Austin, TX – Exciting news in the food and beverage world as Applied Food Sciences (AFS) takes another great step in furthering the safety and validation of its AMATEA® organic guayusa extract by presenting its GRAS dossier to the Food and Drug Administration for review. 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 premium, organic energy. The industry generally regards the FDA’s merited ‘no further comment’ response as the best response from the FDA and an acknowledgment of the reliable safety data in support of the ingredient. The FDA’s ‘No Comment’ indicates that the 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.
To assist in completing their dossier, AFS turned to one of the oldest and most trusted natural products compliance firms in North America. “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,” says John Endres, Chief Scientific Officer, AIBMR Life Sciences.
About Guayusa – The Next Generation of Caffeine
Guayusa – Illex Guaysua – is an ancient plant of the holly genus that only grows in the Amazon regions of Ecuador and Peru. Guayusa contains a unique combination of caffeine and polyphenol antioxidants that provides a bright and focused energy experience. Used for centuries by the native Kichwa tribes, AFS tapped into a functional energy ingredient for food, beverage, and nutritional supplements. AMATEA® is a fully water-soluble extract with a pleasant tea-like flavor profile that can complement a wide variety of applications.
AFS has worked for several years to build a sustainable supply chain of responsibly and ethically sourced guayusa through co-ops and foundations across Ecuador and Peru. Protecting both the ecosystem and the cultures that surround the botanical ingredients are most important to AFS’ mission statement. AFS now adds an FDA GRAS ‘no comment’ conclusion to help food and beverage manufacturers looking to adopt a highly effective energy ingredient in their products.
Quick Facts about AMATEA:
- Provides a bright, focused energy
- Delivers caffeine + antioxidants
- Fully water-soluble with pleasant tea-like flavor
- Socially responsible supply chain
- USDA Organic / FDA ‘No Comment’ GRAS
- Well studied for safety and efficacy
What is GRAS – A Regulatory Requirement for Food & Beverages?
‘GRAS’ is an acronym for Generally Recognized As Safe, and it is one of the key pathways provided by the FDA for getting ingredients approved for use in food products. According to the FDA, any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a food additive. This process is called self-affirmed (or self-determined) GRAS and, while it is ultimately the product manufacturer’s responsibility, it can be costly and take a lot of time to complete. Therefore, many credible ingredient suppliers, like Applied Food Sciences, will have a GRAS dossier or equivalent completed for each ingredient they provide. A GRAS conclusion can also be significant in aiding in the regulatory process for dietary supplement ingredients.
“The FDA is, in essence, the ultimate authority on safety for ingredients in food and beverages,” explains Chris Fields, VP of Scientific Affairs for Applied Food Sciences. “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.”
About Applied Food Sciences
Applied Food Sciences (AFS) brings inspiration and innovation to functional ingredients for companies in the natural products industry. Quality is transparent through organic farming, ethical sourcing, and sustainability. AFS cares about every stakeholder from rural farmers to the largest companies in the world.
AIBMR Life Sciences has a dedicated team of experts with decades of experience in FDA regulatory consulting. They specialize in structuring supportive toxicological studies, collectively providing a unique perspective in the food and supplement industries.
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