Kratom Sample Chain of Custody: How a Lot Becomes a Defensible COA

The short answer

A certificate of analysis is only as meaningful as the connection
between the report and the product lot it supposedly represents. A
laboratory can produce technically accurate measurements on the sample
it received while the buyer still lacks proof that the sample came from
the claimed lot, was collected representatively, remained protected in
transit or matches the package in hand.

That connection is the sample chain of custody: a
documented history of collection, identification, sealing, transfer,
storage, receipt, opening, subdivision, analysis and disposition. A
strong record answers five basic questions:

1. What exact lot was available for sampling?
2. Who collected the sample, when, where and under what procedure?
3. How was the sample identified and protected against substitution,
   contamination or deterioration?
4. Who handled it from collection through laboratory receipt and
   analysis?
5. How does the final report link back to the lot and the consumer
   package?

Chain of custody does not make an unrepresentative sample
representative. It does not validate a weak laboratory method, correct
an incorrect specification or prove that every unit in a lot is
identical. It does something narrower and essential: it helps
demonstrate continuity and integrity from the sampled lot to the
reported result.

What “chain of custody” means

NIST defines chain of custody as a chronological record of the
transfer, handling and storage of an item from collection through its
final return or disposal. FDA’s laboratory materials describe sample
accountability as a continuous record that provides objective evidence
that sample integrity was preserved and handling remained
continuous.

For routine commercial quality testing, that history may involve only
a few people:

• an authorized sampler at the warehouse;
• a quality employee who seals and releases the package to a
  carrier;
• the carrier;
• a laboratory receiving custodian;
• an analyst or sample-preparation technician; and
• a laboratory reviewer who approves the report.

The record grows more complicated when a contract manufacturer,
broker, importer, third-party sampler, fulfillment warehouse or multiple
laboratory locations are involved. Complexity is not automatically a
problem. Undocumented complexity is.

The chain should be understandable without relying on one employee’s
memory. If a question arises months later, the records should show what
happened, who was responsible and which identifiers connected every
step.

Four ideas that should
not be confused

1. Sample identity

Sample identity asks, “What is this material?” A botanical-identity
examination may use macroscopic or microscopic features, chemical
analysis, DNA methods or a scientifically justified combination.
Identity testing helps determine whether a sample is consistent with
Mitragyna speciosa or another claimed material.

2. Sample representativeness

Representativeness asks, “Does this portion fairly reflect the lot?”
A perfectly labeled jar taken only from the easiest-to-reach top corner
of one bag may have an excellent chain of custody and still fail to
represent a 500-kilogram lot. Sampling design, selection locations,
increments, tools and compositing decisions determine
representativeness.

3. Sample integrity

Integrity asks, “Did the sample remain materially unchanged in a way
that could affect the result?” Open containers, moisture exposure, dirty
tools, unsuitable storage, leaking liquid vials and broken seals can
compromise integrity.

4. Measurement traceability

Measurement traceability asks whether a result can be related to
suitable references through a documented calibration chain. NIST
expressly distinguishes metrological traceability from chain-of-custody
traceability. A calibrated balance, certified reference material and
traceable standard may support the measurement, while custody records
support the identity and handling history of the physical sample.

A defensible COA may need evidence from all four areas. Success in
one does not substitute for failure in another.

Why a COA PDF is not the
whole story

A report commonly identifies a client, sample name, lot number,
laboratory accession number, receipt date, analysis date, methods and
results. Those fields are useful, but they normally begin near the point
of laboratory receipt. They may not reveal:

• how the commercial lot was defined;
• whether every container was available for selection;
• whether the supplier chose a favorable-looking portion;
• whether the sample came from a sealed finished package or an open
  bulk bag;
• whether the person collecting it followed a written plan;
• whether tools were clean and suitable;
• whether the package was sealed immediately;
• whether custody changed before shipment;
• whether the laboratory received the seal intact;
• whether a mismatch was corrected after arrival; or
• whether the report was later paired with a different lot
  online.

This is why “third-party tested” should not be treated as a complete
quality conclusion. It describes who may have performed a test. It does
not disclose who selected the material, how it was protected or whether
the public-facing report remains attached to the correct lot.

A five-link model from lot
to report

Think of the evidence as five connected links.

