
As of mid-September 2026, federal law treats two kinds of kratom product very differently. Plain kratom leaf and its main alkaloid, mitragynine, are still not federally controlled. Concentrated 7-hydroxymitragynine (7-OH) is on a fast track toward Schedule I: the Drug Enforcement Administration (DEA) published a notice of intent on July 6, 2026 to temporarily schedule 7-OH above a specified threshold, but a search of the Federal Register on September 17, 2026 turned up no final temporary scheduling order for 7-OH itself.23
What did take effect is narrower. On August 26, 2026, the DEA temporarily placed three semi-synthetic relatives of 7-OH (mitragynine pseudoindoxyl, MGM-15 and MGM-16) in Schedule I. The same day, the Department of Health and Human Services (HHS) extended the comment period on its proposed 7-OH threshold to September 10, 2026.45
States have moved faster and in different directions. Florida used emergency rules to schedule concentrated 7-OH and later six related compounds. Ohio went from a 180-day emergency rule to a standing rule that permits only plain leaf. California, Louisiana and Tennessee took broader action that reaches kratom itself, not just 7-OH. The sections below set out what each action covers and what remains unsettled.
How the federal process started: FDA’s July 2025 recommendation
The current federal push began on July 29, 2025, when the Food and Drug Administration (FDA) announced that it was recommending a scheduling action under the Controlled Substances Act (CSA) for certain 7-OH products. FDA Commissioner Marty Makary described 7-OH as an opioid that can be more potent than morphine. The agency was explicit about scope: it said it was targeting 7-OH as a concentrated product and was not focused on natural kratom leaf products.1
Under the CSA, the FDA cannot schedule a substance on its own. HHS provides a scientific and medical evaluation, and the DEA makes the scheduling decision. According to the DEA’s later notice, HHS sent that evaluation in a letter dated July 28, 2025, under the title “Basis for the Recommendation to Control 7-Hydroxymitragynine and its Salts, As Present in excess of the Specified Threshold Limit.”3
The recommendation followed enforcement activity earlier that summer. The DEA notice records that the FDA issued seven warning letters between June and July 2025 to firms selling 7-OH as a drug, as a dietary supplement or as an ingredient in conventional food. The FDA’s position is that 7-OH is not an approved drug, is not authorized as a food additive, and counts as a new dietary ingredient with no evidence of pre-1994 marketing. One warning letter concerned gummies whose packaging the agency said could appeal to children.3
Why single out 7-OH? It is present in the leaf only in trace amounts, while mitragynine is the dominant alkaloid. Products sold as “7-OH” tablets, shots and gummies contain far more of the compound than leaf does, often produced by chemically converting mitragynine. Our explainer on mitragynine vs 7-hydroxymitragynine covers the pharmacology in more detail.
The DEA’s July 2026 notice and the 0.050 percent threshold
On July 1, 2026, the DEA announced two notices of intent under the temporary scheduling provisions of 21 U.S.C. 811(h). Both were published in the Federal Register on July 6, 2026. The first, document 2026-13580 (91 FR 40917), covers 7-OH above a specified threshold. The second covers the three synthetic derivatives.23
The threshold detail matters, because it is what separates leaf from concentrate. The DEA adapted the definition from HHS, and it has two parts:
- Botanical material: any plant material of Mitragyna speciosa that contains more than 0.050 percent 7-OH on a dry weight basis.
- Alternative articles: products made by synthetic methods, or leaf material further processed into extracts, concentrates, processed edibles or pressed pills (including material exposed to chemical or thermal transformation), that contain more than 0.050 percent 7-OH by weight/weight, weight/volume or volume/volume, or more than 1.00 milligram of 7-OH in the article.
The “or more than 1.00 milligram” clause is the part retailers should read closely. A finished product, such as a tablet or a shot, that contains more than 1 mg of 7-OH would fall within the definition even if its percentage concentration were low. Most products marketed on their 7-OH content advertise amounts well above that figure.3
The notice said the temporary order would not be published before August 5, 2026, and would take effect on publication. Once issued, it would last two years, with a possible one-year extension while permanent scheduling proceeds. It also states that federal control would not preempt stricter state laws.3
Why the order has not appeared yet
Alongside the DEA notice, the HHS Office of the Assistant Secretary for Health published a request for information asking whether data support the proposed threshold or an alternative, and whether other measurement methods would work better. The original deadline was July 31, 2026. On August 26, 2026, HHS extended it to September 10, 2026 after a request for more time.4
No federal document we reviewed gives a date for the final 7-OH order. The practical reading is that the DEA’s legal waiting period has passed, the threshold consultation has only just closed, and the order could be published at any time. Until it is, 7-OH is not a federally controlled substance, although the FDA continues to treat 7-OH products as unlawful under food and drug law.
