According to Hank Wang, technical director of Nascent, the FDA’s ‘no questions’ letter expands upon the agency’s previous No Objection for its Reb A to now include all steviol glycosides it extracts from the leaf.
Stevia is a natural sweetener and sugar substitute derived from the leaves of Stevia rebaudiana, which is native to Brazil and Paraguay. The active compounds are steviol glycosides, which have 30-150 times the sweetness of sugar
“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,” said Wang.
Nascent is the North American representative for Zhucheng Haotian Pharm Co (ZCHT), which produces the SoPure Stevia family of stevia products, sold in more than 80 countries. With an annual production capacity of 6,000 metric tons of plant-based stevia extract, ZCHT is the largest manufacturer of commercial stevia globally.
Stevia glycosides have proven to be heat-stable, pH-stable, and not fermentable, and the company claims its SoPure Stevia has been successfully incorporated into products like baked goods (breads, cakes, cookies, brownies), puddings and snacks (cereal bars, confectionery, chocolate), among others applications.
The natural ingredient supplier was assisted with its submission by GRAS Associates – a wholly owned subsidiary of Nutrasource – which assists companies with full regulatory scientific services, including regulatory guidance and programme development, establishing safety of ingredients, claims substantiation and technical label review for US market access.
The company is ideally positioned as a leading nutraceutical life sciences company with a state-of-the-art clinical trial site and a series of third-party certification programmes focused on natural ingredients.
“GRAS Associates is pleased to have assisted Nascent Health Sciences in realising its goals of GRAS status and FDA ‘no questions’ for the GRAS notification (GRN 983) of SoPure purified steviol glycosides,” said Amy Mozingo, VP of US Nutra Regulatory Sciencies, Nutrasource/GRAS Associates.
“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 towards the successful conclusion by the FDA.”