Link	Core question	Typical records
Lot definition	What population did the sample represent?	Receiving record, pallet map, container count, lot code, quantity and status
Collection	How were portions selected?	Sampling plan, sampler authorization, locations, increments, tools and observations
Protection and transfer	Was substitution or deterioration detectable?	Container ID, tamper-evident seal, photographs, custody signatures, dates, times and carrier tracking
Laboratory control	What happened after receipt?	Accession record, seal condition, storage, internal transfers, preparation batch and analyst worksheet
Report reconciliation	Does the released COA match the actual product?	Laboratory report ID, lot match, methods, dates, specifications, approval and website record

The strength of the final claim is limited by the weakest material
link. A sophisticated instrument cannot reconstruct a missing lot
identity. A perfect custody form cannot rescue a sample collected from
the wrong batch.

How product type
changes custody planning

Different forms create different handling risks.

Product type	Primary custody concern	Practical implication
Whole or cut leaf	Visual variation and nonuniform foreign material	Record selection points and avoid choosing only visually preferred leaves.
Plain powder	Settling, segregation, moisture and airborne cross-contact	Use clean tools, control dust and document increment locations and depths.
Pure-leaf capsules	Lot identity, fill variation and packaging-stage mix-ups	Record unit count, package codes and whether capsules came from bulk or finished packages. Kiody capsules are approximately 500 mg of pure leaf, not extract.
Extract powder	Hygroscopic behavior and higher concentration	Use compatible, tightly closed containers; record the exact extraction lot and reporting basis.
Liquid extract	Leakage, evaporation, phase separation and container interaction	Mix only when the procedure requires it; document conditions and use compatible leak-resistant vials.
Enhanced leaf	Segregation between leaf and added material	A small grab may not represent added alkaloid distribution; sampling and blend-uniformity evidence are critical.
Concentrated 7-OH	Legal status, high analyte levels and potential carryover	Do not treat it as botanical leaf. Kiody does not sell concentrated 7-OH. Laboratories need suitable range, contamination-control and authorization procedures.
Manufactured derivative	Controlled-substance and identity issues	Federal or state authorization and controlled-substance custody requirements may apply independently.

Package format does not determine composition. A capsule may contain
pure botanical powder, an extract, an enhanced blend or a manufactured
ingredient. The custody record should use the precise product
description rather than “capsules” alone.

The
federal quality benchmark—and an important limitation

Title 21 CFR Part 111 contains dietary-supplement manufacturing
requirements that are useful as a quality-system benchmark. Section
111.80 calls for representative samples of unique component lots and
shipments, in-process materials, selected finished batches, received
products and packaged-and-labeled lots. Section 111.83 requires reserve
samples of each distributed lot of packaged and labeled dietary
supplements, identified by lot and held in a protective
container-closure system.

Section 111.75 requires appropriate, scientifically valid tests or
examinations for selected specifications and lists organoleptic,
macroscopic, microscopic, chemical and other scientifically valid
methods. It also describes conditions for relying on some supplier COAs
and calls for quality-control review.

These provisions explain useful quality principles: define lots,
collect representative samples, use appropriate methods, preserve
records and keep investigation material. They do not
mean FDA has approved kratom or accepts kratom as a lawful dietary
ingredient. FDA’s current kratom page states the opposite. Kiody should
present Part 111 as a quality benchmark, not as a marketing endorsement
or legal-status certificate.

Before
collection: build the sampling assignment

A strong chain begins before anyone opens a container. The assignment
should identify:

• the material or finished product name;
• product category and formulation;
• supplier, manufacturer or packager;
• supplier lot and any internal lot;
• shipment or receiving number;
• total lot size and number of containers;
• physical location and quarantine status;
• tests requested and the laboratory;
• minimum sample quantity;
• container and preservation needs;
• sampling pattern or statistical plan;
• whether individual increments remain separate or become a
  composite;
• reserve or retain quantity;
• known hazards and protective equipment;
• authorized sampler; and
• deviations that require approval before proceeding.

The requested tests influence collection. Microbiological analysis
calls for contamination controls that may differ from chemistry
sampling. Volatile-solvent work may require limited headspace and
compatible closures. Moisture or water-activity testing requires
protection from ambient humidity. A broad powder sample collected into a
thin, repeatedly opened bag may be acceptable for one question and poor
for another.

