DEA Moves to Schedule 7-OH Kratom Extract Above a Threshold

The Drug Enforcement Administration on Wednesday published notices of intent to place 7-hydroxymitragynine and mitragynine pseudoindoxyl — the two compounds concentrated in the vape-shop products sold as kratom extracts — in Schedule I of the Controlled Substances Act whenever a product carries more than 1 milligram of either per gram, or per milliliter in liquid form.

The limit, equal to roughly one-tenth of one percent by weight, follows a Health and Human Services recommendation dated Oct. 8 and replaces a lower threshold the department proposed in 2025. DEA said it will publish the temporary scheduling order on or after Nov. 13, opening a two-year window of federal control that the agency can later convert into a permanent rule.

What the threshold actually measures

The notices, docketed as DEA-1570 and DEA-1644, define a product as covered in two ways. The first is concentration: more than 1 milligram of 7-hydroxymitragynine, or of mitragynine pseudoindoxyl, per gram of powder, capsule material or other solid, or per milliliter of liquid. The second is proportion, and it is the one aimed at engineered products. A preparation also falls inside Schedule I when the mass of mitragynine divided by the mass of 7-hydroxymitragynine — or by the combined mass of 7-hydroxymitragynine and mitragynine pseudoindoxyl — comes out below 100.

In practical terms, that ratio test catches a product in which the alkaloid that manufacturers isolate or add makes up more than one percent of the mitragynine content, even if the absolute concentration sits under the milligram figure. Natural leaf powder, by contrast, carries 7-hydroxymitragynine only in trace amounts, which is why DEA built an exemption into the order at all.

Why the agency says the line had to move

DEA grounded both notices in the temporary-scheduling authority at 21 U.S.C. 811(h), finding that unregulated manufacture, distribution, importation and possession of the two compounds pose "an imminent hazard to public safety." The agency said it is aware of no currently accepted medical use for either substance in the United States, and that available data show a high potential for abuse and a lack of accepted safety for use under medical supervision.

The notices are explicit that the threshold is not a safety finding. "Individuals should not infer from this notice of intent that DEA views 7-hydroxymitragynine or mitragynine pseudoindoxyl below this threshold as safe for consumption," the agency wrote, adding that it "still views kratom and its two major psychoactive ingredients, mitragynine and 7-hydroxymitragynine, as drugs of concern."

A narrower order replacing a broader one

The action rewrites a sequence that began in the summer. DEA published a notice of intent on July 7 to schedule 7-hydroxymitragynine above the lower threshold HHS had recommended in July 2025, then issued a temporary order on Aug. 26 that placed mitragynine pseudoindoxyl in Schedule I with no threshold at all, alongside MGM-15 and MGM-16, two related semi-synthetic compounds.

With the new HHS letter, the agency is withdrawing the July notice and intends to withdraw the August order for mitragynine pseudoindoxyl, replacing it with a version that applies the concentration and ratio tests. MGM-15 and MGM-16 stay in Schedule I unchanged; the second notice exists mainly to separate their paperwork from the compound whose status HHS reopened. The August order remains in force until the replacement publishes.

What changes on the shelf — and what does not

Once the order lands, manufacturing, distributing or possessing the two compounds above the threshold becomes a Schedule I activity, carrying the criminal exposure that comes with it. Products below the line may remain on sale in the states that permit them. Neither HHS nor DEA found those lower-concentration products safe, according to the notices; the agencies simply concluded that a line was necessary because trace amounts occur in the plant itself.

States are already drawing their own boundaries. The Pennsylvania House voted unanimously on Oct. 5 for a bill that would allow adults to buy natural leaf kratom while banning products containing more than 0.5 percent 7-hydroxymitragynine. Missouri's attorney general issued civil investigative demands and cease-and-desist letters to nine more companies on Oct. 15, arguing that 7-OH and related compounds are illegal analogues — a theory that rested in part on the fact that the federal government had not scheduled 7-OH itself, which the new notices begin to change. Utah allows only pure leaf kratom under a law that took effect in May.

The Missouri enforcement campaign is covered in the Oct. 16 report on the attorney general's demands, and the August federal order is described in the Aug. 27 article on synthetic kratom scheduling.

Where the advocates split

The American Kratom Association, which has spent a decade fighting federal scheduling, endorsed the synthetic-targeted approach. "We are absolutely supportive of banning or scheduling these synthetics," Mac Haddow, the group's senior fellow on public policy, told Gizmodo.

Sean McCabe, director of the Center for the Study of Drugs, Alcohol, Smoking and Health at the University of Michigan, said the regulatory question should not obscure the clinical one. "The FDA has not approved kratom as a safe or effective treatment for any condition," he said. "There are other much more effective proven medications to treat addiction that have been tested."

A study McCabe led, published in May, estimated that roughly five million Americans have used kratom at least once, including more than 100,000 children ages 12 to 17, and that about 53 percent of recent users reported a substance use disorder in the past year. Survey data cited by Gizmodo put the number of Americans 12 and older who used kratom in 2021 at about 1.7 million.

The enforcement problem the rule creates

A concentration standard moves the fight from the shelf to the laboratory: whether a given pouch of powder, gummy or shot is a controlled substance depends on analytical testing that a patrol officer cannot perform at a counter. The notices also skip public comment. DEA invoked the good-cause exception in the temporary-scheduling statute, finding "manifest urgency to avoid an imminent hazard to public safety," so the order will take effect without the notice-and-comment period that a permanent rule would require.

That leaves two years in which the policy can be litigated, and a decision for the next scheduling cycle about whether 7-hydroxymitragynine joins mitragynine on the permanent list. People who use kratom to manage opioid withdrawal, or who have been sold a product marketed as botanical, fall on both sides of a line that will now be measured in milligrams per gram rather than in the language on the label. Background on the plant and how it interacts with opioid receptors is collected in the kratom condition guide.