Lutein-fortified infant formula for newborn health: a comprehensive patent review and a systematic review of clinical trials.

Lutein is a diet-derived carotenoid present in human milk through maternal intake and has been associated with visual and neurodevelopmental processes in infancy. Lutein-containing infant formulas have therefore been developed to increase lutein exposure, although no evidence shows that formula fortification fully reproduces the biological effects associated with human milk. This review provides a comprehensive synthesis of clinical evidence on lutein supplementation in infants, patented formulations, and delivery technologies that influence lutein stability, bioavailability, and safety. The first section of the review evaluates lutein fortified infant formulas, including their health effects, regulatory standards, patent claims, and commercialization in the U.S. market. Although patents frequently include lutein as an optional ingredient, relatively few emphasize its developmental relevance or address the specific formulation challenges. The systematic review evaluates human and animal studies on clinical outcomes of lutein-fortified infant formulas, including lutein bioavailability, distribution in circulation and key tissues (brain and retina), safety, and tolerance. Across studies, lutein-fortified formulas consistently increase circulating lutein concentrations relative to unfortified formulas, yet bioavailability remains lower than that of breast milk. By combining both the patent and clinical literature, this review identifies critical scientific, technological, and regulatory gaps and highlights opportunities for future innovation in newborn nutrition.