According to the company, FDA issued no objections following an extensive review of toxicology and clinical research data obtained from both animal and human testing.
The notification, assisted by Soni & Associates, Inc. of Vero Beach Florida, also provided detailed composition of krill oil, said the company, including “the most extensive elucidation to date showing 69 distinct choline-containing phospholipids, believed to be responsible for the unique benefits of krill”.
Under the 1994 Dietary Supplements Health & Education Act (DSHEA), firms are required to notify the FDA if they intend to market a dietary supplement in the US that contains a ’new dietary ingredient’ (which has not been marketed in the US dietary supplements market before October 15, 1994) and demonstrate that it is safe.
Dietary ingredients used in dietary supplements before this date were ‘grandfathered in’ and considered safe.
"Krill oil has been legally marketed in the US for many years," said 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."
Krill are tiny shrimp gaining attention as a rich source of omega-3, as well as other nutrients.
There are about 85 species of the deepwater marine planktonic crustacean, or deepwater shrimp, which are the planet's most abundant animal biomass and which when captured and converted to oil, pack 48 times the antioxidant punch of standard fish oils, according to ORAC antioxidant scales.