The Drug Enforcement Administration issued two Notices of Intent on October 9, 2026, that would place kratom-derived 7-OH products above a set strength in Schedule 1 of the Controlled Substances Act, the same category that holds heroin. The threshold is 1 milligram per gram in solid products or 1 milligram per milliliter in liquids.
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Nothing is final yet. The notices announce a plan to issue a temporary scheduling order, and the agency says the earliest it can act is 30 days after publication. What the notices do reveal is how federal regulators now draw a line between the kratom leaf sold for years and concentrated opioid products that retailers have been selling in tablets, gummies and shots.
The DEA notices and the 1 milligram line
According to the FDA’s 7-OH page, the DEA acted on new scientific information and recommendations from the Department of Health and Human Services. HHS recommends Schedule 1 control when 7-OH, a related compound called MGPI, or their combined amount exceeds 1 milligram per gram in solid products or 1 milligram per milliliter in liquid products, or when the ratio of mitragynine to those compounds is less than 100 to 1. The stated aim is to separate products deliberately enhanced with these opioids from products whose alkaloid makeup resembles botanical kratom.
The Federal Register version, published October 14 under Docket DEA-1570, adds that the order would not be issued before November 13, 2026, would take effect on publication and would last two years, with a possible one-year extension. DEA also says products below the threshold are not considered safe for consumption. A companion notice on MGM-15 and MGM-16 was filed the same day.
What Schedule 1 means, and the August order
Schedule 1 is the strictest tier. The DEA’s scheduling page defines these as drugs with no currently accepted medical use and a high potential for abuse, and names heroin as its first example. Putting a gas-station supplement in that company is a significant step, and the agency has been moving quickly toward it.
The FDA page records that on August 26, 2026, DEA temporarily placed MGPI, MGM-15 and MGM-16 into Schedule 1, and that those controls stay in place during the new 30-day notice period. The Federal Register notice says DEA is withdrawing its earlier July 2026 notice that proposed a lower threshold for 7-OH, replacing it with the October approach.
The legal route is also unusual. DEA’s notice cites the three statutory factors of abuse history, abuse scope and public health risk, and concludes that temporary scheduling is needed to avoid an imminent hazard to public safety. It adds that the action is not subject to the usual notice-and-comment process and that temporary orders are not subject to judicial review, so the main remaining checkpoint is the 30-day wait itself. A permanent listing would require a separate rulemaking later.
Why regulators call 7-OH an opioid
Natural kratom leaf contains only trace 7-OH. The FDA’s scientific report says botanical kratom contains less than 2 percent of its alkaloid content as 7-OH, so concentrated products are likely made by chemically converting mitragynine isolates. The report cites lab work in which 7-OH produced respiratory depression with more than three times the potency of morphine, and it says rodent studies show physical dependence and withdrawal.
The harm data are messier. The report says the DEA’s toxicology database identified 103 cases from 2019 to 2025 involving mitragynine, 7-OH or a related compound, some fatal, with fatal cases about three times as frequent in 2023 through 2025 as in 2019 through 2022. It cautions that deaths often cannot be pinned on 7-OH alone because the body also produces it from mitragynine. Poison centers logged 53 exposure cases involving 7-OH from February to April 2025, most with minor or moderate outcomes, though three had major outcomes and six involved people under 18.
FDA Commissioner Marty Makary said when the agency asked DEA to act in July 2025 that “7-OH is an opioid that can be more potent than morphine,” according to the FDA announcement. The same announcement said FDA had sent warning letters in June 2025 to seven companies illegally distributing 7-OH tablets, gummies, drink mixes and shots, and that the products turn up online, at gas stations, in corner stores and in vape shops. FDA also worried that fruit-flavored gummies appeal to children and teens, and that products may be mislabeled or marketed as ordinary kratom. The agency stressed that its action targets 7-OH specifically and not natural kratom leaf, and that no FDA-approved 7-OH drugs exist. The FDA page itself carries the message that “the time to act is now,” and directs people with suspected adverse events to the Poison Help line at 1-800-222-1222 or to the MedWatch reporting program.
This article was produced with the assistance of AI and reviewed by Morning Overview editors prior to publication.
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