A Multi-Criteria Decision Analysis Model to Assess the Safety of Botanicals Utilizing Data on History of Use

Botanicals (herbal materials and extracts) are widely used in traditional medicines throughout the world. Many have an extensive history of safe use over several hundreds of years. There is now a growing consumer interest in food and cosmetic products, which contain botanicals. There are many publications describing the safety assessment approaches for botanicals, based on the history of safe use. However, they do not define what constitutes a history of safe use, a decision that is ultimately a subjective one. The multi-criteria decision analysis (MCDA), is a model that has been developed, which assesses the safety of botanical ingredients using a history of use approach. The model evaluates the similarity of the botanical ingredient of interest to its historic counterpart – the comparator, the evidence supporting the history of use, and any evidence of concern. The assessment made is whether a botanical ingredient is as safe as its comparator botanical, which has a history of use. In order to establish compositional similarity between the botanical ingredient and its comparator, an analytical ‘similarity scoring’ approach has been developed. Applicability of the model is discussed with an example, Brahmi (Bacopa monnieri). This evolution of the risk assessment of botanicals gives an objective, transparent, and transferable safety assessment approach.