The laboratory should confirm quantity and container requirements
before collection. Sending an undersized sample can cause the lab to
omit tests, overuse a single preparation, reject the submission or leave
too little material for confirmation.

Define the lot before
choosing the sample

“Lot” should refer to a specific quantity intended to have uniform
character and quality within defined limits. A shipping pallet is not
automatically a manufacturing lot. One delivery may contain several
supplier lots, and one production lot may be split across several
pallets or storage sites.

Record both external and internal identifiers when they differ. For
example:

• Supplier lot: MS-GR-260812
• Receiving lot: RCV-260827-04
• Blending batch: BL-260829-02
• Finished package lot: PK-260830-A

Those codes describe different stages. A component COA for the
supplier lot cannot automatically serve as a finished-product COA after
blending and packaging. The chain should show how each downstream batch
used the upstream material.

Before collection, verify that the stated lot is physically
segregated or otherwise identifiable. Photograph representative pallet,
drum, bag or finished-package codes. Note damaged, wet, open, relabeled
or mismatched containers. Do not quietly exclude abnormal units when the
plan says the full lot is the sampling population.

Collection:
document actions, not conclusions

A custody form should record observable facts. “Sample collected
properly” is a conclusion. Better entries state:

• container 3 of 18 selected using the approved random list;
• outer bag code matched MS-GR-260812;
• liner intact before opening;
• unused stainless-steel thief opened immediately before
  collection;
• increments collected from upper, middle and lower zones;
• 75 grams placed in container COC-1047-A;
• lid closed and seal S-88214 applied at 10:42 a.m.; and
• no visible moisture, tears or foreign odor observed.

Precise notes make later review possible. They also reveal when a
deviation matters.

Clean tools and
controlled surroundings

Powders move easily. A scoop used first on an enhanced product and
then on plain leaf can transfer material. An open sample jar left near
an active blender can collect airborne dust. Gloves can protect the
sample only when changed at the right time.

The record should identify the tool, its cleaned or single-use
status, the sampling area and any conditions that could affect the
result. For microbiology work, use sterile equipment and containers
where the method requires them. “Food grade” is not the same as
sterile.

Individual increments
versus composites

A composite sample combines increments before
analysis. It can estimate an average but may conceal a localized high or
low result. Separate increments preserve location information but
require more laboratory work.

The form should state whether the submitted jar is:

• one grab sample;
• one increment from a named location;
• a field composite made from identified increments;
• a laboratory composite created after receipt; or
• a finished retail unit.

Do not call a sample “composite” without documenting what was
combined. A laboratory cannot infer the original sampling pattern from a
homogeneous-looking jar.

Sample
identifiers should be unique and durable

A sample ID should not depend only on a handwritten product name. Use
a unique identifier that links the physical container, custody form,
laboratory submission and final report.

A practical format might include a program prefix, date and sequence:
KDY-260903-017. If there are multiple containers or split
portions, append distinct suffixes such as -A,
-B and -R for laboratory, confirmation and
reserve portions.

Each container label should include, as applicable:

• unique sample ID;
• product name;
• supplier and internal lot;
• portion or subsample number;
• collection date and time;
• sampler initials;
• storage condition; and
• hazard or handling note.

Never place the only identifier on a removable lid. Lids can be
switched during handling. Label the body and, when appropriate, use a
seal that bridges the lid and container.

Tamper evidence and seals

A custody seal should make unauthorized opening detectable. The seal
identifier belongs on the custody form, and the application should be
dated or otherwise linked to the collector. A photo can supplement the
record, but a photo does not replace the physical seal or transfer
history.

FDA’s 2026 Investigations Operations Manual instructs investigators
to handle, identify and seal official samples to maintain integrity and
a clear custody record. It also describes sealing packages so they
cannot be opened without evidence of tampering and documenting every
broken and replaced seal.

Commercial firms should not copy FDA’s official seals or imply that a
private sample is an FDA sample. The useful lesson is the control
principle:

1. use a uniquely numbered tamper-evident device;
2. apply it so access requires visible disturbance;
3. record its condition at every custody transfer;
4. document any authorized opening; and
5. apply and record a new seal after resealing.

A seal can be intact while the sample is wrong. It only protects the
contents placed inside. Lot verification and representative collection
still come first.

