As of 5 September 2026, kratom leaf and mitragynine are not controlled substances under United States federal law. Neither is 7-hydroxymitragynine, the plant’s minor alkaloid. Three laboratory-made relatives of mitragynine are, and they have been for ten days.
That is the whole federal position, and almost nothing written about it says so plainly. The reason is that the United States has produced a decade of documents that look like scheduling and mostly are not: a notice of intent that was withdrawn, an international review that recommended watching rather than controlling, a proposal still taking comments, and one order that did take effect and covers three compounds most readers have never heard of.
The five words that have to stay apart are proposed, withdrawn, recommended, pending and in force. Collapsing them is how a reader ends up believing kratom was banned in 2016. This is a record of what each document did, taken from the documents.
August 2016: a notice of intent, not a ban
On 31 August 2016 the Drug Enforcement Administration published a notice of intent to place mitragynine and 7-hydroxymitragynine temporarily in Schedule I (81 FR 59929). The action it announced was the temporary scheduling power in the Controlled Substances Act, which turns on a finding that control is “necessary to avoid an imminent hazard to the public safety.” The Administrator had made that finding.
A notice of intent is not the order. The document says so itself, in a single line under supplementary information: “Any final order will be published in the Federal Register and may not be effective prior to September 30, 2016.”
That final order never came.
October 2016: withdrawn, with two reasons stated
Six weeks later, on 13 October 2016, the DEA withdrew the notice (81 FR 70652) and opened a public comment period running to 1 December 2016. The withdrawal document gives two reasons and no others.
The first is public response. The agency says it “received numerous comments from members of the public challenging the scheduling action and requesting that the agency consider those comments and accompanying information before taking further action.”
The second is the one that matters for everything after. The DEA writes that it “will receive from the Food and Drug Administration (FDA) a scientific and medical evaluation and scheduling recommendation for these substances, which DEA previously requested.”
So the agency stopped, in part, to wait for a recommendation it had asked for. Whether that recommendation arrived, and what it said, is where the public record becomes thin.
2017 to 2020: a gap we cannot fill from the record
Between the withdrawal and 2021 there is no Federal Register document that proposes, withdraws or effects any scheduling of kratom or its alkaloids. We searched the full Federal Register index for kratom, mitragynine, 7-hydroxymitragynine and Mitragyna speciosa, across every document type, and the years 2017 to 2020 return nothing of that kind.
Accounts of this period circulate widely. They describe an FDA scheduling recommendation sent to the DEA, and a later withdrawal of that recommendation by the Department of Health and Human Services. Neither document has been published by the agency that wrote it, and we could not obtain either one. We are therefore not going to describe their contents. A summary of a letter nobody has published is exactly the kind of claim this site exists not to repeat.
What can be said from the record is narrower and still useful. The evaluation the DEA said in October 2016 that it would receive has never produced a scheduling action for mitragynine or for the leaf, in the ten years since.
2021 and 2022: the international review said surveillance
In July 2021 the FDA asked the public for comments on kratom, mitragynine and 7-hydroxymitragynine, among seven substances, to prepare the United States response to the World Health Organization (86 FR 39038). This is a required step under the Controlled Substances Act whenever the WHO is considering international control.
The WHO’s Expert Committee on Drug Dependence conducted a pre-review, which is the stage before a critical review rather than a decision on scheduling. The FDA reproduced the committee’s conclusions in the Federal Register on 15 February 2022 (87 FR 8586), and they are worth quoting because they are so often paraphrased into something else:
The Committee concluded that there is insufficient evidence to recommend a critical review of kratom. With respect to mitragynine and 7-hydroxymitragynine, the Committee, except for one member, also concluded that there is insufficient evidence to recommend a critical review at this time.
Recommendation: The Committee recommended that kratom, mitragynine, and 7-hydroxymitragynine be kept under surveillance by the WHO Secretariat.
Two things follow, and they point in opposite directions.
“Insufficient evidence to recommend a critical review” is not a finding that kratom is safe, and it is not a finding that it is legal anywhere. It is a finding about the state of the evidence at that date. The same document records the committee’s view that 7-hydroxymitragynine “has been shown to be self-administered, supporting a likely abuse liability”, that opioid-like withdrawal follows cessation in humans, and that liver toxicity cases have been documented.
