Mycotoxin testing can look like a small corner of a certificate of analysis, but it answers a question that an ordinary yeast-and-mold count cannot: did certain molds leave behind particular chemical toxins?
That distinction matters. A microbiology result measures organisms under the conditions of a specified test. A mycotoxin assay measures named chemical compounds. A powder may have a low yeast-and-mold count and still require a separate mycotoxin evaluation. Conversely, visible mold or an elevated mold count does not, by itself, identify which toxin is present or how much is there.
This guide explains how to read a kratom mycotoxin COA without turning one line of laboratory data into a broader claim than the test supports. It focuses on aflatoxins B1, B2, G1 and G2, total aflatoxins, and ochratoxin A. It also explains sampling, reporting limits, units, analytical methods, specifications, screening results, confirmation, and common document problems.
This is educational information for adults 21 and older. It is not medical advice, legal advice, a promise that any product is risk-free, or a statement that FDA has approved kratom. FDA states that kratom is not lawfully marketed in the United States as a drug, dietary supplement, or food additive. Kiody does not sell concentrated 7-hydroxymitragynine (7-OH).
The short answer
A useful kratom mycotoxin COA should let a reviewer answer at least eight questions:
- What exact batch and product was tested?
- Was the sample botanical leaf powder, a finished capsule, an extract, or another matrix?
- Which mycotoxins were included in the panel?
- Were aflatoxin B1, B2, G1 and G2 reported individually, as a total, or both?
- Was ochratoxin A included?
- What method, units, limit of detection and limit of quantitation were used?
- What product specification was applied, and where did it come from?
- Did an authorized quality reviewer connect the laboratory report to the correct lot before release?
A report that says only “mycotoxins: pass” leaves most of those questions unanswered.
What is a mycotoxin?
Mycotoxins are chemical substances produced by certain fungi. FDA’s current mycotoxin overview identifies aflatoxins, deoxynivalenol, fumonisins, patulin, ochratoxin A, T-2 and HT-2 toxins, and zearalenone among the mycotoxins on which the agency focuses in human food monitoring.
Aflatoxins B1, B2, G1 and G2 are associated with certain Aspergillus molds. Ochratoxin A can be produced by certain Aspergillus and Penicillium molds. Which toxins are reasonably relevant depends on the crop, geography, harvest conditions, drying, storage, processing and other evidence. A multi-mycotoxin panel can provide a wider view, but a longer analyte list is not automatically better unless the method is appropriate for the actual matrix and the reporting limits are useful.
The U.S. Department of Agriculture’s Mycotoxin Handbook makes a crucial point: visible mold can signal a greater possibility of toxins, but the absence of visible mold does not assure that toxins are absent. That principle is useful well beyond the grain-inspection context in which USDA applies it.
Mold is the organism; a mycotoxin is a chemical product
It helps to separate three different questions:
- Is viable mold recoverable under the microbiology method? A yeast-and-mold enumeration test may answer this in colony-forming units per gram.
- Is a named toxin detectable and quantifiable? A chemical assay for aflatoxin B1 or ochratoxin A addresses this.
- Is the lot acceptable? That is a quality decision based on an established specification, an appropriate method, representative sampling, the result, the product and the applicable regulatory context.
These questions overlap, but they are not substitutes for one another.
A toxin may persist even when the mold that produced it is no longer viable or recoverable. Drying, aging, processing or uneven distribution can further separate the microbiology picture from the chemical-toxin picture. A low mold count therefore does not prove that aflatoxins or ochratoxin A are absent. A mycotoxin result also does not replace microbial pathogen testing, total aerobic counts, yeast-and-mold enumeration, moisture analysis or water-activity assessment.
The five product categories a reviewer should keep separate
“Kratom” is not one uniform laboratory matrix. A defensible COA review begins by identifying the tested material.
1. Whole or coarsely cut botanical leaf
Whole or cut leaf may preserve more visible botanical structure than a fine powder. Contamination can still be uneven. A visually clean sample is not proof of a toxin-free lot.
