Reference
Regulatory Status of 7-OH and Kratom Alkaloid Products
Last reviewed: 12 September 2026. This page is informational and is not legal advice.
Rules change frequently — verify against the primary sources linked below before relying
on anything here.
Summary
| Compound | Federal status | Since |
|---|---|---|
| 7-hydroxymitragynine (7-OH) above a specified threshold | Proposed for temporary Schedule I — not yet in effect | Notice of intent published 6 July 2026 |
| Mitragynine pseudoindoxyl (MP) | Schedule I — any amount | 26 August 2026 |
| MGM-15 | Schedule I — any amount | 26 August 2026 |
| MGM-16 | Schedule I — any amount | 26 August 2026 |
| Botanical kratom leaf below the 7-OH threshold | Not covered by the federal action; state law still applies | — |
Federal timeline
- July 2015 – 2016: FDA and DEA actions on kratom; the DEA withdrew its
2016 notice of intent to schedule mitragynine and 7-OH after significant public comment. - 15 July 2025: FDA issued warning letters to seven companies marketing
products containing 7-OH, describing them as unapproved new drugs, adulterated dietary
supplements and unsafe food additives. - 29 July 2025: FDA formally recommended that the DEA place 7-OH in
Schedule I. - 6 July 2026: DEA published two notices of intent — one covering 7-OH
above a specified threshold, one covering MP, MGM-15 and MGM-16. - 26 August 2026: The DEA’s temporary order scheduling MP, MGM-15 and MGM-16
took effect. The comment period on the 7-OH threshold was extended and closed on
10 September 2026. - Current: no temporary scheduling order covering 7-OH itself has been
published. It can issue at any time.
What the threshold means
The proposed federal action covers products containing more than 0.05% 7-OH by dry weight for
botanical kratom, and more than 0.05% by concentration or more than 1 mg of 7-OH per article for
synthetic or processed products. Natural kratom leaf typically contains 7-OH at roughly
0.003% to 0.04% by dry weight, which falls below the line.
State law
State law operates independently of the federal position and, in most places, is what
currently governs retail. Nine states are reported as banning kratom and its alkaloids
outright: Alabama, Arkansas, Connecticut, Indiana, Kansas, Louisiana, Tennessee, Vermont and
Wisconsin. Others — including Florida, Ohio and Virginia — restrict concentrated
7-OH specifically while leaving botanical leaf regulated. More than thirty states regulate the
category under a Kratom Consumer Protection Act, typically requiring 21+ age verification,
third-party testing and specific labelling.
Canada
Kratom and its alkaloids are not listed under the Controlled Drugs and Substances Act.
However, Health Canada has not authorised them as a natural health product, food or therapeutic
good, and selling them for human consumption, or advertising health benefits, is contrary to the
Food and Drugs Act and the Natural Health Products Regulations. Vendors operate by labelling
products as not for human consumption or for research use only.
Safety information
Concentrated 7-OH is an opioid-receptor agonist. Published FDA material has associated it
with respiratory depression, seizures, liver toxicity, dependence and death, and notes that it
has shown greater potency than morphine in preclinical studies. Combining it with alcohol,
opioids, benzodiazepines or other central nervous system depressants raises the risk of
respiratory depression.
If you or someone you know is struggling with dependence: SAMHSA’s National
Helpline — 1-800-662-4357 — is free, confidential and open 24/7.
In Canada, contact your provincial health line or ConnexOntario at 1-866-531-2600.
Primary sources
- DEA press release, 1 July 2026 — notice of intent to temporarily schedule 7-OH and
related substances. - Federal Register, 6 July 2026 — Schedules of Controlled Substances: Temporary
Placement of 7-Hydroxymitragynine Above a Specified Threshold in Schedule I (proposed rule). - Federal Register, 26 August 2026 — Temporary Placement of Mitragynine Pseudoindoxyl,
MGM-15 and MGM-16 in Schedule I (final rule, effective 26 August 2026). - FDA warning letters to marketers of 7-OH products, July 2025.
- Health Canada guidance on unauthorized natural health products.
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