Latest news with #GlobalKratomCoalition
Associated Press
16-07-2025
- Health
- Associated Press
Global Kratom Coalition Applauds FDA Crackdown on 7-Hydroxymitragynine Products
FDA action draws sharp distinction between natural kratom leaf and dangerous synthetic 7-OH products fueling the gas station heroin crisis The Global Kratom Coalition (GKC) today applauded the U.S. Food and Drug Administration (FDA) for issuing warning letters to firms marketing '7,' a potent and dangerous novel product that is being illegally sold across the country. (See FDA press release here ). This decisive action by the FDA draws a much-needed line between responsibly used, traditionally consumed kratom leaf and the synthetic or highly concentrated products, like 7, that pose a clear threat to public health. 'The FDA's move is a critical step in protecting consumers,' said Matthew Lowe, Executive Director of the Global Kratom Coalition. 'We have long warned that products like 7 are driving harm and putting lives at risk. The FDA's action sends a clear message: these dangerous products have no place in the marketplace.' While 7-hydroxymitragynine (7-OH) is a naturally occurring alkaloid in kratom leaf, it is present only in trace amounts in its natural state. The products targeted by the FDA are chemically manipulated to contain dangerously high levels of semi-synthetic 7-OH, significantly increasing the potential for harm. These products have been linked to serious adverse events and are highly addictive. The Global Kratom Coalition supports rigorous enforcement against these deceptive and harmful products and urges lawmakers and regulators to distinguish clearly between natural kratom and synthetic or adulterated substances. 'The future of kratom depends on responsible regulation,' Lowe added. 'We commend the FDA for taking action today and urge continued vigilance in order to protect consumers.' 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
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
Associated Press
13-03-2025
- Health
- Associated Press
Global Kratom Coalition Supports Nebraska's Kratom Consumer Protection Act (LB 230)
GKC celebrates the closing of loopholes to protect consumers from dangerous 7-hydroxymitragynine products mislabeled as kratom LOS ANGELES, CA, March 12, 2025 (EZ Newswire) -- The Global Kratom Coalition (GKC) has been working with the Nebraska legislature since early 2024 in support of Nebraska's Legislative Bill 230, the Kratom Consumer Protection Act, introduced by State Senator Bob Hallstrom (District 1, Lincoln-NE). This proposed legislation aims to establish common-sense regulations that will enhance consumer safety and promote responsible manufacturing, marketing, and sale of kratom products in Nebraska. Among the bill's key provisions are measures designed to protect consumers, including prohibiting the marketing of kratom products designed to appeal to children, prohibiting the sale of kratom products to individuals under 21 years of age, and requiring product labeling that discourages use by women who are pregnant or breastfeeding. One of the most important regulations in LB 230 ensures that any level of 7-hydroxymitragynine (7OH) does not exceed 2% of the overall alkaloid composition of the product. This safeguard effectively eliminates the risk associated with synthesized high-potency isolate 7OH products (known as '7') that are proliferating across the state. Unlike natural-leaf kratom products, synthesized products like '7' contain eight unknown compounds and 100 times more 7OH than true kratom products. These new, untested products have no scientific data to support their use. They are being marketed as a cure for the opioid crisis when in fact they are fueling their own addiction and health crises through their unfettered access across the nation. Organizations such as the Holistic Alternative Recovery Trust (HART) are attempting to either kill kratom regulations bills or strike out core consumer safety provisions that protect consumers from these dangerous synthetic products. They have no data to support their position and contradict opinions expressed by the leading kratom scientists in the US who say '7" products should not be considered kratom. Proponents of '7" are not making factual or credible claims about the safety and efficacy of these products. HART's aim to promote '7" products comes at the risk of consumers. During a press event held by HART in October 2024, panel members advocated for the regulation of 7OH products as if they were natural kratom, making unapproved new drug claims. 'When organizations like HART make unapproved claims that 7OH products are intended for pain relief or opioid use disorder, they are promoting these products as drugs as defined by the FDA,' said Matthew Lowe, Executive Director of the Global Kratom Coalition. 'Without prior FDA approval, such products are unlawful to sell.' The Global Kratom Coalition has been actively involved in encouraging the development of LB 230 since its introduction on January 14, 2025, working alongside stakeholders to ensure that consumers have access to safe, natural kratom products and are protected from dangerous synthesized alternatives. 'Our goal is to support legislation that empowers consumers to make informed decisions while maintaining continued access to responsibly manufactured kratom products,' Lowe added. 'Nebraska's Kratom Consumer Protection Act is a significant step forward in achieving those goals.' The Global Kratom Coalition urges lawmakers and stakeholders to support LB 230 and reject any attempts to weaken the bill's vital protections for consumers. About the 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 Patrick George
Associated Press
09-03-2025
- Business
- Associated Press
Global Kratom Coalition Applauds Utah Legislature's Decision to Suspend HB 509; Encourages UDAF's Drive To Stringently Enforce Current Kratom Regulations