2. Fine botanical leaf powder
Grinding may distribute material more evenly within a prepared sample, but it cannot repair poor field sampling. A few scoops from the top of a bulk container may not represent the entire shipment.
3. Pure-leaf capsules
A finished capsule is not automatically represented by a raw-powder report. Encapsulation introduces handling, equipment, environmental and lot-linkage questions. A reviewer should determine whether testing was performed on the ingredient, the finished capsules or both, and whether the quality plan supports that choice.
4. Extracts or extract-containing products
Extraction can change the matrix and the relative concentration of compounds. A method validated for grain, leaf powder or another food cannot simply be assumed to perform identically in a concentrated extract. Recovery, ion suppression, co-extractives and dilution must be evaluated for the actual product.
5. Enhanced, synthesized or semi-synthesized alkaloid products
These products are not interchangeable with ordinary botanical leaf. Mycotoxin testing says nothing about whether a product contains concentrated 7-OH, mitragynine pseudoindoxyl, MGM-15, MGM-16 or another synthesized or semi-synthesized substance. A mycotoxin “pass” is not an alkaloid-composition test and not a legal-shipping determination.
Kiody’s educational material distinguishes ordinary botanical leaf and pure-leaf products from extracts, enhanced products and concentrated 7-OH. Kiody does not sell concentrated 7-OH.
Aflatoxin B1, B2, G1 and G2
Aflatoxin panels commonly list four analytes:
- Aflatoxin B1
- Aflatoxin B2
- Aflatoxin G1
- Aflatoxin G2
“Total aflatoxins” generally means the sum of those four results, but a reviewer should confirm the laboratory’s definition. A result for B1 alone is not the same thing as total aflatoxins. A generic line labeled “aflatoxin” is ambiguous unless the method or report defines what it includes.
FDA’s human-food Compliance Policy Guide says the agency may consider human food containing total aflatoxins above 20 micrograms per kilogram—equivalent to 20 parts per billion—to be adulterated under the cited provision of the Federal Food, Drug, and Cosmetic Act. The guide describes total aflatoxins as B1, B2, G1 and G2 and provides regulatory-action criteria for human foods other than several commodities addressed by separate guides.
That 20 ppb figure must not be converted into a misleading “FDA-approved kratom limit.” FDA’s kratom position is that kratom is not lawfully marketed as a dietary supplement or conventional-food additive. The aflatoxin guide is nonbinding agency guidance for human food enforcement, not a kratom approval, product registration or safe-harbor certificate. A company still needs a documented, product-specific basis for its internal specification and must consider state requirements, customer requirements, exposure, method capability and legal advice.
Ochratoxin A
Ochratoxin A, often abbreviated OTA, is a different analyte from the aflatoxins. FDA describes it as a toxin produced by certain Aspergillus and Penicillium molds and notes its occurrence in several stored crops and foods.
Unlike the broad human-food aflatoxin statement in CPG 555.400, the official sources reviewed for this article do not establish one universal federal OTA action level for every human-food matrix, much less a kratom-specific national limit. FDA’s current compliance program states that action, advisory or guidance levels exist for some mycotoxins in certain foods and that other findings may be evaluated case by case.
That means a kratom COA should not present an OTA limit as “the FDA kratom limit” unless a direct, current government source actually says so. The specification may instead be an internal quality limit, a customer requirement, a state rule, a foreign-market limit or another documented standard. The report or accompanying specification record should identify which it is.
Other mycotoxins: when a wider panel may be appropriate
Some laboratories offer panels that also include deoxynivalenol, fumonisins, T-2 toxin, HT-2 toxin and zearalenone. FDA’s current LC-MS/MS method covers twelve mycotoxins in specified matrices: aflatoxins B1, B2, G1 and G2; deoxynivalenol; fumonisins B1, B2 and B3; HT-2 toxin; ochratoxin A; T-2 toxin; and zearalenone.
This does not mean every kratom lot must automatically use that exact panel, nor does it show that FDA’s method is validated for kratom. The published method’s listed matrices include corn, peanut butter, rice and wheat flour. A laboratory applying a similar method to kratom should be able to support its matrix validation or verification, extraction recovery, calibration, reporting limits and quality controls.
