7-OH Kratom Products: The 2026 Scheduling Steps

Table of Contents

1. What Was Announced in July 2026
2. Who Does What: DEA, HHS and the FDA
3. The Proposed 7-OH Threshold, in Plain Numbers
4. Natural Leaf Versus Concentrated Products
5. The Evidence the DEA Cites
6. The Second Action: Mitragynine Pseudoindoxyl, MGM-15 and MGM-16
7. The HHS Request for Information and Its Extension
8. What These Actions Do Not Do
9. Dates and Legal Status as of 11 October 2026
10. State Laws the DEA Notice Describes
11. How the 2026 Steps Fit Earlier Federal Kratom Actions
12. Primary Documents
13. Key Research Papers
14. Connections

1. What Was Announced in July 2026

On 1 July 2026 HHS issued a press release titled “HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products.” It described two DEA notices of intent, both signed by DEA Administrator Terrance C. Cole on 1 July and published in the Federal Register on 6 July 2026:

1. 7-OH above a specified threshold. A notice of intent to issue a temporary scheduling order placing 7-hydroxymitragynine “above a specified threshold,” with its isomers, esters, ethers and salts, in Schedule I (91 FR 40917, Docket No. DEA-1570).
2. Three related compounds. A notice of intent to temporarily place mitragynine pseudoindoxyl (MP), MGM-15 and MGM-16 in Schedule I (91 FR 40909, Docket No. DEA-1644). HHS describes MP as a chemical rearrangement product of 7-OH and MGM-15 and MGM-16 as synthetic derivatives, none of which occurs naturally in the plant.

Alongside the DEA notices, the HHS Office of the Assistant Secretary for Health (OASH) published a request for information asking only about the proposed 7-OH threshold (section 7). The FDA’s page “Hiding in Plain Sight: 7-OH Products,” updated 13 July 2026, summarizes the same steps and states that “these actions are intended to target concentrated and synthetic 7-OH products and are not intended to apply to natural kratom leaf containing only naturally occurring trace levels of 7-OH.”

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2. Who Does What: DEA, HHS and the FDA

The Controlled Substances Act (CSA) is the federal law that sorts drugs into five schedules. Schedule I is the strictest: the DEA notice describes Schedule I substances as having “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.” Once a substance is in Schedule I, making, distributing, importing, exporting, researching or possessing it falls under the CSA’s registration rules and its administrative, civil and criminal penalties.

The 7-OH action uses a fast-track power, temporary scheduling (21 U.S.C. 811(h)). Under it the Attorney General, who has delegated the authority to the DEA Administrator, may place a substance in Schedule I for two years, without the full scientific review that permanent scheduling requires, after finding the step “necessary to avoid an imminent hazard to public safety.” Temporary scheduling can only ever place a substance in Schedule I. The two years can be extended by up to one year while permanent scheduling proceedings are under way. For that finding the DEA weighs three statutory factors: the substance’s history and current pattern of abuse; the scope, duration and significance of abuse; and the risk to public health.

The procedure has fixed steps. The DEA first notifies HHS, then publishes a notice of intent in the Federal Register (the government’s daily journal of rules and notices). The temporary order itself cannot be issued until at least 30 days after both. Each action is filed under a docket number, a public case file where the documents and any public comments are kept. The notice states that temporary scheduling orders are not subject to the notice-and-comment process that applies to ordinary rules, and are not subject to judicial review.

HHS and the FDA are the medical advisers in this process, not the decision-makers. The DEA’s 7-OH notice records that:

• in a letter dated 28 July 2025, HHS gave the DEA a scientific and medical evaluation recommending that 7-OH and its salts above the specified threshold be controlled in Schedule I, and the threshold in the notice “was adapted from the definition used by” HHS;
• the DEA Administrator notified HHS of the planned temporary order by letter on 24 February 2026;
• by letter of 6 March 2026 the Assistant Secretary for Health replied that, based on an FDA review, there were no investigational new drug applications and no approved new drug applications for 7-OH, and that HHS had no objection to the temporary placement.

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3. The Proposed 7-OH Threshold, in Plain Numbers

The notice of intent does not cover all 7-OH. It covers 7-OH “above a specified threshold,” defined in three parts:

• (A) Kratom plant material — any botanical material of Mitragyna speciosa that contains more than 0.050 percent 7-OH on a dry-weight basis.
• (B)(i) Synthetic products — any article made by synthetic methods that contains more than 0.050 percent 7-OH (by weight or volume) or more than 1.00 milligram of 7-OH in the article.
• (B)(ii) Processed kratom products — material derived from the plant and further processed into “extracts, concentrates, processed edibles, or pressed pills,” including material exposed to “chemical, thermal, or other methods leading to chemical transformations,” that contains more than 0.050 percent 7-OH or more than 1.00 milligram of 7-OH in the article.

