FDA’s Concentrated 7-OH Product Crackdown
Natural Leaf Kratom Products Are NOT Affected
The U.S. Food and Drug Administration (FDA) has recommended that concentrated 7-hydroxymitragynine (also known as 7-OH) be classified as a Schedule I substance. This regulatory action targets illicit, high-potency synthetic opioids that are often dangerously and deceptively mislabeled as "kratom". 7-OH is an oxidative byproduct compound found in trace amounts in dried leaf kratom (less than 0.01%) and can be mass-produced by chemically altering concentrated kratom extracts.
The Global Kratom Coalition supports the FDA's science-led decision to protect consumers from these dangerous synthetic substances. Crucially, federal officials have made it clear that this scheduling recommendation does not apply to natural leaf kratom products.
FDA Commissioner Makes a Clear Distinction
FDA Commissioner Dr. Marty Makary underscored that the agency is not targeting natural leaf kratom, which has been used for centuries and is considered to have minimal health concerns. He clarified that the sole focus is on a concentrated synthetic byproduct that functions as a potent opioid. This critical distinction helps the public understand the specific health risks associated with the synthetic substance, not the traditional plant.
FDA Press Release Regarding 7-OH
On July 29, 2025, the FDA announced it is taking action against dangerous, concentrated 7-OH opioid products. The agency is targeting these substances due to their potential for abuse, noting they can be more potent than morphine and are sold in places like vape shops. This regulatory step aims to prevent a new wave of the opioid epidemic while clarifying that natural leaf kratom is not the focus of this action. Learn More.
FDA Action Targets Only Synthetic Derivatives
The FDA's recommendation applies only to products containing concentrated, unnatural levels of 7-OH—it does not affect products made with natural leaf kratom. Natural leaf kratom is a whole-plant product, harvested from the Mitragyna speciosa tree, that has earned consumer trust through centuries of safe, traditional use.
Natural Leaf Kratom is Distinct and Unaffected
Concentrated 7-OH products bear no resemblance to the natural leaf kratom products used by more than 20 million Americans. These traditional products are commonly consumed in forms such as capsules, powders, and teas. Federal officials have clearly stated there is a "night and day" difference in public health risk between natural leaf kratom and the synthetic 7-OH products being targeted.
Consumer Education is Key
Natural leaf kratom provides a range of benefits but is often misunderstood. The Global Kratom Coalition believes that consumers have the right to understand what they are consuming. We proudly support research and education, uphold the highest quality standards, and advocate for consumer access while prioritizing safe consumption practices. By fostering a better understanding of this botanical, we can empower consumers to make informed choices. There is a great deal of misinformation about kratom stemming from the misconception that all kratom is the same. Leaf kratom, used for centuries in Southeast Asia, differs significantly from the extracts, concentrates, and synthetic isolates sold in the U.S.. We are committed to providing consumers with the truth and replacing fiction with facts.
Our Commitment to Responsible Regulation
The Global Kratom Coalition champions increased regulation for leaf kratom to ensure consumer safety. Our policy goals include:
- Establishing clear definitions for leaf kratom and extract products.
- Banning synthesized kratom derivatives.
- Preventing the adulteration of leaf kratom products.
- Limiting 7-OH content to trace amounts consistent with natural leaf kratom.
- Implementing robust labeling standards.
- Ensuring packaging includes accurate serving measurements.