is chemically identified as Methyl (E)-2-((2S,3S,7aS,12aR,12bS)-3-ethyl-9-fluoro-7a-hydroxy-8-methoxy1,2,3,4,6,7,7a,12,12a,12b-decahydroindolo[2,3-a]quinolizin-2-yl)-3methoxyacrylate and is also known as 9-fluorodihydro-7-hydroxymitragynine or 10-fluoro-dihydro-7-hydroxymitragynine. These specific chemical identifications define the scope of the substances now under federal control.

Why It Matters

The temporary placement of these substances into Schedule I subjects them to the highest level of regulatory control under federal law. This designation restricts handling to authorized entities and imposes legal penalties for unauthorized distribution or possession. The determination of an imminent hazard to public safety allows the agency to bypass the standard rulemaking timeline to address immediate risks.

The coordination with the Department of Health and Human Services ensures that the scheduling decision aligns with medical and scientific evaluations. The absence of approved or investigational new drug applications indicates that these substances are not currently recognized for legitimate medical use within the United States. This regulatory action formalizes the federal stance on these specific 7-hydroxymitragynine-related compounds.

Timeline

The notice of intent discussed findings from the Drug Enforcement Administration’s three-factor analysis dated May 2026. The Drug Enforcement Administration published a notice of intent to temporarily schedule mitragynine pseudoindoxyl, MGM-15, and MGM-16 in the Federal Register on July 6, 2026. The Drug Enforcement Administration issued a temporary scheduling order placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I of the Controlled Substances Act.

The Drug Enforcement Administration determined that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in Schedule I is necessary to avoid an imminent hazard to public safety.

What's New

Additional context identifies the Drug Enforcement Administration as a United States federal law enforcement agency. On the same day the scheduling order was issued, the Health and Human Services Department published a notice titled Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making on 2026-08-24.

How Sources Differ

Sources vary in their description of the Drug Enforcement Administration's status. Wikidata describes the Drug Enforcement Administration as a United States federal law enforcement agency.