Applied Foods Sciences has received a letter from the U.S. Food and Drug Administration affirming that AMATEA, an organic guayusa extract, has been given Generally Recognized as Safe (GRAS) status, qualifying the safety and efficacy of the ingredient.
 
AMATEA is a branded guayusa extract that uses a patented process to yield high concentrations of caffeine and antioxidants naturally occurring in guayusa leaves to provide energy. The industry generally regards FDA’s “no further comment” response as the best response to receive from the agency as an acknowledgement of the reliable safety data in support of the ingredient. The FDA’s “no comment” indicates that the agency has reviewed AFS’s safety data and does not disagree with their conclusion that AMATEA is safe for the intended use in food and beverage applications set out in the dossier.
 
To assist in completing their dossier, AFS turned to AIBMR Life Sciences, which gathered the safety data.
 
“AIBMR Life Sciences was proud to partner with Applied Food Sciences to use our GRAS expertise to help them achieve this historical first ‘no questions letter’ from the FDA’s Office of Food Additive Safety (OFAS) for a natural caffeine-containing botanical ingredient,” John Endres, chief scientific officer, AIBMR Life Sciences, said. 
 
Guayusa is an ancient plant of the holly genus that grows exclusively in the Amazon regions of Ecuador and Peru. Guayusa contains a unique combination of caffeine and polyphenol antioxidants, and has a history of use by indigenous Kichwa tribes spanning centuries. AMATEA can be used as a functional energy ingredient for food, beverage, and nutritional supplements. It is fully water-soluble, with a tea-like flavor profile.
 
AFS sources its guayusa from a chain of co-ops and foundations across Ecuador and Peru.