Regulation
Three 7-OH Analogs Are Now In Schedule I. The 7-OH Threshold Order Itself Still Has Not Issued.

The federal action this publication has been tracking since July arrived in two pieces this week — and neither is the one that had been expected. The Drug Enforcement Administration's temporary scheduling order placing three 7-hydroxymitragynine-related substances into Schedule I published in the Federal Register on Wednesday, August 26, and took effect on publication. Separately, the Department of Health and Human Services has reopened the public comment window on the 7-OH threshold it had closed on July 31.
The order that would place 7-hydroxymitragynine itself above a specified threshold into Schedule I has not been issued.
What Was Signed
The DEA document is a temporary scheduling order under Docket No. DEA-1644, signed on August 24, 2026 by DEA Administrator Terrance C. Cole and filed for public inspection the same afternoon. Its stated action is a "temporary amendment; temporary scheduling order" — the final step in the sequence, not another proposal.
It reaches three substances, described in the order as "three 7-hydroxymitragynine-related substances": mitragynine pseudoindoxyl; MGM-15, which the order notes is "also known as dihydro-7-hydroxymitragynine"; and MGM-16, "also known as 9-fluoro-dihydro-7-hydroxymitragynine." Each is covered "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." Because the naming conventions for these compounds are not standardized internationally, the order adds that "compounds of this structure, regardless of numerical designation of atomic positions are covered."
The legal basis is the same one that governs the wider proceeding. The DEA states it "bases this action on a finding that placing mitragynine pseudoindoxyl, MGM-15, and MGM-16 in schedule I is necessary to avoid an imminent hazard to public safety," the standard set by 21 U.S.C. 811(h).
The Detail That Separates This From The 7-OH Proposal
This order carries no threshold.
That is the substantive difference between the document signed Monday and the one still pending. As this publication reported on August 3, the DEA's July 6 notice of intent on 7-hydroxymitragynine, Docket No. DEA-1570, proposed to reach only material containing "more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis," or, for synthetic articles and processed dosage forms, "greater than 1.00 milligram of 7-hydroxymitragynine in the article." Those figures were the entire subject of the public comment docket.
No comparable number appears in the order for the three analogs. They are scheduled as substances, without a concentration or per-article cutoff, and enter the schedules as new paragraphs (h)(89) through (h)(91) of 21 CFR 1308.11.
The order carries the standard duration: it is effective on the date it publishes in the Federal Register and runs "until August 26, 2028," with the DEA noting that "if this order is extended or made permanent, DEA will publish a document in the Federal Register." On the effective date, the three substances become subject to the registration, recordkeeping, and administrative, civil and criminal provisions that apply to anyone who manufactures, distributes, imports, exports, researches, or possesses a Schedule I substance.
Justice Department Names A Limit, And A Carve-Out
The Department of Justice announced the action publicly on Tuesday, in a release numbered 26-971 issued the day before the order's publication. It supplies two things the Federal Register document does not: an attributed rationale, and an enforcement policy.
Attorney General Todd Blanche framed the timing as pre-emptive. "The Justice Department is acting before these dangerous compounds become a broader threat," he said. "These are potent opioids being manufactured and sold in consumer products, often under labels that obscure their true risks." The department describes the three substances, on preclinical evidence, as "potent mu-opioid receptor agonists" that "may present risks associated with other mu-opioid agonists, including dependence and respiratory depression" — a characterization attributed here to the department rather than adopted by this publication. It also notes that MGM-16 "has not been confirmed in the consumer market."
The scope sentence is unusually direct: "This action is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom."
What follows it is narrower than that sentence alone suggests, and the department drew the edges carefully. It states that "the published scientific literature has not established MGPI as a naturally occurring kratom alkaloid" — MGPI being the department's abbreviation for mitragynine pseudoindoxyl — while acknowledging that "scientific and analytical questions remain about whether MGP1 may be reported at incidental trace levels in some botanical products as a result of processing, storage or analytical conditions." On that basis, the department says it "will exercise enforcement discretion when only incidental trace amounts of MGPI are confirmed in a product otherwise consistent with botanical kratom."
