Three months after proposing a federal line through the kratom market, the Drug Enforcement Administration is replacing it with a different one. The first never took effect.
In documents filed for public inspection on October 9 and scheduled for Federal Register publication on October 14, DEA says it intends to place two potent kratom alkaloids, 7-hydroxymitragynine and mitragynine pseudoindoxyl, in Schedule I when a product contains more than a set amount of them. The proposal replaces a July notice that covered 7-hydroxymitragynine alone, at a lower concentration. It follows a new recommendation from the Department of Health and Human Services, dated October 8.
Kratom leaf is not scheduled under either version. DEA is explicit that this is not an endorsement. Neither agency, the notice says, “has made a finding that these substances are safe to use at below-threshold levels,” and DEA “still views kratom and its two major psychoactive ingredients” as drugs of concern.
The new test is not simply a looser version of the old one. It changes what is being measured.
What July proposed and what October proposes
The July notice set a single cutoff: more than 0.050 percent 7-hydroxymitragynine, known as 7-OH, by dry weight in botanical material. That is 0.5 milligrams per gram. For synthetic products and processed forms such as extracts and pressed tablets, it added a second limit: more than 1 milligram of 7-OH in the article, whatever its size.
The October notice has two limbs, and a product is covered if it fails either.
The first is concentration. A product is in Schedule I if 7-OH, mitragynine pseudoindoxyl, or the two combined exceed 1 milligram per gram in a solid or 1 milligram per milliliter in a liquid. That is twice the July concentration. The per-article limit of 1 milligram is gone.
The second is composition. A product is also covered if the mass of mitragynine, the plant’s main alkaloid, divided by the mass of 7-OH and pseudoindoxyl is less than 100. In plain terms, the potent alkaloids may not exceed 1 percent of the mitragynine present.
The notice is a statement of intent. A temporary scheduling order may issue 30 days or more after the notice is published and would last two years.
Where each substance stands
Mitragynine, and kratom leaf as such, are not federally scheduled and are not proposed to be.
7-OH is not yet scheduled. DEA says it is withdrawing the July proposal in a separate document, which was not yet on the public inspection list on October 13. The October proposal is pending.
Mitragynine pseudoindoxyl has been in Schedule I since August 26, when DEA placed it there by temporary order with no threshold. The notice says that order stays in effect until a new one replaces it, so that for now any amount of the compound is controlled.
MGM-15 and MGM-16, two related compounds scheduled in the same August order, stay in Schedule I. A companion notice says DEA will reissue their placement unchanged, for the procedural purpose of separating them from pseudoindoxyl.
Why the line moved
DEA gives one reason for using a threshold at all: both alkaloids “have supposedly been found in trace amounts in some botanical kratom products.” It does not explain why the number changed or where the ratio of 100 comes from. The notice cites an October 8 HHS letter for the threshold. The companion notice dates the letter October 6 and says it related only to pseudoindoxyl. We have not found any such letter published, so we cannot tell whether there is one letter or two, or what reasoning HHS gave.
The change arrived while DEA was being sued over the August order. The American Kratom Association filed suit in federal court in Washington on August 26, the day the pseudoindoxyl order took effect, and moved for partial summary judgment a week later. On September 18 a court order recorded the government’s statement that it anticipated the parties “may be able to resolve this suit without further need for litigation.” A joint motion to stay the case was filed on October 9, the day the new notice went on public inspection. A docket service shows the court granted it the same day and stayed the case through November 13.
A second suit, filed in federal court in California on August 31 by a company called New Hope Botanicals, matters for one detail. Its complaint asks the court to read the August order as not reaching kratom that contains “at least 100 parts mitragynine for every 1 part of combined 7-OH and pseudoindoxyl.” That is the ratio DEA has now proposed. The notice does not cite the complaint or say where its number came from.
The association called the new thresholds “an important victory” and welcomed “the resolution of its litigation.” The docket shows a stay, not a dismissal, and nothing in DEA’s notice attributes the change to either lawsuit. The timing is a sequence, not a stated cause.
Looser or tighter, depending on the product
What follows is our reading of the rule’s text. DEA does not state these conclusions.
The simplest reading is that the threshold doubled. That holds for the concentration limb only.
