Expert Review Panel for Kombucha Tea

1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 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.

Yes

The SLV data don’t provide any accuracy evaluation of the method using any reference materials. Spike recovery evaluation to some extent may support the accuracy of the method. The precision data are provided for 10 injections of low-level in house sample. This is precision of injection not the analysis. The authors did apply the method to the commercial samples. Information is not available to support the precision of the method in analysis of ethanol in Kombucha tea samples. No information available about the evaluation of the method accuracy employing the Certified reference materials, The analytical range of the method not specified.

No information available about the evaluation of the method accuracy employing the Certified reference materials,

The analytical range of the method not specified.

3. Is there information demonstrating that the

The SLV data support the accuracy of the method by spike recovery evaluation. But it doesn’t provide whether spike recovery was performed in Kombucha product or in ethanol in water. It doesn’t specify how many replicates were analyzed at every spike level. It seems only single replicate was analyzed at three spike level. Provided % Recovery data meets SMPR requirements. The precision data are provided for 10 injections of low-level in house sample. This is precision of injection not the analysis. The authors did apply the method to the commercial samples. Information is not available to support the precision of the method in analysis of ethanol in Kombucha tea samples

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.

Data about the analytical range, LOD and LOQ are not available.

The SLV data don’t provide any accuracy evaluation of the method using any reference materials. Spike recovery evaluation to some extent may support the accuracy of the method

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.

Yes. Precaution in use of flammable solvents and gases under pressure may be mentioned.

The method does not indicate any system suitability criteria. The method may indicate resolution requirement of ethanol and internal std peak as they elute very close to each other. The method may also indicate requirement of repeat-ability of the lowest calibrant and the ruling out any interference from the method blank.