OSLO, Norway—FDA had no objections to Superba™ krill oil receiving a New Dietary Ingredient Notification (NDIN). Aker BioMarine™, which supplies Superba, said the notification was accepted after FDA reviewed toxicology and clinical research data obtained from animal and human testing, which provided significant support for evidence of safety. Aker BioMarine further provided detailed composition of krill oil, showing 69 choline-containing phospholipids, believed to be responsible for the unique benefits of krill.
The NDIN process was coordinated by the regulatory group at Aker BioMarine Antarctic with the assistance of Soni & Associates Inc. of Vero Beach Florida.
"Krill oil has been legally marketed in the United States for many years," stated Nils Hoem, Ph.D., chief scientist at Aker BioMarine. "However, in addition to our GRAS submission already in place, we felt 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 krill oil achieved a Novel Food approval for the EU in 2009.
Aker BioMarine's proprietary Eco-Harvesting™ technology and on-board processing result in the unique composition of Superba krill oil and provide traceability from sea to shelf. The Marine Stewardship Council (MSC) granted MSC Certification for sustainable and well managed fisheries to Aker BioMarine. Aker sponsors in vitro, in vivo, and human clinical trials with phospholipid eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) from krill oil.
Superba krill oil is a natural source of phospholipid EPA and DHA omega-3 essential fatty acids (EFAs) and the naturally occurring antioxidant astaxanthin.
