ABSTRACT

Use of botanicals in traditional medicines is quite well known, has a long history of safe usage and is acknowledged for its efficacy. The Dietary Supplement Health and Education Act trigged a movement from an illness-centric drug-based approach to a wellness centred approach through diet, exercise, mediation and use of botanically based supplements/nutraceuticals. This chapter provides different insights to deal with the safety assessment of botanicals and the need for innovative strategies. It is neither logical nor scientific to demand a conventional toxicology and safety profile data by putting all botanicals on the same platform as a synthetic drug. Traditional texts describe a number of ways in which botanicals are processed for consumption either as food items or during preparation of foods or specifically described processes for preparing a supplement or a traditional medicine preparation. Standard guidelines are available for computing human equivalent dose for safety studies of traditional botanicals and/or their products.