7-OH in 2026: Where DEA Scheduling Stands and Why the Threshold Matters

As of September 17, 2026, 7-hydroxymitragynine (7-OH) is not yet a federally controlled substance, but it is close. On July 6, 2026, the Drug Enforcement Administration (DEA) published a notice of intent to place 7-OH in Schedule I on a temporary basis, but only “above a specified threshold.” For kratom plant material, that threshold is more than 0.050 percent 7-OH by dry weight. For extracts, pressed pills, edibles and synthetic products, it is more than 0.050 percent or more than 1.00 milligram of 7-OH in the article.¹

The notice said the temporary order would be published on or after August 5, 2026. A search of the Federal Register through mid-September 2026 shows no temporary order for 7-OH itself. The DEA did issue a separate temporary order, effective August 26, 2026, placing three related compounds (mitragynine pseudoindoxyl, MGM-15 and MGM-16) in Schedule I without any threshold.⁷ Meanwhile, the Department of Health and Human Services (HHS) extended its public comment period on the 7-OH threshold to September 10, 2026.³

The threshold is the center of the whole action. It is how federal agencies plan to separate concentrated and semi-synthetic 7-OH products from ordinary kratom leaf, which contains the alkaloid naturally in small amounts. Below is what the documents actually say, how temporary scheduling works, and what is still unsettled.

How 7-OH reached this point: the FDA recommendation

The federal process started with the Food and Drug Administration (FDA). On July 29, 2025, the FDA announced that it was recommending that 7-OH be scheduled under the Controlled Substances Act (CSA). The agency stressed that it was targeting 7-OH as a concentrated product and “is not focused on natural kratom leaf products.”⁵ FDA Commissioner Marty Makary described 7-OH as an opioid that can be more potent than morphine. The announcement followed seven FDA warning letters sent in June 2025 to companies selling 7-OH tablets, gummies and similar products.⁵

The DEA notice fills in the paper trail. In a letter dated July 28, 2025, HHS sent the DEA a scientific and medical evaluation recommending Schedule I control of 7-OH “as present in excess of the specified threshold limit.” The DEA then notified HHS of its temporary scheduling plan on February 24, 2026, and HHS replied on March 6, 2026 that there were no open investigational or approved drug applications for 7-OH and that it had no objection.¹

Chemically, 7-OH is a minor alkaloid in Mitragyna speciosa. The DEA notice says it makes up less than 2 percent of total alkaloid content in the natural plant, while mitragynine is the major alkaloid. 7-OH can also be made from mitragynine in a single chemical step, and the body produces it as a metabolite of mitragynine.¹ For more on how the two compounds differ, see our explainer on mitragynine vs 7-hydroxymitragynine.

What the July 2026 DEA notice of intent says

Federal Register document 2026-13580 (Docket No. DEA-1570) is labeled a “proposed amendment; notice of intent.” It is not the scheduling order itself. It gives the 30 days of public notice that federal law requires before a temporary order can be issued.¹

The notice defines covered 7-OH, including its isomers, esters, ethers and salts, in two parts:¹

• (A) Botanical material: any kratom plant material that contains more than 0.050 percent 7-OH on a dry weight basis.
• (B) Alternative articles: (i) synthetic products, or (ii) kratom-derived material processed into extracts, concentrates, processed edibles or pressed pills, including material exposed to chemical, thermal or other methods that transform its alkaloids, that contain 7-OH at more than 0.050 percent (weight/weight, weight/volume or volume/volume) or more than 1.00 milligram in the article.

The DEA says it adapted this definition from one used by HHS. Once the order is published, anyone who manufactures, distributes, imports, exports, researches, analyzes or possesses 7-OH above the threshold would be subject to Schedule I controls and criminal, civil and administrative penalties.¹

To support its “imminent hazard” finding, the DEA cites several data sources. Poison centers logged 165 exposure cases involving 7-OH from January through July 2025. The FDA Adverse Event Reporting System held 86 cases as of late February 2026, including 9 deaths. The DEA’s own toxicology program identified 7-OH in 85 overdose cases since 2019, 55 of them fatal.¹ These figures come with caveats that the notice itself acknowledges. Many cases involved other drugs, such as fentanyl or benzodiazepines, and 7-OH is also a metabolite of mitragynine, which makes it hard to tell leaf use apart from use of concentrated products.

Key federal documents on 7-OH scheduling

Date	Document	What it did
July 28, 2025	HHS evaluation letter to DEA	Recommended Schedule I for 7-OH above a specified threshold
July 29, 2025	FDA announcement	Recommended scheduling 7-OH; said natural leaf was not the focus
July 1, 2026	DEA and HHS press releases	Announced plans to temporarily schedule 7-OH and three related compounds
July 6, 2026	DEA notice of intent (FR 2026-13580)	Set out the threshold; said the order would come on or after August 5, 2026
July 6, 2026	HHS request for information (FR 2026-13608)	Asked for data on the threshold; comments due July 31, 2026
August 26, 2026	DEA temporary order (FR 2026-17429)	Scheduled mitragynine pseudoindoxyl, MGM-15 and MGM-16 through August 26, 2028
August 26, 2026	HHS extension (FR 2026-17409)	Extended threshold comments to September 10, 2026

