The ingredient is extracted from the root of Withania somnifera using a proprietary process to produce high purity active constituents (withanolides), said the company. The self-affirmation now allows the use of the extract in a range of products, including cereals, cereal bars, candies, chewing gum, cookies/biscuits and type I beverages.
A spokesperson for the company told NutraIngredients-USA that Ixoreal Biomed is already in discussions with food companies. “It is expected that a product will be on store shelves by the end of 2012,” they said.
KSM-66, which has a neutral, bitterless taste, can be used in the specified foods at levels of 25 to 80 mg/serving, according to the determination.
The extract has also been evaluated in five scientific studies with an additional two studies ongoing in the area of healthy stress management, said the company.
“A significant amount of work was completed to ensure that KSM-66 met the highest standards related to the self-affirmed GRAS determination,” said Kartikeya Baldwa, Director for Ixoreal Biomed.
The spokesperson added that the company is proceeding forward with the self-affirmed determination at present. “If circumstances arise where an FDA letter of no objection is needed, we'll consider it at that time,” they added.