FDA Doesnt Object to Superba GRAS Status
August 9, 2011
OSLO, NorwayAker BioMarine Antarctic received a no objection" letter from FDA on the GRAS (generally recognized as safe) status of its Superba krill oil. FDA also recently acknowledged Akers new dietary ingredient notification (NDIN), and these two recognitions provides regulatory safety support for existing and prospective customers of Superba krill oil for inclusion in new products and in the U.S. market.
"Consumer safety and trust is paramount in the natural ingredients arena, and Aker BioMarine Antarctic has developed an extensive safety dossier for Superba krill oil," said Matts Johansen, executive vice president of sales and marketing. We are very pleased to offer our customers the support of these two important safety and regulatory compliant distinctions. Helping our customers confidently launch new Superba krill oil-based supplements and food and beverage products is essential to our business development."
After self-determining GRAS status in February 2011, Aker said it is exploring functional food applications in the United States as well as in Europe where Superba krill oil is notified under the Novel Foods regulation. Superba can be formulated into a number of food categories including beverages, cereals, cheese, and dairy products, as well as dietary supplements.
Krill oil provides eicosapentaenoic acid (EPA) and docosahexaenoic (DHA) in the phospholipid form, which provides highly bioavailable omega-3 fatty acids. It also naturally contains the antioxidant astaxanthin. Aker uses a proprietary Eco-Harvesting technology, on-board processing, and traceability from sea to shelf. The Marine Stewardship Council (MSC) granted MSC Certification to Akers fisheries.
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