Illegal Drug Manufacturers Cook Up Fake Studies to Promote Dangerous Gas Station Heroin Products as Safe

Associated Press

11-07-2025

Pilot study of 7 and Pseudo in dogs commissioned by leading manufacturer illuminates significant public health concerns with synthetic drugs
The Stop Gas Station Heroin coalition reviewed the beagle study commissioned by CBD American Shaman, a Missouri-based company that reports generating the majority of its revenue from the sale of '7' products in over 200 retail locations, to evaluate the effects of escalating oral doses of their formulations of 7 (semi-synthetic 7-hydroxymitragynine), and Pseudo (semi-synthetic mitragynine pseudoindoxyl).
Commissioned to support an Investigational New Drug (IND) submission, the study's clear conflicts of interest are as alarming as its findings. Consider that CBD American Shaman, the sponsor of the research, has falsely marketed and sold these products as dietary supplements since 2022. Moreover, the study was released by the Holistic Alternative Recovery Trust (HART), an advocacy group comprised of members with a vested interest in 7-OH products.
This study raises serious concerns about the safety of 7 and Pseudo products, especially with regard to CBD American Shaman's marketed 'serving size' of 7.5 mg per serving, or half a tablet. More concerning is that in reality users consume significantly greater amounts of these products, and misuse risks include tolerance and addiction.
Critically, the study's findings suggest that doses of more than 0.3 mg exceed a conservative threshold for human safety. This figure is based on adverse effects observed in dogs at 10 mg doses, scaled to a human-equivalent dose using FDA-recommended methods.
In other words, CBD American Shaman's marketed serving size is more than 25 times greater than what could be considered reasonably safe based on the study's own preclinical data, and many more times greater if measured against normal consumption of these products.
Lastly, what HART is ignoring, irrespective of the science they put forward, is that 7 and Pseudo have been chemically formulated and put into the market with the intent to cure, treat and mitigate disease; that is in relation to chronic pain, and opioid use disorder. Despite marketing their products as natural botanicals, they are producing unapproved new pharmaceutical drugs, which is illegal.
In order to protect Americans, they should be conducting rigorous peer reviewed science that is published in a journal and vetted as a part of a robust IND submission that proves the efficacy and safety of 7 and Pseudo in comparison to the prescription drugs they are attempting to mimic. Without this critical research and approval from the FDA for prescribed use of 7 and Pseudo, these products should not be on the market.
The study's design, results, and implications are expanded upon below:
The original study design sought to give 10, 20, 40 mg of 7-OH or mitragynine psuedoindoxyl twice daily for 7 days for beagles ranging from 8–10.2 kg. However, at the lowest dose of 10 mg, a Serious Adverse Event (SAE) occurred causing the study to be halted).
What does this mean?
After the SAE, the sponsor adjusted its protocol to 1/10 of the original doses (1, 2, 4 mg per day in dogs), which is 1/20 of the daily dose. However, even at doses at 1 mg, 2 mg and 4 mg per day, adverse events (AEs) were still 2.5–2.7x more common than placebo. Specific AEs include GI disturbances, including blood and mucus in feces. All episodes of drooling appeared in dogs only after the daily dose was escalated to 4 mg.
What does this mean?
Missing pieces in research design and unfinished reports:
The presented study of 7 and Pseudo in dogs was incomplete, missing key safety endpoints, and inappropriately designed to assess safe use of the test articles. Some of these are described below
In Summary
The study is incomplete, shows significant public health risk with these products, and it doesn't justify extrapolating to humans to establish the safety of 7 or Pseudo, especially when:
Final Thoughts
What HART is ignoring, irrespective of the science they put forward, is that 7 and Pseudo have been chemically formulated and put into the market with the intent to cure, treat and mitigate disease — namely chronic pain and opioid use disorder. They have intentionally produced a novel drug and are currently marketing it without FDA approval, which is a clear violation of federal law. They should be doing more science as a part of a robust Investigational New Drug (IND) and New Drug Application (NDA) submission that not only proves the efficacy and safety of 7 and Pseudo but also shows that they are better than the drugs they seek to replace (Oxycontin, Percocet, etc.). Until such time that they have done this and gained approval from the FDA for prescribed use of 7 and Pseudo, these products should not be on the market, and should certainly not be available for $6 a pill at your local smoke shop or convenience store.
To learn more about Stop Gas Station Heroin and its mission, navigate to stopgasstationheroin.com.
Sources
[1] Human Equivalent Dose (HED) = Animal Equivalent Dose (AED) x 0.54. This is based on conversion mentioned in study design and also standard dose conversion.
About Stop Gas Station Heroin
Stop Gas Station Heroin is a national coalition that aims to educate consumers about harmful synthetic drugs and advocate for smart regulation that distinguishes between legitimate, natural botanicals and dangerous, synthetic drugs, combined with enforcement of current federal laws around unapproved drugs. To learn more, navigate to stopgasstationheroin.com.
Media Contact
Colby Wilson
[email protected]
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SOURCE: Stop Gas Station Heroin
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