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October 09, 2023
Guelph, ON – GRAS Associates (a SGS Nutrasource company), is pleased to have partnered with Cypress Systems, Inc. to achieve independent/self GRAS of SelenoExcell® as a source of selenium in infant formula intended for healthy, full-term infants. The notice of GRAS conclusion (GRN 1149) for the use in infant formula has been submitted to FDA’s GRAS notification program and is the first such notification for an organic selenium source for use in infant formula.
Cypress’s focus has long been perfecting the process of fermentation for organically bound minerals to yeast, which creates natural, food-form minerals that can be easily absorbed by the body. In 2009, SelenoExcell® received a no questions letter from FDA for the GRAS conclusion for use in a variety of food categories.
“Obtaining infant GRAS has always been Cypress’s aspiration. SelenoExcell® is the gold standard for maternal health supplementation, so extending its benefits to infants is a seamless evolution. Its significance to infant health was confirmed in 2019 when it became a required mineral in infant formula,” says Michelle Martin, President/COO of Cypress Systems, Inc.” We are honored to be the first selenium ingredient for use in infant formula notified to FDAs GRAS notification program. Maternal and infant health are integral to Cypress’s core values—our non-profit aids young mothers and their infants in Africa, reflecting our deep commitment to global wellness. We appreciate the Nutrasource team’s invaluable role in this milestone.”
Amy Mozingo, VP of US Nutra Regulatory Sciences at GRAS Associates, comments, “As selenium is a required nutrient in infant formula, notification of the GRAS conclusion to FDA for transparency is important. GRAS Associates is honored to have worked with this industry pioneer of high selenium yeast to achieve independent GRAS status for use of their SelenoExcell® in infant formula.”
About SGS Nutrasource Pharmaceutical and Nutraceutical Services
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, Nutrasource offers a series of third-party natural ingredient product certification programs (NutraStrong™, IFOS™, IKOS™, IGEN™, IPRO™, and ICAP™).
About Cypress Systems, Inc.
Manufacturing quality ingredients for the nutraceutical and food industries for optimal global wellness is the foundation for Cypress Systems, Inc. Since inception, Cypress’s primary focus has been perfecting the process of fermentation for organically bound minerals to yeast, creating natural, food-form minerals easily absorbed by the body. Among the ingredients developed through this process was a high selenium yeast at 1200 ppm - SelenoExcell®’.
SelenoExcell®’s bioavailability and effectiveness changed the oncology world’s view of a nutritional agent’s role in cancer prevention based on results from an NCI-funded Prevention of Cancer Trial in 1995. Since its establishment in the market and FDA GRAS status acquisition in 2009, it has been trusted in prostate, thyroid, brain, immune, maternal, infant health formulations, and more.
Carrying forward the same high standards used in developing our yeast-based ingredients, Cypress expanded into the chelated mineral market in 2020 with its fully reacted line of ingredients, TheCHELATES. Our commitment to pioneering global wellness drives our vision of supporting a healthier world through access to high-quality ingredients and our purpose-driven business. cypressingredients.com