Originally published October 24 2005
Biotech company says human lactoferrin is ready for FDA trials
by Mike Adams, the Health Ranger, NaturalNews Editor
After holding three studies to evaluate the effect of its human lactoferrin, Dutch biotech company Pharming prepares to put its product on the U.S. market and submit it to the FDA for safety approval.
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."
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