To put 0.050 percent in perspective: it equals 0.5 milligrams of 7-OH per gram of dry material. The 1.00-milligram limit applies to the whole article, so a single tablet or gummy holding more than 1 mg of 7-OH would fall inside the definition whatever its percentage. The notice assigns the listing DEA drug code 9675 and proposes adding it to the Schedule I list as paragraph (h)(91) of 21 CFR 1308.11.

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4. Natural Leaf Versus Concentrated Products

The DEA notice explains why the line is drawn at a concentration rather than at the compound itself. Kratom is a tropical evergreen tree native to Southeast Asia. Of its many alkaloids, mitragynine (the major one) and 7-OH (a minor one) are described as mainly responsible for its effects. According to the notice:

• in the natural leaf, 7-OH “makes up less than two percent of the total alkaloid content or occurs in trace amount”;
• 7-OH can be made from mitragynine in a one-step chemical reaction, and the body also produces it from mitragynine as an active metabolite;
• synthetic and plant-derived 7-OH have identical chemical structures, so the molecule acts the same way whatever its source;
• people taking the raw plant “may experience a modified or attenuated physiological effect” because of the other alkaloids present, while isolated or semi-synthetic products deliver the compound undiluted, which the notice calls “a distinct public safety profile when concentrated above the proposed threshold.”

The notice states that 7-OH acts on opioid receptors with a pharmacological profile similar to Schedule II opioids such as morphine, and that animal (preclinical) data point to a high abuse potential with tolerance, dependence and slowed breathing (respiratory depression) comparable to classic opioid painkillers. It describes concentrated products sold online, in gas stations and in smoke shops as tablets, liquid shots, capsules, powders, syrups, vapes, sublingual strips and pouches, nasal sprays and chewables, often labeled as natural kratom extracts. It cites one published investigation that identified 250 such products sold between September 2024 and February 2025, with 7-OH content ranging from 1 mg to 700 mg in a single dose or serving. It adds that “no controlled clinical trials have been conducted to establish safe consumption limits or standardized dosing” for these products.

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5. The Evidence the DEA Cites

The notice summarizes the data the DEA weighed for its “imminent hazard” finding (its full three-factor analysis is filed in Docket DEA-1570):

• FDA warning letters. Between June and July 2025 the FDA sent seven warning letters to sellers over the use of 7-OH as a drug, a dietary supplement or an ingredient added to food. The letters stated that 7-OH is not an approved drug and that no food additive regulation authorizes it. The FDA classified it as a “new dietary ingredient,” with no evidence of marketing as a dietary ingredient before 15 October 1994, and some letters stated that, as a supplement, it is adulterated because there is inadequate information to show it does not present a significant or unreasonable risk of illness or injury. One letter noted packaging that could appeal to children.
• Law-enforcement lab reports. The National Forensic Laboratory Information System recorded 42 reports of 7-OH from 12 states in 2025. The notice says this likely undercounts, because labs often stop at identifying mitragynine and seldom test for minor alkaloids that are not federally controlled.
• Poison centers. From 1 January to 31 July 2025, U.S. poison centers recorded 165 exposure cases involving 7-OH. Among cases involving 7-OH alone, 35 percent resulted in serious health problems and 67 percent of people were treated at a healthcare facility. Reported symptoms included nausea and vomiting, agitation, confusion, loss of consciousness, seizures, sweating, a fast heart rate, high blood pressure and difficulty breathing.
• FDA Adverse Event Reporting System. A query on 27 February 2026 found 86 cases involving 7-OH, 79 of them reported as serious, including 9 deaths.
• DEA toxicology testing. The DEA’s overdose-sample program has identified 7-OH in 85 cases since 2019, 55 fatal and 30 non-fatal, with a median age of 36. Samples often also contained mitragynine, mitragynine pseudoindoxyl or other drugs such as fentanyl, benzodiazepines or ketamine.
• Case reports. The notice tabulates published case reports, including a cardiopulmonary arrest reversed with naloxone (the standard opioid-overdose antidote) and a case of withdrawal that required inpatient buprenorphine stabilization (see Key Research Papers).

