Case study on Taiwan FDA application (2)

We would like to share the case of 2FL for application to Taiwan FDA on non-traditional food ingredients request this time. The ingredient had been accepted by a famous international food company to employ it into her baby formula products. The ingredient also got GRAS from USFDA as well as got substantial equivalence approval from EFSA. It, however, is produced by GMO. This can be quite sensitive for Taiwan FDA.

What should we have for its application strategy (pathway) ? We proposed to
1).apply for non-traditional food ingredient listing as the first step;
2).register the baby formula product employing this ingredient after the listing is permitted by Taiwan FDA as the second step.

The regulatory team of this international company, however, believe they have fully experience on regulation compliance and so they sent the application the same time. It turned out Taiwan FDA replied this case would need to have a lot of cross-department discussion. It still is going on for cross-department meeting arrangements. To us, the step-by-step strategy will be better for all aspects, including the Taiwan FDA officers.

Taiwan FDA-on functional foods