The ratio can bind first. It is the tighter limb for any product with less than 100 milligrams of mitragynine per gram, because 1 percent of that is under 1 milligram. A published human study of dried kratom leaf powder used a product whose certificate of analysis showed 13.3 milligrams of mitragynine per gram. For leaf at that strength, the ratio test allows roughly 0.13 milligrams per gram of 7-OH and pseudoindoxyl combined. That is about a quarter of what the July proposal permitted in botanical material, and far below the new 1-milligram ceiling. The same paper reports that product’s 7-OH content as below 0.01 percent, which is under 0.1 milligrams per gram, so that product would pass. It is one product in one study.
The ratio also reaches products the concentration limit would miss. One that contains 7-OH and no mitragynine has a ratio of zero and is covered at any strength.
The products that gain room are those rich in mitragynine. An extract with 200 milligrams of mitragynine per gram could carry up to 1 milligram per gram of the potent alkaloids and pass both limbs. Under the July text, a processed product was covered above 0.5 milligrams per gram, or once the article held more than 1 milligram of 7-OH in total.
These are calculations from the rule’s text, not a survey of the market. Neither notice reports how much 7-OH ordinary leaf products contain, so we cannot say how many would clear the ratio.
The design does tell us what the government is now regulating. The test turns on how far a product’s alkaloid profile departs from the plant’s, in addition to how much of one compound it holds.
Same molecule, different exposure
The public argument is usually framed as natural kratom against synthetic 7-OH. DEA’s own text does not support that framing. Its July notice says synthetic and naturally occurring 7-OH are chemically identical and that the molecule’s pharmacology is the same “regardless of its source.” What differs, it says, is that people consuming the raw plant “may experience a modified or attenuated physiological effect” because of the plant’s other alkaloids.
The research is consistent with a difference in exposure and does not settle the question of risk. A 2019 study in mice and in human liver preparations found that the body converts mitragynine into 7-OH, and that in mice the metabolite could account for most or all of mitragynine’s opioid-mediated pain relief. In the human leaf-powder study, 7-OH appeared in participants’ blood after they took leaf alone; that study was funded by a kratom company, and two of its authors consult for the American Kratom Association.
So leaf produces some 7-OH in the body, and a concentrated product delivers the compound directly. Neither study compares the resulting exposure or the risk between the two, and we found no controlled human data that do.
The mortality data cannot fill that gap. A CDC analysis of 27,338 overdose deaths reported by participating states from July 2016 through 2017 found kratom on toxicology in 152. A medical examiner or coroner judged it a cause in 91, and it was the only substance detected in seven. Fentanyl was listed as a cause of death in about two-thirds of the kratom-positive cases. Those records do not distinguish leaf from extracts or concentrated 7-OH, and detection on a toxicology screen is not a finding of cause.
What the states are doing
DEA says its action would not preempt more restrictive state law. It counts ten states that prohibit 7-OH and 19 that have adopted consumer protection acts governing manufacture, labeling and age of sale. We have not checked each of those statutes.
The one we read shows why the categories matter. Kansas lawmakers added 7-OH to the state’s Schedule I in their 2025 to 2026 session, with no threshold in the enrolled bill’s text and no mention of kratom or mitragynine. If the compound is present in leaf at trace levels, as DEA says has been reported, a ban on the molecule with no floor can reach further than its wording suggests.
The state picture is divergent, not moving one way, and the argument is organized on both sides. The American Kratom Association applauded the federal thresholds. An advocacy group, End Kratom Addiction, released a film on October 12 about the risks of products sold as natural kratom leaf.
The narrower reading
The October notice may be a technical correction. If laboratory testing finds trace pseudoindoxyl or 7-OH in ordinary leaf, a zero-tolerance order and a low cutoff would have scheduled products the government said it was not targeting. A threshold and a ratio would then bring the rule back to its stated scope. On that view the two-part test carries out DEA’s original aim, scheduling concentrated products and leaving leaf alone, more precisely than the July text did.
That reading fits DEA’s one stated reason, and it fits the purpose for which the same ratio was proposed in the California complaint. It does not by itself explain the doubled concentration limit or the removal of the per-article limit. HHS’s letter would answer those questions, and it is not public.
The next step is Federal Register publication, scheduled for October 14. The temporary order cannot issue until 30 days after that, which on the current schedule is mid-November. Until then the only kratom-related compounds in federal Schedule I are the three placed there in August.