Based on these data, the DEA Administrator states his finding that placing 7-OH above the threshold in Schedule I “is necessary in order to avoid an imminent hazard to the public’s safety.” Opioid overdose and its treatment are covered on the site’s Opioid Overdose page.

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6. The Second Action: Mitragynine Pseudoindoxyl, MGM-15 and MGM-16

The second notice of intent (91 FR 40909, 6 July 2026, Docket No. DEA-1644) became a final temporary scheduling order on 26 August 2026 (91 FR 54948, FR Doc. 2026-17429), signed by the DEA Administrator on 24 August. The order is effective from 26 August 2026 until 26 August 2028, and covers all forms of the three compounds, not just those above a threshold:

• Mitragynine pseudoindoxyl (MP) — a chemical rearrangement product of 7-OH, also described in the order as an oxidative metabolite of 7-OH;
• MGM-15 (dihydro-7-hydroxymitragynine) — a derivative of 7-OH;
• MGM-16 (a fluorinated form of dihydro-7-hydroxymitragynine) — made synthetically for research purposes.

The order states that MP and MGM-15 have moved “from experimental substances studied in research to widely available commercial products” sold as powders, tablets and liquid shots, and that all three are potent agonists at the mu-opioid receptor, the receptor morphine and fentanyl act on. It reports preclinical data showing MP to be about 100 times more potent than mitragynine at that receptor, and MGM-15 and MGM-16 to be about 50 and 240 times more potent than morphine in animal models. According to the DEA’s toxicology program, MP was identified in at least 56 overdose cases between February 2025 and May 2026, 48 of them fatal, and MGM-15 in 17 overdose cases from February through April 2026, 16 of them fatal.

As with 7-OH, the order records that HHS (by letter of 20 January 2026, after notice from the DEA dated 15 December 2025) reported no investigational or approved drug applications for these substances and had no objection to the temporary placement.

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7. The HHS Request for Information and Its Extension

A request for information (RFI) is a formal call for public input; it decides nothing by itself. The OASH notice “Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information” (91 FR 41049, 6 July 2026, Docket No. HHS-OASH-2026-0232), signed by Assistant Secretary for Health Brian Christine, opened a public docket on two questions only:

1. whether additional data support this threshold or an alternative one, and specifically “what concentration or quantity of 7-OH in a product constitutes an imminent hazard to public safety”;
2. whether data support other ways of expressing (measuring) the threshold.

The notice states that OASH is not seeking comment on “any permanent scheduling decision, the general safety or utility of kratom-derived products, or other policy questions outside the scope of the threshold determination.” Comments are passed by the Secretary of HHS to the Attorney General for consideration.

The original deadline was 31 July 2026. On 26 August 2026 OASH published an extension (91 FR 55104, FR Doc. 2026-17409) in response to a request for more time, reopening the comment period until 10 September 2026. That deadline has passed.

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8. What These Actions Do Not Do

• They do not target natural leaf kratom. The HHS release states: “These actions are not intended to regulate natural leaf kratom that does not contain enhanced levels of 7-OH.” The proposed threshold for plant material (more than 0.050 percent 7-OH by dry weight) is the line the documents draw between the leaf and enhanced products.
• They do not schedule mitragynine. Kratom’s main alkaloid is not named in either 2026 notice.
• They have not yet scheduled 7-OH itself. As of the Federal Register record through 11 October 2026, the DEA has published only the notice of intent for 7-OH; no temporary scheduling order for 7-OH has appeared (section 9).
• They are not permanent scheduling. Temporary orders last two years, with a possible one-year extension, pending the regular rulemaking process, which involves a formal hearing and is subject to judicial review.
• They do not override stricter state laws. The DEA notice states that its action “does not preempt more restrictive state law” on 7-OH.
• The RFI does not reopen the wider kratom debate. Its scope is limited to the threshold level and how it is measured.

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9. Dates and Legal Status as of 11 October 2026

Update, filed 9 October 2026 (publication in the Federal Register scheduled for 14 October 2026): the DEA filed a new notice of intent to temporarily place 7-hydroxymitragynine and mitragynine pseudoindoxyl in Schedule I “when either substance alone, or their combined amount if both are present, is above a specified threshold” (Docket No. DEA-1570). It is based on an HHS letter of 8 October 2026 recommending a new threshold: more than 1 mg per gram for solid forms or more than 1 mg per milliliter for liquids, or a mass of mitragynine less than 100 times the mass of the controlled substance or substances present. The notice states that, in a separate document in the same issue, the DEA is withdrawing the July 2026 notice of intent for 7-OH. It also states that the 26 August 2026 order placing mitragynine pseudoindoxyl in Schedule I without a threshold “remains in effect until either it expires or the new temporary order is published and the previous order is withdrawn, whichever occurs first.” The DEA writes that “neither HHS nor DEA has made a finding that these substances are safe to use at below-threshold levels.” A companion notice (FR Doc. 2026-20942) concerns MGM-15 and MGM-16. As of 11 October 2026 these are filed documents, not yet published, and no 7-OH temporary order exists.

