DEA Plans Schedule I Order for Two Kratom Compounds Above Threshold

The Drug Enforcement Administration published a notice of intent on October 14, 2026, announcing that it will issue a temporary order placing two kratom-related substances, 7-hydroxymitragynine and mitragynine pseudoindoxyl, in Schedule I of the Controlled Substances Act whenever either substance alone, or their combined amount if both are present, exceeds a new concentration threshold recommended by the Department of Health and Human Services.

The notice, published at 91 FR 65370 under Docket No. DEA-1570, was signed on October 8, 2026, by DEA Administrator Terrance C. Cole. The temporary scheduling order will be published in the Federal Register on or after November 13, 2026, and the Administrator intends to issue it as soon as possible after the 30-day waiting period required by 21 U.S.C. 811(h) expires.

When issued, the order will impose Schedule I regulatory controls and the administrative, civil, and criminal sanctions that apply to persons who handle or propose to handle the substances above the threshold, covering manufacture, distribution, reverse distribution, importation, exportation, research, instructional activities, chemical analysis, and possession. The placement covers the substances’ isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such forms is possible.

The HHS-Recommended Threshold

Under the threshold recommended by HHS, the two substances would be controlled in Schedule I when either substance alone, or their combined amount, is “greater than 1 mg per gram (for solid powders, encapsulated material, or other solid forms) or greater than 1 mg per milliliter (for liquid preparations).” Control would also apply when the mass of mitragynine present divided by the mass of 7-hydroxymitragynine, mitragynine pseudoindoxyl, or their combined amount is less than 100.

The recommendation came in an October 8, 2026, letter to the DEA Administrator from HHS Assistant Secretary for Health Admiral Brian Christine, M.D., and the Administrator transmitted the required notice of DEA’s intention to the Assistant Secretary by letter the same day. In earlier correspondence dated January 20, 2026, and March 6, 2026, the Assistant Secretary advised DEA that, based on Food and Drug Administration reviews, there were no investigational new drug applications or approved new drug applications for mitragynine pseudoindoxyl or for 7-hydroxymitragynine, respectively. The October 8 letter provided no contrary information.

Neither HHS nor DEA has made a finding that the substances are safe to use at below-threshold levels, and the notice states that individuals should not infer that DEA views below-threshold material as safe for consumption. DEA continues to view kratom and its two major psychoactive ingredients, mitragynine and 7-hydroxymitragynine, as “drugs of concern,” according to the notice.

The action revises two earlier DEA steps. On July 6, 2026, DEA published a notice of intent (91 FR 40917) to temporarily schedule 7-hydroxymitragynine above a lower threshold based on a threshold HHS provided in July 2025; DEA is withdrawing that notice in a separate document in the same Federal Register issue. On August 26, 2026, DEA published a temporary order (91 FR 54948) placing mitragynine pseudoindoxyl and two related substances, MGM-15 and MGM-16, in Schedule I without any threshold. That order remains in effect until August 26, 2028, or until the new temporary order is published and the previous order is withdrawn, whichever occurs first, an arrangement the document describes as intended to avoid an enforcement gap.

Under 21 U.S.C. 811(h), the Attorney General, with scheduling authority delegated to the DEA Administrator, may temporarily place a substance in Schedule I for two years upon finding the action necessary to avoid an imminent hazard to public safety, with a possible one-year extension if permanent scheduling proceedings are initiated. Temporary scheduling orders are not subject to judicial review. DEA stated it intends to pursue formal rulemaking under 21 U.S.C. 811(a) by gathering data and requesting an HHS scientific and medical evaluation and scheduling recommendation under 21 U.S.C. 811(b). The agency also stated that the Administrative Procedure Act’s notice-and-comment requirements do not apply to the notice of intent because section 811(h) directs temporary scheduling by order, and that the Administrator took into consideration comments submitted by the Assistant Secretary.

Abuse and Public-Health Evidence Cited by DEA

To support its finding, DEA described a retail market in which 7-hydroxymitragynine products are sold online and in gas stations and smoke shops as powders, tablets, gummies, and sublingual films. In botanical Mitragyna speciosa, the notice states, 7-hydroxymitragynine makes up less than two percent of total alkaloid content, while commercially available extracts and synthetic formulations contain significantly higher concentrations. One investigation cited in the notice identified 250 products sold between September 2024 and February 2025, with concentrations ranging from 1 mg to 700 mg in a single dose or serving and an average cost of about $3.97 per dose.

According to preclinical data summarized in the notice, 7-hydroxymitragynine has opioidergic activity comparable to Schedule II opioids such as morphine, with risks of tolerance, dependence, and respiratory depression. Preclinical studies cited by DEA indicate that mitragynine pseudoindoxyl, a synthetic rearrangement product of 7-hydroxymitragynine whose first confirmed appearance in consumer products was reported in 2024, is a potent mu-opioid receptor agonist about 100 times more potent than mitragynine and more potent than morphine in analgesic effect.

Between June and July 2025, FDA issued seven warning letters to marketers and distributors of 7-hydroxymitragynine, stating that it is not an FDA-approved drug product and that no food additive regulation authorizes its use in food; a June 25, 2025, letter cautioned that gummy products could appeal to children because of their packaging. At the state level, the notice states, ten states (Alabama, Arkansas, Connecticut, Indiana, Kansas, Louisiana, Massachusetts, Tennessee, Vermont, and Wisconsin) have prohibited 7-hydroxymitragynine consumption, and 19 states have enacted kratom consumer protection acts requiring safe manufacturing, accurate labeling, and appropriate distribution. Mississippi has set a limit of one percent of total alkaloid content, or 0.5 mg per container, for 7-hydroxymitragynine. DEA stated the intended temporary control does not preempt more restrictive state law.

Data cited in the notice include 165 exposure cases involving 7-hydroxymitragynine reported to U.S. poison centers from January 1 through July 31, 2025, with 35 percent of single-substance exposures resulting in serious health problems and 67 percent of individuals treated at a healthcare facility. The FDA Adverse Event Reporting System held 86 cases involving 7-hydroxymitragynine as of a February 27, 2026, query, of which 79 were reported as serious, including nine deaths. DEA’s toxicology testing program has identified 7-hydroxymitragynine in 85 overdose cases since 2019, 55 fatal and 30 non-fatal with a median age of 36, and identified mitragynine pseudoindoxyl in at least 31 overdose cases between February 2025 and February 2026, of which 25 were fatal.

The National Forensic Laboratory Information System recorded 42 reports of 7-hydroxymitragynine from 12 states in 2025 and one report of mitragynine pseudoindoxyl in New York as of a February 26, 2026, query, though DEA noted forensic reporting may be limited because the substances are not federally controlled and some laboratories do not prioritize non-controlled substances. The notice also cites National Survey on Drug Use and Health estimates that, as of 2021, 1.7 million people aged 12 or older had used kratom in the past year. In 2025, health authorities in California, Pennsylvania, and Texas linked 7-hydroxymitragynine and concentrated extracts to illness and overdose cases, according to the notice.

Based on the data summarized, DEA found that the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of the two substances poses an imminent hazard to public safety, and that the substances have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. The document proposes corresponding amendments to 21 CFR part 1308. The temporary order will take effect on the date it is published in the Federal Register and remain in effect for two years, with a possible one-year extension pending completion of the regular scheduling process.