We are pleased to share a major regulatory milestone for Vitalarmor® Lactoferrin in the U.S. market.
The FDA has confirmed that Armor Protéines' lactoferrin is covered by an existing GRAS notice, meaning that no separate GRAS notice is required for the use of our lactoferrin in infant formula.
This confirmation represents an important milestone in our ambition to support the development of high-quality infant nutrition solutions in the U.S. market.
Armor Protéines is now ready to supply its Vitalarmor® lactoferrin to infant formula manufacturers and to support them in their new infant formula notification submissions to the FDA.
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Meeting the Growing Demand for Premium Lactoferrin Ingredients
As demand for premium lactoferrin ingredients continues to grow, this milestone further strengthens Armor Protéines' ability to support customers in the US infant nutrition market.
“Achieving this regulatory milestone marks an important step in strengthening our position in the US infant formula market. It gives us the right to play with the right tools and reinforces our ability to support customers with our infant-grade lactoferrin ingredient.
Beyond market access, it also contributes to the visibility and brand recognition of Armor Protéines as a trusted partner in early life nutrition. We believe this can positively influence future developments with our customers in the US and other key markets.”
~ Thierry Dubois, Commercial Director, Armor Protéines
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Beyond its commercial significance, this milestone also highlights the growing importance of scientific expertise, ingredient quality, and regulatory excellence in advancing infant nutrition solutions.
"Lactoferrin is more and more a key ingredient in infant formula which allows infant nutrition to come one step further closer to mother’s milk. The GRAS equivalent status of the Vitalarmor® Lactoferrin is a clear recognition of the quality and the purity of our ingredient.
Expecting regulatory requirements to become increasingly strict, it is a strong sign that we should continue to work towards high-quality ingredients, particularly for infants' nutrition."
~ Laurent Bellego, Research & Development Director, Armor Protéines
