Expert Review Panel for Dietary Supplements

2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 3. Is there information demonstrating that the

Reference materials suggested in the SMPR were not used

There is only one quantity being tested, the total soluble phenolic content and it appears in the SMPR tables. In the tables it is listed as the mean phenolic content (where the content is from the aqueous extraction).

IV. General Submission Package

No

Blank and check samples at the lowest and midpoint of the analytical range were required along with evaluation of matrix and interfering compound. The authors performed reasonable calibration tests and investigated the potential interference from sugars. (there are positive results for ascorbic acid, amino acids, and sugars).

The authors used gallic acid calibration and information about the performance of the samples on different days. However there were no reference materials used.

A multifactor analysis was performed