AFS Guayusa Extract GRAS Dossier Receives “No Comment” From FDA

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Guayusa leaves. Image courtesy of AFS.

Austin, TX—Applied Food Sciences (AFS) has presented the GRAS dossier for its AMATEA organic guayusa extract to FDA for review, according to a press release, and has received a “no  further comment” response. AFS partnered with AIBMR Life Sciences to compile their dossier.

The “no further comment” response indicates that FDA 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, the release says, noting that this response is generally regarded in the industry as the best possible response from FDA.

Guayusa is a plant of the holly genus that only grows in the Amazon regions of Ecuador and Peru, the press release says. Guayusa contains a combination of caffeine and polyphenol antioxidants. AMATEA is a water-soluble extract with a tea-like flavor profile.

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“The FDA is, in essence, the ultimate authority on safety for ingredients in food and beverages,” says Chris Fields, VP of Scientific Affairs, AFS, in the press release. “Since it has extensively reviewed our safety data, our customers are provided the added trust and reliability on the level of regulatory acceptance for this ingredient. ‘No comment’ provides that extra layer of substantiation for the integrity of an ingredient to both regulatory bodies and, more importantly, our customers.”

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