The Dietary Supplement Health and Education Act of 1994 specified that dietary supplements must be swallowed. In this study, we investigated whether kratom-derived products are being sold to consumers in nonswallowed formulations. Kratom is the fresh or dried leaf powder of the Mitragyna speciosa tree. We identified 49 kratom-derived products being sold in the form of sublingual strips (24%), buccal pouches (8%), and vaping products (67%). Most contained 7-hydroxymitragynine (an alkaloid that the US Food and Drug Administration seeks to make a controlled substance), but we also identified mitragynine extract and mitragynine pseudoindoxyl products. The majority had flavoring or a scent, and some had mascots, pictures of fruit or mint, or formulation colors or packaging that could appeal to children. Most products were not sold in child-resistant packaging. Several kratom vaping products additionally contained intoxicating hemp cannabinoids. With no clinical, safety, or pharmacokinetic data for kratom-derived products that bypass first-pass metabolism (ie, where a chemical absorbed through the stomach or intestines is metabolized in the liver before reaching the general bloodstream), people should be advised to avoid these products, and regulatory action is needed to prevent their sale to consumers.
Keywords: 7-hydroxymitragynine; dietary supplements; kratom; mitragynine; mitragynine pseudoindoxyl; patient safety.