A Sweeping Safety Claim Enters the Court Record
Botanic Tonics and the Global Kratom Coalition repeatedly tell the federal court that they supplied Utah regulators with 14 peer-reviewed, published clinical trials supporting Feel Free Classic and natural-leaf kratom.
The pleadings characterize that evidence broadly: plaintiffs say the studies establish that kratom leaf presents no significant or unreasonable risk of illness or injury when consumed by healthy adults according to label directions and across dosing levels.
Utah’s State Chemist Says He Reviewed All 14
Utah State Chemist Brandon Forsyth states under penalty of perjury that Botanic Tonics provided him with studies of 14 clinical trials concerning kratom and kratom/kava products.
That is Forsyth’s sworn assessment, not a judicial finding. But it creates a direct evidentiary dispute: the research plaintiffs present as establishing safety is characterized by Utah’s State Chemist as insufficient and methodologically problematic.
The Six-Day Problem
One of the studies in the record concerns repeated use of Feel Free over only six days. That provides controlled short-term information. By design, it cannot answer every question about months or years of repeated exposure.
The FDA Study: What Botanic Tonics Says
Botanic Tonics specifically relies on an FDA human kratom study and says it used the same kratom leaf used in Feel Free Classic and the company’s Natural Leaf Kratom capsules.
The pleadings characterize the study as revealing “no significant or unreasonable risk of illness or injury” across dosing levels.
The important question is whether the study itself made such a broad safety determination or whether the litigation draws a broader conclusion from a limited clinical experiment.
The FDA-Funded Study Was a Small Dose-Finding Experiment
The FDA-funded human study was a controlled single-dose pharmacokinetic/pharmacodynamic experiment designed to characterize exposure and effects across increasing doses and help inform later research, including research relevant to human abuse potential.
The FDA Study Found Adverse Effects
The study did not report a complete absence of adverse effects. Reported treatment-emergent events included nausea, vomiting, somnolence, dizziness, presyncope, anxiety, euphoric mood and irritability.
The investigators also concluded that nausea and vomiting appeared attributable to kratom exposure rather than simply the burden of swallowing capsules.
The Study Also Measured Abuse-Related Effects
The FDA-funded study found opioid-like pupillary constriction at higher doses. At 12 grams, subjects showed significantly greater ratings of drug liking and “high” than placebo.
Participants at higher doses also rated effects as similar to opioids and benzodiazepines. The investigators stated that some findings may be indicative of abuse potential and called for additional adequately powered research.
The Investigators Explicitly Warned About Sample Size
The published study cautions that its sample size was insufficient to thoroughly characterize the safety profile and that it was not powered to capture rare or infrequent adverse events.
The study’s value is not diminished by acknowledging its design. Evidence should be interpreted according to the question it was built to answer.
The Literature-Selection Question
Forsyth also criticizes how some supporting safety literature was assembled. His declaration points to an assessment that relied in part on literature supplied by Botanic Tonics’ Chief Science and R&D Officer Ramsey Atallah and attorney Jonathan Emord, along with additional literature selected to support claims under review.
That does not automatically invalidate an assessment. It creates a legitimate methodological question: was the evidence gathered through a systematic search designed to capture favorable and unfavorable findings, or primarily assembled to support a predefined regulatory position?
Industry Involvement Does Not Automatically Invalidate Research
A study can be scientifically valid even when a manufacturer supplies test material, employs an author or supports research. Those facts alone do not prove that results are false.
They do make transparent disclosure and careful interpretation important. Readers should be able to distinguish independent evidence from company-involved research and understand the sponsor’s role in study design, product supply, analysis and publication.
How to Audit the “14 Studies” Claim
The strongest way to resolve the dispute is not to count citations. It is to audit the studies one by one.
- Study design and control group
- Number and characteristics of participants
- Single-dose versus repeated dosing
- Total exposure duration
- Kratom preparation and alkaloid content
- Whether Feel Free itself was tested
- Primary and secondary endpoints
- Adverse events
- Dependence and withdrawal assessment
- Abuse-potential measures
- Funding, product supply and conflicts
- What the authors actually concluded
What the Court Record Does — and Does Not — Establish
- It does show that Botanic Tonics and GKC repeatedly rely on a 14-study safety claim.
- It does show that Utah’s State Chemist says he reviewed those studies and considered them biased and incomplete.
- It does show that the Feel Free repeated-dose study discussed in the record lasted six days.
- It does show that plaintiffs’ own expert says six days is not a long-term addiction study.
- It does not establish that the 14 studies are scientifically worthless.
- It does not establish that industry involvement automatically invalidates a publication.
- It does not establish that FDA approved kratom or Feel Free, or determined either proven safe for long-term use.
The Question for Policymakers
When lawmakers are told that clinical trials establish kratom safety, the useful response is not to argue over the citation count.
Read the Source Record
The combined federal court documents used for 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.