The Global Kratom Coalition (GKC) today applauded the U.S. Department of Health and Human Services (HHS) for taking decisive action to protect public health by moving to schedule products that contain high concentrations of 7-hydroxymitragynine (7-OH or “7”). Scheduled drugs are those with a high potential for abuse, with no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision.
The announcement, made by Health Secretary Robert F. Kennedy Jr. and U.S. Food and Drug Administration (FDA) Commissioner Dr. Marty Makary, targets manipulated, high-potency, synthetic products like “7” that are opioids masquerading as dietary supplements and are being sold online and in smoke shops across the country.
The introduction of these products in the last two years has raised alarm among public health experts and responsible kratom advocates alike, who warn that these synthetic products pose a serious risk to consumers and undermine the safe, traditional use of kratom leaf.
“The Department of Health and Human Services is showing bold, science-driven leadership by taking aim at these rogue 7-OH products,” said Walker Gallman, legislative director of the Global Kratom Coalition. “Secretary Kennedy and Commissioner Makary deserve enormous credit for drawing a clear line between dangerous synthetics and the natural plant. This is a huge win for public health and for millions of Americans who responsibly use leaf kratom to improve their quality of life.”
HHS made clear that natural leaf kratom is not the target of this action. Federal officials have rightly distinguished between the traditionally used botanical with centuries of safe use and synthetic derivatives like “7,” which pose significant health risks due to their potency and opioid-like effects. This distinction is critical to protect public health while preserving access to natural kratom for the millions of Americans who use it safely and responsibly.
Today’s announcement follows FDA actions taken earlier this month. The FDA has already begun ramping up enforcement, issuing seven warning letters to manufacturers of 7-OH products. This action sets the stage for stronger measures ahead, including potential product seizures and civil penalties.
Today’s announcement also featured strong support from Sen. Markwayne Mullin (R-Okla.), who has been an advocate for distinguishing natural leaf kratom from synthetic opioids, as well as powerful testimony from natural leaf kratom consumer Melody Woolf of Kalamazoo, Michigan.
Woolf, a longtime advocate for natural kratom, described how natural kratom leaf helped her in her daily life but warned that synthetic 7-OH products represent a dangerous and misleading alternative.
“It was only the powdered kratom leaf that saved my life,” Woolf testified. “Now I’m seeing something very dangerous happen. 7-OH is being sold over the counter, and it’s not the plant. It’s concentrated and addictive. People think it’s kratom, but it’s not. And it’s dragging some back toward opioid use. 7-OH needs to be off the shelves.”
Gallman added, “Melody’s story is one of thousands. She represents what we’re fighting for—access to natural, responsibly regulated kratom. We applaud HHS for standing with consumers like her and protecting them from deceptive, dangerous knockoffs.”
The Global Kratom Coalition encourages HHS to work closely with the Drug Enforcement Administration (DEA) to move swiftly through the federal scheduling process for synthetically derived 7-hydroxymitragynine products. Coordinated action is essential to ensure these dangerous, highly concentrated substances are removed from the market before they can cause further harm. By partnering on enforcement and regulation, HHS and DEA can protect consumers while preserving access to safe, natural kratom leaf.
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
Patrick George
info@globalkratomcoalition.org
+1 916-202-1982
