FDA Says Kratom Not Legal Drug After Issuing Warning Letters

The US FDA reiterated Kratom, the Southeast Asian herb popular for its stimulating and pain-relieving properties, is not legally marketed in the US as a drug product after the agency sent warning letters to companies selling products with concentrated amounts of 7-hydroxymitragynine (7-OH).

• While Kratom naturally has trace amounts of 7-OH, warning letters targeted concentrated versions of tablets, gummies, drink mixes, and shots sold in gas stations, smoke shops and corner stores: FDA
• Kratom is not approved as a dietary supplement and there is not enough information that it doesn’t present a “significant or unreasonable risk of illness or injury”: ...