What was actually scheduled on August 26, 2026
The DEA’s temporary scheduling order for the three derivatives was published as document 2026-17429 (91 FR 54948) and took effect on August 26, 2026. It places the following in Schedule I, including their isomers, esters, ethers and salts:5
- Mitragynine pseudoindoxyl (MP)
- Dihydro-7-hydroxymitragynine (MGM-15)
- The 9-fluoro derivative of dihydro-7-hydroxymitragynine (MGM-16)
The order runs for two years, to August 2028, with a possible one-year extension. These are compounds that had started to appear in the same retail channels as 7-OH, sometimes marketed as next-generation alternatives. HHS Secretary Robert F. Kennedy Jr. called the targeted substances “dangerous opioids that fuel addiction.”2
Plain-leaf kratom and mitragynine: still federally unscheduled
Neither the FDA recommendation nor the DEA notices propose scheduling mitragynine or the kratom plant. HHS and the FDA have said the actions are not intended to apply to natural leaf that contains only naturally occurring trace levels of 7-OH, and the threshold is written to exclude it.12
That is a notable contrast with 2016, when the DEA proposed temporarily scheduling both mitragynine and 7-OH and then withdrew the notice after public opposition. The 2026 approach uses a concentration threshold instead of listing the plant.
Unscheduled does not mean approved. The FDA has not approved kratom for any medical use, and it has long maintained that kratom is not a lawful dietary ingredient. Federally, leaf kratom sits in a gray zone: not a controlled substance, but not a lawful supplement or food ingredient in the FDA’s view. Whether leaf is legal to buy or possess depends on the state. Our state by state guide tracks those rules.
One practical issue remains for leaf products. Because the botanical threshold is 0.050 percent 7-OH on a dry weight basis, leaf that has degraded, been mishandled or been “enhanced” could, in principle, test above it. Sellers relying on the leaf exclusion will likely need lab reports showing 7-OH content, not just mitragynine.
State emergency orders and bans, 2025 to 2026
The DEA notice lists nine states that already prohibited 7-OH consumption: Alabama, Arkansas, Florida, Indiana, Kentucky, Louisiana, Ohio, Vermont and Wisconsin. It also notes that Arizona, Colorado, South Carolina and Texas cap 7-OH as a share of total alkaloids, and that 19 states had enacted a version of the Kratom Consumer Protection Act.3 These are the actions we could confirm with government or news sources.
Florida
On August 13, 2025, Attorney General James Uthmeier issued an emergency rule adding isolated and concentrated 7-OH to Schedule I under state law. His office said the rule did not affect whole kratom leaf.6 On June 22, 2026, a further emergency rule added six related compounds: mitragynine pseudoindoxyl, 7-acetoxymitragynine, 9-hydroxycorynantheidine, 10-hydroxycorynantheidine, MGM-15 and MGM-16. The Florida Phoenix reported that more than 23,000 packages had been pulled from retailers under the earlier rule.7
Ohio
Ohio’s path was less direct. Governor Mike DeWine first asked the Board of Pharmacy to act in August 2025, withdrew that request, and renewed it in December 2025. On December 12, 2025, the board adopted a 180-day emergency rule that banned most kratom-related products, including 7-OH, while allowing products made solely of mitragynine, including natural leaf.8 According to local reporting, a new rule effective May 19, 2026 permits only unprocessed leaf, as whole dried leaf or plain powder, with no dosing or ingestion claims on the label. Capsules, shots, extracts, edibles and isolated compounds such as 7-OH are treated as Schedule I.9
California
On October 24, 2025, the California Department of Public Health declared foods, dietary supplements and drugs containing kratom or 7-OH illegal to make or sell under the state’s Sherman Food, Drug, and Cosmetic Law. This is a food and drug law action rather than drug scheduling. In March 2026, the governor’s office reported 95 percent retailer compliance after 4,502 licensee visits.10
Louisiana and Tennessee
These two states went furthest, banning kratom itself. Louisiana’s Act 41 of 2025 took effect August 1, 2025. It made it unlawful to produce, distribute or possess kratom, with penalties of up to five years in prison and fines of up to $50,000.11 Tennessee’s HB 1649, known as Matthew Davenport’s Law, took effect July 1, 2026. It covers any part of the plant containing mitragynine or 7-OH. Possession is a Class A misdemeanor and sale is a Class C felony.12
| Jurisdiction | Action and date | Covers 7-OH? | Covers plain leaf? |
|---|---|---|---|
| Federal (FDA/HHS) | Scheduling recommendation, July 2025 | Yes, concentrated | No |
| Federal (DEA) | Notice of intent, July 6, 2026; final order not yet published | Yes, above 0.050% or 1.00 mg | No |
| Federal (DEA) | Temporary Schedule I for MP, MGM-15, MGM-16, Aug. 26, 2026 | No (derivatives only) | No |
| Florida | Emergency rules, Aug. 2025 and June 2026 | Yes, plus six related compounds | No |
| Ohio | Emergency rule Dec. 2025; new rule May 19, 2026 | Yes | No, but only unprocessed leaf or powder is allowed |
| California | CDPH declaration, Oct. 24, 2025 | Yes | Yes, as food, supplement or drug |
| Louisiana | Act 41, effective Aug. 1, 2025 | Yes | Yes |
| Tennessee | HB 1649, effective July 1, 2026 | Yes | Yes |
Other state actions have been reported in 2026, including in Kansas, Connecticut, Virginia and Rhode Island. We have not yet confirmed them against primary state sources, so they are left out of this summary.
