Lutemax protects eye from blue light and UV rays, which helps reduce eye strain and fatigue and may lower the risk of age-related macular degeneration. Breast milk naturally contains significant amount of Lutein to meet infant’s need whereas formula fed infants lacks lutein. Therefore, to bridge the gap between the lutein need and demand, OmniActive Technology have developed an infant formula named Lutemax Free Lutein — a key advancement in nutritional product development and food product innovation for infant health. Additionally, Lutemax supports healthy skin by protecting it from oxidative stress and environmental damage, thereby improving skin and brightness. [1]
FDA Grants GRAS Recognition (GRN 390) to OmniActive’s Lutemax Lutein for Use in Infant Formula
Lutemax protects eye from blue light and UV rays, which helps reduce eye strain and fatigue and may lower the risk of age-related macular degeneration. Breast milk naturally contains significant amount of Lutein to meet infant’s need whereas formula fed infants lacks lutein. Therefore, to bridge the gap between the lutein need and demand, OmniActive Technology have developed an infant formula named Lutemax Free Lutein — a key advancement in nutritional product development and food product innovation for infant health.
Additionally, Lutemax supports healthy skin by protecting it from oxidative stress and environmental damage, thereby improving skin and brightness. [1]
What is Lutein?
Lutein is an antioxidant in the carotenoid family; a pigment found in fruits and vegetables. It ranges from yellow, orange to red colours. Since human body cannot produce lutein, it must be obtained through diet or supplements.
Lutein content can be increased by inclusion of Green leafy vegetable like kale, spinach, turnip greens, broccoli, corn, peas, squash, grapes, kiwis, egg yolks, etc
General dosage / recommendation – 10mg of Lutein and 2mg of zeaxanthin for eye health. In the context of food ingredient innovation & development of infant formula, lutein plays a crucial role in replicating the natural nutrient profile of breast milk.
How lutein support eye health and brain development
Lutein gets accumulated in the retina of the eye and in brain tissues, especially during early life and infancy. It is delivered to the fetus through cord blood and then to infants via breast milk and diet.
Eye health mechanism
- Lutein is concentrated in macula, where it forms part of macular pigment
- It filters and absorbs damaging short wavelength blue light, thus protecting retinal photoreceptors against oxidative stress.
- It is potent antioxidant which helps in neutralizing reactive oxygen species thereby reducing oxidative damage to retinal cells (crucial during eye’s developmental and maturation phases) [2]
Brain development mechanism
- Lutein accumulates selectively in brain regions involved in learning and memory (frontal and occipital cortex, hippocampus)
- It protects highly unsaturated fatty acids like DHA in neural membranes from oxidative damage.
- It also influences cortical folding and supports maturation of neural cells such as oligodendrocytes that is important for brain development [3]
These findings position lutein as a functional ingredient in food formulation & development, especially for infant nutrition applications.
Health Benefits of Lutein
The following table summarises the health benefits along with the underlying mechanism of action. [4]
Health Benefits | Mechanism involved |
Anti-Inflammatory Effects | It modulates by reducing pro inflammatory cytokines and oxidative stress markers, contributing to lower tissue inflammation |
Cardiovascular Health | It reduces LDL oxidation, lipid peroxidation and atherosclerotic risk. It may improve endothelial function. |
Skin Protection | It filters UV and high energy visible light, by protecting skin cells from photo oxidative damage |
Liver Health | It decreases oxidative stress and lipid accumulation in liver, potentially reducing the risk of NAFLD |
Bone Health | It stimulates bone formation and reducing bone resorption through regulatory effects on inflammatory pathways and NF-KB signalling |
What is meant by FDA Approved product? How does GRAS number work?
An FDA Approved product is the one that undergoes rigorous review process to evaluate its safety, effectiveness and quality before allowed into market. This approval is granted on scientific evidence from laboratory and clinical studies. FDA Approval means the benefits of product outweigh its risk when used as directed and the product met specific regulatory standards for labelling, manufacturing and marketing.
GRAS stands for “Generally recognised as Safe”, a designation given by FDA to substances added to food that are considered safe based on long history of common use in food or on the results of scientific research.
Application examples
Why Lutemax is Approved by FDA?
Lutemax ingredients primarily include Lutein, RR-Zeaxanthin, RS (meso) – Zeaxanthin
These three macular carotenoids are present in the same 5:1 ratio as found naturally in the diet. Lutemax is naturally derived from marigold flowers (non-GMO). It is a patented extract delivering all the key carotenoids required for infant’s health.
Also, lutein is approved by FDA with GRN 390 for use in infant formula for premature infants, demonstrating compliance with safety and quality standards essential to food product development and food formulation & development.
Common brands marketing lutein supplements
- Similac Advance (Abbott Nutrition)
- Known as one of the few infant formulas that include lutein, designed to help support brain and eye development like breast milk.
- Enfamil NeuroPro (Mead Johnson Nutrition)
- Contains lutein along with DHA, aimed at supporting cognitive development and vision in infants.
- Gerber Good Start Gentle (Nestlé)
- Includes lutein as part of the formulation targeting immune and visual development for babies.
- Earth’s Best Organic Infant Formula
- Includes lutein as a nutrient to support early brain and eye health.
- Similac Plus Stage 3
- A follow-up formula for toddlers (12-24 months) with lutein, DHA, and other critical nutrients to support growth and development.
Product Example
Brand Name: Abbott Nutrition
Product Name: Similac Advance
Product Category: Infant Formula Milk based Powder
Clinical Study
- The randomized clinical trial “Effects of lutein supplementation on biological antioxidant status in preterm infants” examined whether oral lutein could improve the total antioxidant status (TAS) in preterm infants.
- Seventy-seven preterm infants (gestational age ≤34 weeks) were enrolled in the study and randomized to receive daily doses of lutein plus zeaxanthin or placebo beginning on day 7 of life until 40 weeks postmenstrual age or discharge.
- The study found no statistically significant differences in TAS between the lutein and placebo groups during the time of the study; however, there was a modest, yet significant, positive correlation between plasma lutein and zeaxanthin levels and TAS, demonstrating that higher carotenoid levels are correlated with increased antioxidant status.
- The authors concluded that oral lutein supplementation was ineffective at statistically significantly increasing biological antioxidant capacity in preterm infants and stated that future studies will define how lutein is bioavailable in neonates and the best strategy to reach adequate supplementation. [5]
Conclusion
Infants, especially preterm are born with immature antioxidant defense system as the key antioxidant enzymes and compounds develop late in gestation. This immaturity limits their ability to neutralise harmful reactive oxygen species (ROS) leading to oxidative stress. This in turn damages vital organs and interfere with normal body mechanism. Unlike adults, infants rely heavily on maternal lutein obtained through breast milk or supplemented formula to protect tissues and lay the foundation for eye and brain health. Therefore, to enrich the food products with lutein various assessment methods followed by scientific evidence have will be performed to give a value-added product. Partner with us for innovation at Food Research Lab — your trusted collaborator in food product innovation and evidence-based product design.
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