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

Yes, The method describes and is based on the use of "LCS" and "MRL" which are in house Reference materials for analysis of relevant proteins (pea, rice and soy). The uthors may provide more details how these materials are prepared for method opeartion.

Yes in most parts. Two minor differences/exceptions. 1. The SMPR requires analysis of false-positive rate of the method with samples containing non-protein ingredients at 10% target concetration. The validation study has performed analysis of false-positive rate of the method with samples containing non-protein ingredients at 0.42-7.85% target concetration. 6 out of 8 non-protein ingredient were evaluated under 2% traget concentration. 2. The method did not target any peptides (molecular weight <10,000 daltons) for false positive identification nor anay nontarget proteins (molecular weight >10,000 daltons) in the mathod validation.

IV. General Submission Package

No

The method does not describe a distinct system suitability tests or controls but entire method is based on use of LCS and MRL. The authors may adda paragraph defing their role also in system suitability.

Yes