Latest news with #7hydroxymitragynine
Associated Press
a day ago
- Health
- Associated Press
Kratom Consumer Advisory Council (KCAC) Position Statement About HART's New 'Animal Safety' Study
Kratom Consumer Advisory Council (KCAC) today released a position statement about Holistic Alternative Recovery Trust (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 Media Contact Dr. C. Michael White [email protected] ### SOURCE: Kratom Consumer Advisory Council (KCAC) Copyright 2025 EZ Newswire
Associated Press
03-07-2025
- Health
- Associated Press
Global Kratom Coalition Applauds FDA Action Against Hydroxie and Expects Broader Crackdown Against Synthetic Opioids Like 7
FDA action aligns with a growing chorus of scientists, public health experts, and advocates warning against the public health risk associated with the proliferation of 7 The Global Kratom Coalition (GKC) today commended the U.S. Food and Drug Administration (FDA) for issuing a comprehensive and forceful warning letter to Hydroxie, LLC, a seller of synthetic 7-hydroxymitragynine (otherwise known as '7') products falsely marketed as dietary supplements, shots, and drink mixes. The GKC hailed the move as a critical step in addressing these products that masquerade as natural dietary supplements but are actually unapproved new drugs. 'This warning letter is a major step in a broader effort to remove dangerous '7' products from store shelves and online marketplaces,' said Walker Gallman, Legislative Director of the Global Kratom Coalition. 'These actions should protect consumers and safeguard the integrity of the dietary supplement marketplace. It should result in a cascade of warnings to other 7 makers.' In the June 25, 2025, letter , the FDA identified multiple violations of the Food, Drug, and Cosmetic Act, citing Hydroxie's products as both unapproved new drugs and adulterated food. The FDA noted that Hydroxie's 7 products—including its 'Hydroxie 15mg 7-OH Tablets,' 'Hydroxie Red Shots,' and 'Hydroxie 7-OH Drink Mix"—are marketed with drug claims and contain an ingredient not generally recognized as safe. 'Your Hydroxie 15mg 7-OH Tablets, Hydroxie Red 15mg Tablets... are drugs as defined by section 201(g)(1) of the FD&C Act... because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,' the FDA stated in the letter. 'Based on our review... the use of 7-OH in conventional food does not satisfy the criteria for GRAS status... [and] raises serious concerns about potential harm associated with 7-OH,' the agency warned. 'This is a watershed moment,' said Gallman. 'The FDA has now publicly and definitively recognized that products like Hydroxie's, which are made up of synthetically boosted and highly concentrated levels of 7-hydroxymitragynine, are deceptively marketed as dietary supplements or conventional foods and are illegal. They are not kratom products; they are not dietary supplements; they are not legal; they are unapproved drugs and adulterated foods masquerading as legal, natural products.' FDA Warning Letter Addresses Persistent 'Bad Actors' Damaging Industry The GKC has long warned that certain actors in the marketplace are undermining public trust in the dietary supplement industry by selling synthetically enhanced or adulterated 7 products, often under the guise of 'all natural' or 'dietary supplement' or as 'kratom'. However, these products are marketed by the companies that sell them and the advocacy organizations that support them ( Holistic Alternate Recovery Trust (HART) and 7-Hope Alliance ) as drugs to treat chronic pain and opioid use disorder. The FDA's letter made clear that: 7 has not been evaluated by the FDA for safe use. Without formal safety evaluation, consumers are left exposed to unknown risks from products that have never undergone rigorous scientific review. The FDA has received adverse event reports associated with 7. Reports of harm linked to 7 include serious side effects such as liver toxicity, seizures, and respiratory issues, underscoring the need for immediate regulatory scrutiny. 7 has opioid-like effects and poses unique safety concerns. Because concentrated, synthetic 7 is a novel, potent opioid receptor agonist, its presence in unregulated consumer products raises red flags about addiction, misuse, and overdose. 'We urge the FDA and state regulators to continue down this path,' said Gallman. 'The longer these products are on the market, the greater the threat to public safety.' A Growing Chorus of Concern About Synthetic 7-Hydroxymitragynine Products The FDA warning letter also adds to a growing chorus of scientists, researchers, and industry stakeholders who have issued concerns about 7 products. In reaction to the FDA warning letter on social media, Dr. Christopher R. McCurdy, PhD, from the University of Florida College of Pharmacy said , 'The FDA is taking action on semi-synthetic kratom alkaloid derivatives, and this is exactly what we count on the FDA to do! These non-kratom products need to be removed from the market as they are no different from the many synthetic cannabinoids that made up 'spice' and caused harm to many … These novel chemicals synthesized from kratom extracts are potent opioids and a public health threat as currently marketed. They might be beneficial if pursued through the same pathways that all novel drugs gain approval.' In a statement released last week, Dr. C. Michael White, Pharm.D., FCP, FCCP, FASHP, a pharmacist, distinguished professor of pharmacy practice at the University of Connecticut School of Pharmacy, and Kratom Consumer Advisory Council chair said: 'Selling potent opioid receptor-stimulating 7 products in gas stations, convenience stores, and smoke shops in unlimited quantities within arm's reach of candy bars and energy drinks is a public health recipe for disaster. It allows a whole new generation of consumers to potentially get hooked on opioids, and we know where that leads.' In late 2024, leading kratom researchers at Johns Hopkins University and the University of Florida issued urgent warnings about proliferation of 7 products and for its potential for abuse, dependence, severe withdrawal , and even respiratory depression, dangers that run directly counter to it being marketed as a treatment for opioid addiction. GKC Committed to Transparency and Science The Global Kratom Coalition will continue to encourage and support federal and state regulators to investigate vendors who make false or misleading claims about their products, particularly those promoting unapproved drugs disguised as dietary supplements. About Global Kratom Coalition The Global Kratom Coalition is an alliance of kratom consumers, experts, and industry leaders dedicated to protecting access to kratom while advancing scientific research, driving consumer education, and developing robust regulations to protect consumers. For more information, visit Media Contact Patrick George +1 916-202-1982 [email protected] ### SOURCE: Global Kratom Coalition Copyright 2025 EZ Newswire
