July 2019 PAC ERP Review Book

PAC Method Re-submission Review Form

Submission Date

2019-07-07 20:06:33

Name

Hong You

Email

hongyou@eurofinsus.com

Organization

Eurofins Scientific, Inc.

Candidate Method Number:

PAC-01

Has the resubmitted method met the requirements outlined on December 15, 2017? Please provide justification for your answer. If specific requirements were made in the December 17, 2017 meeting, please explain how those requirements have been met or not met.

Yes

In general, the authors have conducted enough experiments to show the potential of using the proposed method to distinguish the A-type PAC from B- type PAC in various samples. The method is therefore aligned with the Applicability requirements of the SMPR and is able to identify the presence of A- type PAC proanthocyanidin in cranberry and cranberry-containing dietary supplement.

However, there are still flaws in using the presented method as a quality control procedure in the related industries:

1. The method lacks a clear data processing SOP. Therefore, it will be a subjective decision for a method user to determine the identity of an unknown sample. Because authors have discovered the presence of A-type PAC in non- cranberry products, such SOP is of great importance for the identification of cranberry ingredient. 2. The method didn't provide any LOD (limit of determination) information. This may underestimate/overestimate the capability of using this method to determine the presence of low-level cranberry in a dietary supplement product that has many ingredients.