A rational panel is risk-based. The decision can consider supplier history, origin, climate, drying and storage practices, prior findings, product form, intended market and applicable rules. The panel should not be copied from another commodity without documenting why it fits the product under review.
Why sampling is often the hardest part
A sophisticated instrument cannot correct a sample that never represented the lot.
Mycotoxins may occur in localized “hot spots.” One container, bag or region of a bulk lot can differ from another. If a sampler takes a small grab from an easy-to-reach surface, the laboratory may analyze that sample precisely while still providing a poor estimate of the lot.
A sound sampling plan should address:
- the lot definition and total lot size;
- the number and location of increments;
- how containers are selected;
- the amount collected from each location;
- the composite-sample procedure;
- tools, sanitation and cross-contamination controls;
- sample security and chain of custody;
- how the laboratory sample is reduced, ground and homogenized;
- how reserve samples are stored;
- what happens when an initial result is near or above a limit.
USDA’s Mycotoxin Handbook is designed for specified grains and commodities, not kratom. Still, its emphasis on sample preparation, grinding, dividing, test-kit range and documentation illustrates why sampling is part of the measurement system rather than a clerical prelude.
Composite samples: useful, but not magic
A composite sample combines increments from multiple points in a lot. It can improve coverage, but only if the increments were chosen and combined appropriately. A composite can also hide information about where contamination occurred.
The plan should say whether the decision applies to:
- one container;
- a defined production lot;
- an incoming shipment made up of multiple supplier lots;
- a finished batch; or
- a warehouse inventory grouped for convenience.
Combining unrelated lots can make the result difficult to interpret. A passing composite cannot automatically clear every source lot if the sampling plan was not designed for that decision.
Grinding and homogenization
Particle size affects how evenly a contaminant is distributed in the test portion. Laboratories may grind and mix a bulk sample before taking the much smaller analytical portion used for extraction.
The COA does not need to reproduce every bench instruction, but the method record should make clear that sample preparation was controlled. Useful questions include:
- Was the entire laboratory sample ground or only a subsample?
- What particle-size target or grinder was used?
- How was the ground material mixed?
- How was the analytical portion selected?
- Were carryover controls used between samples?
- Was the procedure verified for fibrous botanical powder?
A result with many decimal places does not compensate for weak homogenization.
Units: ppb, micrograms per kilogram and nanograms per gram
For solid samples, these units are numerically equivalent:
- 1 microgram per kilogram (µg/kg) = 1 part per billion (ppb)
- 1 nanogram per gram (ng/g) = 1 part per billion (ppb)
- 1 milligram per kilogram (mg/kg) = 1 part per million (ppm)
- 1 ppm = 1,000 ppb
The unit must stay attached to the number. A report of “5” is not interpretable without knowing whether it means 5 ppb, 5 ppm, 5 µg/kg or something else.
For liquids, extracts or products reported by volume, density and basis may matter. “As received,” “dry weight,” “per serving” and “per gram” are not interchangeable. A reviewer should not convert between them without the needed data and a documented formula.
LOD, LOQ and reporting limit
Three terms commonly appear on mycotoxin reports:
- Limit of detection (LOD): the lowest level at which the method can reliably distinguish a signal from background under its defined conditions.
- Limit of quantitation (LOQ): the lowest level at which the method can quantify the analyte with acceptable performance under its criteria.
- Reporting limit: the lowest level the laboratory routinely reports quantitatively. It may equal the LOQ, but that should be confirmed.
The exact definitions can vary by laboratory and method. The COA or method documentation should define them.
“Not detected” does not mean absolute zero. It means the analyte was not detected at or above the applicable detection or reporting threshold under that method and sample preparation. If the specification is lower than the reporting limit, an ND result may not demonstrate compliance.
Example
Suppose a fictional internal OTA specification is no more than 3 ppb, while the laboratory reports “ND, LOQ 5 ppb.” The result does not prove that OTA is at or below 3 ppb. The true value could be below 5 ppb but above the specification. A more sensitive method or a different decision rule is needed.
