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Home | News | OmniActive: Lutemax® Free Lutein Receives FDA GRAS Clearance for Infant Formula Use

OmniActive: Lutemax® Free Lutein Receives FDA GRAS Clearance for Infant Formula Use

A New Chapter in Infant Nutrition Starts Now

We’re excited to share and celebrate a major regulatory milestone—OmniActive’s Lutemax® Free Lutein has been acknowledged by the U.S. FDA as GRAS (Generally Recognized as Safe) for use in infant formula.

This achievement not only reinforces the safety and quality of their flagship lutein ingredient but also opens up an entirely new category: early life nutrition. Lutemax Free Lutein is now cleared for inclusion in one of the most sensitive and highly regulated food categories—giving infant formula manufacturers a differentiated, science-backed lutein source to support visual and cognitive development during the most critical stages of life.

Why It Matters:

  • Lutein is abundant in breast milk and essential for brain and eye development.
  • Infants cannot synthesize lutein on their own—dietary sources are vital.
  • Lutemax Free Lutein offers a stable, safe, and highly bioavailable form, derived from premium marigolds.

As part of OmniActive’s ongoing commitment to science, safety, and innovation, this GRAS clearance is a testament to over 20 years of research and their vision to nourish health—from prenatal to every stage of life.

For more details on how Lutemax Free Lutein can elevate your early life nutrition products, please contact Domnic Lobo today.

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