Botanicalfamily

AMERICAN KRATOM ASSOCIATION CALLS ON AMA TO PROPERLY IDENTIFY THE REAL PUBLIC HEALTH THREAT: CHEMICALLY MANIPULATED 7-OH OPIOIDS THAT ARE NOT NATURAL LEAF KRATOM PRODUCTS Failure to differentiate between chemically manipulated opioid products from traditional natural kratom leaf products confuses consumers and creates immense policy problems The American Kratom Association (AKA) today applauded the American Medical Association (AMA) for recognizing the growing public health concerns associated with highly concentrated 7-hydroxymitragynine (7-OH) products but urged the AMA to more clearly distinguish these chemically manipulated opioid products from traditional natural kratom leaf products. In a policy statement adopted at its Annual Meeting, the AMA highlighted concerns about concentrated 7-OH products and supported restrictions on their sale and marketing, particularly where children and adolescents may be exposed. The AMA specifically noted that manufacturers are increasingly extracting and concentrating 7-OH into products that are chemically manipulated opioids that have no legitimate relationship to traditional kratom leaf products. While the AMA’s concerns regarding chemically manipulated 7-OH opioid products are justified, the American Kratom Association believes the policy statement unintentionally contributes to ongoing public confusion by repeatedly characterizing these products as “kratom products” when they have no resemblance to natural kratom leaf products. “The AMA correctly identifies the danger posed by concentrated 7-OH products, but it stops short of making the most important distinction,” said Mac Haddow, Senior Fellow on Public Policy for the American Kratom Association. “These chemically manipulated 7-OH opioids are not traditional kratom products. They are highly concentrated opioids manufactured through chemical conversion processes that fundamentally alter the natural composition of kratom.” Natural kratom leaf contains mitragynine as its dominant alkaloid, while 7-OH exists only in trace amounts. The products now appearing on the market often reverse that natural relationship by chemically converting mitragynine into concentrated 7-OH opioids, creating products with pharmacological profiles dramatically different from natural kratom leaf. The scientific evidence increasingly demonstrates why policymakers must distinguish between these chemically manipulated opioids and natural kratom. In a human dose-finding safety study conducted under FDA oversight, healthy adult participants consumed kratom doses up to 12 grams of leaf material without experiencing serious adverse events. Researchers concluded that kratom was generally well tolerated across all dose levels tested, with only nausea being the most commonly reported non-serious adverse event experienced by both the kratom and the placebo test groups. More recently, the National Institutes of Health announced the approval of a groundbreaking human clinical trial evaluating whether kratom can serve as a treatment for opioid use disorder and help individuals reduce or eliminate dependence on more dangerous opioids. That study, led by researchers at the University of Florida, could not proceed without approval by an independent Institutional Review Board (IRB), which is legally and ethically required to determine that human participants will not be exposed to unreasonable or unacceptable safety risks. “The significance of the NIH announcement cannot be overstated,” Haddow continued. “A study designed to evaluate kratom as a tool to help people overcome opioid addiction could not move forward unless an independent ethics review concluded that participation in the study presents an acceptable safety profile for human subjects. That is fundamentally inconsistent with the narrative that natural kratom leaf is itself a significant public health threat.” The AKA strongly supports federal and state actions targeting chemically manipulated 7-OH products. In fact, the Association has consistently advocated for strict regulation and scheduling of chemically converted 7-OH opioids that are marketed as kratom despite possessing pharmacological characteristics far removed from natural leaf material. The FDA itself has warned consumers about concentrated 7-OH products, and both HHS Secretary Robert F. Kennedy Jr. and former FDA Commissioner Marty Makary have emphasized that federal enforcement efforts are focused on chemically manipulated 7-OH products rather than properly manufactured natural kratom leaf products. Unfortunately, when public statements fail to clearly distinguish between natural kratom and concentrated 7-OH opioids, consumers, healthcare providers, legislators, and regulators are left with the mistaken impression that all kratom products present the same risks. That confusion undermines efforts to develop evidence-based public health policy. The American Kratom Association calls on the AMA, public health officials, and policymakers to accurately identify the source of the emerging safety concerns: chemically manipulated 7-OH opioid products masquerading as kratom. “The solution is not to stigmatize or prohibit natural kratom leaf products that millions of Americans use responsibly,” Haddow said. “The solution is to focus regulatory attention where it belongs—on chemically manipulated 7-OH opioid products that are fundamentally different from natural kratom and should not be marketed as kratom in the first place.” The AKA remains committed to advancing science-based regulation, protecting consumers from dangerous synthetic and chemically manipulated 7-OH opioid products, and preserving access to properly manufactured natural kratom leaf products that meet established safety and quality standards. americankratom.org/news/call…