The Drug Enforcement Administration moved Friday to place concentrated 7-OH products, the kratom-derived tablets, gummies and powders sold online and at gas stations and smoke shops, in Schedule I of the Controlled Substances Act. That schedule is reserved for substances with a high potential for abuse and no currently accepted medical use. The agency is withdrawing a notice it issued in July and replacing it with a new one built on limits the Department of Health and Human Services recommended this week. The Justice Department announced the change Friday.
The recommendation came in an Oct. 8 letter to the DEA from Adm. Brian Christine, the assistant secretary for health. Under it, 7-hydroxymitragynine, the compound sold as 7-OH, and a related compound called mitragynine pseudoindoxyl, or MGPI, would be placed in Schedule I whenever either one, or the two together, exceeds 1 milligram per gram in a solid product or 1 milligram per milliliter in a liquid. A product would also be covered if it holds less than 100 times as much mitragynine, the leaf's main alkaloid, as it does of the two compounds. HHS recommended the limits to separate products that were deliberately enhanced or concentrated from those whose alkaloid makeup looks like the plant's own, according to the Justice Department.
"Dangerous and addictive opioids do not belong behind convenience store counters," Attorney General Todd Blanche said in the announcement. Health Secretary Robert F. Kennedy Jr. described the aim in a statement quoted by the New York Post: "We are drawing a clear line between natural kratom and dangerous, enhanced opioid products."
The notice is scheduled to run in the Federal Register next week, Pain News Network reported, and it says the temporary order can be published 30 days after that or later. The nonprofit outlet, which covers chronic pain and kratom, put the effective date at Nov. 13. Once in force, the order would apply the regulatory controls and the administrative, civil and criminal sanctions that govern Schedule I drugs to anyone who makes, distributes, imports, exports or possesses the compounds above the limits. Temporary scheduling lasts two years and can be extended by up to a year if permanent scheduling proceedings begin.
The revision also reaches a ban already in effect. On Aug. 26 the DEA temporarily placed MGPI and two other 7-OH relatives, MGM-15 and MGM-16, in Schedule I, and it covered MGPI without any threshold. That order stays in force until it expires or until the new order is published and the old one withdrawn. HHS's updated analysis found that 7-OH occurs naturally in the leaf at relatively low levels and pointed to information suggesting MGPI may show up in trace amounts in some botanical products. HHS said the science on MGPI's presence in such products is still developing but recommended the same threshold approach for both compounds. The DEA is reissuing its notice on MGM-15 and MGM-16 without changing how those substances are handled.
Neither agency is vouching for what stays on shelves. The notice acknowledges that the new threshold, which is higher than the one proposed in July, would allow some products to remain on the market, but it says neither HHS nor the DEA has found the compounds safe at lower levels. It describes 7-OH as having a pharmacological profile similar to morphine and other Schedule II opioids, says fatal overdoses involving it have been reported and notes that the synthetic and natural forms are chemically identical. In the plant, 7-OH accounts for less than 2 percent of the alkaloid content, but it can be made from mitragynine in a single chemical step, and the agency cites evidence that commercial extracts and synthetic products contain far higher concentrations than the leaf. The DEA says it still regards kratom and its two main psychoactive ingredients as drugs of concern.
The American Kratom Association, an advocacy group for natural leaf kratom that had sued the DEA over its scheduling of MGPI, praised the DEA and the Justice Department and welcomed the resolution of its litigation. "This is an important victory for science, sound public policy, and the millions of Americans who rely on responsibly manufactured natural kratom products," said Mac Haddow, the group's senior fellow on public policy. According to Pain News Network, the revision was largely a response to the group's lawsuit, something the Justice Department's announcement did not mention. Haddow told the outlet the association agreed to dismiss the case on the condition that the DEA publishes "under the schedule that they submitted to the court," and he called the new 7-OH standard "much more restrictive" because it "captures more of the potential synthetic products."
Makers and users of 7-OH were disappointed, the outlet reported, and hope to win changes before Nov. 13. "This is still a Notice of Intent, not a scheduling order," the 7-HOPE Alliance said in a note to advocates. "The revised proposal would still threaten access to 7-OH products. We do not agree with how these new thresholds are being set."
Pressure is coming from the other side as well. Republican Sens. Chuck Grassley of Iowa, Mike Lee of Utah and Susan Collins of Maine wrote to the DEA and the Food and Drug Administration this week seeking the immediate scheduling of 7-OH and urging officials to "consider scheduling the entire kratom plant," according to a separate Pain News Network report. Leaf kratom remains legal under federal law, though dozens of states, cities and counties have banned it.
The association is now pressing state legislatures and attorneys general to follow the federal thresholds rather than adopt sweeping prohibitions that treat the leaf and chemically altered products the same.