The company recently notified FDA of the Generally Recognized as Safe (GRAS) status of its Pomella pomegranate extract. FDA responded with a letter of no objection.
Pomella, a branded pomegranate extract from Verdure Sciences Inc. (Noblesville, IN), is now Generally Recognized as Safe (GRAS). The company recently notified FDA of Pomella’s GRAS status, and FDA responded with a letter of no objection.
The GRAS notification covers Pomella’s use as an ingredient in dairy milk, fruit and vegetable juices, and chocolate candy food products at doses of up to 50 mg per serving. The ingredient itself is a patented pomegranate (Punica granatum) extract that is standardized to punicalagins and polyphenols. It provides ellagitannins and their gut microbial metabolites, urolithins.
Verdure Sciences was aided in preparing its GRAS notification by regulatory consultant Rejimus Inc. (Santa Ana, CA). In a press release, Ajay Patel, CEO of Verdure Sciences, stated, “Verdure is exceptionally proud to have received a ‘no objection’ letter for GRAS status from the FDA for Pomella…This is a critical achievement for our customers and their consumers.”
Sonya Cropper, Verdure Sciences’ executive vice president, added, “Increased regulatory evaluations and scrutiny over food ingredients in the U.S. 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."