Company Refers National Advertising
Division to the FDA for Confirmation of Claims Regarding Its Human
Milk-Based Fortifiers
DUARTE,
Calif., July 24, 2024 /PRNewswire/
-- 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 morbidity1,2
- Reduce risk of necrotizing enterocolitis
(NEC)3-5
- Reduce incidence of feeding intolerance3
- Achieve adequate growth6-8
- 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 incidence4,10 and
evaluations9
- Improve long-term outcomes such as
neurodevelopment11,12
- Shorten stays in the neonatal intensive care unit
(NICU)3
- Reduce hospital costs3,13
"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."
For more information about Prolacta Bioscience, visit
prolacta.com.
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 at
www.prolacta.com, on X, Instagram,
Facebook, and LinkedIn.
Media Contact:
Loren Kosmont
Lkosmont@prolacta.com
310-721-9444
References
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Data on file; estimated number of premature infants fed
Prolacta's products from January 2007
to August 2023.
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SOURCE Prolacta Bioscience