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The Utah Files · Part IV

What’s Actually in the Bag?

The PACER exhibits move beyond arguments about pharmacology. They contain laboratory identity reports, out-of-specification findings, fungal structures and unusually specific descriptions of how commercial “natural leaf” kratom is processed before sale.

Case No. 2:26-cv-00267-HCN-DBP · U.S. District Court, District of Utah
2Botanical samples with OOS identity findings
HPTLCFurther identity testing recommended
99.99%Bacterial reduction claimed for processing
ChlorinatedHeated water described in leaf processing

The Court Record Contains Actual Product-Quality Evidence

Much of the Utah litigation concerns constitutional law, controlled substances and competing interpretations of kratom science. Buried in the exhibits is something more concrete: laboratory work on the plant material itself.

Botanic Tonics submitted botanical microscopy reports from Alkemist Labs for kratom leaf powder identified as product BTI-003. Two tested lots generated out-of-specification identity findings.

The important finding is not that the laboratory proved the material was “fake kratom.” It did not. The important finding is that the initial botanical identity assessment was not satisfactory and the laboratory recommended additional testing.

Lot 29230: “Not Characteristic of Mitragyna speciosa Leaf”

The Alkemist certificate identifies the sample as Kratom Leaf Powder, lot 29230, submitted by Botanic Tonics. The microscopy report describes plant structures and also notes septate hyphae with chlamydospores that were not consistent with the references used for comparison.

The laboratory concluded that the sample “indicates presence but is not characteristic of Mitragyna speciosa leaf.”

An out-of-specification report was generated — OOS-10526 — and the laboratory recommended further identity testing by HPTLC.

What this means: The report indicates that microscopy alone did not produce a satisfactory botanical identity result for that sample. The report itself calls for follow-up testing rather than declaring that the material was definitively not kratom.

A Second Lot Raised the Same Type of Question

The PACER materials contain a second Alkemist microscopy certificate involving another Botanic Tonics kratom leaf lot. That sample likewise generated an OOS identity report and a recommendation for further HPTLC testing.

The presence of more than one OOS result makes the follow-up especially important.

The unanswered question is simple: what happened after the OOS reports?
  • Was confirmatory HPTLC performed?
  • What were the final identity results?
  • Were the lots accepted or rejected?
  • Was the supplier investigated?
  • Was any affected material used in commercial production?
  • Was any affected material used in research or clinical-study product?

The Reports Also Describe Fungal Structures

The microscopy report for lot 29230 describes septate hyphae with chlamydospores and states that those structures were not consistent with the botanical references used in the analysis.

Other testimony in the litigation discusses fungal organisms as one possible mechanism relevant to chemical changes in kratom alkaloids. But the laboratory report itself should not be stretched beyond what it says.

Evidence boundary: The microscopy report describes observed fungal structures. It does not, by itself, establish a particular fungal species, prove a health hazard, or prove that those structures caused formation of mitragynine pseudoindoxyl.

What Does “Natural Leaf” Processing Actually Mean?

The amended pleadings contain a detailed description of commercial kratom processing. Botanic Tonics and GKC argue that ordinary Good Manufacturing Practice-compliant processing uses heated chlorinated water to wash and sanitize or pasteurize pulverized kratom leaf.

The plaintiffs say this process is used to kill 99.99 percent of bacteria in the hydroscopic plant material.

According to the plaintiffs’ own pleading, commercial natural-leaf kratom may require substantial microbial-control processing before it reaches a retail bottle or capsule.

The Plaintiffs Say the Treatment Changes the Material

The pleading says chlorinated-water sanitization oxidizes organic molecules and inactivates enzymes. It also says the process leaves residual chlorine in finished kratom products sold at retail.

Botanic Tonics separately maintains that chlorinated byproducts are controlled below applicable limits. Nothing in these filings establishes that consumers are being harmed by chlorine.

