American Kratom Association (AKA) is issuing a national consumer alert to warn consumers, retailers, and distributors of the serious health risks posed by products that contain dangerously high levels of 7-hydroxymitragynine (7-OH) — a powerful, highly psychoactive compound that is not naturally present in kratom leaf in any meaningful amount. The warning letters appropriately include 7-OH + pseudoindoxyl products that are an enhanced manipulation of the naturally occurring kratom compounds.
The U.S. Food and Drug Administration (FDA) has recently issued multiple warning letters to companies selling these adulterated and illegal products, making it unequivocally clear: 7-OH products are unsafe, misleadingly marketed, and violate federal law.
Why Consumers Should Be Concerned
- 7-OH is a full opioid receptor agonist, unlike natural kratom and other alkaloids found in it which act as partial agonists. This distinction makes 7-OH products more likely to cause respiratory depression, addiction, and overdose.
- High-dose 7-OH products are being sold under the false label of “kratom,” misleading consumers into thinking they are purchasing safe, natural kratom products.
- Scientific studies show that 7-OH is only present in kratom leaf in trace amounts—yet these products contain magnified concentrations, sometimes exceeding 100 mg per serving.
- The National Institute on Drug Abuse (NIDA) and respected kratom scientists have repeatedly warned that these synthetic and semi-synthetic 7-OH products do not represent the natural kratom plant and carry a completely different safety profile.
Retailers and Manufacturers Beware
- These manipulated kratom compounds violate the federal Food, Drug, and Cosmetic Act
- Risks of manufacturing, storing, or distributing 7-OH products include FDA enforcement actions including product seizures, fines, and injunctions
- Jeopardize consumer trust and public safety
- Increase exposure to high-risk product liability lawsuits for marketing products defined by the FDA as being highly dangerous
- Threaten the legal status of natural kratom products by confusing policymakers and the public with dangerous, misbranded products
The AKA applauds the FDA’s long-overdue action to protect consumers and remove these hazardous products from the marketplace. For years, AKA has advocated for commonsense regulations through state-level Kratom Consumer Protection Acts (KCPAs) that clearly prohibit dangerous alkaloid manipulation, including limits on 7-OH to no more than 2% of total alkaloid content—a threshold that corresponds with less than 1 mg per serving.
What Consumers Can Do
- Check product labels: If the product contains “7-hydroxymitragynine” or “7-OH” in concentrations greater than 1 mg per serving, do not use it.
- Ask your vendors for certificates of analysis verifying the 7-OH content.
- Avoid products marketed as having euphoric, intoxicating, or opioid-like effects.
- Report suspected 7-OH products to your local health department or directly to the FDA.
Additional Resources
- FDA warning letters on 7-OH products: www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-products-containing-7-hydroxymitragynine
- Learn about safe kratom use and state-level KCPAs: KratomAnswers.org
The Bottom Line: If it’s not natural kratom, it’s not kratom.
- 7-OH products are dangerous, misleading, and illegal.
- The AKA urges every consumer to reject these products and calls on all vendors and retailers to stop selling them immediately.
