Superba krill oil NDI notification accepted by FDA

Superba krill oil NDI notification accepted by FDA

Aker BioMarine Antarctic announces that information demonstrating the safety of Superba Krill Oil has been evaluated by the U.S. Food & Drug Administration via the New Dietary Ingredient Notification process.

Aker BioMarine(TM) Antarctic announces that information demonstrating the safety of Superba(TM) Krill Oil has been evaluated by the U.S. Food & Drug Administration via the New Dietary Ingredient Notification process (NDIN). FDA had no objections following review of extensive toxicology and clinical research data obtained from animal and human testing, which provides significant support for evidence of safety. Aker BioMarine further provided detailed composition of krill oil, including the most extensive elucidation to date showing 69 distinct choline-containing phospholipids, believed to be responsible for the unique benefits of krill.

"Krill oil has been legally marketed in the US for many years," stated Nils Hoem, PhD, Chief Scientist at Aker BioMarine. "However, in addition to our GRAS submission already in place, we felt that our choice to submit information to FDA for review via the NDI process fully validates our safety dossier. Further, our unique manufacturing process uses ethanol, a more internationally accepted solvent."

Superba(TM) Krill is a minimally processed whole food harvested from the pristine Antarctic waters, naturally pure and essentially free of contaminates and chemicals. Also, because krill is on the bottom of the food chain and consume algae, there is no bioaccumulation of heavy metals.

The NDIN process was coordinated by the regulatory group at Aker BioMarine Antarctic with the assistance of Soni & Associates, Inc. of Vero Beach Florida.

Superba(TM) Krill Oil achieved a Novel Food approval for EU in 2009.

Aker BioMarine is the only krill ingredient marketer that is primary in its supply. Aker BioMarine's proprietary Eco-Harvesting(TM) technology and on-board processing result in the unique composition of Superba(TM) Krill Oil and provide full traceability from sea to shelf.

The Marine Stewardship Council (MSC) has granted MSC Certification for sustainable and well-managed fisheries to Aker BioMarine, an exclusive distinction that no other krill fishery has earned. As part of an established commitment to substantiating krill's health benefits, Aker continues to sponsor in vitro, in vivo, and human clinical trials with phospholipids EPA & DHA from krill oil, consistently demonstrating a higher uptake of phospholipids omega-3 fatty acids, improved blood lipid profiles, and increased uptake of DHA in brain tissue compared to other omega-3 fatty acid sources.

Maki, et. Al., "Krill oil supplementation increases plasma concentrations of eicosapentaenoic and docosahexaenoic acids in overweight and obese men and women" Nutrition Research 2009 29:9 pp 609-615 Winther, et. al., Elucidation of Phosphatidylcholine Composition in Krill Oil Extracted from Euphausia superba Lipids 2010 46:1 pp 25-36

About Superba(TM) Krill Oil

Superba(TM) Krill Oil is a pure, natural source of the health-promoting phospholipids EPA & DHA omega-3 essential fatty acids and the naturally occurring antioxidant astaxanthin. The uniqueness of Superba(TM) Krill Oil is that the omega-3 fatty acids are provided in phospholipids form. In vitro, in vivo, and human clinical research has demonstrated the safety and efficacy of Superba(TM) Krill Oil.

About Aker BioMarine(TM)

Aker BioMarine is an integrated biotechnology company dedicated to the sustainable harvesting of krill and development of krill-derived biotech products. The company supplies biomarine ingredients through an optimized value chain from raw materials to customers. Aker BioMarine's Superba(TM) Krill products are provided with 100% traceability from the Antarctic Ocean to the end user. Only Aker's krill fishery has been awarded Marine Stewardship Council (MSC) Certification.

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