DEA Moves to Schedule 7-OH and a Second Kratom-Derived Opioid. The Control Would Apply Above a Threshold.
A DEA notice published Oct. 14 would place 7-hydroxymitragynine and mitragynine pseudoindoxyl in Schedule I for two years when a product is above 1 mg per gram or its mitragynine ratio is below 100. The order cannot come before Nov. 13.
On Oct. 14, the Drug Enforcement Administration published a notice of intent to temporarily place 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MP) in Schedule I of the Controlled Substances Act. Both are opioid-active compounds derived from kratom alkaloids. The control would apply only to products above a specified threshold.
The notice is based on an Oct. 8 letter from the Department of Health and Human Services. In a separate notice the same day, DEA is withdrawing a July 7 notice of intent that would have scheduled 7-OH above a lower threshold HHS set in 2025. For clinicians, the practical question is what patients may be taking and how to ask about it.
What the notice proposes
Either substance, or the two combined if both are present, would be in Schedule I when a product meets either of two conditions. The first is a concentration above 1 mg per gram for powders, capsules and other solid forms, or above 1 mg per milliliter for liquids. The second is a ratio: the mass of mitragynine divided by the mass of 7-OH, MP or the two combined is less than 100. A product that meets either condition would be controlled.
The ratio test reaches products that have been enriched with 7-OH or MP relative to the plant's main alkaloid, even at low total concentrations. The notice says that “neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels.” Products under the threshold could stay on the market without Schedule I controls. DEA also says the action does not preempt more restrictive state laws.
Timing
DEA says the temporary order will be published on or after Nov. 13, 30 days after the notice. It would take effect on publication and last two years, with one possible one-year extension while permanent scheduling proceeds. DEA says the notice-and-comment requirements of the Administrative Procedure Act do not apply to a notice of intent.
An Aug. 26 temporary order already placed MP and two related substances, MGM-15 and MGM-16, in Schedule I with no threshold. DEA says that order stays in effect until it expires on Aug. 26, 2028, or until the new order is published and the earlier one is withdrawn, whichever comes first.
What DEA cites about harm
DEA says 7-OH makes up less than 2 percent of the total alkaloid content of the kratom plant but can be made from mitragynine in a one-step chemical reaction. It says commercial products, sold as powders, tablets, gummies and sublingual films, often contain far higher concentrations than the plant. DEA describes MP as a semi-synthetic opioid and a potent mu-opioid receptor agonist.
The notice cites 86 cases involving 7-OH in the FDA Adverse Event Reporting System as of a Feb. 27 query, 79 of them serious and nine fatal, with 66 reported in 2025. It also cites 85 cases in DEA toxicology testing since 2019, 55 of them fatal, and notes that samples often contained other drugs such as fentanyl, benzodiazepines or ketamine. For MP, it cites at least 31 overdose cases between February 2025 and February 2026, 25 of them fatal. These are spontaneous reports and forensic samples, so they cannot establish incidence, and other substances complicate attribution.
The scheduling action is about product concentration. It does not turn leaf kratom use into a clinical non-issue, and it does not tell you what any one patient has taken.
What it means in clinic
The notice does not address prescribing or patient care. The clinical points are the familiar ones. Ask about kratom and 7-OH products by name in substance use histories, since patients may describe them as supplements. Expect opioid-type tolerance and withdrawal in regular users, and remember that labels may not reflect content. According to the notice, poison centers recorded 165 exposures involving 7-OH from Jan. 1 to July 31, 2025, and 35 percent of the cases involving 7-OH alone had serious health outcomes.
Practices that treat opioid use disorder may get questions from patients as the order approaches. Check your state's rules as well, since the federal order sets a floor, not a ceiling.
This article is for professional education and does not replace clinical judgment. Treatment decisions should be based on the individual patient and current guidelines.