How temporary scheduling works under 21 U.S.C. 811(h)

Most scheduling decisions go through formal rulemaking “on the record after opportunity for a hearing,” which can take years. Section 811(h) of the CSA provides a faster route when the Attorney General (a power delegated to the DEA Administrator) finds that temporary Schedule I placement is needed “to avoid an imminent hazard to the public safety.”⁶

The statute sets out a short list of requirements:⁶

1. Notice: the order cannot be issued until 30 days after a notice of intent is published in the Federal Register and 30 days after notice is sent to HHS.
2. Limited factors: the agency considers only three of the eight usual scheduling factors: the history and current pattern of abuse, the scope, duration and significance of abuse, and the risk to public health.
3. Duration: a temporary order lasts 2 years and can be extended for up to 1 more year while permanent scheduling proceedings are pending.
4. End point: the order is vacated once a permanent rulemaking on the substance concludes.
5. No court challenge: a temporary order is not subject to judicial review.

The 30 days is a minimum waiting period, not a deadline. The DEA notice says the order would take effect on the day it is published and would stay in place for two years, with a possible one-year extension.¹

Why the threshold matters

The threshold decides which products become Schedule I substances and which stay legal under federal law. Four points stand out.

It is designed to spare natural leaf

HHS said the actions “are not intended to regulate natural leaf kratom that does not contain enhanced levels of 7-OH,” and the DEA’s July 1 release said the same about botanical products below the threshold.⁸⁴ Kratom leaf that tests at or below 0.050 percent 7-OH by dry weight (0.5 milligrams per gram) would fall outside the order. Researchers who reviewed 7-OH products described 7-OH as undetectable or not present in fresh kratom leaves, and a separate analysis of 341 US kratom products, mostly whole leaf, found consistent alkaloid profiles with no sign of adulteration.¹⁰¹¹ Neither study was designed to test products against this specific threshold, so how many leaf products on the market sit below it has not been published.

It targets concentration, not the molecule itself

The DEA notes that natural and synthetic 7-OH are chemically identical. Its reasoning is that the leaf’s other alkaloids may blunt the effects, while concentrated products “deliver unattenuated, high-potency effects.”¹ A threshold is how regulators turn that difference into law. In 2016, by contrast, the DEA proposed scheduling both mitragynine and 7-OH outright, then withdrew that notice.

The 1 mg limit covers nearly every 7-OH product

For extracts, pills, edibles and synthetics, the alternative limit is more than 1.00 milligram per article. The DEA notice cites research finding 7-OH products ranging from 1 mg to 700 mg per dose or serving.¹ A limit that low would cover almost every product sold specifically as 7-OH. Because the definition uses “or,” a processed product with a low concentration but more than 1 mg of total 7-OH could also be covered. How the DEA will apply that to multi-serving extracts has not been spelled out.

It turns lab testing into a legal question

Under a threshold rule, legal status depends on a measured number. Sample preparation, dry weight versus as-sold weight, and a lab’s detection limits can all affect whether a product appears to pass. That makes third-party certificates of analysis more important, not less. Our guides to reading a kratom lab report and red flags on a kratom COA explain what to look for. HHS has also asked for comments on whether the threshold should be stated in a different way.²

Where regulation stands as of September 2026

Based on the Federal Register and agency announcements reviewed for this article:

• 7-OH above the threshold: notice of intent published July 6, 2026. No temporary scheduling order was found in the Federal Register as of mid-September 2026. Until an order is published, 7-OH is not federally scheduled. The FDA still considers 7-OH an unlawful ingredient in dietary supplements and foods.¹⁵
• Mitragynine pseudoindoxyl, MGM-15 and MGM-16: temporarily in Schedule I from August 26, 2026 until August 26, 2028, unless extended or made permanent.⁷
• Threshold input: the HHS request for information (docket HHS-OASH-2026-0232) closed September 10, 2026, after an extension. HHS said comments would go to the Attorney General. It did not seek comments on permanent scheduling or on kratom’s general safety.²³
• Mitragynine and kratom leaf: not federally scheduled, and not included in these actions.¹

Federal agencies have not publicly explained why the 7-OH order came later than the related compounds. The timing is consistent with HHS still gathering threshold comments, but that is an inference, not a stated reason.

What happens next

Once the DEA publishes the temporary order, it takes effect that day. Products above the threshold would then fall under Schedule I rules and could no longer be legally sold. The DEA could also revise the threshold in the final order after reviewing the HHS comments. The notice does not rule that out, but it does not promise it either.

