SGS Nutrasource is pleased to announce that BTC, a Korea-based manufacturer, with support from GRAS Associates (GA), a SGS Nutrasource company, has received an Acknowledgement Letter from the FDA following the New Dietary Ingredient (NDI) notification for their ingredient, FermenGIN. An enzyme-treated ginseng root extract powder, FermenGIN is recommended for use in healthy adults with a daily serving up to 3.5 g/day for up to three months.
“With the help of GRAS Associates, the BTC Corporation successfully completed the FDA NDIN process (No. 1362). GA’s team was highly professional, providing clear guidance appropriate to the situation on the materials required for the submission,” says Dogulas Kim, BTC’s R&D Center Director. “Their experts, with diverse backgrounds, offered valuable insights, particularly on safety considerations, ensuring our application was robust and well-prepared. Additionally, GA’s extensive experience in communicating with the FDA was invaluable. They expertly managed amendments and guided us through the complexities of the process with confidence and efficiency. We highly recommend GA for anyone seeking reliable and expert support for FDA submissions.”
Containing red ginseng root extract, a botanical extract, and deactivated cellulase, FermenGIN meets the requirements to be recognized as a dietary ingredient and offers up to 35 mg/g of ginsenosides. The benefits of red ginseng are widely recognized, and the additional regulatory approvals for FermenGIN position it to reach a broader global audience.
“GRAS Associates was pleased to partner with BTC Corporation and our Nutrasource Asia team to successfully complete a new dietary ingredient notification (NDI 001362) for BTC’s FermenGIN ingredient,” notes Amy Mozingo, Vice President of GRAS Associates (a SGS Nutrasource company). “The project team, led by Rebecca Tarrien, compiled a comprehensive dossier addressing the safety in use of the new dietary ingredient and adequately addressed questions from the NDI Notification review team.”
Congratulations to BTC on achieving this milestone
