Sinew Consulting Group

Case study on Taiwan FDA application (3)

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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 SAMR/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 Taiwan FDA 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 Taiwan FDA . Unfortunately, we got official response letter from Taiwan FDA 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 Taiwan FDA reviewal committee is conservative on the safety assessments even though the ingredient got approvals from 4 governmental agencies.

novel ingredient for Taiwan FDA

functional food for Taiwan FDA