Screening methods and confirmatory methods
Rapid immunoassay kits can be useful screening tools when they are appropriate for the commodity and concentration range. Chromatographic methods—such as HPLC with fluorescence detection or LC-MS/MS—can provide analyte-specific quantitative or confirmatory information.
Method names should not be treated as quality rankings in isolation. A good review asks:
- Is the method suitable for this matrix?
- Is it quantitative, qualitative or semi-quantitative?
- What is its calibrated range?
- What happens when a result is outside that range?
- How are presumptive positives confirmed?
- Are recoveries and controls acceptable?
- Can the method distinguish B1, B2, G1 and G2?
- Is the result corrected for recovery, and is that policy documented?
USDA evaluates rapid mycotoxin kits for official use in specified grains and commodities. An FGIS-verified kit is not automatically verified for kratom. The laboratory must support the matrix to which it applies the method.
LC-MS/MS and matrix effects
Liquid chromatography-tandem mass spectrometry separates compounds and detects selected mass transitions. FDA’s current multi-mycotoxin method uses stable-isotope dilution LC-MS/MS for a defined set of analytes and matrices. Stable-isotope internal standards can help account for losses and signal effects, but they do not eliminate the need for validation.
Kratom leaf contains pigments, alkaloids and other plant compounds that may alter extraction or instrument response. This is called a matrix effect. A laboratory extending a method to kratom should evaluate at least:
- selectivity;
- calibration model and range;
- accuracy or recovery;
- precision;
- LOD, LOQ or reporting limit;
- carryover;
- dilution integrity;
- analyte stability;
- matrix suppression or enhancement;
- performance across representative product forms.
“LC-MS/MS” on a COA is helpful, but it is not itself proof that the method was suitable for the tested product.
HPLC with fluorescence detection
HPLC with fluorescence detection is another established approach for certain mycotoxins. Depending on the analyte and procedure, it may use cleanup and derivatization steps. USDA notes that its reference testing may use HPLC coupled with fluorescence or mass-spectrometric detection.
The review questions remain the same: matrix suitability, extraction, cleanup, calibration, recovery, precision, sensitivity, controls and identification criteria. The instrument platform is only one part of the result.
Recovery and why 100% is not the only acceptable number
Recovery describes how much of a known amount of analyte added to a sample is measured after extraction and analysis. Botanicals can be difficult matrices, so some loss or signal alteration is expected.
A recovery result should be compared with the method’s pre-established acceptance range. A value below 100% is not automatically a failure, and a value above 100% is not automatically fraud. What matters is whether the recovery is scientifically acceptable, consistent with the method and handled correctly in the calculation.
Warning signs include:
- no recovery data in the supporting run record;
- acceptance criteria chosen after results are known;
- a failed spike with the batch result still released;
- an unexplained correction factor;
- recovery studies performed only in grain but not in a botanical matrix;
- large differences among product forms without investigation.
How to read “total aflatoxins”
A good total-aflatoxin report either lists all four components and the total or clearly defines how the total was calculated.
Problems arise when one or more components are below the quantitation limit. Laboratories may use different conventions, such as:
- treating a non-detect as zero;
- substituting one-half the reporting limit;
- reporting the total as less than a calculated maximum;
- declining to calculate a numeric total.
None of those conventions is self-evidently correct for every decision. The laboratory and specification owner should define the rule before results are reviewed.
Fictional calculation example
Assume a report states:
- B1: 4.0 ppb
- B2: 1.0 ppb
- G1: ND, reporting limit 1.0 ppb
- G2: ND, reporting limit 1.0 ppb
Adding only the quantified values gives 5.0 ppb. But the report should not imply that the exact total is 5.0 ppb unless its calculation convention says so. The two non-detects mean each analyte is below the method’s stated threshold, not necessarily zero. A more cautious expression may be needed.
Specifications: laboratory data do not create the limit
The laboratory measures; the specification owner decides what result is acceptable. Those roles should be separated.
