Liver injury due to herbal and dietary supplements are well described in literature and its incidence has been on the rise in the past decade. Labelling an herbal product as non-medicinal and as a supplement precludes protocols needed for testing, trials and marketing criteria. This has led to rampant use of clinically unproven multi-herb-based drugs use for a myriad of lifestyle diseases. In this report, we discuss a new dietary weight loss supplement, Safe Lean™ that was found to be the cause of liver injury in a young obese woman, that resolved after discontinuation, and discuss current literature on component, toxicology and chemical analysis of the offending drug.
Keywords: CAM; DILI; DMAA, Dimethylamylamine; DNA, Deoxyribonucleic Acid; GMP, Good Manufacturing Practices; HDS, Herbal Dietary Supplements; ICP-OES, Inductively Coupled Plasma – Optical Emission Spectrometry; RUCAM, Roussel Uclaf Causality Assessment Method; TQ-GC-MS-MS, Triple Quadruple Gas Chromatography and Dual Mass Spectroscopy; ULN, Upper Limit of Normal; WHO, World Health Organization; ayurveda; herbal; liver injury.