Nutrasource Pharmaceutical and Nutraceutical Services has successfully submitted a GRAS Notice to the FDA on behalf of Nascent Health Sciences, a natural ingredient supplier.
Amy Mozingo, VP of US Nutra Regulatory Sciences, Nutrasource said: “GRAS Associates is pleased to have assisted Nascent Health Sciences in realising their goals of GRAS status and FDA ‘no questions’ for the GRAS notification (GRN 983) of their SoPure purified steviol glycosides. Our scientific team is uniquely positioned to provide expert guidance for achieving GRAS status for steviol glycosides ingredients as over half of the GRAS conclusion notified to FDA have been successfully submitted by GRAS Associates.”
GRAS Associates, a fully owned subsidiary of Nutrasource, assists supplement and food ingredient companies with regulatory scientific services from concept to claim, including regulatory guidance and program development, establishing safety of ingredients, claims substantiation, and technical label review for U.S. market access.
"We are very pleased to receive the FDA's No Objection Letter regarding SoPure Stevia’s GRAS status," says Hank Wang, Technical Director of Nascent Health Sciences. "This confirmation expands upon the FDA's previous No Objection for our Reb A to now include all steviol glycosides we extract from the leaf. This now provides our manufacturing customers with confidence knowing that their stevia supply is not only grown naturally and sourced sustainably but is also safe and backed by the most stringent regulatory approvals.”
SoPure Stevia has been successfully incorporated in products including beverages, baked goods and deserts, as well as condiments and sauces.