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February 23, 2022
Guelph, ON – 23 Feb 2022 –HOWTIAN®, formerly known as Zhucheng Haotian Pharma Co., Ltd (ZCHT), has announced today the reception of their 2nd FDA No Questions GRAS notice for another stevia sweetener product. GRAS Associates, a fully owned subsidiary of Nutrasource, successfully submitted the notice to the FDA on behalf of HOWTIAN, the world’s largest manufacturer of natural stevia extracts.
Amy Mozingo, Vice President of US Nutra Regulatory Sciences, Nutrasource/GRAS Associates shared, “GRAS Associates is pleased to have assisted adding another steviol glycoside preparation into the HOWTIAN portfolio permitted for import and use in the US marketplace with the successful GRAS conclusion and notification to FDA for their enzyme-modified steviol glycosides (GRN 999).”
GRAS Associates assists supplement and food ingredient companies with full 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 excited to receive the Letter of No Objection from the FDA to our Enzyme Modified Steviol Glycosides (EMSG) GRAS notification. The response underscores the safety of HOWTIAN's EMSG products, opening the opportunity to use them in a wide range of applications,” said Mavis Ran, Business Director at HOWTIAN. “HOWTIAN's leaf-based product portfolio, which also includes our natural stevia extracts, minor glycosides and specialized blends, offers more possibilities now to address the increasing consumer demand for low sugar or zero sugar food and beverage products using non-artificial sweeteners.”
Glycosoylated stevia products offer improved taste via enzyme-treated steviol glycosides that are extracted from the leaf. These can serve as sweeteners or flavor enhancers, mask unpleasant flavors and augment overall taste.
“Nutrasource was instrumental in outlining all the documents we needed to provide for the best chance for a seamless review by the FDA,” noted Hank Wang, Technical Director at HOWTIAN. “The positive results from both our recent GRAS applications showed that they were a great partner to collaborate with.”
Learn more about GRAS Associates
Learn more about SoPure™ Stevia
About Enzyme Modified Steviol Glycosides Associated with this GRAS Notice
- Enzyme modified steviol glycosides are produced when additional glucose moieties are bonded to the original steviol glycoside structure via α(1-->4) linkages.
- With this GRAS Notice (GRN 999, Enzyme-modified steviol glycosides) - there are two preparations covered:
- SoPure™ Stevia glucosylated steviol glycosides - GSG 80 (≥80% total steviol glycosides with ≥75% glucosylated steviol glycosides and ≤20% dextrin)
- GSG 95 (≥95% total steviol glycosides with ≥75% glucosylated steviol glycosides and ≤5% dextrin)
About Nutrasource Pharmaceutical and Nutraceutical Services Inc.
Nutrasource is a leading nutraceutical and pharmaceutical life sciences company that brings together the strategy, expertise and services required to help clients commercialize health and wellness products with strong science and regulatory confidence. Our unique offering of clinical trial management, strategic and regulatory consulting services along with a state-of-the-art clinical trial site has been developed with one goal in mind – your success in the global marketplace. We also offer a series of third-party certification programs focused on natural health ingredients such as omega-3s (IFOS™), probiotics (IPRO™), non-GMO (IGEN™), and CBD (ICAP™). All of our groups work closely with our research and development team, which is developing timely products such as POC (Point-of-Care) technology and a RWD (Real World Data) system for consumer information collection. www.nutrasource.ca
About HOWTIAN
HOWTIAN® is a global leader in producing and supplying premium quality natural sweeteners, nutritional and functional ingredients, and a full-service solutions provider for the food & beverage, nutraceutical, pharmaceutical, and personal care industries. Creators of innovative ingredient brands including SoPure™ Stevia and PureQQ® Pyrroloquinoline Quinone. HOWTIAN (formerly known as ZCHT) is a privately owned enterprise that was incorporated in 1999. Over the last decades, HOWTIAN has grown into a global leader in naturally extracted stevia products, and one of the world’s top 7 ingredient businesses in sugar reduction. Alongside its flagship stevia business, HOWTIAN is a global leader in the production of inositol and baicalin root extracts, serving customers in over 80 countries.