The significance is narrower: the court record itself describes “natural leaf” as plant material that may undergo heat, chlorinated-water treatment, microbial reduction and chemical oxidation during commercial processing.

Why Bacteria Became a Legal Issue

Botanic Tonics and GKC use the processing evidence to attack Utah’s statutory requirements. They argue that restrictions on nonkratom substances and processing could interfere with methods they consider necessary to render leaf free of harmful bacteria and comply with manufacturing requirements.

In other words, the bacterial-control evidence was submitted by the plaintiffs to support their case against Utah — not as an admission that their finished products are microbiologically unsafe.

Context matters: The plaintiffs’ position is that proper processing improves safety. The public-interest question is what those processing requirements reveal about the raw botanical supply and how regulators verify that appropriate controls were actually performed.

The Supply-Chain Questions Are Bigger Than One Company

Botanical identity, microorganisms, storage conditions, oxidation and alkaloid variability are not merely branding issues. They determine whether the material in a finished product is what the label says it is and whether its chemistry changes between harvest and consumption.

The PACER record suggests several basic questions regulators could ask of any commercial kratom processor:

  • How is incoming plant material authenticated?
  • What happens when identity testing generates an OOS result?
  • What confirmatory method is required before a lot is released?
  • How are microbial contaminants controlled?
  • How are suppliers qualified and audited?
  • Are alkaloids measured before and after processing?
  • Are MP and 7-OH measured after storage as well as on receipt?
  • Are rejected lots documented and traceable?

The MP Question Returns

Part I of The Utah Files examined plaintiffs’ assertion that MP is endogenous to kratom. The processing evidence creates another unanswered analytical question because the pleadings say commercial sanitization oxidizes organic molecules while other material in the case discusses oxidation as relevant to MP formation.

Does MP concentration change between incoming raw leaf, sanitized leaf, stored material and the finished retail product?

The PACER record reviewed here does not answer that question. A properly controlled paired analysis could.

What the Court Record Does — and Does Not — Establish

  • It does show that Botanic Tonics submitted kratom samples that generated botanical identity OOS reports.
  • It does show that further HPTLC identity testing was recommended.
  • It does show that fungal structures were observed in microscopy.
  • It does show that plaintiffs describe heated chlorinated-water processing as part of commercial microbial control.
  • It does show that plaintiffs say the process oxidizes organic molecules and leaves residual chlorine.
  • It does not establish that the OOS material was sold to consumers.
  • It does not establish that the samples were definitively not Mitragyna speciosa after all confirmatory testing.
  • It does not establish that detected fungal structures caused consumer harm.
  • It does not establish that chlorinated-water processing makes finished kratom unsafe.

The Missing Records Matter

The most valuable next documents would be the records that close the quality-control loop:

  • HPTLC results following OOS-10526 and the companion OOS report
  • Final lot-disposition records
  • Supplier qualification and corrective-action records
  • Microbial test results before and after processing
  • Original analytical reports for MP, 7-OH and mitragynine
  • Paired alkaloid testing across processing and storage
  • Records identifying whether the tested lots were used commercially or in research
An OOS report is the beginning of a quality investigation, not the end. The decisive evidence is what the manufacturer did next.

Why This Matters for Lawmakers

Kratom legislation often focuses on percentage limits, labels and age restrictions. The Utah record illustrates a more basic regulatory problem: identity and process control come before the number printed on a label.

A statutory alkaloid limit has little value if regulators cannot verify botanical identity, sampling, analytical sensitivity, microbial control, lot disposition and changes that occur during processing or storage.

Before deciding what a legal kratom product may contain, lawmakers may first need to decide how anyone will reliably determine what is actually in the bag.

Read the Source Record

The combined federal court documents used for all four parts of The Utah Files are available for direct review.

Case: Botanic Tonics, LLC and Global Kratom Coalition, Inc. v. Pehrson et al., Case No. 2:26-cv-00267-HCN-DBP, U.S. District Court for the District of Utah.