DEA Proposes Temporary Schedule I Classification for Three 7-Hydroxymitragynine-Related Substances

What this means for your practice

This proposed temporary scheduling action by the DEA carries critical implications for all healthcare businesses. Schedule I substances are classified as having a high potential for abuse and no currently accepted medical use in treatment in the United States. For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare operators, this means that once the temporary order is published, handling (manufacturing, distributing, prescribing, dispensing, or possessing) these three specific substances will be subject to the most severe regulatory controls and administrative, civil, and criminal sanctions under the CSA. Practices should conduct immediate reviews of any products, supplements, or compounds they may be utilizing or recommending to ensure they do not contain mitragynine pseudoindoxyl, MGM-15, or MGM-16. Given the Schedule I classification, any legitimate medical or research use would require specific DEA registration and compliance with rigorous security, recordkeeping, and reporting requirements, which are generally not feasible for standard clinical practice. Non-compliance could lead to severe legal and financial repercussions, including license revocation and federal charges. Vigilance is paramount to avoid inadvertent violations.

The Drug Enforcement Administration (DEA) has announced its intention to issue a temporary order to classify three specific 7-hydroxymitragynine-related substances—mitragynine pseudoindoxyl, MGM-15, and MGM-16—as Schedule I controlled substances under the Controlled Substances Act (CSA).

Published on July 6, 2026, this notice signals the DEA Administrator's intent to utilize the emergency scheduling provisions of 21 U.S.C. 811(h) to address what has been identified as an imminent hazard to public safety. The temporary scheduling order is expected to be published in the Federal Register on or after August 5, 2026.

The Substances in Question

The three substances identified for temporary Schedule I placement, along with their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, include:

• Mitragynine pseudoindoxyl: Also known as Methyl ( E )-2-((1′ S, 6′ S, 7′S)-6′-ethyl-4-methoxy-3-oxo-3′,5′,6′,7′,8′,8a′-hexahydro-2′ H -spiro[indoline-2,1′-indolizine]-7′-yl)-3-methoxyacrylate.
• MGM-15: Commonly known as dihydro-7-hydroxymitragynine, or Methyl ( E )-2-((2 S, 3 S, 7 aS, 12 aR, 12 bS )-3-ethyl-7 a -hydroxy-8-methoxy-1,2,3,4,6,7,7 a, 12,12 a, 12 b -decahydroindolo[2,3- a ]quinolizin-2-yl)-3-methoxyacrylate.
• MGM-16: Commonly known as 9-fluoro-dihydro-7-hydroxymitragynine, or Methyl ( E )-2-((2 S, 3 S, 7 aS, 12 aR, 12b S )-3-ethyl-9-fluoro-7 a -hydroxy-8-methoxy-1,2,3,4,6,7,7 a, 12,12 a, 12 b -decahydroindolo[2,3- a ]quinolizin-2-yl)-3-methoxyacrylate.

These substances are not currently listed in any schedule under the CSA, nor are there any exemptions or approvals for them under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), according to a review by the Food and Drug Administration (FDA).

Understanding Schedule I Classification

Schedule I is the most restrictive category under the CSA. Substances placed in Schedule I are determined to have:

• A high potential for abuse.
• No currently accepted medical use in treatment in the United States.
• A lack of accepted safety for use under medical supervision.

When the temporary scheduling order is enacted, individuals and entities that handle these three 7-hydroxymitragynine-related substances will be subject to all regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances. This includes, but is not limited to, restrictions on manufacturing, distribution, reverse distribution, import, export, research, instructional activities, chemical analysis, and possession.

Legal Authority and Inter-Agency Consultation

The Attorney General, through delegation to the DEA Administrator, possesses the authority under 21 U.S.C. 811(h) to temporarily place a substance in Schedule I for two years without full administrative rulemaking procedures. This authority is invoked when such action is deemed necessary to avoid an imminent hazard to public safety.

As part of this process, the DEA Administrator notified the Secretary of the Department of Health and Human Services (HHS) of this intent. In response, by letter dated January 20, 2026, the Assistant Secretary for Health of HHS confirmed, based on FDA review, that there were no investigational new drug applications (IND) or approved new drug applications (NDA) for mitragynine pseudoindoxyl, MGM-15, and MGM-16. HHS also stated it had no objection to the temporary placement of these substances in Schedule I of the CSA.

To make a finding of

Key Facts

| Detail | Value | |---|---| | Agency | Drug Enforcement Administration (DEA), Department of Justice | | Action | Notice of Intent to Temporarily Schedule | | Substances Affected | Mitragynine pseudoindoxyl, MGM-15, and MGM-16, including their isomers, esters, ethers, and salts | | Proposed Schedule | Schedule I of the Controlled Substances Act (CSA) | | Legal Authority | 21 U.S.C. 811(h) | | Temporary Order Publication Date | On or after August 5, 2026 |

Frequently Asked Questions

What substances are specifically targeted by this DEA action?

The DEA intends to temporarily schedule mitragynine pseudoindoxyl, MGM-15 (dihydro-7-hydroxymitragynine), and MGM-16 (9-fluoro-dihydro-7-hydroxymitragynine), including their isomers, esters, ethers, and salts.

What does a Schedule I classification mean for these substances?

Once classified as Schedule I, these substances will be subject to the most stringent regulatory controls and administrative, civil, and criminal sanctions applicable under the Controlled Substances Act, implying a high potential for abuse and no accepted medical use.

Why is the DEA implementing this temporary scheduling?

The DEA is taking this action under the authority of 21 U.S.C. 811(h) to avoid an imminent hazard to public safety posed by these substances.

When can we expect the temporary scheduling order to be published?

The temporary scheduling order is anticipated to be published in the Federal Register on or after August 5, 2026.

Are there any approved medical uses or investigational applications for these substances?

No, based on a review by the Food and Drug Administration (FDA) and advised by HHS, there are currently no investigational new drug applications (IND) or approved new drug applications (NDA) for mitragynine pseudoindoxyl, MGM-15, or MGM-16.

Source: DEA — Proposed Rule: Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I · 2026-07-06