Microsoft Word - Candidates for 2017 ERP of the Year

AOAC Stakeholder Panel on Dietary Supplements (SPDS) - Report: SPDS Expert Review Panels for Aloe Vera, Echinacea, Ginger, Ginseng, Kavalactones, Skullcap, SAMe and Vitamin B 12 SAMe ERP Members Absent: Mohamed Koroma, Pharmavite; Hong You, Waters Observers: Cristina Amarillas, Traditional Medicinals; Steven Dentali, Dentali Botanical Sciences; Mehmet Gumustas, Ankara University; Bailey Rhea Ireland, Eurofins; Wenjuan Elaine Jobgen, Eurofins; Veronica Kays; Eurofins; Scott Krepich, Phenomenex; Dana Krueger, Krueger Food Laboratories; Adam Kuszak, NIH; Celine Lesuer, Danone; Deepali Mohindra, ThermoFisher; Mimi Park, The Nature’s Bounty Company; Jeroen van Soest, Eurofins; Brad Stawick, SGS North America; John Szpylka, Mérieux NutriSciences, Tomasz Tuzimski, Medical University of Lublin; Laura Wood, NIST; Jinchuan Yang, Waters; Jupiter Yeung, Nestlé; Kurt Young, NutraManufacturing; Hui Zhao, Agilent AOAC Staff and Technical Consultants: Scott Coates, Christopher Dent, Dawn Frazier, Nora Marshall, and Maria Nelson

ERP Decisions

Consensus

Decision Date

Candidate Method #

Manuscript Title, Submitter and Reviewers SAMe Method and its Validation Data --- Submitted by: Joseph Zhou, Sunshineville Health Products --- Primary Reviewer: Jinchuan Yang, Waters Secondary Reviewer: Mehmet Gumustas, University of Ankara

MOTION to approve candidate method SAM-001 to First Action Official Methods of Analysis SM status (Yang/Solyom) 3 in favor, 4 opposed, 1 abstention. The motion failed. MOTION to approve the first action requirements as presented for SAM-001 (Gumustas/Yang) 7 in favor, 0 opposed, 0 abstentions. The motion passed.

The ERP had a vote to move this method to First Action Official Methods of Analysis SM status, but the vote did not pass.

First Action Requirements:

- Re-write into single SOP format - Provide stability data for standards and samples as per Item 9 in the SMPR. - Report the data in mg/g of the original samples as per the SMPR. - Recovery data must be demonstrated for the entire range of products as per Table 3 of the SMPT. - Clearly demonstrate system suitability as per Item 6 in the SMPR with current method conditions.

SAM-001

08/25/2018

11