Transfers: every
handoff needs continuity

For each transfer, record:

• sample ID and seal number;
• released by and received by;
• organization or role;
• date and time;
• purpose of transfer;
• condition of container and seal;
• storage or transport condition; and
• signature, secure electronic approval or other controlled
  authentication.

A courier tracking number is useful but incomplete. It shows carrier
movement, not necessarily who sealed the sample, the condition at pickup
or the condition at laboratory receipt. Keep the tracking record with
the custody package and reconcile it to the lab’s received date.

When a sample is left in a pickup area, locker or security desk,
document that event. Avoid vague entries such as “sent to lab.” Name the
carrier or custodian and capture time, tracking and condition.

Shipping and storage
conditions

Plain dry botanical powder is not automatically immune to handling
changes. Moisture uptake, extreme heat, torn packaging, leaked liquids
and prolonged delays can affect some analyses or create uncertainty.

The shipping plan should address:

• primary container compatibility;
• leak resistance for liquids;
• secondary containment;
• protection of the custody seal;
• cushioning against breakage;
• temperature needs, if scientifically justified;
• light protection, if relevant;
• carrier restrictions;
• expected transit time;
• weekend or holiday delays; and
• action limits for delayed, damaged or temperature-excursion
  shipments.

Do not invent a universal “kratom must ship refrigerated” rule.
Storage needs depend on the matrix and planned analysis. The laboratory
and written procedure should establish the relevant conditions.

Laboratory receipt and
accessioning

The laboratory’s first documented examination is a critical control
point. Receiving staff should compare the package with the submission
and record:

• laboratory accession number;
• client sample ID;
• product and lot identifiers;
• receipt date and time;
• carrier or hand-delivery details;
• container type and count;
• seal number and condition;
• sample quantity;
• temperature when required;
• leakage, breakage, unusual odor or contamination;
• paperwork discrepancies; and
• acceptance, conditional acceptance or rejection.

A mismatch should not be silently edited. If the container says lot A
and the form says lot B, the laboratory should place the sample on hold,
document the discrepancy and obtain a controlled correction from an
authorized client contact. The final report should not hide a material
identity correction.

Accession number versus lot
number

The accession number is the laboratory’s internal identity for the
submission. The lot number is the manufacturer’s or supplier’s identity
for the product population. They are not interchangeable.

A public COA should make the lot connection visible. A report
displaying only an accession number requires another controlled record
to prove which commercial lot it represents.

Inside the laboratory

Custody continues after receipt. The laboratory should be able to
reconstruct:

• secure storage location;
• authorized access;
• date and person opening the seal;
• amount removed;
• sample preparation or homogenization;
• portions assigned to each method;
• internal transfers between rooms or analysts;
• preparation and analytical batch identifiers;
• remaining quantity;
• deviations or nonconforming work;
• return, retention or disposal; and
• technical and administrative review.

The laboratory may use an electronic laboratory information
management system, controlled paper forms or both. The format matters
less than the ability to protect records, identify users, preserve
changes and connect the sample to the raw data and report.

An instrument sequence name alone is not custody. It should connect
to a preparation record and sample accession. Likewise, an analyst’s
initials on a worksheet do not explain who held the sealed sample before
it was opened.

Report issuance and
website reconciliation

Before a COA is released or posted, compare:

• client name;
• product name and matrix;
• lot or batch number;
• laboratory accession and report number;
• received, prepared and analyzed dates;
• test methods;
• units and reporting basis;
• results and reporting limits;
• specification or decision rule, if shown;
• amendments or superseded versions; and
• authorized laboratory approval.

The public-facing QR code or COA library should resolve to the
current approved report for the lot on the package. Reusing one
“representative COA” for later lots breaks that connection. So does
renaming a report file without checking its internal lot number.

If a laboratory issues an amended report, preserve the original
version in controlled records and replace the public copy with the
amendment. State why it was amended when the laboratory provides that
information. Do not edit laboratory PDFs to make a correction; request a
laboratory-issued revision.

Reserve samples and
investigation readiness

A reserve sample allows later examination when there is a complaint,
unexpected result, regulatory question or suspected packaging problem.
Section 111.83 provides a useful benchmark: retain a lot-identified
sample in the same or essentially equivalent protective container system
and keep at least twice the amount needed for all relevant specification
tests.