LOS ANGELES, CA, March 8, 2025 (EZ Newswire) -- The Global Kratom Coalition (GKC) commends the Utah Legislature for its decision to allow House Bill 509 (HB 509) to expire without moving to a floor vote, thereby avoiding onerous and vague pre-market approval requirements on a segment of kratom products in Utah. While the bill authors should be commended for their desire to strengthen Utah's kratom regulations, HB 509 proposed pre-market approval requirements that go far beyond Federal regulations. This action would have impeded consumer access to demonstrably safe products and created a costly and overreaching bureaucracy. 'We appreciate the desire for the bill's sponsors to address safety concerns. However, suspending HB 509 represents a positive outcome for Utah consumers and the dietary supplement industry at large,' said Matthew Lowe, Executive Director of the Global Kratom Coalition. 'Enacting pre-market approval measures would have been contrary to federal law, specifically the Dietary Supplement Health and Education Act (DSHEA) of 1994, marking an unprecedented regulatory paradigm.' With the failure of HB 509, the GKC is encouraged by the Utah Department of Agriculture's (UDAF) push to strengthen enforcement of the existing Kratom Consumer Protection Act (KCPA) through ensuring that all kratom products sold in the state are registered with UDAF and highly potent synthetic products like '7' are not sold in the state. This legislation, already in place, provides a framework for ensuring the safety and quality of kratom products. By enhancing enforcement efforts, UDAF can effectively weed out bad actors while supporting responsible businesses that comply with state regulations. Funding for enforcement remains an issue in Utah. A recent survey showed that 64 percent of the kratom products sold in Utah are not registered with UDAF. Strong compliance through enforcement will ensure that all compliant kratom companies are properly registered with the state and will therefore pay their requisite registration fees which will in turn help better fund the program. Beyond this, the GKC fully supports the implementation of a tax on kratom products that would give the necessary funding to UDAF to help them better regulate the kratom marketplace. The GKC will continue to work with the legislature to consider a tax in coming legislative sessions. 'The marketplace in Utah will be made safer through enforcement of existing laws, which serve to protect consumers from harmful products like those containing elevated levels of 7-hydroxymitragynine,' said Lowe. 'By focusing on strict adherence to the KCPA and requiring product registration, along with comprehensive labeling and safety standards, Utah can maintain a safe and regulated kratom marketplace that meets the needs of consumers.' The Global Kratom Coalition remains committed to working collaboratively with legislators and stakeholders to promote sensible regulation that ensures public health and safety while preserving access to kratom for those who rely on it. About the 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 SOURCE: Global Kratom Coalition
Associated Press
07-03-2025
- Business
- Associated Press
Global Kratom Coalition Applauds ReFuel Market for Removing Dangerous 7-Hydroxymitragynine Products
GKC calls on 7-hydroxymitragynine ('7') product manufacturers to stop marketing products in states where they are Illegal LOS ANGELES, CA, March 7, 2025 (EZ Newswire) -- The Global Kratom Coalition (GKC) commends ReFuel Market for its promise to activist David Bregger to remove the prohibited product 7-Hydro from its Texas retail locations. The GKC also commends ReFuel for its pledge to eliminate synthetic 7-hydroxymitragynine products (also called '7') in other states where the company does business. The GKC's recognition comes in response to a recent exposé by Houston Chronicle columnist Chris Tomlinson, highlighting the proliferation of illegal 7 products in Texas. In his column, Tomlinson specifically named ReFuel Market as a retailer selling products branded 7-Hydro marketed by The Collective Group, LLC (doing business as Real Botanicals), manufactured by Charlotte Extraction Labs LLC in Pineville, NC. A 'secret shopper' investigation conducted by the Global Kratom Coalition—a central part of the story—confirmed the sale of these dangerous products at multiple ReFuel locations. ReFuel's decision follows a call to action from activist David Bregger, who is dedicated to addressing the dangers of mislabeled and highly potent synthetic substances falsely marketed as kratom. Bregger, a retired businessman turned activist, has made it his mission to eliminate illegal access to dangerous products like 7 after his own son passed away due to complications involving unlabeled, highly potent substances. Concerned that a reputable retailer like ReFuel was selling 7 products, Bregger contacted ReFuel CEO Mark Jordan on February 26. Just one day later, Jordan responded positively with a commitment to remove these products from Texas locations, with a full nationwide removal to follow. This shows ReFuel's and Jordan's commitment to ensuring their customers' well-being and safety. 'This is a significant victory for consumer safety and a testament to the power of advocacy and investigative journalism,' said Matthew Lowe, Executive Director of the Global Kratom Coalition. 'ReFuel Market should be commended for recognizing the dangers of these products and taking swift action to remove them. Their leadership sets a precedent for other retailers, manufacturers, and law enforcement to follow.' Products known as 7 are often deceptively branded as kratom and are synthetic derivatives that pose serious risks to consumers. Unlike natural kratom, which is derived from plant leaves and contains a spectrum of naturally occurring alkaloids, these synthetic compounds are far more potent, highly addictive, and associated with severe health risks. Many state laws, including Texas, limit the amount of 7-hydroxymitragynine in kratom products to 2% or less of total alkaloids to prevent dangerous, adulterated substances from being marketed as kratom. Leading scientists have warned that synthetic 7 products exceed these limits, posing serious risks to consumers. The Global Kratom Coalition urges other retailers to follow ReFuel's example and remove these hazardous products from their shelves. Additionally, manufacturers like Charlotte Extraction Labs must cease selling 7 products in states where they are prohibited. In states that have banned these products, the Attorney General must enforce the law to prevent further harm to consumers. 'Whilst this development marks a major step forward, the fight against illicit 7 products is far from over,' said Lowe. 'GKC will continue to call for law enforcement and responsible retail practices to ensure that what is sold to the public is both legal and safe.' About the Global Kratom Coalition