A specification should document:
- analyte or analyte group;
- numeric limit and units;
- basis, such as as-received or dry-weight;
- applicable product and matrix;
- method or method-performance requirements;
- rounding and decision rule;
- treatment of values below LOD or LOQ;
- whether uncertainty is considered;
- source and rationale;
- approval date and version;
- required action after a failure or near-limit result.
The dietary-supplement CGMP regulation at 21 CFR 111.70 requires covered firms to establish limits on contamination that may adulterate or lead to adulteration, and 21 CFR 111.75 requires appropriate, scientifically valid tests or examinations and corrective-action plans when specifications are not met. Kiody cites these provisions as a quality-system benchmark. They are not evidence that FDA approves kratom or considers it a lawful dietary supplement.
There is no single universal federal “kratom mycotoxin panel”
The federal sources reviewed for this guide do not establish one nationwide list of mycotoxins that every kratom product must be tested for, nor one kratom-specific OTA limit. FDA does provide human-food enforcement guidance for total aflatoxins and monitors multiple mycotoxins, but that is not a complete kratom standard.
Responsible quality review therefore requires documented judgment. A panel should be broad enough for the identified risks, and the method should be capable enough to evaluate the chosen specifications. “We tested what the lab offered” is not a strong rationale by itself.
State rules and customer contracts may impose additional requirements. Legal eligibility must be reviewed separately from laboratory quality.
A ten-step review of a kratom mycotoxin COA
Step 1: Match the report to the physical lot
Compare product name, supplier, lot number, batch number, production date, sample date and quantity. Resolve abbreviations and handwriting. A perfect result for the wrong lot has no release value.
Step 2: Identify who sampled the material
Determine whether the sample was collected by the manufacturer, supplier, laboratory, retailer or another party. Look for a written sampling plan and chain of custody.
Step 3: Confirm the tested matrix
Was it raw leaf, ground leaf, finished powder, finished capsules, an extract or a blend? The report should not silently reuse a raw-material result for a different finished product.
Step 4: Confirm the analyte list
For an aflatoxin claim, verify whether B1, B2, G1 and G2 were tested and how total aflatoxins were derived. Confirm whether ochratoxin A was included. Do not assume “mycotoxins” means a comprehensive panel.
Step 5: Read the method and its scope
Look for the method identifier, revision, instrument platform and matrix validation or verification. “FDA method” is too broad if the cited method was validated only for other foods.
Step 6: Check units and basis
Confirm ppb, ppm, µg/kg or ng/g. Confirm as-received versus dry-weight reporting. Do not compare numbers until units and basis match.
Step 7: Compare reporting capability with the specification
The LOQ or reporting limit should be low enough to support the decision. ND with an inadequate reporting limit is not a pass.
Step 8: Review controls and quality flags
Check spikes, blanks, duplicates, internal standards, calibration and any qualifiers. A clean-looking final COA may omit run-level problems that appear in the data package.
Step 9: Apply the approved decision rule
Use the specification version in force when the lot was reviewed. Apply pre-established rounding, total-calculation and uncertainty rules. Do not round a failure down to make it pass.
Step 10: Connect the result to batch disposition
Record approval, quarantine, rejection, investigation, retest or other disposition. A COA is evidence; it is not the release signature.
Five worked reviews
The numbers below are fictional teaching examples. They are not Kiody specifications, legal limits or claims about any real product.
Review 1: Low mold count, detectable aflatoxin
A finished powder reports yeast and mold below 100 CFU/g. A separate chemical panel reports total aflatoxins at 8 ppb against the company’s documented internal limit of 10 ppb.
Review: The microbiology result did not predict the toxin result. Both tests may meet their respective fictional specifications, but neither replaces the other. The lot still requires review of sampling, method capability, panel completeness and all other release requirements.
Review 2: “ND” with an LOQ above the limit
OTA is reported ND with a 5 ppb LOQ. The approved fictional specification is no more than 3 ppb.
Review: The result is not adequate to show compliance. The quality unit should not label it a pass solely because it says ND. A method with sufficient sensitivity is needed.
Review 3: B1-only result presented as total aflatoxins
The COA lists aflatoxin B1 at 2 ppb but omits B2, G1 and G2. The summary page says “total aflatoxins: pass.”