Custody controls still apply to reserves. Record:

• reserve sample ID;
• associated lot;
• quantity;
• container-closure system;
• storage location;
• access controls;
• retention period;
• every opening and withdrawal;
• remaining amount; and
• final disposition.

A reserve sample is not useful if its label falls off, its container
differs materially from the distributed package, it is opened repeatedly
without documentation or too little remains for meaningful analysis.

A 12-step chain-of-custody
review

Step 1: Match the package lot

Read the lot or batch code directly from the package. Do not start
with the filename of a downloaded COA.

Step 2: Identify the
product category

Determine whether the product is leaf, pure-leaf capsule, extract,
enhanced material, concentrated 7-OH or another manufactured
product.

Step 3: Confirm the lot
definition

Ask what quantity and containers the submitted sample represented. A
report should not be generalized beyond its sampling population.

Step 4: Identify the sampler

Record whether the sample was taken by the manufacturer, supplier,
independent sampler, retailer or laboratory employee. “Third-party
tested” does not answer this question.

Step 5: Review the
sampling procedure

Check selection points, increments, tool controls, composite
decisions and requested quantity.

Step 6: Verify the sample ID

The container, custody form, submission, lab accession and report
should be reconcilable.

Step 7: Review seal evidence

Confirm a unique seal or equivalent tamper-evident control, plus
condition at dispatch and receipt.

Step 8: Reconstruct transfers

Look for names or authenticated identities, dates, times, purpose and
condition at every handoff.

Step 9: Check shipping
conditions

Review tracking, transit time, packaging, leakage and any
scientifically required temperature control.

Step 10: Review laboratory
receipt

Confirm quantity, seal status, discrepancies, acceptance and
accessioning.

Step 11: Reconcile the final
report

Match product, lot, matrix, dates, methods, units, result version and
laboratory authorization.

Step 12: Preserve the
evidence package

Retain the approved report, custody form, photos, tracking, receipt
record, deviations, amendments and reserve-sample record under document
control.

Five fictional examples

These examples teach review logic. They do not describe real Kiody
lots or laboratories.

Example 1:
The accurate result from an unknown lot

A laboratory report lists “Green Leaf Powder” and an accession number
but no client lot. The website displays it beside a package marked
GL-260901.

Assessment: The report may accurately describe the
tested sample, but the public record does not prove it represents
GL-260901. Obtain the laboratory submission or a revised report linking
the accession to that lot. Do not fill the gap by renaming the PDF.

Example 2: The
intact seal on a biased sample

A supplier scoops powder from the top of one open bag in a 40-bag
shipment, seals it correctly and documents every transfer.

Assessment: Custody continuity may be strong, but
representativeness is weak. An intact seal does not correct biased
collection. Review the lot-wide sampling plan before accepting
conclusions about all 40 bags.

Example 3: The broken seal
at receipt

The laboratory records that seal S-10018 was torn and the outer
shipping box was crushed. The sample jar remained closed, and the lab
asks whether to proceed.

Assessment: Place the sample on hold. Evaluate what
testing is planned, whether substitution or contamination is plausible,
whether photos and tracking explain the damage, and whether recollection
is appropriate. If analysis proceeds, document the authorization and
qualification; do not erase the receiving observation.

Example 4:
The leaf COA applied to enhanced capsules

A component COA for plain botanical powder is posted for capsules
later produced with added extract.

Assessment: The component report does not represent
the enhanced finished batch. The product category, composition and
relevant analyte levels changed. Finished-batch sampling and appropriate
testing are needed.

Example 5: The amended result

A laboratory discovers that two client lot numbers were transposed
during report entry. Raw data and accession records are correct. The
laboratory issues an amended report with a revision date and reason.

Assessment: Preserve both versions in controlled
records, replace the public copy with the laboratory-issued amendment
and document the website change. Do not alter the original PDF
internally.

