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December 19, 2024
December 19, 2024 (Guelph, ON) - SGS Nutrasource is pleased to announce that BTC, a Korea-based manufacturer, with support from GRAS Associates (GA), a SGS Nutrarouce Company, has received an Acknowledgement Letter from 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.
About BTC
BTC has grown to become a market leader in Korea's nutraceutical ingredients market since its inception in 2006. We have a number of conversion technologies, including enzyme treatment, fermentation, and encapsulation, which we use to create our branded botanical extracts. Our technology overcomes the limitations of plant extracts, allowing us to provide better solutions to our customers. All of the products we offer are manufactured in our own factory, which is GMP, HACCP, and FSSC 22000 certified. BTC is committed to providing the most effective and high-quality products. As a serious and dependable partner, BTC promises to always be one step ahead.
Our portfolio includes FermenGIN, a fermented red ginseng product; ThinkGIN for memory improvement; and DermaNiA, which supports skin and liver health.
In collaboration with global distributors, we supply functional food materials to markets in Korea, the United States, Japan, and Southeast Asia. With over 18 years of research expertise in natural materials, we are committed to developing anti-aging functional ingredients to address the needs of a growing aging population.
About SGS Nutrasource
SGS Nutrasource is a leading nutraceutical and pharmaceutical life sciences company focused on helping clients commercialize health and wellness products. In addition to a unique offering of clinical trial management, strategic and regulatory support services along with a state-of-the-art clinical trial site, SGS Nutrasource offers a series of third-party natural ingredient product certification programs (NutraStrong™, IFOS™, IKOS™, IAOS™, IGEN™, IPRO™, and Radioactivity Tested & Certified™.)
Learn more: www.nutrasource.ca