Schedules of Controlled Substances: Temporary Placement of 7- Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I
Key claim: DEA intends to temporarily classify 7-hydroxymitragynine and mitragynine pseudoindoxyl as Schedule I drugs whenever either substance, or both combined, exceeds a specified amount, so making, selling, importing, researching, or possessing those higher-concentration products would carry the same criminal and regulatory penalties as other Schedule I substances, while products below the threshold would not be scheduled.
Abstract
(Proposed Rule · Justice Department, Drug Enforcement Administration) The Administrator of the Drug Enforcement Administration (DEA) is issuing this notice of intent to publish a temporary order to schedule 7-hydroxymitragynine and mitragynine pseudoindoxyl (including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers, and salts is possible) when either substance alone, or their combined amount if both are present, is above a specified threshold, in schedule I of the Controlled Substances Act (CSA). Based on a different threshold provided by the Department of Health and Human Services (HHS) in July of 2025, DEA published a notice of intent to temporarily schedule 7-hydroxymitragynine above that lower threshold on July 7, 2026. Additionally, DEA published a temporary order placing mitragynine pseudoindoxyl without a threshold in schedule I of the CSA on August 26, 2026. On October 8, 2026, HHS sent a letter recommending that DEA place of the CSA 7-hydroxymitragynine and mitragynine pseudoindoxyl in schedule I when either substance alone, or their combined amount if both are present, is above a new specified threshold. Based on the October 8, 2026 letter, DEA is issuing this notice of intent. While the new threshold recommended by HHS would permit certain products to remain in the marketplace without being subject to schedule I controls, neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels. When a temporary order is issued, it will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess) or propose to handle 7- hydroxymitragynine and/or mitragynine pseudoindoxyl above the specified threshold. In a separate document contained in this issue of the Federal Register, DEA is withdrawing the July 7, 2026 notice of intent related to 7-hydroxymitragynine. The August 26, 2026 temporary order placing mitragynine pseudoindoxyl in schedule I of the CSA without a threshold remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.
Why this matters
This proposal is the first DEA scheduling action to use a combined concentration threshold across two kratom-derived alkaloids, creating a bright line between kratom products that remain federally unscheduled and those that would carry Schedule I criminal and regulatory consequences. For patients using kratom products, vendors, and researchers, the threshold determines which formulations stay on the consumer market versus becoming contraband. The structure also previews how DEA may handle other naturally occurring alkaloids where potency varies by extraction and concentration.