Twenty chain-of-custody
warning signs

1. The COA shows no lot or batch number.
2. The website filename contains a lot number that is absent from the
   report.
3. The package lot and report lot differ by a character with no
   controlled explanation.
4. No one can identify who collected the sample.
5. The supplier always chooses the submitted portion without a defined
   plan.
6. The sampler records no total lot size or container count.
7. A “composite” has no list of increments or locations.
8. Sample tools were used across product categories without documented
   cleaning.
9. Enhanced and plain products were sampled in the same dusty area
   without controls.
10. The container has no unique sample identifier.
11. The only label is on a removable lid.
12. The seal number is missing from the form.
13. The seal was broken, but no opening and resealing record
    exists.
14. Carrier tracking dates conflict with collection or receipt
    dates.
15. The laboratory recorded damage or leakage that the final review
    ignored.
16. A mismatch was corrected by overwriting the original entry.
17. The accession number cannot be linked to the client sample ID.
18. One COA is reused for later lots or different product formats.
19. An edited laboratory PDF has no laboratory-issued amendment
    history.
20. No reserve sample or investigation material remains when a complaint
    arises.

One warning sign does not automatically prove misconduct. It
identifies a question that should be resolved before relying on the
report.

Chain-of-custody record
template

Assignment and lot

• Record ID
• Request date
• Requester
• Product name
• Product category
• Manufacturer
• Supplier
• Supplier lot
• Internal lot
• Shipment or receiving number
• Total lot quantity
• Number and type of containers
• Physical location
• Quarantine or release status
• Tests requested
• Laboratory
• Required sample amount
• Required reserve amount
• Sampling-plan identifier and version

Collection

• Sampler name and authorization
• Collection date
• Start and finish time
• Sampling location
• Environmental observations
• Containers available
• Containers selected
• Selection method
• Increment locations and depths
• Individual or composite status
• Tool identifier
• Tool cleanliness or sterility status
• Gloves and protective controls
• Sample quantity
• Primary container type
• Sample ID
• Subsample or portion IDs
• Photographs
• Deviations and approvals

Protection and transfer

• Seal type
• Unique seal number
• Date and time sealed
• Person applying seal
• Seal photograph
• Storage condition before shipment
• Released by
• Released date and time
• Received by or carrier
• Transfer purpose
• Tracking number
• Secondary packaging
• Temperature control, if required
• Expected delivery date

Laboratory receipt and
report

• Receipt date and time
• Received by
• Seal condition
• Container condition
• Receipt temperature, if required
• Quantity received
• Discrepancies
• Acceptance status
• Authorized discrepancy resolution
• Laboratory accession number
• Storage location
• Date opened
• Opened by
• Preparation batch
• Analyst or internal custodian
• Report number
• Report version
• Report approval date
• Public posting or QR verification
• Reserve location and quantity
• Final disposition

The template is intentionally broad. A written procedure should
identify which fields are required for each product and test type.

Current 7-OH and derivative
note

As of September 3, 2026, the federal proceeding concerning 7-OH above
a specified threshold remains a proposal. HHS extended the comment
deadline through September 10, 2026. A proposal is not a final
scheduling order and should not be described as one.

A separate DEA order placed mitragynine pseudoindoxyl (MGPI), MGM-15
and MGM-16 temporarily in Schedule I effective August 26, 2026. Those
compounds should not be collapsed into the pending 7-OH threshold
proceeding. Product and sample custody involving controlled compounds
may require obligations beyond the general quality practices described
here.

For botanical-leaf samples, record the product form, manufacturing
history, method, result, units, reporting basis and reporting limit. A
bare “ND” entry without a stated analyte and reporting limit is not
enough to evaluate a threshold. Kiody does not sell concentrated
7-OH.

Frequently asked questions

1.
Does a COA prove that the tested sample came from my package lot?

Only when the report and supporting records reliably connect the
laboratory sample to that lot. A matching filename alone is not
sufficient evidence.

2. Is chain
of custody the same as a sampling plan?

No. The sampling plan explains how a representative portion should be
selected. Chain of custody documents what happened to the selected
material afterward. Both matter.

3.
Does an intact tamper seal prove the sample is representative?

No. It supports protection after sealing. It does not show that the
collector chose suitable locations or included the correct lot.

4. Who should collect a
kratom sample?

A trained, authorized person following a written procedure. Whether
that person works for the manufacturer, an independent sampler or the
laboratory should be disclosed and considered in the review.

5. Is
manufacturer-collected testing automatically invalid?

No. It has a different independence profile, but documented training,
randomized selection, controlled tools, seals and complete records can
still provide useful evidence. Marketing should accurately describe who
collected and who tested.

