Identity Standard Reference Materials for Dietary Supplements

The National Institute of Standards and Technology (NIST) in collaboration with the National Institutes of Health Office of Dietary Supplements (NIH-ODS), and AuthenTechnologies has recently added species identification as a certified property to SRM 3246, Ginkgo biloba (Leaves). Current Good Manufacturing Practices (cGMP), enforced by the United States Food and Drug Administration (FDA) require identity testing of dietary ingredient components to prevent accidental or intentional (economically motivated) adulteration of dietary supplement products. Through the addition of identity data, NIST is helping to support American industry and protect public health. Sanger sequencing, performed by AuthenTechnologies, was used on two independent chloroplast gene regions, psbA-trnH intergenic and trnL intron regions for authentication of SRM 3246. Chloroplast DNA sequences from authenticated Ginkgo biloba samples were used to establish inclusivity; chloroplast DNA sequences from close relatives were used to establish exclusivity.

In addition to the DNA data, high resolution mass spectrometry data is being collected at NIST and by the United States Department of Agriculture (USDA) and the supplemental data will be added to certificates. Authenticity data will be added to more SRMs and RMs including: Actaea racemosa (Black Cohosh), Camellia sinensis (Green Tea), Hypericum perforatum (Saint John's Wort), Serenoa repens (Saw Palmetto), Trifolium pratense (Red Clover), Pueraria montana (Kudzu), Panax ginseng (Asian Ginseng), Eleutherococcus senticosus (Siberian Ginseng), Zingiber (Ginger), and Curcuma longa (Turmeric).