ABSTRACT

Accurate botanical species authentication and detection of adulterants are arguably the greatest challenges for raw materials and natural product manufacturers today, especially given the requirement for 100% identity testing in the Food and Drug Administration (FDA)’s dietary supplement cGMPs (21 CFR part 111). After all, the safety and quality of foods, herbal supplements, and other natural products depends on using ingredients that are (1) the correct identity and (2) free of contaminants. Although there are a wide range of technologies developed for authentication and adulterant detection, from microscopy and organolepsis, high-performance thin layer chromatography (HPTLC) and thin layer chromatography (TLC), and Fourier transform infrared (FTIR) and near infrared (NIR) to name a few, still major challenges remain especially regarding differentiation between closely related species and identication of multiple species in a mixture. As a result, there is widespread adulteration in the natural products industry. The combination of an increase in economically motivated adulteration and number of ingredients being sold as extracts and blends rather than in their whole unprocessed form makes the task of identi- cation and detection of contaminants more challenging than ever. As illustrated in

Introduction .............................................................................................................. 43 DNA Is the Basis of Species Identity ..................................................................50