Nutrasource Receives 2nd FDA “No Questions” Letter for GRAS Notice on Behalf of HOWTIAN Sweetener Extract

Stevia leaves with sugar in a wooden spoon on a wooden background

Guelph, ON—Natural stevia extracts manufacturer HOWTIAN, formerly known as Zhucheng Haotian Pharma Co., Ltd, received its second FDA No Questions GRAS notice (GRN 999, Enzyme-modified steviol glycosides) for its stevia sweetener product SoPure Stevia Enzyme Modified Glucosylated Steviol Glycosides, according to a press release. GRAS Associates, a fully owned subsidiary of Nutrasource, successfully submitted the notice to the FDA on behalf of HOWTIAN. GRAS Associates 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.

“GRAS Associates is pleased to have assisted adding another steviol glycoside preparation into the HOWTIAN portfolio permitted for import and use in the U.S. marketplace with the successful GRAS conclusion and notification to FDA for their enzyme-modified steviol glycosides (GRN 999),” shared Amy Mozingo, Vice President of US Nutra Regulatory Sciences, Nutrasource/GRAS Associates, in the release.

Mavis Ran, Business Director at HOWTIAN, added, “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. 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.”

The companies also shared information about the enzyme modified steviol glycosides associated with the GRAS Notice, noting:

  • Enzyme modified steviol glycosides are produced when additional glucose moieties are bonded to the original steviol glycoside structure via α(1–>4) linkages.
  • There are two preparations covered with this GRAS Notice (GRN 999, Enzyme-modified steviol glycosides):
    • 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)
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Thanking Nutrasource for their role, Hank Wang, Technical Director at HOWTIAN, said, “Nutrasource was instrumental in outlining all the documents needed to provide for the best chance for a seamless review by the FDA. The positive results from both our recent GRAS applications showed that they were a great partner to collaborate with.”