• 7-OH above the threshold: proposed (notice of intent only). The notice stated that the temporary order “will be published in the Federal Register on or after August 5, 2026,” and that once published it would take effect that day and last two years. A query of the Federal Register’s public records for “hydroxymitragynine,” “7-OH” and “kratom” on 11 October 2026 returned no temporary scheduling order for 7-OH; the most recent related documents are the 26 August 2026 order on the three related compounds and the comment extension of the same day. Until an order is published, 7-OH is not federally controlled under the CSA.
• Mitragynine pseudoindoxyl, MGM-15, MGM-16: final temporary order in effect from 26 August 2026 until 26 August 2028, unless extended or made permanent, in which case the DEA states it will publish a Federal Register document.
• HHS threshold RFI: closed on 10 September 2026 (extended from 31 July 2026).

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10. State Laws the DEA Notice Describes

The DEA notice summarizes state rules as background, drawing on a 2025 survey of state kratom laws:

• nine states — Alabama, Arkansas, Florida, Indiana, Kentucky, Louisiana, Ohio, Vermont and Wisconsin — have prohibited 7-OH consumption;
• Arizona, Colorado, South Carolina and Texas, among others, limit 7-OH to a set percentage of total alkaloid content;
• Mississippi sets a limit of one percent of total alkaloid content, or 0.5 mg per container;
• 19 states have enacted model legislation known as the Kratom Consumer Protection Act, which sets manufacturing, labeling and age rules for kratom products;
• Illinois, New Hampshire, North Carolina and Tennessee have bans in some localities.

State laws change often; these are the notice’s figures as published on 6 July 2026.

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11. How the 2026 Steps Fit Earlier Federal Kratom Actions

2016: a broader attempt, withdrawn. On 31 August 2016 the DEA published a notice of intent to temporarily place both mitragynine and 7-OH — “the main active constituents of the plant kratom” — in Schedule I (81 FR 59929, Docket No. DEA-442). On 13 October 2016 it withdrew that notice (81 FR 70652), stating that it had received “numerous comments from members of the public challenging the scheduling action” and that it would receive from the FDA a scientific and medical evaluation and scheduling recommendation it had requested. It opened a public comment period on the scheduling of both compounds until 1 December 2016.

2025: the FDA and HHS focus on 7-OH. The 2026 documents describe how federal attention narrowed from the plant to concentrated 7-OH. The FDA sent its seven warning letters in June and July 2025, and HHS sent the DEA its recommendation, limited to 7-OH above a threshold, on 28 July 2025. The HHS release also lists an FDA seizure of 7-OH products in December 2025 among the earlier steps.

2026: two tracks. The July 2026 notices split the issue in two. The lab-made relatives of 7-OH, which do not occur in the plant, were scheduled outright and quickly. 7-OH itself, which does occur in the plant, was proposed for scheduling only above a concentration line, with the line itself put out for public comment. Compared with 2016, mitragynine and the plain leaf are outside the proposal entirely.

For the wider context of opioid medicines and their regulation, see Opioids for Chronic Non-Cancer Pain and Addiction and Substance Use Disorders.

