Prolacta Bioscience demonstrates leadership in human milk science with history of voluntarily reviewing health claims with the FDA

DUARTE, Calif., July 24, 2024 – Prolacta Bioscience^®, the world’s leading hospital provider of 100% human milk-based nutritional products, takes its obligation to the critically ill and premature infants it serves, and to the doctors providing them with care, extremely seriously. As such, Prolacta is addressing a recent challenge made regarding certain advertising claims.

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^1,2
• Reduce risk of necrotizing enterocolitis (NEC)^3,4,5
• Reduce incidence of feeding intolerance³
• Achieve adequate growth^6,7,8
• Reduce incidence of bronchopulmonary dysplasia (BPD)^3,4,6,9
• Reduce incidence of retinopathy of prematurity (ROP)^3,4,9,10
• Reduce late-onset sepsis incidence^4,10 and evaluations⁹
• Improve long-term outcomes such as neurodevelopment^11,12
• Shorten stays in the neonatal intensive care unit (NICU)³
• Reduce hospital costs^3,13

“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. Learn more on X, Instagram, Facebook, and LinkedIn.

Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310.721.9444

References

1. Lucas A, Boscardin J, Abrams SA. Preterm infants fed cow’s milk-derived fortifier had adverse outcomes despite a base diet of only mother’s own milk. Breastfeed Med.
   2020;15(5):297-303. doi:10.1089/bfm.2019.0133
2. Abrams SA, Schanler RJ, Lee ML, Rechtman DJ. Greater mortality and morbidity in extremely preterm infants fed a diet containing cow milk protein products. Breastfeed Med.
   2014;9(6):281-285. doi:10.1089/bfm.2014.0024
3. Assad M, Elliott MJ, Abraham JH. Decreased cost and improved feeding tolerance in VLBW infants fed an exclusive human milk diet. J Perinatol. 2016;36(3):216-220. doi:10.1038/jp.2015.168
4. Hair AB, Peluso AM, Hawthorne KM, et al. Beyond necrotizing enterocolitis prevention: improving outcomes with an exclusive human milk-based diet [published correction appears in Breastfeed Med. 2017 Dec;12 (10):663]. Breastfeed Med. 2016;11(2):70-74. doi:10.1089/bfm.2015.0134
5. Sullivan S, Schanler RJ, Kim JH, et al. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010;156(4):562-7.e1. doi:10.1016/j.jpeds.2009.10.040
6. Huston R, Lee M, Rider E, et al. Early fortification of enteral feedings for infants <1250 grams birth weight receiving a human milk diet including human milk-based fortifier. J Neonatal Perinatal Med. 2020;13(2):215-221. doi:10.3233/NPM-190300
7. Huston RK, Markell AM, McCulley EA, Gardiner SK, Sweeney SL. Improving growth for infants ≤1250 grams receiving an exclusive human milk diet. Nutr Clin Pract. 2018;33(5):671-678. doi:10.1002/ncp.10054
8. Hair AB, Hawthorne KM, Chetta KE, Abrams SA. Human milk feeding supports adequate growth in infants ≤1250 grams birth weight. BMC Res Notes. 2013;6:459. Published 2013 Nov 13. doi:10.1186/1756-0500-6-459
9. Delaney Manthe E, Perks PH, Swanson JR. Team-based implementation of an exclusive human milk diet. Adv Neonatal Care. 2019;19(6):460-467. doi:10.1097/ANC.0000000000000676
10. O'Connor DL, Kiss A, Tomlinson C, et al. Nutrient enrichment of human milk with human and bovine milk-based fortifiers for infants born weighing <1250 g: a randomized clinical trial [published correction appears in Am J Clin Nutr. 2019 Aug 1;110(2):529] [published correction appears in Am J Clin Nutr. 2020 May 1;111(5):1112]. Am J Clin Nutr. 2018;108(1):108-116. doi:10.1093/ajcn/nqy067
11. Hair AB, Patel AL, Kiechl-Kohlendorfer U, et al. Neurodevelopmental outcomes of extremely preterm infants fed an exclusive human milk-based diet versus a mixed human milk + bovine milk-based diet: a multi-center study. J Perinatol. 2022;42(11):1485-1488. doi: 10.1038/s41372-022-01513-3
12. Bergner EM, Shypailo R, Visuthranukul C, et al. Growth, body composition, and neurodevelopmental outcomes at 2 years among preterm infants fed an exclusive human milk diet in the neonatal intensive care unit: a pilot study. Breastfeed Med. 2020. 15(5):304- 311. doi:10.1089/bfm.2019.0210
13. Ganapathy V, Hay JW, Kim JH. Costs of necrotizing enterocolitis and cost-effectiveness of exclusively human milk-based products in feeding extremely premature infants. Breastfeed Med. 2012;7(1):29-37. doi:10.1089/bfm.2011.0002
14. Data on file; estimated number of premature infants fed Prolacta's products from January 2007 to August 2023.