Review: The summary is unsupported unless another page or method record documents all four components and the calculation. B1 alone is not total aflatoxins.
Review 4: Supplier powder result reused for finished capsules
A supplier tested one incoming leaf-powder lot. Three months later, a finished-capsule batch made from that powder is released using the supplier COA alone. No lot reconciliation or process-risk justification is recorded.
Review: The document may support information about the incoming ingredient, but it does not automatically represent the finished batch. The manufacturer should document lot linkage, controls during storage and encapsulation, the verification plan and why any finished-product testing is or is not required.
Review 5: Presumptive rapid-screen positive
A rapid kit gives a presumptive aflatoxin result above an internal action point. A second scoop from the same open bag tests below the point.
Review: Averaging the two or selecting the lower result is not a sound automatic response. Quarantine the defined lot, investigate the sampling plan, preserve samples, and use the pre-approved confirmation and disposition procedure. Localized contamination makes casual resampling especially risky.
Retesting: when “test until pass” is not acceptable
Retesting can be legitimate when the original result is invalidated for a documented laboratory cause or when a written investigation and sampling plan support additional analysis. It becomes misleading when repeated tests are used only to find a passing number.
A defensible retest procedure should establish in advance:
- who may authorize the retest;
- what constitutes an invalid analytical run;
- whether the original result remains part of the record;
- how a new sample is selected;
- whether confirmation uses the same or a different method;
- how multiple valid results are interpreted;
- when the lot must be rejected;
- whether adjacent lots require review.
Mycotoxin heterogeneity makes these controls especially important. A lower result from a second grab sample may reflect a different part of the lot, not an error in the first measurement.
Moisture and water activity are prevention clues, not toxin results
Poor drying or storage can contribute to conditions in which molds grow, but moisture content and water activity answer different questions from a mycotoxin assay.
- Moisture content describes how much water is present by the stated method.
- Water activity estimates how available that water is for physical, chemical and microbial processes.
- A mycotoxin assay measures named toxins in the tested portion.
Low water activity at the time of testing does not prove that toxin production never occurred earlier. A product may have been exposed to unfavorable storage conditions and later dried. Environmental and storage records therefore complement, but do not replace, chemical testing.
Packaging and storage review
Mycotoxin control does not end when an incoming lot passes. A quality program should consider:
- warehouse temperature and humidity monitoring;
- container integrity;
- condensation risk;
- segregation from wet or damaged goods;
- pest and leak controls;
- first-expire-first-out or appropriate stock rotation;
- hold times before processing;
- resealing of opened bulk containers;
- transport conditions;
- investigation of water intrusion or package damage.
The appropriate response to an excursion depends on the duration, severity, material condition and documented risk assessment. A visual check alone may be insufficient.
Twenty warning signs on a mycotoxin COA or data package
- The report says only “mycotoxins: pass.”
- The lot number does not match the product under review.
- The sample date predates manufacture of the identified finished batch.
- The tested matrix is not stated.
- A raw-powder report is presented as a finished-capsule report.
- “Aflatoxin” is listed without defining B1, B2, G1, G2 or total.
- Total aflatoxins are reported but the total-calculation rule is missing.
- Ochratoxin A is claimed but not included in the analyte table.
- Results have no units.
- The reporting basis is unclear.
- ND is treated as absolute zero.
- The LOQ exceeds the specification.
- The method is identified only as “FDA” or “USP” without a number or revision.
- A grain method is used for kratom with no matrix-support record.
- Spike recovery or control failures are not resolved.
- A rapid-screen result is presented as confirmed without a defined procedure.
- Multiple retests appear and the original result is omitted.
- The specification source is described inaccurately as an “FDA kratom limit.”
- A mycotoxin pass is used to imply pathogen, potency or alkaloid compliance.
- The COA has been edited, cropped or separated from its authentication page.
A proposed 42-field mycotoxin review record
The following template can help keep document review consistent. It is a proposed educational model, not a mandated federal form.
