Kratom in the United States

"Kratom (Mitragyna speciosa Korth.) refers to herbal products derived from the leaves of a tropical tree in the Rubiaceae family that grow throughout Southeast Asia and regions of Africa, China, and India (Brown et al., 2017). Domestic cultivation in Florida and Hawaii was also reported. Kratom products marketed in the United States (US) and globally are diverse. These include dried leaf powder that is used in tea-like decoctions, pressed into pellets or encapsulated, as well as more concentrated extracts that range widely in their content of kratom’s major alkaloid, mitragynine (MG), and other minor alkaloids or metabolites, including 7-hydroxymitragynine (7OHMG) (Prozialeck et al., 2020; Todd et al., 2020; Manwill et al., 2022; Sengnon et al., 2023; Grundmann et al., 2024).

"In the United States, kratom products are marketed as dietary ingredients and meet criteria under the Food, Drug and Cosmetic Act for regulation by the United States Food and Drug Administration’s (FDA’s) Office of Dietary Supplements but have yet to be accepted for regulation or provided with any regulatory standards for product purity, ingredients, labeling or warnings (FDA, 2024a). At least six kratom products were submitted to FDA by kratom product manufacturers as new dietary ingredient notifications; all were rejected by FDA (Johnson, 2022). 1 At this writing, we are not aware of any submissions to FDA of new drug applications containing kratom or kratom derivatives. The FDA regulatory position on kratom evolved over the past decade and as of 22 February 2024, it included the following statement on its kratom website: “kratom is not lawfully marketed as a dietary supplement and cannot be lawfully added to conventional foods” (FDA, 2024)."