On July 15, 2025, the U.S. Food and Drug Administration (FDA) issued a public announcement stating that it had sent seven warning letters to multiple companies for illegally selling products containing 7-hydroxymitragynine (7-OH), one of the active constituents of kratom. This compound exhibits potent opioid effects.
This move reflects the FDA’s growing concern over the illegal distribution of novel potent opioid substances. These products are often marketed in forms such as tablets, gummies, drink mixes, and energy drinks, and are sold online and in smoke shops, gas stations, and corner stores—posing significant health risks.
01. What Is Kratom?
Kratom (scientific name Mitragyna speciosa) is a tropical tree native to Southeast Asia. Its leaves are processed and sold in forms such as powder, capsules, and extracts. In the U.S., kratom products are widely available through both online sales and brick-and-mortar retailers. The leaves contain several alkaloids, the most notable being mitragynine and 7-hydroxymitragynine (7-OH-mitragynine), which are thought to have pain-relieving and mood-altering effects.
02. Why Is Kratom Not Allowed in Dietary Supplements or as a Food Additive?
The FDA has clearly stated that kratom is not appropriate for use as a dietary supplement.
Based on current scientific data, kratom is considered a New Dietary Ingredient (NDI), but there is insufficient information to reasonably assure that it does not pose a significant or unreasonable risk to consumers, therefore, dietary supplements that are or contain kratom are adulterated under section 402(f)(1)(B) of the FD&C Act.
Further, FDA has determined that kratom, when added to food, is an unsafe food additive within the meaning of section 409; food containing an unsafe food additive, such as kratom, is adulterated under section 402(a)(2)(C)(i). Based on these determinations by FDA, kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods.
03. Drug Status: Still Unapproved
Currently, the FDA has not approved any prescription or over-the-counter drugs containing kratom or its main active ingredients (mitragynine, 7-OH-mitragynine). If a new drug application (NDA) is submitted for kratom (or one of its components) to treat a specific medical condition, FDA will review the scientific data to determine if a drug product containing kratom (or its components) is safe and effective to treat that specific medical condition.
04. Conclusion
The FDA emphasizes that kratom-containing products carry significant health risks, especially at high concentrations, and are not recommended for medical or food use. The agency will continue monitoring these substances and update regulatory actions accordingly. In summary, based on the FDA’s current position, kratom is not lawfully marketed in the U.S. as a drug product, a dietary supplement, or a food additive in conventional food.
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