- Review record number
- Review date
- Reviewer name
- Reviewer authority or role
- Product name
- Product form
- Supplier name
- Manufacturer name
- Supplier lot number
- Internal lot number
- Finished batch number
- Lot size
- Manufacturing date
- Sample date
- Laboratory receipt date
- Test date
- Report date
- Sampler identity
- Sampling-plan identifier
- Number of increments
- Composite-sample description
- Chain-of-custody reference
- Tested matrix
- Laboratory name
- Laboratory accreditation and applicable scope
- Method identifier and revision
- Instrument or platform
- Matrix validation or verification reference
- Aflatoxin B1 result
- Aflatoxin B2 result
- Aflatoxin G1 result
- Aflatoxin G2 result
- Total-aflatoxin result and calculation rule
- Ochratoxin A result
- Other mycotoxin results
- Units and reporting basis
- LOD, LOQ or reporting limit
- Specification identifier, version and source
- Quality-control flags or qualifiers
- Deviations, investigation or retest reference
- Disposition decision and rationale
- Approval signature and date
What a mycotoxin COA cannot prove
Even a complete, authentic report cannot establish all product-quality questions. A mycotoxin COA cannot by itself prove:
- botanical identity;
- absence of pathogens;
- acceptable total aerobic, yeast or mold counts;
- absence of heavy metals or pesticide residues;
- alkaloid composition or potency;
- absence of concentrated 7-OH;
- absence of mitragynine pseudoindoxyl, MGM-15 or MGM-16;
- compliance with every state or local rule;
- lawful marketing under federal law;
- correct labeling;
- correct packaging;
- representative sampling of the entire lot;
- shelf life;
- clinical safety;
- FDA approval.
COAs work best as linked records within a broader quality system.
Current federal 7-OH and derivative context
Laboratory-quality literacy should not blur the difference between contaminants and controlled alkaloid derivatives.
As of August 31, 2026, DEA’s July 6 publication concerning 7-hydroxymitragynine above a specified threshold is a proposed amendment and notice of intent. It describes controls that would apply when a temporary scheduling order is issued; it is not itself the final temporary scheduling order.
Separately, DEA’s temporary order placing mitragynine pseudoindoxyl, MGM-15 and MGM-16 in Schedule I became effective August 26, 2026. Unauthorized retail sale and possession of those substances are not allowed under the federal Controlled Substances Act.
These legal statuses are unrelated to whether a product passes a mycotoxin panel. A laboratory report must not be used to imply that an enhanced or synthesized product is lawful. Kiody is 21+ and does not sell concentrated 7-OH.
Frequently asked questions
1. Is a yeast-and-mold test the same as a mycotoxin test?
No. Yeast-and-mold enumeration measures viable organisms recoverable under the method. A mycotoxin test measures named chemical toxins. One cannot substitute for the other.
2. Can a product have low mold counts but still contain a mycotoxin?
Yes. The tests measure different things, and toxins can remain even when mold is no longer viable or evenly distributed. Low counts are not proof that aflatoxins or ochratoxin A are absent.
3. Does no visible mold mean the product is free of mycotoxins?
No. USDA’s handbook expressly notes that absence of visible mold does not assure absence of toxins.
4. What does “total aflatoxins” mean?
It generally means the combined result for aflatoxins B1, B2, G1 and G2. The laboratory’s definition and treatment of non-detects should be confirmed.
5. Is aflatoxin B1 the same as total aflatoxins?
No. B1 is one analyte. Total aflatoxins normally includes B1, B2, G1 and G2.
6. What does 20 ppb mean?
Twenty parts per billion in a solid is numerically equivalent to 20 micrograms per kilogram or 20 nanograms per gram. FDA’s human-food guidance discusses total aflatoxins above 20 ppb, but it is not an FDA approval or a kratom-specific safe harbor.
7. Is there a federal FDA limit specifically for aflatoxins in kratom?
The official sources reviewed for this guide do not establish a kratom-specific FDA aflatoxin limit. FDA’s general human-food guidance and current position that kratom is not lawfully marketed as a food or dietary supplement must both be stated accurately.
