The US Drug Enforcement Administration has replaced the proposal it made in July to put concentrated 7-hydroxymitragynine (7-OH, a minor kratom alkaloid) into Schedule I. A new notice of intent, published in the Federal Register on 14 October 2026 under the same docket, sets a different test for what would be controlled. It raises the concentration limit, adds a second test based on the ratio of mitragynine to 7-OH, and brings a related compound, mitragynine pseudoindoxyl, under the same threshold.
Nothing in the notice is in force. It is a statement of what the DEA intends to do. The agency says the temporary scheduling order itself “will be published in the Federal Register on or after November 13, 2026”, and that the order will take effect on the day it is published. This article describes the position as of 24 October 2026.
The DEA says it acted on a letter from the Department of Health and Human Services (HHS) dated 8 October 2026 recommending a new threshold. Under the temporary-scheduling statute, the DEA must notify HHS before it acts and take HHS’s comments into account.
What the new test says
Under the notice (91 FR 65370), 7-OH and mitragynine pseudoindoxyl would be in Schedule I “when either substance alone, or their combined amount if both are present”, meets either of two conditions:
- A concentration limit. More than 1 milligram per gram in a solid (powders, capsules and other solid forms), or more than 1 milligram per millilitre in a liquid. One milligram per gram is 0.1 per cent by weight.
- A ratio. The mass of mitragynine present, divided by the mass of 7-OH, pseudoindoxyl or the two combined, is less than 100. Put the other way round, a product is caught where the 7-OH and pseudoindoxyl together weigh more than one hundredth of its mitragynine.
Mitragynine is the main alkaloid in kratom leaf. It is not scheduled federally and the notice does not propose scheduling it. Its only role here is as the yardstick for the ratio.
How that differs from July
The July notice (91 FR 40917, published 6 July 2026) drew its line in two places, and the new one changes both.
For plant material, July proposed control of “any botanical material” of the plant containing more than 0.050 per cent 7-OH on a dry weight basis. That is 0.5 milligrams per gram. The new limit, 1 milligram per gram, is twice as high, and it names no dry-weight basis.
For extracts, synthetic products and other processed forms, July would have caught any article with more than 0.050 per cent 7-OH or more than 1.00 milligram of 7-OH in the article as a whole. That second limb would have reached a product with a low concentration if it held enough material to contain more than a milligram in total. The new notice has no per-article limb. It applies the same per-gram or per-millilitre limit to every form, and adds the ratio.
So the new proposal is looser on concentration and drops the total-content test, and it is stricter in one respect July was not: a product with a low absolute amount of 7-OH could still be caught if its mitragynine has been stripped out or its 7-OH enriched, because the ratio would then fall below 100.
Where the numbers come from
The notice itself does not explain the figures. The HHS letter it relies on does, and the DEA has put it in the public docket on Regulations.gov.
HHS points to Florida and to public comments. The letter, signed by the Assistant Secretary for Health, says the combination of a 1 mg per gram limit and a 100-to-1 mitragynine ratio was “suggested in public comments” and “has been implemented under Florida state rulemaking”, where the tests cover 7-OH together with other specified alkaloids. It describes the ratio as “a means of identifying products intentionally enhanced or concentrated in 7-OH content relative to natural kratom’s composition”. Our Florida page covers that state’s rule.
On unaltered kratom products, HHS is cautious. Its category is “products purported to be unaltered chemically from natural kratom”, which includes leaf but is wider. Tested against product results submitted to the docket and through other channels, the letter says, the criteria “would appear to establish Schedule I status for various intentionally enhanced products, and rarely establish a product as Schedule I for products purported to be unaltered chemically from natural kratom”. It adds that this finding “is based on data and studies for which FDA has not had direct access.” That is a tentative statement about submitted test results, not a guarantee about any particular product, and we do not turn it into one.
The 1 mg figure rests on animal studies. The letter, which relays analyses by the Food and Drug Administration, says no human studies have given 7-OH on its own. It converts doses from rodent self-administration studies, in which animals choose to take a drug, into human-equivalent doses, and says these “suggest reinforcing doses in the range of 1-3 mg”. On that basis it recommends Schedule I above 1 mg per gram or millilitre, which it says “would prohibit the manufacturing, distribution and possession of such products in this dosage range”. Separately, extrapolating from animal potency ratios, it estimates that 3 to 15 mg of 7-OH would have effects similar to 30 mg of morphine, the common comparator dose in human abuse-potential studies.
Pseudoindoxyl: control would narrow
Mitragynine pseudoindoxyl is a compound the DEA describes as a chemical rearrangement product of 7-OH, sold in concentrated products. It has been in Schedule I in any amount since 26 August 2026, under a temporary order (91 FR 54948) that appears in the federal regulations as entry (h)(89) of the Schedule I list. That entry was still in the eCFR, the official online edition of federal regulations, as of 20 October 2026.
The new notice proposes to remove that entry and list pseudoindoxyl again under the same threshold as 7-OH. If the new order is issued as proposed, pseudoindoxyl below the threshold would fall outside Schedule I, where today it is inside it in any amount. Until then, the DEA says, the August order “remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.” The August order runs to 26 August 2028.
Two other compounds covered by the August order, MGM-15 and MGM-16, are not changed. A companion notice (91 FR 65381) proposes a new temporary order for them “without change”, which the DEA says it is issuing “only for the technical and procedural purpose” of separating them from pseudoindoxyl. It refers to an HHS letter dated 6 October 2026 that “related only to mitragynine pseudoindoxyl”. The two notices therefore name HHS letters of different dates; we report both as written.
What the DEA says about safety
The notice is explicit that a higher threshold is not a safety finding:
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.
What has not happened yet
The July notice has been announced as withdrawn, but we have not read the withdrawal. The new notice says that “in a separate document contained in this issue of the Federal Register, DEA is withdrawing the July 7, 2026 notice of intent”. The Federal Register’s own record dates that July notice to 6 July. We searched the Federal Register’s listing of every DEA document published from 13 October 2026, through the documents scheduled for 26 October, and found no withdrawal notice. Until that document appears, we report the withdrawal as stated by the DEA, not as published.
There is no public comment period on this notice. The DEA says it does not consider a notice of intent to temporarily schedule to be subject to the notice-and-comment requirements of the Administrative Procedure Act, and that it took into account comments from HHS. The public did have a say earlier, through HHS rather than the DEA: a request for information on the July threshold, published on 6 July 2026, whose comment period HHS later extended to 10 September 2026. The HHS letter says some of the test data it weighed arrived through those comments.
No order has been issued. Temporary scheduling under 21 U.S.C. 811(h) lasts two years and can be extended by up to one year if permanent scheduling proceedings are started in the meantime. The two-year clock would start on the day an order is published, not on the date of this notice. The same applies to the proposed new order for MGM-15 and MGM-16, which would run on its own clock rather than to the August order’s 2028 end date.
What this does not change
Kratom leaf is not a federally controlled substance, and neither is mitragynine. The new notice is about 7-OH and pseudoindoxyl above a threshold. Some US states, among them Alabama, Arkansas and Indiana, control kratom’s alkaloids under their own law. The federal notice does not amend any state schedule. Our United States page sets out the federal position and links to the state pages we have written.
We will check the Federal Register from 13 November 2026 for the temporary order and, before then, for the withdrawal document.