December 2, 2024
Kratom (Mitragyna speciosa) was once listed as a prohibited substance under the Narcotics Act. Kratom was then removed from the narcotics list in 2021 and is now regulated under the Kratom Plant Act B.E. 2565 (2022), which allows the trading, use, import, and export of kratom. Furthermore, the Ministry of Public Health has allowed the use of kratom in food and drink, food supplements, and herbal products. Anyone who wishes to launch kratom food or herbal products must first obtain a product license from the Thai Food and Drug Administration (FDA). On September 4, 2024, the Thai FDA announced guidelines specifically for powdered kratom leaves and kratom leaf extracts (using water or ethanol as solvents) as ingredients in food supplements. These guidelines aim to provide business operators with a clear framework for launching kratom-based food products in Thailand. Key points from these guidelines include: Raw material specifications and standards: Powdered kratom leaves and kratom leaf extracts must contain at least the prescribed amount of mitragynine (one of the primary active compounds in kratom) as a marker of quality. For example, mitragynine must account for at least 1% by mass for powdered kratom leaves. Food supplement specification and standards: Food supplements containing powdered kratom leaves or kratom leaf extracts must not have a dosage of over 0.2 mg/day of mitragynine (including 7-hydroxymitraglynine, which may occur naturally), or 1 mg/day for food supplements containing kratom extracts that use water as a solvent. Addition of 7-hydroxymitraglynine to food supplements is prohibited. Mitragynine content in food supplement products must not exceed the specified dosage limit. Additionally, the food supplement product must be in a ready-to-eat form (e.g., liquid, gel, tablet, or capsule). If powdered kratom leaves or kratom leaf extracts are to be used as ingredients in food categories other than food supplements,