The two-year clock then starts. To make control permanent, the DEA would need to begin formal rulemaking under 21 U.S.C. 811(a), which includes a hearing opportunity and a final decision that can be reviewed in court. If that process is underway, the temporary order can be extended by up to a year.⁶ If the DEA does not act, the temporary control expires. People affected cannot challenge the temporary order in court, but they can take part in the permanent process.¹

State actions

States have moved faster than federal agencies. The DEA notice lists nine states that it says have prohibited 7-OH consumption: Alabama, Arkansas, Florida, Indiana, Kentucky, Louisiana, Ohio, Vermont and Wisconsin. It says Arizona, Colorado, South Carolina and Texas cap 7-OH as a share of total alkaloid content, and that Mississippi sets a limit of 1 percent of total alkaloids or 0.5 mg per container. It also counts 19 states with versions of the Kratom Consumer Protection Act.¹ These counts came from secondary legal summaries, and some were compiled in 2025, so check current state law directly. Our state-by-state kratom guide tracks these changes.

Florida shows how a state can act through the executive branch. On August 13, 2025, Attorney General James Uthmeier filed an emergency rule placing isolated and concentrated 7-OH in Schedule I under state law, which took effect immediately. The rule was aimed at concentrated forms rather than whole leaf.⁹ News outlets reported a further Florida emergency rule in June 2026 covering more 7-OH-related products, but this article did not review that rule’s text.

The DEA says that federal control above the threshold does not override stricter state laws.¹ A product that falls below the federal threshold can still be illegal in a state that bans 7-OH at any level or bans kratom altogether.

Frequently asked questions

Is 7-OH illegal federally right now?

As of September 17, 2026, no temporary scheduling order for 7-OH had appeared in the Federal Register, so it is not yet a federally controlled substance. The DEA has said it intends to schedule 7-OH above a set threshold, and the FDA already treats it as an unlawful supplement and food ingredient. Many states restrict it separately.

What is the exact threshold?

For kratom plant material, more than 0.050 percent 7-OH by dry weight. For synthetic or processed products such as extracts, pressed pills and edibles, more than 0.050 percent or more than 1.00 milligram of 7-OH in the article.

Will regular kratom leaf be banned?

Not by this federal action. Leaf that tests at or below the threshold is not covered, and the DEA and HHS have both said natural leaf is not the target. State laws may differ.

How long would the temporary scheduling last?

Two years from the day the order is published, with a possible one-year extension while permanent scheduling proceedings are pending.

Can the threshold still change?

Possibly. HHS asked for data on whether a different level or measurement would be more appropriate, and said those comments would go to the Attorney General. No revised threshold had been announced as of mid-September 2026.

Sources

1. Drug Enforcement Administration. Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I (notice of intent, FR Doc. 2026-13580). Federal Register, 2026. https://www.federalregister.gov/documents/2026/07/06/2026-13580/
2. Office of the Assistant Secretary for Health, HHS. Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I; Request for Information (FR Doc. 2026-13608). Federal Register, 2026. https://www.federalregister.gov/documents/2026/07/06/2026-13608/
3. Office of the Assistant Secretary for Health, HHS. Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period (FR Doc. 2026-17409). Federal Register, 2026. https://www.federalregister.gov/documents/2026/08/26/2026-17409/
4. Drug Enforcement Administration. DEA to Temporarily Schedule 7-OH and Related Substances to Protect Public Safety. DEA, 2026. https://www.dea.gov/press-releases/2026/07/01/dea-temporarily-schedule-7-oh-and-related-substances-protect-public
5. U.S. Food and Drug Administration. FDA Takes Steps to Restrict 7-OH Opioid Products Threatening American Consumers. FDA, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-restrict-7-oh-opioid-products-threatening-american-consumers
6. Legal Information Institute. 21 U.S. Code 811: Authority and criteria for classification of substances. Cornell Law School. https://www.law.cornell.edu/uscode/text/21/811
7. Drug Enforcement Administration. Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I (FR Doc. 2026-17429). Federal Register, 2026. https://www.federalregister.gov/documents/2026/08/26/2026-17429/
8. U.S. Department of Health and Human Services. HHS, FDA Commend DEA Action Against Dangerous Enhanced 7-OH Products. HHS, 2026. https://www.hhs.gov/press-room/hhs-fda-support-dea-7-oh-scheduling.html
9. Office of the Attorney General of Florida. Attorney General James Uthmeier Files Emergency Rule; Immediately Removing Dangerous 7-OH from Store Shelves. State of Florida, 2025. https://www.myfloridalegal.com/newsrelease/attorney-general-james-uthmeier-files-emergency-rule-immediately-removing-dangerous-7
10. Hill K, Boyer EW, Grundmann O, Smith KE. De facto opioids: Characterization of novel 7-hydroxymitragynine and mitragynine pseudoindoxyl product marketing. Drug and Alcohol Dependence, 2025. https://pubmed.ncbi.nlm.nih.gov/40373645/
11. Sharma A, Smith KE, Kuntz MA, et al. Chemical Analysis and Alkaloid Intake for Kratom Products Available in the United States. Drug Testing and Analysis, 2025. https://pubmed.ncbi.nlm.nih.gov/40377101/

Editorial note: This article is for general information only and is not medical or legal advice. 7-OH and kratom have not been evaluated by the FDA to diagnose, treat, cure or prevent any disease. Laws vary by location and change often, so verify the rules that apply where you are. Always talk to a licensed healthcare provider before use, especially if you are under 21, pregnant or nursing, taking medication, or managing a health condition.