Latest news with #kratom
Bloomberg
15 hours ago
- Health
- Bloomberg
FDA Is Looking for Expanded Power to Crack Down on Illegal Vapes
The Food and Drug Administration is taking a closer look at kratom extracts and preparing to ask Congress for expanded authority to shut down illegal vaping imports, according to the agency's head. In an interview, FDA Commissioner Marty Makary said that the US is essentially wide open to shipments of dangerous products including unauthorized vapes as well as an opioid-like substance found in potent kratom extracts. Another product of concern is tianeptine, which has been dubbed 'gas station heroin' and is available at convenience stores nationwide.
Reuters
4 days ago
- Health
- Reuters
National Consumer Alert on 7-OH Products Posing Significant Dangers
WASHINGTON, DC, July 18, 2025 (EZ Newswire) -- American Kratom Association (AKA), opens new tab is issuing a national consumer alert to warn consumers, retailers, and distributors of the serious health risks posed by products that contain dangerously high levels of 7-hydroxymitragynine (7-OH) — a powerful, highly psychoactive compound that is not naturally present in kratom leaf in any meaningful amount. The warning letters appropriately include 7-OH + pseudoindoxyl products that are an enhanced manipulation of the naturally occurring kratom compounds. The U.S. Food and Drug Administration (FDA) has recently issued multiple warning letters to companies selling these adulterated and illegal products, making it unequivocally clear: 7-OH products are unsafe, misleadingly marketed, and violate federal law. Why Consumers Should Be Concerned Retailers and Manufacturers Beware The AKA applauds the FDA's long-overdue action to protect consumers and remove these hazardous products from the marketplace. For years, AKA has advocated for commonsense regulations through state-level Kratom Consumer Protection Acts (KCPAs) that clearly prohibit dangerous alkaloid manipulation, including limits on 7-OH to no more than 2% of total alkaloid content—a threshold that corresponds with less than 1 mg per serving. What Consumers Can Do Additional Resources The Bottom Line: If it's not natural kratom, it's not kratom. About American Kratom Association (AKA) American Kratom Association (AKA) is a consumer-based, nonprofit organization, focused on furthering the latest science as guidance for kratom public policy. AKA works to give a voice to millions of Americans by fighting to protect their rights to access safe and natural kratom. For more information, visit and learn more at Media Contact Mac Haddowpress@ ### SOURCE: American Kratom Association (AKA) Copyright 2025 EZ Newswire See release on EZ Newswire
Associated Press
5 days ago
- Health
- Associated Press
Kratom Consumer Advisory Council (KCAC) Releases White Paper Debunking Claims on Safety of '7' Products
New analysis calls out misinformation, urges public health protections from dangerous 7-hydroxymitragynine (7-OH) formulations Kratom Consumer Advisory Council (KCAC) today released a comprehensive white paper challenging recent claims that products containing isolated 7-hydroxymitragynine (also known as '7') are safe for widespread, uncontrolled consumer use. The white paper, " Have '7' Products with 7-Hydroxymitragynine (7-OH) Been Proven to Be Safe? " directly refutes assertions made in a July 7 press release by the Holistic Alternative Recovery Trust (HART), which KCAC says misrepresented findings from a report HART itself commissioned from healthcare consulting firm Marwood Group. KCAC Chair Dr. C. Michael White, Pharm.D., FCP, FCCP, FASHP, and Distinguished Professor of Pharmacy Practice at the University of Connecticut, issued a stark warning: 'It is dangerously misleading to suggest that 7 products are safe for public sale without medical oversight. Marwood Group's own report, despite being commissioned by HART, clearly concludes that synthetic 7-hydroxymitragynine is a potent opioid agonist with high abuse potential, rapid tolerance development, and physical dependence in animal models. HART's attempt to erase key parts of the report after publication, including these risk statements, is an alarming act of public deception that endangers consumers.' The KCAC white paper cites the following key concerns from the Marwood Group report that HART initially published and then quietly removed: The KCAC paper refutes Marwood Group's assertion that 7-hydroxymitragynine has a lower risk of respiratory depression. They used a surrogate marker called beta-arrestin recruitment to say the risk was lower without looking at actual animal studies where breathing was assessed and shown to be depressed, just like with morphine. It also provides a balanced perspective on anecdotal experiences with 7 products where consumers report widespread recreational use for euphoria and suffering from severe addiction. 'We've seen this playbook before, downplaying the risks of potent opioids while encouraging unregulated use. The opioid crisis of the 2000s began with similar false assurances,' said Dr. White. 'We must not repeat history with synthetic 7-hydroxymitragynine. These products must be evaluated through rigorous clinical trials and carefully controlled, not sold like candy at gas stations.' The white paper also highlights KCAC's support for the FDA's July 15 warning letters against firms illegally marketing synthetic 7-hydroxymitragynine products and making unsubstantiated medical claims. KCAC calls on regulators, lawmakers, and the media to take a clear-eyed view of the risks posed by synthetic 7-hydroxymitragynine products and urges a halt to the sale of these potent synthetic derivatives outside of clinical or research settings. The full white paper, 'Have '7' Products with 7-Hydroxymitragynine (7-OH) Been Proven to Be Safe?' is available here. 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
Medscape
6 days ago
- Health
- Medscape
FDA Warns Companies Hawking ‘Legal Morphine' Products
The FDA has sent warning letters to seven companies for illegally marketing products containing added or concentrated 7-hydroxymitragynine (7-OH), a potent metabolite of kratom. 'This action reflects the agency's growing concern around novel potent opioid products being marketed to US consumers and sold online and in smoke shops, gas stations, and corner stores,' the FDA said in a statement. Since late 2023, there has been a surge in 'kratom' products marketed as '7-OH,' '7-Hydro,' or 'legal morphine,' as reported by Medscape Medical News. 7-OH occurs naturally in trace amounts in kratom. By contrast, concentrated 7-OH preparations are 30-40 times more potent at opioid receptors and produce rapid-onset analgesia, euphoria, respiratory depression, and classic opioid-type withdrawal. As previously reported by Medscape Medical News, research has shown that 7-OH has high abuse potential and may also increase the intake of other opiates. The FDA warning letters focus on companies illegally selling tablets, gummies, drink mixes, shots, and other products that contain 7-OH as an added ingredient or at concentrated levels. According to the agency, some products are adulterated conventional foods or dietary supplements because 7-OH does not meet the relevant safety standard. Others are unapproved new drugs with unproven claims such as relieving pain and managing anxiety, the FDA said. '7-OH is not lawful in dietary supplements and cannot be lawfully added to conventional foods. Additionally, there are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH,' the FDA warned. The warning letters were sent to the following companies: Images of the products being illegally marketed by the seven companies that received warning letters can be viewed online. The FDA has requested a response from each company within 15 business days.
Associated Press
6 days ago
- 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
