Global Kratom Coalition Applauds FDA Action Against Hydroxie and Expects Broader Crackdown Against Synthetic Opioids Like 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 globalkratomcoalition.org.
Media Contact
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SOURCE: Global Kratom Coalition
Copyright 2025 EZ Newswire
https://app.eznewswire.com/news/global-kratom-coalition-applauds-fda-crackdown-on-synthetic-opioids
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