Case study on TFDA application (3)

Today’s sharing is interesting one. The target ingredient is so called from natural plant (vegetable). Why did it turn out need to file for non-traditional edible ingredient listing and been required for 90-days sub-chronic toxicity study?

A US biotek company extracted a seed of a natural plant and dried it into powder with certain active compounds. They had done the safety tests for Acute oral toxicity test, Sub-acute toxicity study, and Genotoxicity test. The ingredient also had got GRAS from USFDA, noval food ingredient approval from CFDA, as well as the filing with herb active ingredient from Australia and Canada. It looks very positive.

Our expert team, however, found all these approvals failed to prove the consumption history of it is over 25 years. We had reminded that TFDA may still ask to apply the non-traditional edible ingredient listing via attachment 2 process. It will require 90-days sub-chronic toxicity study and teratogenicity test for attachment 2 process.

The client still decided to send the application with current technical documents via attachment 1 process to TFDA . Unfortunately, we got official response letter from TFDA 6 months later for asking to go through the attachment 2 process. The client is working on 90-days sub-chronic toxicity study and teratogenicity test now. This case tell us that TFDA reviewal committee is conservative on the safety assessments even though the ingredient got approvals from 4 governmental agencies.

novel ingredient for TFDA

functional food for TFDA