Not legal advice. Methodology and industry baselines only. Counsel must verify licensing before category change.
Terminology Crosswalk — Cannabis to Kratom / Dietary Supplement
Authority: 01-RFP-RESPONSE.md Section 2
References: 21 CFR Part 111, AKA GMP Standards Program
Not legal advice.
1. Regulatory framework
| Cannabis / state-regulated term |
Kratom / dietary supplement term |
Notes |
| State processor / manufacturer license |
Food facility registration (FDA); state KCPA where enacted; AKA GMP (voluntary) |
No single federal kratom manufacturer license |
| METRC / seed-to-sale track-and-trace |
Batch/lot master record (21 CFR 111.415) |
Cannot commingle systems |
| Cannabis inventory tag |
Lot number / batch code |
QR-linked COA common in kratom retail |
| Schedule I / state cannabis control |
Unscheduled federally (as of 2026); state-specific kratom rules |
Jurisdiction varies |
| OMMA / UDAF / MED inspector |
FDA dietary supplement CGMP (if applicable); third-party AKA auditor |
Dual audit in Scenario B |
2. Quality unit and release
| Cannabis term |
Supplement / AKA GMP term |
Notes |
| QA officer / compliance manager |
Quality control unit (QCU) — 21 CFR 111.103 |
QCU approves release |
| Batch release |
Certificate of analysis release + QCU sign-off |
Every lot tested before sale (AKA) |
| Hold / quarantine (METRC) |
Quarantine until tested (111.420) |
Physical segregation required |
| Remediation (THC) |
Rework / rejection SOP; kill-step reprocessing |
Different science, same QMS pattern |
| OOS investigation |
OOS / deviation / CAPA |
Same CAPA discipline |
3. Testing and specifications
| Cannabis term |
Kratom term |
Typical method |
| Potency (THC, CBD, total cannabinoids) |
Alkaloid identity and strength (mitragynine, 7-OH) |
HPLC / UPLC |
| Pesticides (state panel) |
Pesticide panel (where required) |
Multi-residue LC-MS |
| Residual solvents (butane, ethanol) |
Residual solvents (if extract SKUs) |
GC headspace |
| Microbial (state cannabis limits) |
Salmonella, E. coli, APC, Y/M |
AOAC / FDA BAM |
| Heavy metals |
Pb, As, Cd, Hg |
ICP-MS (AOAC 2013.06) |
| Moisture / water activity |
Moisture / water activity |
Karl Fischer / aW meter |
| Terpenes |
Not applicable (powder) |
— |
4. Processing operations
| Cannabis term |
Kratom term |
Gap |
| Extraction (CO2, BHO, ethanol) |
Alkaloid extraction (optional SKU) |
Different solvents and specs |
| Milling / grinding (biomass, flour) |
Milling to 40–80 mesh powder |
Similar equipment; different mesh |
| Decarboxylation |
Not applicable (kratom leaf alkaloids) |
— |
| Winterization / dewax |
Not applicable (powder) |
— |
| Distillation |
Concentrate / extract SKUs only |
— |
| Kill step (uncommon in flour) |
Pasteurization / sterilization |
Major addition |
| Blending (homogenization) |
Blend-before-test |
Same equipment; different sampling SOP |
| Encapsulation |
Capsule fill (common SKU) |
Reuse if cannabis caps existed |
5. Material handling and sanitation
| Cannabis term |
Supplement term |
Notes |
| Biotrack / METRC manifest |
Bill of lading + supplier COA + receiving record |
Import docs for SE Asia supply |
| Clean room (extraction) |
Clean, dry processing area (111.360 sanitation) |
Dust control emphasis for kratom |
| Allergen (uncommon cannabis) |
Cross-contact / allergen (111.360) |
Multi-botanical facilities |
| Sanitation SOP |
Sanitation + pest control program (AKA audit) |
Environmental swabbing for Salmonella |
| Waste (regulated cannabis) |
Non-controlled botanical waste |
Disposal path changes |
| Child-resistant packaging |
Age-restricted labeling (21+); state KCPA labels |
Different format rules |
6. Documentation
| Cannabis document |
Supplement document |
| METRC transfer |
Receiving log + supplier qualification file |
| Batch production record (state) |
Master manufacturing record (MMR) / batch record (111.255) |
| COA (state lab) |
Third-party ISO 17025 COA |
| SOP (sanitation, extraction) |
SOP index per 111.103 — receiving, kill step, milling, pack |
| Recall (state) |
Recall and adverse event SOP (AKA requirement) |
| Employee badge / agent card |
GMP training records |
7. Acronym quick reference
| Acronym |
Meaning |
| AKA GMP |
American Kratom Association Good Manufacturing Practices (voluntary) |
| cGMP |
Current Good Manufacturing Practices |
| 21 CFR 111 |
FDA Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements |
| KCPA |
Kratom Consumer Protection Act (state-level) |
| QCU |
Quality Control Unit |
| COA |
Certificate of Analysis |
| MMR |
Master Manufacturing Record |
| OOS |
Out of specification |
| CAPA |
Corrective and preventive action |
| TYC |
Total yeast and mold |
| 7-OH |
7-hydroxymitragynine |
| NFPA 652 |
Combustible dust standard |
8. Language guardrails (external comms)
Per 03-COMPLIANCE-NOTES.md:
| Avoid |
Prefer |
| "FDA approved kratom" |
"AKA GMP aligned" / "quality-focused processes" |
| "Fully compliant" |
"Documentation practices aligned to 21 CFR Part 111 framework" |
| Medical / therapeutic claims |
"Botanical wellness" / "dietary supplement category" |