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Successful FDA GRAS and NDI Notifications Conferred on Superba Krill Oil


Successful FDA GRAS and NDI Notifications Conferred on Superba Krill Oil

Date:11 August 2011

Type:Regulatory News

Source:Nutrition Horizon

Sector:Fats & Oils

Summary:Aker BioMarine Antarctic continues to make its Superba Krill Oil available to companies for inclusion in their dietary supplement offerings.

Aug 11 2011 --- Aker BioMarine Antarctic announces that the US FDA has accepted with no objections the notification of its independent GRAS determination for Superba Krill oil for use as a food ingredient. This acceptance, plus FDA’s recent acknowledgement of Aker BM’s New Dietary Ingredient Notification (NDIN), provides regulatory support for existing and prospective customers of Superba Krill oil for inclusion in new products and in new markets.

“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. The FDA’s earlier acknowledgement of our NDIN was important for our existing and future customers to introduce Superba products in all supplement channels, while the new self-affirmed GRAS Notice acceptance solidly opens the door to applications in the food and beverage industries as well,” stated Matts Johansen, EVP 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,” Johansen concluded.

Aker BioMarine Antarctic continues to make its Superba Krill Oil available to companies for inclusion in their dietary supplement offerings.

Nils Hoem, PhD, Chief Scientist at Aker BM, added, "We have clinical studies underway and in development with our customers internationally. Seeking to substantiate the health benefits of krill oil for joint health, mental acuity, heart health issues and other emerging areas of study will help our customers deliver krill products with validated health benefits, expanding the scope of the omega-3 market today.”

The phospholipid-bound EPA & DHA present in Superba Krill oil provide highly bioavailable omega-3 fatty acids for use in a number of food categories including beverages, cereals, cheese, and dairy products, as well as dietary supplements. The company is actively exploring functional food applications in the U.S. as well as in Europe where Superba Krill oil is notified under the Novel Foods regulation.

Aker BioMarine Antarctic is the only krill ingredient marketer that is primary in its supply. Its proprietary Eco-Harvesting technology and on-board processing result in the unique composition of Superba Krill oil and provide full traceability from sea to shelf. The Marine Stewardship Council (MSC) has granted MSC Certification to Aker BM‘s fisheries, an exclusive distinction that no other krill fishery has earned. As part of an established commitment to substantiating krill‘s health benefits, Aker BM continues to sponsor in vitro, in vivo, and human clinical trials with phospholipid EPA & DHA from krill oil, consistently demonstrating a higher uptake of phospholipid omega-3 fatty acids, improved blood lipid profiles, and increased uptake of DHA in brain tissue compared to other omega-3 fatty acid sources.
 

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