Applied Food Sciences (AFS) has announced that it has received a “no comment” letter from the U.S. Food and Drug Administration (FDA) for its AMATEA organic guayusa extract GRAS [generally recognized as safe] dossier. AMATEA is a branded guayusa extract that uses a patented extraction process to highlight the caffeine and antioxidants naturally occurring in guayusa leaves to provide organic energy. The industry generally regards the FDA’s merited “no further comment” response as the best response from the agency and an acknowledgment 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 the company’s conclusion that AMATEA is safe for the intended use in food and beverage applications set out in the dossier.
To help complete the dossier, AFS turned to AIBMR Life Sciences, a natural products compliance firm. “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,” said John Endres, chief scientific officer, AIBMR Life Sciences.