Market Updates, Regulations

Stevia Extract Receives ‘No Questions’ Letter on GRAS Notice

This confirmation expands upon the FDA's previous No Objection Letters for Nascent's Reb A to now include all steviol glycosides extracted from the leaf.

SoPure Stevia, a stevia extract sweetener manufactured by Nascent Health Sciences, recently received a “No Questions” Letter from the Food and Drug Administration, indicating that the agency had no objections to the conclusions of the company’s self-affirmed process which considered the ingredient to be GRAS (Generally Recognized as Safe). The GRAS notification was based upon third-party testing and consulting carried out by Nutrasource. 
 
“GRAS Associates is pleased t have assisted Nascent Health Sciences in realizing their goals of GRAS status and FDA ‘no questions’ for the GRAS notification (GRN983) of their SoPure purified steviol glycosides,” said Amy Mozingo, vice president of U.S. Nutra Regulatory Sciences with Nutrasource/GRAS Associates. “Our scientific team is uniquely positioned to provide expert guidance for achieving GRAS status for steviol glycosides ingredients as well as over half of the GRAS conclusions notified to FDA which have been successfully submitted by GRAS Associates.”
 
GRAS Associates, a fully-owned subsidiary of Nutrasource, assists supplement and food ingredient companies with full regulatory scientific services, including regulatory guidance, program development, establishing the safety of ingredients, substantiating health claims, 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,” Hank Wang, technical director of Nascent Health Sciences, said. “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. Nutrasource/GRAS Associates was an essential partner in securing the FDA review and confirmation. Their expertise was evident throughout the process as they guided us toward the successful conclusion by the FDA.”
 
SoPure Stevia has been incorporated into beverages, baked goods and desserts, condiments and sauces, confections, dairy products, tabletop sweeteners, and personal care, the company noted.

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