American Kratom Association (AKA) today applauded Secretary Robert Kennedy and FDA Commissioner Dr. Marty Makary for their decisive and science-driven recommendation to classify 7-hydroxymitragynine (7-OH) as a Schedule I substance under the federal Controlled Substances Act. This bold step is a critical milestone in protecting public health and consumer safety from dangerous synthetic products that masquerade as natural kratom.
“Secretary Kennedy and Commissioner Makary have shown exceptional leadership in confronting one of the most urgent public health threats related to mislabeled, manipulated psychoactive substances,” said Mac Haddow, senior fellow on public policy for the American Kratom Association. “These 7-OH products are not kratom. They are chemically altered substances that carry potent opioid-like effects and pose an imminent threat to consumers. This move sends a clear and long-overdue message: the safety of the American public comes first.”
7-hydroxymitragynine is a metabolite — not a naturally occurring substance in the kratom plant — and occurs during the drying of kratom leaves at extremely low levels, typically less than 0.01%. However, unscrupulous manufacturers have exploited chemical manipulation to create concentrated 7-OH products that far exceed natural levels, creating high-potency, opioid-like effects that are addictive and potentially lethal. These products are often falsely marketed under the kratom name, misleading consumers and damaging the reputation of natural kratom, which has a vastly different safety profile.
The American Kratom Association has worked tirelessly to educate policymakers, regulators, and the public on the difference between natural kratom products and chemically manipulated 7-OH formulations. The AKA has advocated for state-based Kratom Consumer Protection Acts (KCPA) to ban the sale of adulterated and dangerously enhanced products. This federal scheduling recommendation is a landmark development that supports those efforts and establishes a much-needed national framework to protect consumers.
“The FDA’s own research shows that natural kratom has a relatively low potential for abuse and may offer harm-reduction benefits when used responsibly,” Haddow continued. “It is the synthetic manipulation of 7-OH that has created the danger. The action by Secretary Kennedy and Commissioner Makary is not only scientifically justified, it is morally imperative.”
The AKA urges swift action by the Drug Enforcement Administration (DEA) to initiate the rule-making process to schedule synthetically manipulated 7-hydroxymitragynine and to make clear that such action does not impact the legal status of natural kratom or its primary alkaloids, mitragynine and unaltered 7-OH occurring within the plant matrix. The goal is to eliminate the threat posed by rogue products while preserving access to safe, regulated kratom.
“We look forward to working with federal agencies and state policymakers to ensure that safe access to natural kratom is protected, while these dangerous imposters are removed from the marketplace,” said Haddow.
Note: The FDA also released "Hiding in Plain Sight: 7-OH Products" to help educate the public.