Equally, surveillance is not control. No international scheduling of kratom followed, which is why every country in our legal tracker has had to decide the question for itself.
July 2026: two proposals and a request for information
Nothing further appears in the Federal Register until 6 July 2026, when three documents published on the same day.
- 91 FR 40909 is a notice of intent to place mitragynine pseudoindoxyl, MGM-15 and MGM-16 in Schedule I. These are laboratory compounds derived from mitragynine, not constituents of the leaf.
- 91 FR 40917 is a second notice of intent, on 7-hydroxymitragynine above a specified concentration threshold rather than on the three laboratory compounds. It carries the same action line as 91 FR 40909 and sat in the same Proposed Rules section: the two are the same class of document, and neither was an order on the day it published.
- 91 FR 41049 is a request for information from the Office of the Assistant Secretary for Health at HHS, opening a docket on the proposed threshold. It asks two questions: whether data support the proposed threshold or a different one, and whether there are better ways of expressing a threshold than the one proposed.
The FDA’s own 7-OH page describes the intent behind both scheduling documents, where the agencies say the actions “are intended to target concentrated and synthetic 7-OH products and are not intended to apply to natural kratom leaf containing only naturally occurring trace levels of 7-OH.”
That is a statement of intent by an agency. It is not an exemption in an instrument, and the distinction is the single most misreported thing on this beat. A threshold is a dividing line, so material below it is outside the rule because of its concentration and not because leaf has been carved out by name.
26 August 2026: one order took effect, and it is narrow
On 26 August 2026 the DEA issued a temporary scheduling order (91 FR 54948) placing three substances in Schedule I. Its dates paragraph is unambiguous: “This temporary order is effective August 26, 2026, until August 26, 2028.”
The order adds three paragraphs to the federal schedule at 21 CFR 1308.11:
| Paragraph | Substance | DEA code |
|---|---|---|
| (h)(89) | mitragynine pseudoindoxyl | 9672 |
| (h)(90) | MGM-15, also known as dihydro-7-hydroxymitragynine | 9673 |
| (h)(91) | MGM-16, also known as 9-fluoro-dihydro-7-hydroxymitragynine | 9674 |
Each entry extends to isomers, esters, ethers and salts. Each also carries a clause saying that because the nomenclature is not internationally standardised, compounds of that structure are covered regardless of how the atomic positions are numbered.
This is the first federal control of any kratom-derived substance, and it covers none of the things a reader is likely to be holding. The order does not reach the leaf, does not reach mitragynine, and does not reach 7-hydroxymitragynine.
What is still open, and the date to watch
Of the two notices of intent published on 6 July, only the one covering the three laboratory compounds (91 FR 40909) matured into an in-force order, the 26 August temporary scheduling order above. The 7-OH threshold notice of intent, 91 FR 40917, has not. It has no effective date and has not become an order, which is precisely the position the 2016 notice of intent was in on 12 October 2016, the day before it was withdrawn. That is not a prediction about what will happen. It is the reason a proposal and an order should never be described in the same words.
The HHS request for information on the threshold was due to close on 31 July 2026. On 26 August it was reopened (91 FR 55104), and comments now close on 10 September 2026, five days after this piece was published. HHS says it acted “in response to a request for an extension to allow interested persons additional time”, and that comments will be provided by the Secretary for Health and Human Services for consideration by the Attorney General.
The pattern, stated carefully
Over ten years the federal government has twice moved to place naturally occurring kratom alkaloids in Schedule I, and neither move has taken effect. The 2016 notice was withdrawn. The 2026 threshold proposal is pending. In between, the one international review reached the stage before a critical review and stopped there.
Meanwhile the thing that did take effect is narrow, chemically specific, and temporary: three semisynthetic compounds, for two years, subject to extension.
None of that means kratom is federally approved, and it is not a statement about whether any of it should be scheduled. Two separate points stand alongside it. The FDA’s position is that kratom “is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food”, because it treats kratom as an adulterated new dietary ingredient under section 402(f)(1)(B) of the Food, Drug and Cosmetic Act and as an unsafe food additive under section 409. And state law is a separate matter entirely. Several states prohibit kratom outright and others regulate it, on their own instruments, whatever the federal schedule says.
Federal scheduling is one question. Whether a product may lawfully be sold, and whether it is lawful where a particular reader lives, are two others.