FDA greenlights first human milk-based fortifier for term infants

USA – The U.S. Food and Drug Administration has approved a human milk-based nutritional product designed specifically for full-term infants. 

Reported by Prolacta Bioscience Hospital, a leading supplier of 100%  human milk-based supplements, the newly approved Surgifort human milk fortifier is aimed at aiding term infants recovering from gastroschisis surgery. 

This marks the first time a human milk-based fortifier has been authorized for use in full-term babies, offering a specialized solution to meet their unique nutritional needs during recovery.

Gastroschisis, a birth defect where an infant’s intestines protrude through the abdominal wall, affects fewer than 2,400 babies annually in the U.S. and requires surgical intervention followed by enhanced nutritional support.

Surgifort fortifier, a pasteurized product derived from donated human milk, is formulated to deliver critical protein, calories, and minerals essential for growth. 

When mixed with term human milk and given in proper amounts, it aligns with the nutritional guidelines set by the National Academy of Medicine. 

According to Prolacta, the fortifier addresses the increased macronutrient demands of infants post-surgery, helping them recover more effectively. 

Research shared by the company shows that infants on an Exclusive Human Milk Diet, including Surgifort, experience quicker weight gain and reach full feeding volumes faster than those on other diets, a vital factor in their healing process.

Scott Elster, CEO of Prolacta Bioscience, hailed the approval as a significant milestone.

 “With Surgifort fortifier, we’re entering a new chapter in specialized human milk-based nutrition, extending its clinically proven benefits to babies who are not born prematurely,” he said. 

“This advances our commitment to develop human milk-based nutritional solutions for infant populations with complex medical needs.” 

The product’s development reflects years of research into the benefits of human milk, long recognized for its role in supporting premature infants, now adapted for this specific group of term babies.

A report by the FDA confirms that Surgifort meets stringent safety and efficacy standards, ensuring it provides a reliable option for hospitals and families. 

The approval expands Prolacta’s portfolio, which has primarily focused on preterm infants, into a new frontier of infant care.

 Elster also noted the company’s ongoing mission to innovate, stating,“We’re proud to offer a product that can make a real difference for these infants and their families.” 

As gastroschisis cases remain rare but challenging, Surgifort fortifier offers a tailored nutritional tool to support recovery, drawing on the natural benefits of human milk to improve outcomes for these vulnerable newborns.