There are risks with not feeding breastmilk and ethics to consider when using breastmilk substitutes. Infants who are not fed with human milk, for whatever reason, should receive special attention from the health and social welfare system since they constitute a risk group.^{1 2} Formula feeding is associated with adverse health outcomes for both lactating parents and infants, ranging from infectious morbidity to chronic disease.³

The protective properties of human milk are unique, multifunctional, and interactive, and complement the developing immune system in the newborn infant. They simply cannot be duplicated in the laboratory.^{4 5} Since human milk feeding is the biological norm for infants, this means that there are risks to using any and all artificial human milk substitutes for infant feeding purposes as they affect bacterial colonization in the gastrointestinal (GI) tract.⁶

Parents and caretakers who cannot (exclusively) breastfeed and who cannot use a wet nurse or donor milk generally turn to infant human milk substitutes. The World Health Organization (WHO) and UNICEF recommend that healthcare providers inform parents and caretakers about the health risks of artificial feeding and the benefits associated with human milk.⁷ The risks are numerous, and many families are not informed about proper handling and preparation. Formula companies have indeed misinformed consumers by making false statements about their products and by neglecting to provide key information.^{8 9} This has widespread health and economic implications in many countries but is devastating to developing nations in particular.¹⁰

Preparing formula
Powdered infant formula needs to be handled and prepared safely, especially for infants under two months, infants born prematurely, or infants with a weakened immune system. Parents and caretakers are often not informed to use boiled water and let it cool for about 5 minutes. This is however especially important in order to avoid potentially deadly Cronobacter infection.^{11 12} Besides Cronobacter, Enterobacter sakasakii is another common contaminant in infant formula (as opposed to possible exposure to). If needed, liquid formula is the most effective control measure to minimize the risks of Cronobacter, Salmonella, and E. sakazakii because it is sterile. ^{13 14}

Prepared infant formula needs to be used quickly, refrigerated within two hours if not used, and discarded after the first feeding attempt because it contains no antibodies or anti-infective properties.^{15 16}

Unlike human milk, human milk substitutes also need to be carefully measured based on their caloric content to ensure that a baby is getting the suggested portion. Caregivers need to be warned against diluting or over-mixing, as doing so may put a child on a path of battling obesity or malnourishment.

Recalls
When using infant formula, risk monitoring by following official safety alerts and education associated with artificial infant feeding is important.^{17 18}

In February of 2022, the FDA issued a warning about infant formula causing four Cronobacter infections and one Salmonella Newport infection, which resulted in a nationwide infant formula recall. The illnesses resulted in hospitalization and Cronobacter may have contributed to the death of two patients. Shockingly, between December 1, 2021, and March 3, 2022, the FDA received not 2 but 9 reports of infant deaths among babies who were fed powdered infant formula manufactured by Abbott Nutrition.^{19 20}

The recall led to a nationwide infant formula shortage and desperation among parents to feed their children. Of course, most coverage of formula shortage as well as official suggestions from most, otherwise, reputable organizations only included where to look for infant formula, reiterating to not feed home-made formulas, goat or cow’s milk, to not dilute, etc. There is typically no mention of the obvious: that families with human milk to feed their own baby can safely help families in need.

Necrotizing Enterocolitis
When it comes to premature babies, Necrotizing Enterocolitis (NEC) is a very dangerous complication of feeding with human milk substitutes. Human milk has been associated with a decrease in NEC in premature babies and should be widely available to all infants in hospitals.^{21 22 23}

Environmental concerns
We are all exposed to environmental contaminants that we have no control over, but there are separate concerns with regard to infant formula, especially in storage and feeding containers. Environmental contaminants include phthalates,²⁴ bisphenol A (BPA),²⁵ and melamine.²⁶ Genetic engineering is also of concern.²⁷

When it comes to the lack of official recommendations and support for milksharing, Karleen Gribble writes that it is the cultural distaste for sharing human milk, as opposed to evidence-based research, that supports official warnings. Regulating bodies should conduct research and disseminate information about how to mitigate possible risks of sharing human milk, rather than proscribe the practice outright.²⁸

