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

Not really applicable, reference materials noted in SMPR just refers to Appendix F.

No, but the SMPR specifies one or more of the proteins specified. The method is specific for what it is stated to be valid for (milk protein), therefore not a problem.

IV. General Submission Package

No.

None stated in SMPR. There is some language in the method that potentially infers a system suitability requirement (around the incubation time), but it is not entirely clear what the intent is for that step.

Not applicable.