6. What is a laboratory
accession number?

It is the laboratory’s unique submission identifier. It should link
to, not replace, the commercial lot number.

7. Should the
sample container have the lot number?

Yes, directly or through a unique sample ID that securely links to a
custody record containing the lot. Using both is often clearer.

8. Is courier
tracking a complete chain of custody?

No. It documents carrier movement. Collection, sealing, release,
receipt condition, laboratory handling and report reconciliation still
need records.

9. Must
dry kratom powder be refrigerated for shipping?

There is no universal rule established by this guide. Conditions
should be based on the matrix, analytes, validated method and laboratory
instructions.

10. What happens if a seal
is broken?

The receiving party should document the condition and place the
sample on hold for evaluation. Recollection may be appropriate. If
testing proceeds, the decision and qualification should remain in the
record.

11. Can several
increments be combined?

Yes, when the sampling plan calls for a field composite. The record
should identify the source and amount of each increment and acknowledge
that compositing can conceal location-specific variation.

12.
Can one sample cover powder and capsules from the same leaf lot?

Not automatically. Encapsulation introduces a downstream batch, shell
or excipient considerations, fill variation and packaging controls.
Define what each test is intended to verify.

13. Can a
supplier COA replace receiving verification?

Not simply because it exists. Section 111.75 describes supplier
qualification, confirmation, method and result details, periodic
reconfirmation and quality-control approval for specified reliance
situations. Identity requirements and FDA’s kratom position must also be
considered.

14. Should a
public COA show custody signatures?

Not necessarily. Personal signatures and confidential operational
details can remain in controlled records. The public report should still
present enough identifiers to match the product, lot, laboratory and
report version.

15. What is a reserve sample
for?

It preserves lot-identified material for appropriate later
investigations or examinations. Its storage, quantity and withdrawals
should be controlled.

16.
Does ISO/IEC 17025 accreditation prove how the manufacturer sampled the
lot?

No. Accreditation can support laboratory competence within an
accredited scope. It does not automatically cover pre-laboratory
collection performed by a client or supplier.

17. Is
blockchain required for chain of custody?

No. A well-controlled paper or electronic system can be effective.
Technology does not correct inaccurate entries, biased sampling or weak
physical controls.

18. Does strong
custody prove a product is safe?

No. It supports the reliability of the sample history. Safety depends
on many additional factors and cannot be certified by one record, one
test or one COA.

Sources

1. FDA, 2026 Investigations Operations Manual, Chapter
   4—Sampling: https://www.fda.gov/media/166532/download?attachment=
2. FDA, Investigations Operations Manual index: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/investigations-operations-manual
3. FDA, ORA Laboratory Manual, Sample Management,
   ORA-LAB.5.8: https://www.fda.gov/media/73966/download
4. FDA, ORA Laboratory Manual, Chain of Custody—Sample
   Handling: https://www.fda.gov/media/74006/download
5. FDA, Private Laboratory Analytical Package
   Procedure: https://www.fda.gov/media/73540/download
6. eCFR, 21 CFR §111.75—determining whether specifications are
   met: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-E/section-111.75
7. eCFR, 21 CFR §111.80—representative samples: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-E/section-111.80
8. eCFR, 21 CFR §111.83—reserve samples: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-111/subpart-E/section-111.83
9. NIST, Chain of Custody definition: https://www.nist.gov/glossary-term/20076
10. NIST, Chemical Metrology—distinguishing measurement
    traceability from custody traceability: https://www.nist.gov/mml/csd/primary-focus-areas/chemical-metrology
11. FDA, FDA and Kratom: https://www.fda.gov/news-events/public-health-focus/fda-and-kratom
12. HHS, 7-OH threshold proceeding; comment-period extension
    through September 10, 2026: https://www.federalregister.gov/documents/2026/08/26/2026-17409/hydroxymitragynine-above-a-specified-threshold-in-schedule-i-extension-of-comment-period
13. DEA, temporary Schedule I placement of MGPI, MGM-15 and
    MGM-16: https://www.federalregister.gov/documents/2026/08/26/2026-17429/schedules-of-controlled-substances-temporary-placement-of-mitragynine-pseudoindoxyl-mgm-15-and