Neptune gains GRAS for NKO
safe for human consumption, opening up the route for its
manufacturer to commercialize it for functional foods.
NKO, derived from the planktonic family of crustacean, is rich in omega-3 as well as phospholipids and antioxidants., has been used in dietary supplements since 2003.
But its maker, Neptune Technologies and Bioressources has been harbouring desires to take it into the functional foods arena.
In 2007 it entered into two agreements with major companies to explore NKO's use in functional foods - Nestle, the world's largest food company, and diary giant Yoplait.
Before they can be commercialized in the United States, foods have to be affirmed as generally recognised as safe (GRAS).
This affirmation is given by an accredited independent committee that studies the scientific and toxicological evidence.
From here, a company has two options: it can either go straight to market, or it can voluntarily submit the documentation to the FDA.
Chief scientific officer Dr Tina Sampalis told NutraIngredients-USA.com that the company has chosen the second route because it gives the ingredient greater weight.
The FDA usually takes three or more months to give its opinion, but Neptune is confident of a positive opinion since its panel of experts - Richard Kraska, PhD, DABT, Robert McQuate, PhD, and Stanley Omaye, PhD - have all worked with the FDA, either at present or in the past.
In addition to meeting a milestone set by Nestle and Yoplait ahead of time, Sampalis said the GRAS notification allows for entry into the functional foods market with other interested companies, with different products and different health conditions.
GRAS status, she said, is the milestone that had been seen as a condition of finalising these deals.
Sampalis was not able to disclosed the health conditions that are covered either by the Yoplait and Nestle agreements, or the other interested parties.
However NKO has been studied for its benefits in a number of therapeutic areas.
Particularly positive results have been seen in the areas of cognitive health (attention deficit hyperactivity disorder) and cardiovascular health (LDL cholesterol reduction).
It is not known how long it may be before the first NKO-containing functional foods appear on the market.
Neptune is also seeking food approval for NKO in other markets.
It expects to make an announcement regarding novel foods approval in Europe quite soon, and is also hoping to have approval for foods in Australia.
