Sinew Consulting Group

Aqueous Extract of Seed of Broccoli Case

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Brassica company had innovated powerful novel ingredient, aqueous extract of seed of Broccoli, and would like to launch it in Taiwan. Broccoli, of course, is a general food and can be consumed daily. Extract of Broccoli seed, however, does not have human consumption history over 25 years since it is produced by a patented process.

SCG had suggested that it should apply for non-traditional food ingredient approval via so called attachment-2 process with Taiwan FDA while Brassica decided to apply for traditional food ingredient approval via so called attachment-1 process with TFDA. Of course, the documents (especially for safety assessment like 90-days feeding test or even genotoxicity test) are not required for attachment-1 process while these are required for attachment-2 process. SCG was consigned to do so for Brassica. TFDA had refused the application 7 months later with official document saying you should go with the attachment-2 process.

One years later, after Brassica was done with the required safety assessment tests, consigned SCG to apply with TFDA again via the attachment-2 process. Two years later, SCG had helped Brassica finally got the approval letter from TFDA.