Federal scheduling actions · 7-OH, MGPI, MGM-15, MGM-16
The federal government drew a line between natural kratom leaf and concentrated opioid products.
On October 9, 2026, the Department of Justice, the Drug Enforcement Administration, and the Department of Health and Human Services took coordinated action against 7-hydroxymitragynine (7-OH) and related compounds that have been concentrated or chemically enhanced. Botanical kratom, whose alkaloid profile naturally contains only trace 7-OH, is not what the thresholds are built to reach.
DOJ
Updated emergency scheduling, targeting concentrated products
DEA
Two new Notices of Intent, 30-day comment window
HHS
Science-based thresholds that exclude natural botanical kratom
Want to understand what this means for you?
Schedule a meetingDOJ: emergency scheduling now aimed at enhanced and concentrated formulations
The Justice Department announced updated emergency scheduling actions covering 7-OH and three related opioid substances: mitragynine pseudoindoxyl (MGPI), MGM-15, and MGM-16. The update incorporates new HHS science and replaces a blanket approach with concentration and ratio thresholds designed to separate products with trace amounts of these compounds from products that were deliberately enhanced or concentrated.
"Dangerous and addictive opioids do not belong behind convenience store counters."
What DOJ said about botanical kratom
HHS's updated analysis confirms 7-OH occurs naturally in botanical kratom at relatively low levels, and that MGPI may also appear at trace levels in some botanical or kratom-derived products. The threshold approach was recommended specifically so products whose alkaloid composition matches botanical kratom are not swept in with intentionally concentrated products.
The Attorney General's framing is directed at "7-OH and other powerful synthetic drugs," with the stated goals of protecting children and communities and holding traffickers accountable.
DEA: two Notices of Intent, one with new thresholds
Acting on HHS's recommendation, DEA is issuing two separate Notices of Intent for temporary (emergency) placement in Schedule I.
Notice 1 · MGM-15 and MGM-16
DEA will reissue its Notice of Intent for these two synthetic 7-OH derivatives without changing the current approach. They have no natural-kratom carve-out because they do not occur in the plant.
Notice 2 · 7-OH and MGPI
A new Notice of Intent for 7-OH and MGPI incorporates HHS's concentration and ratio thresholds. This is the notice that matters for the botanical kratom market.
Status of existing controls
- MGPI, MGM-15, and MGM-16 were temporarily placed in Schedule I on August 26, 2026. Those controls stay in effect during the new 30-day period and until DEA issues a new temporary scheduling order.
- For 7-OH, DEA had not yet issued a temporary scheduling order. It will reissue a Notice of Intent reflecting the updated HHS recommendation.
HHS: science-based thresholds that leave natural kratom out of Schedule I
Following a review of scientific data and public comments, Assistant Secretary for Health Admiral Brian Christine, M.D., recommended concentration and ratio thresholds for 7-OH and MGPI to determine which products are subject to Schedule I control under temporary scheduling.
"We are drawing a clear line between natural kratom and dangerous, enhanced opioid products."
What HHS said about botanical kratom
The recommendation targets concentrated or chemically altered products while distinguishing them from natural botanical kratom, which may contain trace 7-OH and MGPI. Secretary Kennedy said the department listened to the public and followed the science. Admiral Christine said the framework lets DEA focus on products manipulated to deliver dangerous levels of potent opioid compounds.
The science behind the risk
FDA's review found 7-OH is substantially more potent than morphine in preclinical studies (roughly two to nine times, depending on the study) and found evidence of a meaningful risk of opioid-like physical dependence and withdrawal from MGPI.
Regulatory schedule
The thresholds
7-OH and MGPI are controlled in Schedule I when either substance alone, or both combined, meets either test.
Concentration · Solid
> 1 mg/g 7-OH + MGPI
Powders, encapsulated material, and other solid forms.
Concentration · Liquid
> 1 mg/mL 7-OH + MGPI
Liquid preparations such as shots and tinctures.
Ratio
< 100 : 1 Mitragynine ÷ (7-OH + MGPI)
When mitragynine is less than 100 times the 7-OH/MGPI content, the product is controlled. Natural leaf sits well above this ratio.
Why the ratio matters
Mitragynine is the predominant alkaloid in kratom. In natural leaf, 7-OH is only a small fraction of it. A product where 7-OH approaches one percent of the mitragynine content has been enhanced — the ratio test identifies that directly, however diluted the final product is.
Not controlled
Natural botanical kratom
Leaf, powder, and properly formulated products with an alkaloid profile consistent with the plant. Trace 7-OH and MGPI below both thresholds.
Schedule I (temporary)
Enhanced or concentrated products
Isolated, synthesized, or fortified 7-OH or MGPI above 1 mg/g or 1 mg/mL, or mitragynine below 100× the 7-OH/MGPI content. MGM-15 and MGM-16 in any amount.
American Kratom Association · October 9, 2026
AKA applauds DEA and DOJ for protecting consumers through targeted scheduling
AKA credited DEA and DOJ for recognizing the need for specific thresholds that separate chemically manipulated opioid products from properly formulated natural kratom leaf, and welcomed the resolution of its litigation over the MGPI scheduling action.
"Federal drug policy should target the substances and product formulations that actually create the risk."
Haddow called the outcome a victory for science and sound public policy, and for the millions of Americans who rely on responsibly manufactured natural kratom.
To state policymakers
Follow the federal model instead of sweeping prohibitions: concentration thresholds, objective lab testing standards, and clear protections for compliant natural kratom.
To manufacturers
Accurate alkaloid disclosure, appropriate serving sizes, independent testing, and quality controls that preserve the leaf's natural alkaloid profile.
AKA's standing position
Age restrictions, accurate labeling, contaminant testing, GMP, and strong enforcement against adulterated, synthetic, or fortified products.
The message
Consumer protection and consumer access are not competing objectives.
How we got here
The sequence of federal actions on 7-OH and related compounds.
- July 2025
After an FDA evaluation, HHS recommends that 7-OH above a specified threshold be placed in Schedule I.
- July 2026
DEA announces intent to temporarily schedule 7-OH above a threshold; HHS opens public comment.
- Aug 26, 2026
DEA temporarily places MGPI, MGM-15, and MGM-16 in Schedule I. AKA files litigation over trace MGPI in natural products.
- Oct 9, 2026
HHS issues updated thresholds. DOJ announces updated emergency scheduling; DEA issues two new Notices of Intent. AKA litigation resolved.
- Next 30 days
Comment period. Existing controls remain until DEA issues a new temporary scheduling order.
Sources
Primary documents, in full.
- Department of JusticeDepartment of Justice Announces Updates to Emergency Scheduling Actions for 7-OH and Related Opioid Substances
- Health and Human ServicesHHS Recommends Science-Based Thresholds to Target Dangerous Enhanced Kratom Products
- American Kratom AssociationAKA Applauds DEA and DOJ for Protecting Consumers Through Targeted Scheduling of 7-OH and MGPI (PDF)
- Federal RegisterTemporary Placement of 7-Hydroxymitragynine and Mitragynine Pseudoindoxyl in Schedule I (Notice of Intent)
- Federal RegisterTemporary Placement of MGM-15 and MGM-16 in Schedule I (Notice of Intent)
Contact
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