Case study on TFDA application (1)

We would like to share the case of NAD+ for application to TFDAon non-traditional food ingredients request this time. This innovational functional ingredient got its NDI and GRAS from USFDA already. At first stage, the client hired us for compliance status assessment. Our expert team had found that the production process of this novel ingredient had employed several process aids which are not on the positive listing published by TFDA. If you want to convince TFDA the product that processed by these process aids is safe, you will need to provide the evidence that other governmental agencies say so. The client, however, only can provide the safety evidence for medicine regulations not for food regulations. We had this POV in our compliance assessment report.

The client, however, insisted to send the application dossier with current documents as they believe they already got NDI and GRAS number from USFDA as the safety evidence. Even though, we had pointed out this is against the current regulations published by TFDA on foods.

Unfortunately, we got official rejection from TFDA with the same reason two month later after we sent the application. The client is now working on modifying the process that without those process aids or remove the residuals of those process aids. Hope this can work out and let us wait for their next movement.