The growing campaign by sellers and advocates of dangerous high-potency 7-hydroxymitragynine (“7-OH”) products to portray all 7-OH as “natural” and “non-synthetic” is dangerously misleading and threatens to undermine legitimate public health protections designed to prevent consumer harm.
FDA Commissioner Makary made the distinction between trace amounts of 7-OH that occur naturally in kratom raw materials that pose no safety concern and chemically manipulated 7-OH products that are highly concentrated into compounds that pose the same threat to consumers as traditional opioids. Legislators and public health officials are encouraged to review the FDA’s “Hiding in Plain Sight: 7-OH Products” resource webpage and watch the Department of Health and Human Services' “Press Conference on Opioid 7-OH Public Safety Measure.”
State legislators, regulators, and public health officials are increasingly hearing testimony in legislative hearings and regulatory proceedings form 7-OH manufacturers claiming that because trace amounts of 7-OH can naturally occur in kratom leaves through oxidation — and because tiny amounts may be formed in the human body through metabolism of mitragynine — then all commercial 7-OH products must therefore be “natural.” That argument is scientifically flawed, intentionally deceptive, and ignores the critical distinction between naturally occurring trace compounds and chemically manipulated products engineered to make 7-OH the dominant alkaloid.
Natural kratom leaf products contain mitragynine as the overwhelmingly dominant alkaloid, with only trace levels of naturally occurring 7-OH. These naturally occurring trace levels do not remotely approach the concentrations now being sold in highly concentrated tablets, chewable products, gummies, tinctures, and sublingual products marketed as “7-OH.”
The issue confronting policymakers is not the existence of minute naturally occurring trace amounts of 7-OH in kratom. The issue is the deliberate chemical manipulation of kratom alkaloids to convert mitragynine into a concentrated 7-OH dominant compound that bears no resemblance to traditional kratom leaf products consumed by millions of Americans.
That conversion process fundamentally changes the alkaloid profile and pharmacological properties of the product. Once mitragynine is chemically manipulated so that 7-OH becomes the dominant compound, the resulting product acts more like a synthetic opioid than a traditional kratom product.
The argument that these products are “natural” simply because trace 7-OH exists in nature is scientifically indefensible. By that logic, virtually any chemically manipulated substance could be labeled “natural” if a trace precursor existed somewhere in nature.
The FDA’s own materials explain the exact distinction that many industry witnesses are now attempting to obscure before state legislatures:
- naturally occurring trace levels of 7-OH in kratom leaf are not the same as concentrated chemically manipulated 7-OH products;
- and the deliberate enhancement and concentration of 7-OH creates substantially vastly different safety and abuse risks.
Legislators should clearly reject false and misleading testimony claiming that “all 7-OH is natural” or that “7-OH is not synthetic.” These statements intentionally blur the line between trace naturally occurring alkaloid levels found in traditional kratom leaf; and chemically manipulated high-potency 7-OH dominant products engineered for amplified psychoactive effect.
This distinction is central to responsible public health policy.
The current generation of high-potency 7-OH products did not emerge from traditional kratom use. They emerged from chemical manipulation designed to create a far more potent product profile while continuing to exploit the public recognition and goodwill associated with natural kratom.
Increasingly, state lawmakers are recognizing that these products are fundamentally different from traditional kratom products and require separate regulatory treatment — including scheduling consideration, age restrictions, warning labels, potency limits, and prohibitions on deceptive marketing practices that falsely portray synthetic or chemically manipulated products as “natural kratom.”
Public health officials and legislators should rely on the growing body of FDA documentation, toxicological evidence, and pharmacological data — not misleading semantic arguments designed to conceal the true nature of these chemically manipulated products.
Consumers deserve transparency. Legislators deserve accurate science. And policymakers should reject efforts to deliberately confuse the distinction between natural kratom and concentrated chemically manipulated 7-OH products.
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 americankratom.org and learn more at kratomanswers.org.
Disclaimer
This press release is for informational purposes only and does not constitute medical, legal, or regulatory advice. The American Kratom Association (AKA) provides this information as part of its mission to advocate for consumer safety and scientific transparency. While the information provided is based on current pharmacological data and official statements from the FDA and HHS, readers are encouraged to consult with public health officials or legal counsel regarding specific state regulations and scheduling. Reference to third-party government resources does not imply an endorsement of the AKA by the FDA or HHS.
Media Contact
Mac Haddow
Senior Fellow on Public Policy
press@americankratom.org