8. Is there one universal U.S. limit for ochratoxin A in kratom?
No universal federal kratom-specific OTA limit was identified in the official sources reviewed. Companies should document the source and rationale for the specification they use and check applicable state and market requirements.
9. Does “ND” mean zero?
No. It means the analyte was not detected at or above the method’s applicable threshold in the tested sample.
10. What if the LOQ is higher than the product specification?
Then an ND result may not demonstrate compliance. The method must be sensitive enough for the decision.
11. Is LC-MS/MS automatically the best method?
Not automatically. It can be highly selective and capable, but it still needs appropriate validation or verification, sample preparation, calibration, controls and reporting limits for the matrix.
12. Can a rapid test kit be used?
Rapid kits can be useful for appropriate screening applications. Their commodity scope, range and confirmation procedure must be understood. Approval for grain testing does not automatically establish suitability for kratom.
13. Can a supplier COA release a finished batch?
Not by itself in every case. The quality plan must establish lot linkage, supplier qualification, sampling, process controls, specification verification and the authority for finished-batch disposition.
14. Should every lot be tested for every known mycotoxin?
There is no one-size-fits-all answer. The panel and frequency should follow a documented risk assessment, applicable rules, supplier performance, product form and method capability.
15. Can heat treatment guarantee removal of mycotoxins?
No broad guarantee should be made. Processing effects vary by toxin, time, temperature, matrix and process. A microbial reduction step is not automatically a mycotoxin removal step.
16. Does a mycotoxin pass prove a product is safe?
No. It addresses only the named analytes, sample and method. Other contaminants, identity, composition, packaging, labeling, legal eligibility and responsible-use considerations remain separate.
17. Does a mycotoxin COA prove there is no concentrated 7-OH?
No. That requires appropriate alkaloid testing and product review. Mycotoxin methods are not 7-OH methods.
18. Is kratom FDA-approved because it has a COA?
No. A private laboratory report is not FDA approval. FDA currently states that kratom is not lawfully marketed as a drug, dietary supplement or conventional-food additive.
A practical closing rule
Read a kratom mycotoxin COA as a narrow piece of evidence:
This defined sample, analyzed by this method, produced these results for these named toxins at these reporting limits.
Then ask whether the sample represented the lot, the method fit the matrix, the reporting limits fit the specification, the calculations were defined and an authorized quality reviewer made the final disposition.
That approach is less dramatic than a large “PASS” stamp, but it is much more informative.
Related Kiody guides
- Kratom Microbiology COAs: Salmonella, E. coli, Yeast, Mold and CFU
- Kratom Water Activity and Moisture Testing
- Kratom Batch Release and Quarantine
- Nationwide Kratom Leaf Law Tracker
- Nationwide 7-OH Law Tracker
Primary and authoritative sources
- U.S. Food and Drug Administration, Mycotoxins (current page reviewed August 31, 2026).
- FDA, Compliance Program 7307.001: Mycotoxins in Domestic and Imported Human Foods (current program reviewed August 31, 2026).
- FDA, Compliance Policy Guide Sec. 555.400: Aflatoxins in Human Food (June 2021).
- FDA, CAM C-003.03: Determination of Mycotoxins Using Stable Isotope Dilution LC-MS/MS (current method reviewed August 31, 2026).
- USDA Agricultural Marketing Service, Federal Grain Inspection Service, Mycotoxin Handbook (January 6, 2023).
- USDA AMS, Mycotoxin Test Kit Evaluation (current page reviewed August 31, 2026).
- Electronic Code of Federal Regulations, 21 CFR §111.70 — Specifications.
- Electronic Code of Federal Regulations, 21 CFR §111.75 — Determining Whether Specifications Are Met.
- FDA, FDA and Kratom (current page reviewed August 31, 2026).
- Drug Enforcement Administration, Proposed Amendment and Notice of Intent for 7-Hydroxymitragynine Above a Specified Threshold (July 6, 2026).
- Drug Enforcement Administration, Temporary Placement of Mitragynine Pseudoindoxyl, MGM-15 and MGM-16 in Schedule I (effective August 26, 2026).