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12. Primary Documents

1. U.S. Department of Health and Human Services (2026). HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products. HHS press release, 1 July 2026 — hhs.gov press release
2. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I (notice of intent). Federal Register 91:40917–40924, 6 July 2026. Docket No. DEA-1570 — FR Doc. 2026-13580
3. Office of the Assistant Secretary for Health, HHS (2026). Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information. Federal Register 91:41049, 6 July 2026. Docket No. HHS-OASH-2026-0232 — FR Doc. 2026-13608
4. Office of the Assistant Secretary for Health, HHS (2026). Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period. Federal Register 91:55104, 26 August 2026. Docket No. HHS-OASH-2026-0232 — FR Doc. 2026-17409
5. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (notice of intent). Federal Register 91:40909, 6 July 2026. Docket No. DEA-1644 — FR Doc. 2026-13581
6. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (temporary scheduling order). Federal Register 91:54948, 26 August 2026, effective 26 August 2026 until 26 August 2028. Docket No. DEA-1644 — FR Doc. 2026-17429
7. U.S. Food and Drug Administration (2026). Hiding in Plain Sight: 7-OH Products (updated 13 July 2026) — fda.gov public health focus page
8. Drug Enforcement Administration, Department of Justice (2016). Schedules of Controlled Substances: Temporary Placement of Mitragynine and 7-Hydroxymitragynine Into Schedule I (notice of intent). Federal Register 81:59929, 31 August 2016. Docket No. DEA-442 — FR Doc. 2016-20803
9. Drug Enforcement Administration, Department of Justice (2016). Withdrawal of Notice of Intent to Temporarily Place Mitragynine and 7-Hydroxymitragynine Into Schedule I. Federal Register 81:70652, 13 October 2016. Docket No. DEA-442W — FR Doc. 2016-24659
10. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl Above a Specified Threshold in Schedule I (notice of intent). Filed for public inspection 9 October 2026; scheduled for publication 14 October 2026. Docket No. DEA-1570 — FR Doc. 2026-20943
11. Drug Enforcement Administration, Department of Justice (2026). Schedules of Controlled Substances: Temporary Placement of MGM-15 and MGM-16 in Schedule I (notice of intent). Filed for public inspection 9 October 2026; scheduled for publication 14 October 2026 — FR Doc. 2026-20942

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Key Research Papers

1. Hemby SE, McIntosh S, Leon F, Cutler SJ, McCurdy CR (2019). Abuse liability and therapeutic potential of the Mitragyna speciosa (kratom) alkaloids mitragynine and 7-hydroxymitragynine. Addiction Biology 24(5):874-885 — PubMed PMID: 29949228
2. Smith KE, Boyer EW, Grundmann O, McCurdy CR, Sharma A (2025). The rise of novel, semi-synthetic 7-hydroxymitragnine products. Addiction 120(2):387-388 — PubMed PMID: 39627873
3. Hill K, Boyer EW, Grundmann O, Smith KE (2025). De facto opioids: Characterization of novel 7-hydroxymitragynine and mitragynine pseudoindoxyl product marketing. Drug and Alcohol Dependence 272:112701 — PubMed PMID: 40373645
4. Sharma A, Smith KE, Kuntz MA, Berthold EC, Elashkar OI, Guadagnoli N, Kanumuri SRR, Mukhopadhyay S, Panlilio LV, Epstein DH, McCurdy CR (2025). Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States. Drug Testing and Analysis 17(10):1974-1984 — PubMed PMID: 40377101
5. Alsbrook S, Pro G, Koturbash I (2025). From kratom to 7-hydroxymitragynine: evolution of a natural remedy into a public-health threat. Pharmaceutical Biology 63(1):896-911 — PubMed PMID: 41275505
6. Pullman MK, Kanumuri SRR, Leon JF, Cutler SJ, McCurdy CR, Sharma A (2026). Cardio-pulmonary arrest in a patient revived with naloxone following reported use of 7-hydroxymitragynine. Clinical Toxicology 64(1):65-66 — PubMed PMID: 41025553
7. Wightman RS, Hu D (2026). A Case of 7-Hydroxymitragynine Use Requiring Inpatient Medically Managed Withdrawal. Journal of Addiction Medicine 20(4):416-418 — PubMed PMID: 40758956
8. Towers EB, Thomas YT, Holstege CP, Farah R (2026). Increases in Kratom-Related Reports to Poison Centers — National Poison Data System, United States, 2015-2025. MMWR Morbidity and Mortality Weekly Report 75(11):139-145 — PubMed PMID: 41886310

All eight papers are cited in the DEA’s 2026 notice of intent for 7-OH or its temporary order on mitragynine pseudoindoxyl, MGM-15 and MGM-16.

PubMed Topic Searches

1. PubMed: 7-hydroxymitragynine
2. PubMed: mitragynine pseudoindoxyl
3. PubMed: kratom and poison center reports
4. PubMed: alkaloid content of kratom products

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Connections

• FDA and Regulation
• Sedatives, Phenibut and Kratom
• Dangerous Supplements
• Opioids for Chronic Non-Cancer Pain
• Opioid Overdose
• Addiction and Substance Use Disorders
• FDA Public Meeting on What Counts as a Dietary Ingredient (2026)
• FDA Request for Input on Botanical Drugs (2026)
• FDA Final Guidance on Psychedelic Drug Trials (2026)
• FDA Ibogaine Research Notice (2026)

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