KSM-66 Gains Self-Affirmed GRAS Status

HYDERABAD, India Ixoreal Biomed has reported its KSM-66® Ashwagandha has secured self-affirmed GRAS (Generally Recognized As Safe) status after an independent panel of experts assessed the research and safety data on the ingredient. Under its GRAS designation, the ingredient can now be used as an ingredient in  cereals, cereal bars, candies, chewing gum, cookies/biscuits and type I beverages. The GRAS determination on KSM-66  limited its use in these foods to levels of 25 to 80 mg/serving. 

KSM-66 has been investigated in five completed studies and two ongoing studies for possible benefits to stress management by normalizing common physical, chemical and biological stressors.

Ixoreal noted while other ashwagandha extracts use a hydro-alcoholic extraction processes, yielding a rather bitter extract and detracting from its whole-herb character, KSM-66 high-potency ashwagandha has a neutral, bitterless taste sought after by food and beverage manufacturers.  Moreover, the company operates its own ashwagandha farms, production facilities, testing laboratories, research and distribution, which helps it ensure batch-to-batch consistency and maintain a cost-effective, reliable supply base.

"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 forIxoreal Biomed.  "We're extremely pleased that functional food and beverage manufacturers can now incorporate KSM-66 Ashwagandha into their products. We're already excited with the interest we've had from these companies."

For more information on GRAS procedures, check out the SupplySide Store video presentation " Finalizing FDAs Operating Procedures for GRAS Determinations ," featuring Robert McQuate and Richard Kraska from GRAS Associates.