Issues related to botanicals.

Herbal product studies cannot be considered scientifically valid if the product tested was not authenticated and characterized in order to ensure reproducibility in the manufacturing of the product in question. Many studies refer to the use of standardized material, but in reality they are referring to chemical standardization. While chemical standardization is important, its utility is limited when the starting material is not well characterized botanically. Although the resulting studies are sound with respect to the actual product tested, adequate authentication of the product cannot be compared to other products on the market. Also, a comparison of one study to another cannot be made due to inconsistencies in the identity of the botanical matrix. The tools needed for authentication of the field plant material also depend on the plant and process involved. This could be as straightforward as botanical/morphological identification or as elaborate as genetic or chemical profiling. Authenticated raw material is the basic starting point for the development of a botanical product. However, harvesting, storing, processing and formulating methods may dramatically affect the quality and consistency of the final product by altering the desired marker components or by increasing the possibility of unwanted contaminants. Thus, validated methods to ensure quality control in manufacturing and storage are required tools for optimal efficacy and safety of the products. These controls are also critical for the evaluation of pharmacological, toxicological and clinical studies of the botanical supplements.