Dating back to 2007, Prolacta has voluntarily submitted its health-related advertising claims to regulatory review. Prolacta reviews proposed claims and provides the substantiating evidence to its primary regulator, the U.S. Food and Drug Administration (FDA), and the agency works with Prolacta, where and if necessary, to refine the claim language.
In response to a May 2024 complaint filed by Mead Johnson & Company with the BBB National Advertising Division (NAD) challenging certain advertising claims, Prolacta referred NAD to the FDA.
Prolacta stands firmly behind the clinical evidence in support of its products. Compared to cow milk-based products, an exclusive human milk diet (EHMD) with Prolacta's 100% human milk-based nutritional fortifiers, has been clinically proven in numerous clinical studies to:
Lower mortality and morbidity
Reduce risk of necrotizing enterocolitis (NEC)
Reduce incidence of feeding intolerance
Achieve adequate growth
Reduce incidence of bronchopulmonary dysplasia (BPD)
Reduce incidence of retinopathy of prematurity (ROP)
Reduce late-onset sepsis incidence4,10 and evaluations
Improve long-term outcomes such as neurodevelopment
Shorten stays in the neonatal intensive care unit (NICU)
Reduce hospital costs
"Prolacta thanks NAD for its work in this matter but believes that in this case, the FDA is the proper forum for any inquiry regarding health claims," said Scott Elster, CEO of Prolacta Bioscience. "We stand ready and willing to discuss any questions regarding our advertising claims from U.S. government regulatory agencies as we have done throughout our history."
About Prolacta Bioscience:
Prolacta Bioscience® is a global life sciences company dedicated to Advancing the Science of Human Milk® to improve health outcomes for critically ill and premature infants. More than 100,000 extremely premature infants worldwide14 have benefited from Prolacta's human milk-based products, which have been evaluated in more than 30 peer-reviewed clinical studies. Operating the world's first pharmaceutical-grade human milk processing facilities, Prolacta maintains the industry's strictest quality and safety standards, with over 20 validated tests for screening and testing human milk. Prolacta's manufacturing process uses vat pasteurization to ensure pathogen inactivation while protecting nutritional composition and bioactivity.
For more information please visit, www.prolacta.com
