Pharming reports on safety of human lactoferrin for food use
three studies demonstrate that its human lactoferrin can be
considered safe for use in functional foods.
The firm is aiming at to launch the product on the US market initially and the studies will be submitted to the Food and Drug Administration to gain GRAS (Generally Regarded As Safe) notification.
Presenting the results at an international conference on lactoferrin running in Hawaii this week, Bertjan Ziere, the company's senior director, said that toxicity studies demonstrate that the recombinant human lactoferrin can be consumed orally at high amounts with no adverse effect.
Genotoxicity tests have shown that rhLF does not cause any damage to cells or DNA within cells, and the product has also cleared allergenicity testing.
Dr Frans de Loos, director of the lactoferrin project at Pharming, said "the data from these studies will form the core elements of our US FDA filing for rhLF as a GRAS product for functional foods."
