One order landed. The one that matters has not.
On 26 August three synthetic kratom derivatives became Schedule I nationwide. That is done. 7-OH itself has not been scheduled — it is still only a notice of intent, and the public docket behind it closes 10 September 2026.
These are two different things
Almost every account of this runs them together. On 6 July 2026 the DEA published two separate notices of intent, and only one of them has become an order.
- In force: mitragynine pseudoindoxyl, MGM-15, MGM-16 The temporary scheduling order was published and took effect on 26 August 2026. Schedule I nationwide for two years, extendable by one, and it applies to any amount — there is no threshold in it. These are laboratory derivatives of 7-OH, not constituents of the leaf.
- Not in force: 7-OH above a threshold Docket DEA-1570 remains a notice of intent. The notice said the order could publish on or after 5 August 2026. It has not. Instead, on 26 August the comment period on the supporting docket was extended to 10 September — which is the only reason there is still something to say.
We checked this against the Federal Register's own index rather than coverage of it, because the coverage is where the two get merged. If someone tells you 7-OH is already federally scheduled, they are describing the other order.
0.05 percent, on a dry weight basis
The proposed threshold, adapted from the HHS evaluation, reaches:
(A) Any botanical material of the plant Mitragyna speciosa, also known as kratom, and contains more than 0.050 percentage of 7-hydroxymitragynine on a dry weight basis, or (B) Any alternative article to that described in (A) … resulting from synthetic methods and containing 7-hydroxymitragynine present in amounts greater than 0.050 percentage … or greater than 1.00 milligram of 7-hydroxymitragynine in the article … or material derived from Mitragyna speciosa and further processed to manufacture alternative dosage forms such as extracts, concentrates, processed edibles, or pressed pills.
Read paragraph (A) again. It is not limited to concentrates, extracts or anything made in a lab. It reaches any botanical material — the leaf — over 0.05% by dry weight.
Officials have said repeatedly that this does not target natural kratom leaf, and on the averages they are right. The problem is that leaf is not an average.
The synthetics order is defensible. The leaf threshold is not.
We are not going to oppose the 26 August order for the sake of opposing something. Mitragynine pseudoindoxyl, MGM-15 and MGM-16 are synthesised compounds, not things you find in a leaf. Our own model act excludes synthesised alkaloids, and so do the kratom acts in Rhode Island, Texas, Utah, Colorado, Wyoming and Mississippi. Saying so costs us nothing and it is true.
The 7-OH threshold is different, and the objection is not a matter of opinion. The FDA's own assessment of 341 products people were actually using reported 7-OH ranging from below the limit of quantitation up to a maximum of 0.21%, with a mean of 0.01%. Those products were primarily whole leaf. A 0.05% line drawn across that distribution does not separate concentrates from leaf — it runs straight through the leaf, and puts the upper tail of an ordinary botanical product into Schedule I.
It is also a threshold on a quantity that will not hold still. 7-OH varies by cultivar and season, and it moves after harvest: one controlled experiment found it 21–39% higher at 25°C than at 60°C, so heat lowers it rather than raising it. It is the most unstable Mitragyna alkaloid tested across pH 2–10, with significant loss inside eight hours at 40°C and above. A single assay cannot establish what a batch contained last month or will contain next. The measurements are here, with their sources.
That is an administrability argument, and it does not require anybody to agree with us about safety. A rule that cannot be complied with reliably is not a rule, it is a lottery. The answer to a strong product is to measure it and print the number on the package — which is what our Section 13 requires and what a threshold with no testing regime behind it does not.
Temporary scheduling is a fast road with no exits
Both actions run under 21 U.S.C. § 811(h), the temporary scheduling power. It is deliberately quick, and the speed comes out of the parts that normally protect you:
- No notice-and-comment rulemaking. An ordinary rule has to be proposed, argued and answered. A temporary scheduling order does not.
- No judicial review. § 811(h)(6) forecloses it. A court will not be reviewing whether 0.05% was the right number.
- Nothing compels a reply. The docket is a request for information, not a rulemaking comment period. The agency is not obliged to answer what comes in.
So the docket is worth less than a rulemaking comment and considerably more than nothing, because it is the entire public record there is going to be. HHS reported 32,149 comments on the first round, which closed 31 July; the extension to 10 September was granted after that.
On 31 August 2016 the DEA published a notice of intent to place mitragynine and 7-hydroxymitragynine in Schedule I. On 13 October 2016 it withdrew that notice and asked for comments instead. Same agency, same statute, same two alkaloids. It is the only precedent that matters here, and it is the reason a deadline in September is worth treating as a deadline.
Write about the threshold, not about kratom
A general statement of support is the least useful thing you can file. The agency asked a narrow question — whether this threshold is the right one — and a comment that answers the question it asked carries more weight than one that does not. If you have lab results for a product you use, those are data, and data is what a request for information is for.
I am commenting on the proposed 0.05% threshold for 7-hydroxymitragynine. My concern is paragraph (A), which reaches any botanical material over 0.050% on a dry weight basis. FDA's own assessment of 341 marketed products reported 7-OH up to 0.21% in primarily whole-leaf products, which is four times this threshold. So the line does not fall between concentrates and leaf; it falls inside the range that ordinary leaf already occupies. 7-OH also varies by cultivar and season and degrades measurably with heat and time, so the same batch can test on either side of the line depending on when it is assayed. If a threshold is used at all, it should be set from the measured distribution of unadulterated leaf, and it should come with a testing and labeling requirement so that a seller can know which side of the line a product is on.
Read it yourself
- Notice of intent: 7-OH above a threshold, 6 July 2026 (opens in a new tab) — docket DEA-1570. The threshold language quoted above is here.
- Notice of intent: mitragynine pseudoindoxyl, MGM-15, MGM-16 (opens in a new tab) — the one that became an order on 26 August 2026.
- Docket HHS-OASH-2026-0232 (opens in a new tab) — the request for information. Comments due 10 September 2026.
- DEA press release, 1 July 2026 (opens in a new tab) — the agency's own account of what it intends.
- What 7-OH actually is — the measurements behind the argument above, each with its citation.
Last checked 30 August 2026 against the Federal Register's own document index. If the 7-OH order has issued since, this page is out of date and the order wins — check the docket before relying on anything here.