Where regulation stands as of September 2026
Here is the practical picture.
- 7-OH above the threshold: not yet federally scheduled, but a final temporary order is expected. Once published, it takes effect immediately, and possession and sale become federal Schedule I offenses. It is already controlled or banned in several states, including Florida and Ohio.
- MP, MGM-15 and MGM-16: federally Schedule I since August 26, 2026.
- Plain leaf and mitragynine: not federally scheduled and not targeted by the pending order. They remain illegal in states with full bans, including Louisiana and Tennessee, and are restricted elsewhere.
- FDA position: unchanged. Neither kratom nor 7-OH is an approved drug or a lawful food or supplement ingredient.
The main open questions are when the 7-OH order will be published and whether HHS will change the 0.050 percent or 1.00 mg figures after the comment period. Also watch whether states that regulate rather than ban kratom tighten their own 7-OH caps. For how consumer protection laws handle alkaloid limits, see our explainer on the Kratom Consumer Protection Act. For the product differences behind the policy split, see 7-OH vs traditional kratom.
Frequently asked questions
Is 7-OH federally illegal right now?
Not as a controlled substance, as of September 17, 2026. The DEA has announced its intent to place 7-OH above a specified threshold in Schedule I, but the final temporary order had not been published in the Federal Register. The FDA already treats 7-OH products as unlawful under food and drug law.
Does the DEA action ban kratom leaf?
No. The proposed threshold is written to exclude natural leaf with trace 7-OH, and HHS and the FDA have said leaf is not the target. Some states ban leaf kratom under their own laws.
What does the 0.050 percent and 1.00 mg threshold mean?
Plant material is covered if it contains more than 0.050 percent 7-OH by dry weight. Synthetic or processed products are covered if they exceed 0.050 percent or contain more than 1.00 mg of 7-OH in the article.
What changed on August 26, 2026?
Three 7-OH derivatives, mitragynine pseudoindoxyl, MGM-15 and MGM-16, were temporarily placed in Schedule I. HHS also extended its 7-OH threshold comment period to September 10, 2026.
Can a state be stricter than the federal rule?
Yes. The DEA notice says federal control does not preempt more restrictive state laws, which is why leaf kratom can be banned in states like Tennessee while remaining federally unscheduled.
Sources
- 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
- 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
- Drug Enforcement Administration. Schedules of Controlled Substance: Temporary Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I. 91 FR 40917, Federal Register, 2026. https://www.federalregister.gov/documents/2026/07/06/2026-13580/
- Office of the Assistant Secretary for Health, HHS. Hydroxymitragynine Above a Specified Threshold in Schedule I; Extension of Comment Period. 91 FR 55104, Federal Register, 2026. https://www.federalregister.gov/documents/2026/08/26/2026-17409/
- Drug Enforcement Administration. Schedules of Controlled Substances: Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15, and MGM-16 in Schedule I. 91 FR 54948, Federal Register, 2026. https://www.federalregister.gov/documents/2026/08/26/2026-17429/
- Office of the Attorney General of Florida. Attorney General James Uthmeier Files Emergency Rule; Immediately Removing Dangerous 7-OH from Store Shelves. My Florida Legal, 2025. https://www.myfloridalegal.com/newsrelease/attorney-general-james-uthmeier-files-emergency-rule-immediately-removing-dangerous-7
- Florida Phoenix. More 7-OH related products made illegal in Florida by a new emergency rule. Florida Phoenix, 2026. https://floridaphoenix.com/2026/06/22/more-7-oh-related-products-made-illegal-in-florida-by-a-new-emergency-rule/
- Cincinnati CityBeat (Ohio Capital Journal). Ohio Board of Pharmacy Issues Emergency Ruling Banning Most Kratom Products for 180 Days. CityBeat, 2025. https://www.citybeat.com/news/ohio-board-of-pharmacy-issues-emergency-ruling-banning-most-kratom-products-for-180-days/
- WFMJ. Ohio issues new rules for kratom as a “drug of concern.” WFMJ, 2026. https://www.wfmj.com/news/ohio-pennsylvania-news/ohio-issues-new-rules-for-kratom-as-a-drug-of-concern/
- Office of the Governor of California. Governor Newsom announces 95% compliance with prohibition of illegal kratom products. Governor of California, 2026. https://www.gov.ca.gov/2026/03/03/governor-newsom-announces-95-compliance-with-prohibition-of-illegal-kratom-products/
- Louisiana Department of Revenue. New penalties for Kratom in effect Aug. 1. Louisiana Department of Revenue, 2025. https://revenue.louisiana.gov/news-and-announcements/2025/new-penalties-for-kratom-in-effect-aug-1/
- Metro Nashville Beer Permit Board. Metro Beer Permit Board Reminds Businesses of Tennessee Kratom Ban Effective July 1, 2026. Nashville.gov, 2026. https://www.nashville.gov/departments/beer-permits/news/metro-beer-permit-board-reminds-businesses-tennessee-kratom-ban-effective-july-1-2026
Editorial note: This article is for general information only and is not medical or legal advice. Kratom and 7-OH 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.

