Howtian, a company formerly known as Zhucheng Haotian Pharma Co., Ltd, received a second notice from the FDA indicating that another of its stevia sweetener products, SoPure, is GRAS (Generally Recognized as Safe), after the agency issued the company what is known as a “No Questions” letter. This indicates that the agency has no further objections to the safety and full regulatory compliance of the ingredient, nor to the company’s declaration that the ingredient is GRAS.
 
GRAS Associates, a fully-owned subsidiary of Nutrasource, successfully submitted the notice to FDA on behalf of the stevia extract manufacturer Howtian.
 
“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,” Amy Mozingo, vice president of U.S. nutra regulatory sciences, said.

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 sue them in a wide range of applications,” Mavis Ran, business director at Howtian, said. “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.”
 
Glycosylated stevia products offer improved taste via enzyme-treated steviol glycosides that are extracted from the leaf. These can serve as sweeteners or flavor enhancers, can mask unpleasant flavors, and can 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,” Hank Wang, technical director at Howtian, said. “The positive results from both our recent GRAS applications showed that they were a great partner to collaborate with.”