Kratom Consumer Advisory Council (KCAC) Position Statement About HART's New 'Animal Safety' Study
HART's Claim
On July 7, 2025, the HART published a press release with a link to a new study they believe shows that 7-hydroxymitragynine (7-OH) products are safe. As they state clearly in their press release:
'Adding to the body of evidence, a new 2025 study by East Tennessee Clinical Research gave dogs extremely high doses of 7-OH (up to 10 times the typical human dose). The results:
C. Michael White, Pharm.D., FCP, FCCP, FASHP, and KCAC chair, reviewed this 2025 pilot study in beagles and believes that three of these claims are untrue and that the study, in fact, shows serious health concerns for 7-OH and pseudo products.
No Neurological Harm was Found?
According to this paper, the original dose protocol was 10 mg twice daily for 7 days, 20 mg twice daily for 7 days, and then 40 mg twice daily for 7 days. However, when they gave the first beagle the very first 10 mg dose, the beagle had severe neurological issues (severe central nervous system excitation followed by severe central nervous system depression). The adverse event was severe enough that they scrapped the entire original dosing protocol and rewrote it to give the beagles only 1/20th the total daily dose (1 mg once daily for 7 days, 2 mg once daily for 7 days, and 4 mg once daily for 7 days).
The following is an excerpt from the report:
'15.7.1 Adverse events at a higher dose
The study reported herein was modified from an original protocol in which escalating treatments of 10, 20 and 40 mg of MGN were to be administered twice daily. After the first dose of 10 mg, one dog (XYL-4) exhibited marked central nervous system excitation, followed by marked CNS depression. This was classified as a Serious Adverse Event and its relation to treatment with IVP was deemed 'probable', so the trial was discontinued after only one dose and the protocol was amended to reflect the study design reported herein. The amended study design features lower doses and only once daily administration.'
HART's own scientists believed that 10 mg twice daily should have been safe, which is why it was the smallest dose that they intended to give the beagles. It was, in fact, not safe and suggests that HART scientists cannot actually predict the safety of their products in humans given the available data. Since HART's own scientists are touting this study as major proof of safety but did not mention this serious adverse event in their press release, it shows that they do not actually know what is in their own report and its serious potential health implications, or they are hiding this information from the public. Either reason is unconscionable and alarming for public health.
Please see Table 1 (attached) for the dosing schema they intended to give the beagles as evidenced by the excerpt from the report.
The Dose of 7-OH Given Was 10x the Human Dose?
According to the FDA, a dose of 1 mg in a beagle is the same as a 3 mg dose in a 60 kg human. Please see Table 3 (attached) which is the dose conversion table from their guidance.
Use the online calculator to perform the calculation yourself, in accordance with FDA guidance:
Even the 10 mg dose they intended to give (but could not because of the severe neurological issue) would have only been the equivalent of a 32 mg dose in humans.
There are products with 30 mg of 7-OH per serving in them now, and it is common to find 10–15 mg products. As such, the 1 mg, 2 mg, and 4 mg doses that they used are actually 3–5 times lower or similar to what is typically used in humans and clearly not 10x the human dose.
Please see the dosing screenshot (attached) for the dosing regimen they used in the beagle pilot study. 'SID' is a veterinary term for once daily.
The KCAC cautions consumers that rodent studies already found rapid tolerance develops with 7-OH, so giving 1 mg for 7 days and then 2 mg for 7 days, and then 4 mg for 7 days does not mean that the adverse effects found at the 4 mg dose would be the same if 4 mg were given up front to the beagles without getting them accustomed to the effects.
The Only Observed Effect Was Drooling at the Highest Doses?
This is a gross oversimplification of their data. The investigators said this about adverse events, as evidenced by this report excerpt:
'The frequency of Adverse Events was calculated as the total number recorded per group divided by the number of dogs in the group. The comparative frequency of AEs for the various groups were:
Thus, treatment with 7-OH MGN or Pseudoindoxl MGN was 2.66 and 2.53 times more likely to cause Adverse Events, respectively, compared to placebo-treated controls.
Five observations of drooling in two different dogs were considered probably associated with treatment. It is significant to note that all episodes of drooling appeared in dogs only after the daily dose was escalated to 4 mg.'
They found 2.7 times more oral-gastrointestinal adverse events when using 7-OH than when they used a placebo. The adverse events that they found can be seen in the 'Adverse Events Table' (attached) that was pulled from a data table in their report (Group 1 is 7-OH, Group 2 is mitragynine pseudoindoxyl, and Group 3 is a placebo).
While the investigators were able to say that the drooling with 7-OH was 'probably' related to the drug, there were other adverse events that occurred, such as unformed feces, mucus in the feces, blood in the feces, and vomiting, that were all 'possibly' related to 7-OH. The determination was never that it was 'doubtfully' related or 'unrelated.' By their own terminology, it is possible that 7-OH could be responsible for all those adverse events. One thing that strengthens the association is the difference in the number of animals with oral or gastrointestinal issues. Five of the 6 dogs (83.3%) receiving 7-OH had any oral-gastrointestinal adverse events versus only 1 of 4 placebo dogs (25%), a 3.3 fold increase.
Finally, many people may not know that new-onset drooling in dogs can be an early marker of sedation or drug toxicity. When unexplained excessive drooling occurs and there is a new drug or substance ingestion, it is advisable to contact a veterinarian. Remember, the investigators cut back the daily dose to 1/20th of what was originally intended (40 mg twice daily was the highest dose they wanted to give, but it would have been too toxic, and 4 mg once daily was the highest dose they did give). This suggests that at 4 mg, even after 14 days of acclimation and tolerance development, there may still be neurological effects as evidenced by the onset of drooling.
Conclusions
HART put out a press release that they know, or should know, contains three verifiable falsehoods (out of four total statements). This suggests that they are attempting to manipulate available data to create a narrative unaligned with reality. The truth is, there is insufficient evidence to suggest that 7-OH provides any benefits, and there are rodent studies that suggest it causes addiction, rapid tolerance, withdrawal, and respiratory depression (especially at higher doses). This beagle trial did not assess for addiction, tolerance, withdrawal, or respiratory depression and doesn't suggest safety for any of those outcomes of interest. This beagle study took blood and urine samples to assess for safety, but those results are not presented in the report that was released. This beagle study suggests that when doses on the upper end of what is recommended to consumers in 7-OH products are used, there could be severe neurological issues. Consumers have no limitations on what quantities they can purchase, so a consumer can readily purchase and consume a dose that is 10 times the suggested serving, and there is no healthcare professional to prevent it or counsel them against it. This is very risky for public health.
About Kratom Consumer Advisory Council (KCAC)
Kratom Consumer Advisory Council (KCAC) is an independent board made up of a clinician-scientist and consumers that uses the strongest available evidence to produce position statements that promote evidence-based policy. The KCAC is supported by the Global Kratom Coalition which advocates for regulations that protect consumers and curbs the sale of adulterated or synthetic products falsely marketed as kratom. For more information, visit globalkratomcoalition.org/kcac.
Media Contact
Dr. C. Michael White
[email protected]
###
SOURCE: Kratom Consumer Advisory Council (KCAC)
Copyright 2025 EZ Newswire
https://app.eznewswire.com/news/kratom-consumer-advisory-council-kcac-position-on-hart-animal-safety-study
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