The safety assessment of botanicals has been subject of a number of publications and recommendations in recent years. These publications have proposed flow charts for the safety assessment of botanicals and identified data that would be required to perform such risk assessments. An important element, often ignored or undervalued in the various systems proposed for the safety assessment, is information and experience from the traditional use of the plant or plant preparation. This paper explores the various systems proposed and aims to identify the critical and essential requirements that manufacturers of botanical food supplements should observe to verify and assure the safety of their products.