Three limits are attached to that, in the department's own words. The policy "does not create a legal exemption and does not change MGPI's status as a schedule I controlled substance." It "does not apply to MGM-15 or MGM-16, or products containing manufactured, concentrated, fortified or intentionally added MGPI." And it "does not change the scheduling status of any other substance or limit the authority of the Food and Drug Administration under federal law."
Enforcement discretion is a statement of prosecutorial intent, not a change in the law. The substance remains in Schedule I on the terms the order sets.
HHS Reopens The 7-OH Comment Window
The second document, filed Tuesday morning by the Office of the Assistant Secretary for Health, extends the comment period on the 7-OH threshold Request for Information under Docket No. HHS-OASH-2026-0232 — the docket this publication reported closed on July 31.
OASH states it is "extending the comment period to solicit input and comments on a Request for Information (RFI) on a proposed threshold for 7-hydroxymitragynine (7-OH) scheduling under the Controlled Substances Act that appeared in the Federal Register of July 6, 2026," and that it is doing so "in response to a request for an extension to allow interested persons additional time to provide comments." The new deadline is September 10, 2026.
The notice also draws the scope tightly. OASH writes that it "is not soliciting comments on any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination for temporary scheduling." As before, comments "will be provided by the Secretary for Health and Human Services for consideration by the Attorney General." The notice was signed by Brian Christine, Assistant Secretary for Health.
What This Changes For Anyone Tracking The Proceeding
The August 3 report on this site said the 7-OH order could issue any day after August 5, and that anyone tracking it should watch the Federal Register daily rather than wait for an announcement. That remains accurate: as of today the order has not appeared, no publication date has been announced, and the DEA has not stated one.
What has changed is that the federal record on the threshold question is open again through September 10, while the narrower action on the three related substances is finished and now in force. The documents do not explain the relationship between those two facts, and this publication is not going to supply one. The DEA order addresses only the three analogs and does not discuss the timing of the 7-OH order.
The scope limit the earlier coverage described now has an explicit federal statement behind it. The order names three specific compounds and their isomers, esters, ethers and salts, and the Justice Department has said in terms that the action "is directed at deliberately manufactured and concentrated opioid products, not traditional botanical kratom." What the department has not done is create an exemption. The enforcement policy it announced reaches only incidental trace amounts of one of the three substances, in products otherwise consistent with botanical kratom, and it expressly leaves the Schedule I listing intact. The threshold question — where the federal line between leaf and concentrate is drawn, and at what number — is a separate matter, and it is still open at HHS.
Both documents published in the Federal Register on Wednesday, August 26, 2026, as filed. A check of the Federal Register that morning confirms the 7-OH threshold order has still not appeared. The Kratom Council will report it when and if it is published.
Sources
- Federal Register, public inspection — "Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I," DEA temporary scheduling order, Docket No. DEA-1644, FR Doc. 2026-17429 (filed August 24, 2026; publication date August 26, 2026). Filed document (PDF).
- Federal Register, public inspection — "Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period," HHS/OASH, Docket No. HHS-OASH-2026-0232, FR Doc. 2026-17409 (filed August 25, 2026; publication date August 26, 2026). Filed document (PDF).
- U.S. Department of Justice, Office of Public Affairs — "Justice Department Announces Emergency Scheduling of Three Potent Opioid Compounds," Press Release Number 26-971 (August 25, 2026).
- Federal Register — "Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I," DEA notice of intent, Docket No. DEA-1570 (July 6, 2026).
- Federal Register — "Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I," DEA notice of intent (July 6, 2026).
- Federal Register — "Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information," HHS/OASH, Docket No. HHS-OASH-2026-0232 (July 6, 2026).
- The Kratom Council — "The Federal Comment Window On 7-OH Has Closed. The Order Can Issue Any Time After August 5." (August 3, 2026).
- The Kratom Council — "Federal Comment Window On DEA 7-OH Threshold Closes July 31." (July 27, 2026).
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