There is an overall lack of support for people who struggle with breastfeeding and human milk feeding. Parents and caretakers are exposed to media, and clinical or hospital environments filled with formula advertisements that give a strong message that undermines any form of lip service paid to breastfeeding and human milk feeding. This type of marketing and distribution goes directly against the International Code of Marketing Breast Milk Substitutes, a code that aims to protect breastfeeding, protect all lactating parents and babies (whether breastfeeding, formula-feeding, or combination feeding), and prevent aggressive marketing practices that often prevent lactating parents from meeting their own breastfeeding goals.²⁹

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1. WHO. 2003. Global Strategy for Infant and Young Child Feeding bullet 19 ↩︎
2. Also see HIV and the global context of infant feeding ↩︎
3. Allison Stuebe. 2009. The Risks of Not Breastfeeding for Mothers and Infants ↩︎
4. Susan Orlando, RNC, MS. 1995. The Immunologic Signi’cance of Breast Milk ↩︎
5. Cecily Heslett, Sherri Hedberg, Haley Rumble. 2007. Did you ever wonder what’s in… ↩︎
6. Marsha Walker, RN, IBCLC. 2014 Just One Bottle Won’t Hurt” –or Will it? ↩︎
7. WHO – The International Code of Marketing of Breast-Milk Substitutes, bullet 4.2 ↩︎
8. Infact Canada – Genetically Modified Organisms ↩︎
9. Infact Canada – Misinformation: Redefining baby feeding ↩︎
10. Formula for Disaster – This eye-opening documentary reveals how the marketing of powdered milk has caused fewer mothers to breastfeed in the Philippines – including those who can ill afford artificial milk and suffer its harmful consequences. The milk companies’ formula for profits is a formula for disaster. ↩︎
11. CDC – Cronobacter Infection and Infants ↩︎
12. WHO – Safe preparation, storage and handling of powdered infant formula: guidelines ↩︎
13. European Food Safety Authority. 2004. Microbiological risks in infant formulae and follow-on formulae ↩︎
14. Dr. John May, et al. 2005. La Trobe Tables ↩︎
15. Lawrence, Ruth. Breastfeeding, A Guide for the Medical Profession. P. 438. 2005. Print. ↩︎
16. CDC – Infant Formula Preparation and Storage ↩︎
17. Follow the FDA’s Alerts & Safety Information and Reporting Illnesses, Injuries and Problems for the latest recalls of formula. ↩︎
18. For more information on safe practices, sterilization, and the micro bacterial content in powdered formula see the Codex Alimentarius – CODE OF HYGIENIC PRACTICE FOR POWDERED FORMULAE FOR INFANTS AND YOUNG CHILDREN and Codex Alimentarius – STANDARD FOR INFANT FORMULA AND FORMULAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS ↩︎
19. FDA – FDA Warns Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility in Sturgis, Michigan ↩︎
20. eFoodAlerts. 6/8/22. Nine baby deaths reported to FDA during Abbott Nutrition investigation ↩︎
21. Standford Children’s Health – Necrotizing Enterocolitis in the Newborn ↩︎
22. Barbara Noerr. 2003. Current Controversies in the Understanding of Necrotizing Enterocolitis ↩︎
23. What about premature babies? ↩︎
24. Government of Canada – Phthalate Substance Grouping ↩︎
25. MA Department of Public Health – How to Protect Your Baby From BPA (Bisphenol A) ↩︎
26. WHO/FAO/Health Canada. 2008. Toxicological and Health Aspects of Melamine and Cyanuric Acid ↩︎
27. Government of Canada – Novel foods: Safety of genetically modified foods ↩︎
28. Karleen D. Gribble, Bernice L. Hausman. 2012. Milk sharing and formula feeding: Infant feeding risks in comparative perspective? ↩︎
29. World Health Organization. 2003. International Code of Marketing Breast Milk Substitutes. ↩︎