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FDA Has No Objections to Pomella® GRAS Status
News provided byEIN Presswire
Oct 04, 2023, 8:15 AM ET
Verdure Sciences, Inc. has successfully achieved official Generally Recognized as Safe (GRAS) Status for the ingredient Pomella®.NOBLESVILLE, IN, UNITED STATES, October 4, 2023 /EINPresswire.com/ -- Verdure Sciences, Inc. has successfully achieved official Generally Recognized as Safe (GRAS) Status for the ingredient Pomella®, pomegranate extract after notification to the United States Food and Drug Administration (FDA), under the guidance of REJIMUS, INC., a preeminent regulatory consultancy to the Food, Beverage, and Dietary Supplement markets in the United States.
“REJIMUS has helped achieve another successful notification with lots of hard work, and our gratitude to the entire Verdure team for not only the opportunity to work on such a legacy ingredient but also for sharing that commitment of getting through the rigors of an FDA GRAS Notification, is overflowing,” said Brandon Griffin, CEO of REJIMUS, INC. “We lead by example in all that we do, and our track record of successful FDA notifications speaks for itself while reflecting on our mission of ensuring the overall compliance and safety of our clients’ ingredients, finished products and operations, which is second to none.”
“Verdure is exceptionally proud to have received a no objection letter for GRAS Status from the FDA for Pomella®, a patented pomegranate extract available to the food and supplement sectors. We are dedicated to the highest level of transparency and safety of our ingredients”, said Ajay Patel, Founder and CEO of Verdure Sciences, Inc. “This is a critical achievement for our customers and their consumers. Increased regulatory evaluations and scrutiny over food ingredients in the US marketplace today present challenges for companies that do not make such an investment or commitment, so we’re incredibly grateful to REJIMUS and our entire team for their dedication, enabling Pomella® extract to stand apart from the competition”, said Sonya Cropper, Executive VP, Verdure Sciences, Inc.
Pomella®, a patented pomegranate extract (Punica granatum) is standardized to punicalagins and polyphenols, providing ellagitannins and their gut microbial metabolites, urolithins. Beyond quality assurance and traceability parameters, there is a body of science supporting Pomella’s® efficacious antioxidant properties, meeting the consumer demand for clean label ingredients.
The determined acceptable use of Pomella® as an ingredient in dairy milk, fruit and vegetable juices, and chocolate candy food products identified under the GRAS Notification (GRN 1064) is at levels up to 50mg per serving.
About Verdure Sciences, Inc.
Verdure Sciences® is a leading developer and supplier of innovative plant-based ingredients with an emphasis on quality, sustainability, traceability, and supporting research. To learn more about Pomella® or Verdure’s current ingredient initiatives, ingredients for sale, and other services, please visit: https://vs-corp.com/pomella/
About REJIMUS, INC.
REJIMUS® is a preeminent cGMP regulatory management consulting firm enabling companies in the Food & Beverage, Dietary Supplement, Cosmetic and Homeopathic/OTC markets to get their novel ingredients and finished products into the US marketplace faster, through the employment of best compliance practices, strategic project management, and risk-based approaches to navigating current regulatory environments for ingredient notifications and supply-chain compliance. For more information on the markets served and other service offerings, please visit: https://www.rejimus.com
Brandon M Griffin
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