DEA Moves to Schedule Kratom Alkaloids Above Concentration Threshold

The Drug Enforcement Administration has announced its intent to publish a temporary order placing 7-hydroxymitragynine and mitragynine pseudoindoxyl, the two principal psychoactive alkaloids of kratom, in Schedule I of the Controlled Substances Act when they exceed a specified concentration threshold. The notice of intent, signed by DEA Administrator Terrance C. Cole on 8 October 2026, was published in the Federal Register of 14 October 2026 under Docket No. DEA-1570.

The action follows a letter dated 8 October 2026 in which the Assistant Secretary for Health of the Department of Health and Human Services, Admiral Brian Christine, M.D., recommended controlling both substances when either alone, or their combined amount if both are present, is above a new threshold. DEA is simultaneously withdrawing its 7 July 2026 notice of intent on 7-hydroxymitragynine (91 FR 40917) and will replace the 26 August 2026 temporary order (91 FR 54948) that placed mitragynine pseudoindoxyl, MGM-15 and MGM-16 in Schedule I without a threshold.

Under 21 U.S.C. 811(h), the Attorney General may temporarily schedule a substance in Schedule I for two years to avoid an imminent hazard to public safety, with a possible extension of one additional year. The new order will be published on or after 13 November 2026; until then, the August order remains in effect.

A threshold, not a blanket ban

The substances fall under control when either alone, or their combined amount, is:

• Above 1 milligram per gram for solid powders, encapsulated material or other solid forms.
• Above 1 milligram per millilitre for liquid preparations.
• Or where the mass of mitragynine divided by the mass of 7-hydroxymitragynine, mitragynine pseudoindoxyl, or their combined amount, is less than 100.

DEA states that neither HHS nor the agency has found these substances safe below the threshold, and that kratom and its two major psychoactive ingredients remain drugs of concern.

Health data cited by the agency

• An estimated 1.7 million people aged 12 or older used kratom in the past year, 1.4 million of them aged 26 or older, according to the National Survey on Drug Use and Health.
• Poison control centres logged 1,690 exposure calls involving kratom from January to July 2025, a significant increase over 2024.
• The DEA Toxicology Testing Program identified 7-hydroxymitragynine in 85 cases since 2019: 55 fatal and 30 non-fatal, with a median age of 36 and an average concentration of 463.23 ng/mL.
• The FDA Adverse Event Reporting System recorded 1 case in 2023, 2 in 2024 and 11 as of 30 June 2025.
• Mitragynine pseudoindoxyl was identified in at least 31 overdose cases between February 2025 and February 2026, 25 of them fatal.
• Preclinical data show mitragynine pseudoindoxyl is about 100 times more potent than mitragynine at the mu-opioid receptor.

Products, brands and sanctions

7-hydroxymitragynine products are sold in smoke shops, gas stations and online marketplaces in tablets, shots, capsules, powders, syrups, vapes and chewable forms, under names such as 7OHMZ, Press’d, Hydroxie, Kama, Fruity Perks and Happie Tabs. One investigation identified 250 products sold between September 2024 and February 2025; concentrations ranged from 1 mg to 700 mg per single dose, at an average cost of about $3.97 per dose. The Food and Drug Administration has issued warning letters and states that 7-hydroxymitragynine meets no definition of a drug, dietary supplement or dietary ingredient.

Once the order takes effect, Schedule I controls and administrative, civil and criminal sanctions will apply to manufacture, distribution, reverse distribution, import, export, research, instructional activities, chemical analysis and possession.

For the kratom supplement industry and its customers, the notice draws a hard line: products above the threshold become illegal to sell, while lower-concentration botanical material stays outside Schedule I controls — though DEA explicitly warns this is not a finding of safety. The order is not subject to judicial review, and the agency says it will pursue permanent scheduling through formal rulemaking.

Source: Federal Register, Vol. 91, No. 197, 14 October 2026, Proposed Rules, p. 65370 (official reference: 2026-20943).