Moving from 7-OH to mitragynine extract.
The federal thresholds apply to 7-OH, not to mitragynine. If you make concentrated 7-OH products, MIT extract is the raw material that stays outside the scheduling action. Here is what the change means for your supply and your formulation work.
On 14 October 2026 the DEA published a notice of intent (91 FR 65370) to place 7-hydroxymitragynine (7-OH) and mitragynine pseudoindoxyl (MGPI) above a specified threshold into Schedule I. The notice states a temporary scheduling order may be published on or after 13 November 2026, taking effect on publication.
Three related compounds — mitragynine pseudoindoxyl, MGM-15 and MGM-16 — were already placed temporarily into Schedule I on 26 August 2026.
Mitragynine itself is not given a concentration limit by these thresholds. The tests measure 7-OH and MGPI.
Status summarized 12 November 2026. Scheduling actions move quickly — confirm current status against the Federal Register before making decisions.
A raw material problem, on a deadline.
If your product line is built on concentrated 7-OH, the input you have been buying may move into Schedule I. The exposure is not limited to future production: it reaches inventory on hand, work in progress and finished goods sitting with your distributors.
Mitragynine extract sits on the other side of that line. It is the same plant and the same alkaloid family, but it is not what the thresholds measure. For most manufacturers the practical question is no longer whether to move, but how quickly they can qualify a new input and get a compliant product back on the line.
Non-detect for 7-OH.
Our extract is standardized to mitragynine and our lot COAs report 7-OH as non-detect. That clears both parts of the federal threshold with margin, and it means the extract contributes no 7-OH to whatever you press or fill.
Freebase, 80%+ MIT
Powder for tablet pressing and encapsulation. 10 kg minimum, 1 kg units.
Salt form, 75%+ MIT
Powder with different solubility and handling. 10 kg minimum, 1 kg units.
7-OH on every COA
Each lot is tested by an independent lab and the 7-OH figure is reported, so you can document your input.
U.S. inventory
Stock held on both coasts, so a reformulation timeline does not wait on an import.
What a switch actually takes.
This is a materials and documentation exercise. The order below is the one most manufacturers end up following.
- Qualify the input. Request a sample and the current lot COA. Confirm the MIT assay and the 7-OH figure against your own incoming specification.
- Set your target per unit. Decide the MIT content you want in each finished unit. This is your formulation decision and your regulatory exposure, not ours.
- Calculate fill weight from the COA. Extract per unit equals your target MIT divided by the MIT content on that lot's COA, expressed as a decimal. Recalculate for every new lot.
- Re-run blend uniformity. A higher-assay powder at a smaller fill weight behaves differently in the blender and on the press. Treat it as a new blend, not a substitution.
- Re-test the finished product. Your compliance is determined by what is in the finished unit, including everything else in the formula, not by the raw material alone.
- Update labels and documentation. Specifications, batch records, SDS references and anything your own customers rely on.
- Confirm your markets. State rules differ from federal rules and several states restrict kratom and its alkaloids entirely.
We supply raw material and lot documentation. We do not provide potency or dose equivalence between 7-OH and mitragynine products, and nothing here should be read as a conversion factor between them. Serving size, labeling and product claims are decisions for you and your formulator, with your own regulatory counsel.
Supply will tighten before it loosens.
Every manufacturer reading the same notice is looking for the same input on the same timeline. Qualification takes weeks; a sample request today is cheaper than a purchase order in a queue.
- Request a sample and COA now, even if your switch is months out.
- Qualify the material against your incoming spec before you need it.
- Talk to us about holding volume against a forecast rather than ordering spot.
- Check your markets state by state before you commit a production run.
Get a sample and the current lot COA.
Verified manufacturers only. Tell us your volume and which form you are evaluating, and we will include the current 7-OH figure.
Request pricing & a sampleThis page summarizes publicly reported federal actions as of 12 November 2026 and is provided for general information. It is not legal advice. Verify current scheduling status against the Federal Register and consult your own counsel before making compliance decisions.