Emerging importance of geographical indications and designations of origin - authenticating geo-authentic botanicals and implications for phytotherapy.

Pharmacopoeial monographs providing specifications for composition, identity, purity, quality, and strength of a botanical are developed based on analysis of presumably authenticated botanical reference materials. The specimens should represent the quality traditionally specified for the intended use, which may require different standards for medicinal versus food use. Development of quality standards monographs may occur through collaboration between a sponsor company or industry association and a pharmacopoeial expert committee. The sponsor may base proposed standards and methods on their own preferred botanical supply which may, or may not, be geo-authentic and/or correspond to qualities defined in traditional medicine formularies and pharmacopoeias. Geo-authentic botanicals are those with specific germplasm, cultivated or collected in their traditional production regions, of a specified biological age at maturity, with specific production techniques and processing methods. Consequences of developing new monographs that specify characteristics of an 'introduced' cultivated species or of a material obtained from one unique origin could lead to exclusion of geo-authentic herbs and may have therapeutic implications for clinical practice. In this review, specifications of selected medicinal plants with either a geo-authentic or geographical indication designation are discussed and compared against official pharmacopoeial standards for same genus and species regardless of origin.