Formula companies present their products as safe, scientifically tested, and nutritionally complete. But when you look beyond the glossy labels, a different picture emerges—one marked by contamination outbreaks, devastating illnesses like necrotizing enterocolitis (NEC), and a regulatory system that too often looks the other way. For preterm and fragile infants, the risks can be life-altering—or life-ending.
When Powdered Formula Isn’t Safe
Parents often assume that powdered infant formula is sterile. It isn’t. Even after industrial processing, harmful bacteria like Cronobacter sakazakii can survive—or reappear through contaminated factory environments.
That truth came into sharp focus in 2022, when Abbott Nutrition’s Sturgis, Michigan plant became the center of a national crisis. Several infants were hospitalized, and at least one died, after consuming powdered formulas linked to the facility. Inspections revealed troubling lapses in environmental monitoring and sanitation. Cronobacter was found in the plant, and recalls swept Similac, Alimentum, and EleCare off store shelves nationwide (FDA, 2022).
The fallout was immediate: hospitalizations, recalls, and a nationwide shortage of infant formula. Abbott eventually reduced production and upgraded safety protocols, while the FDA scrambled to release a “strategy” to help prevent Cronobacter illnesses in the future (FDA, 2023). But for families, the lesson was painfully clear: powdered formula is not sterile, and contamination can turn a trusted product into a deadly one.
NEC: The Most Devastating Risk of Formula Feeding
Among the risks tied to formula, none is more feared in NIUCs than necrotizing enterocolitis (NEC). NEC is a catastrophic intestinal disease where tissue dies, sometimes perforating the gut and leading to sepsis. Mortality can be as high as 40%. Survivors often face long-term complications like short bowel syndrome or neurodevelopmental delays.
The link between formula and NEC is well established. In 1990, Lucas and Cole published a landmark study of more than 900 preterm infants: those fed exclusively on formula were 6–10 times more likely to develop NEC than those given only human milk, and about 3 times more likely than infants fed a mix of breast milk and formula (Lucas & Cole, 1990).
Decades of research have reinforced the finding. Donor human milk has consistently been shown to reduce NEC risk compared to formula (McGuire & Anthony, 2003). A 2024 Cochrane Review concluded that donor milk cut NEC risk nearly in half compared to formula in very preterm or very low birthweight infants (Quigley et al., 2024). The message is clear: human milk protects, cow’s milk–based formula increases risk.
The Courtroom Battles
The science has now become the basis for lawsuits. Families of preterm infants have filed cases against Abbott (Similac) and Mead Johnson (Enfamil), alleging the companies failed to warn parents and providers about the dangers. In NICUs across the country, parents were handed bottles of formula without being told that the risk of NEC would skyrocket.
Today, more than 500 lawsuits are consolidated in Illinois, arguing that formula companies knowingly exposed preterm infants to NEC without adequate warnings (Drugwatch, 2025). The first trial—Gill v. Abbott—opened in Missouri in 2024. At its center: the story of a premature baby who developed NEC and was left permanently impaired after being fed Similac in the NICU (Reuters, 2024). Families are demanding accountability for what they argue is not just a medical tragedy, but a corporate failure.
Beyond NEC and Cronobacter: Other Risks of Formula
Not all risks tied to formula are as immediate or dramatic as NEC or Cronobacter outbreaks. Some unfold quietly, shaping an infant’s health in ways that may not be obvious until later. The science increasingly shows that formula alters the infant microbiome, raises the risk of common illnesses, and may carry long-term consequences that ripple into childhood and beyond.
Microbiome Disruption
One of the clearest differences between breastfed and formula-fed infants lies in the gut. Breastfed babies typically have a microbiome dominated by Bifidobacterium, a bacteria linked to gut barrier protection and reduced inflammation. Formula-fed babies, by contrast, show greater early microbial diversity and higher levels of species more commonly associated with older children or adults (Milani et al., 2017). On paper, more diversity might sound positive—but in infancy, it may actually signal disruption of normal gut development.
Formula feeding has also been linked to increased gut permeability and a higher bacterial load overall, conditions that may contribute to inflammation and infection risk (Penders et al., 2006). While some formulas now include prebiotics to encourage beneficial bacteria, the effects are modest compared to the robust shifts produced by human milk (Sonnenburg & Bäckhed, 2016).
Increased Risk of Illness
These microbial differences help explain why formula-fed infants consistently show higher rates of illness. Studies link formula feeding to increased gastrointestinal infections, respiratory illnesses, and ear infections in early childhood compared to breastfeeding (Horta & Victora, 2013). Without the antibodies, immune cells, and complex sugars in breast milk, formula-fed infants face infections with fewer defenses. This gap is especially dangerous in preterm or medically fragile infants, where even minor infections can spiral into hospitalization.
Long-Term Health Outcomes
The long-term consequences of formula feeding are harder to pin down but no less important. Observational studies suggest that formula-fed infants are more likely to develop obesity later in life, with breastfeeding associated with a 15–25% reduction in childhood obesity risk (Yan et al., 2014). Other research has raised concerns about differences in metabolic regulation, lipid profiles, and glucose tolerance—factors that may shape cardiovascular and metabolic health in adulthood (Victora et al., 2016).
Cognitive outcomes are more nuanced. Some studies find small but measurable differences in IQ or school performance favoring breastfed infants, though confounding factors such as maternal education and socioeconomic status complicate interpretation (Anderson et al., 1999). Still, the pattern suggests that the absence of breast milk’s unique bioactive components may subtly alter developmental trajectories.
The Bigger Picture
Together, these findings reveal that formula is not just a benign substitute for breast milk. It reshapes the microbiome, raises infection risks, and may tilt the scales toward long-term health challenges. Each new “innovation” in formula—whether synthetic HMOs or added probiotics—is marketed as closing the gap, but without long-term trials, families are left to trust corporate claims rather than independent science.
Why the Risks Are Downplayed
If these risks are so well documented, why don’t parents hear about them? The answer lies in how formula is regulated and marketed.
Companies are not required to place NEC warnings on their labels—even though the risk is widely recognized in research. Courts are now considering whether this omission constitutes negligence (Robert King Law Firm, 2025). In hospitals, formula is normalized; preterm products are stocked in NICUs and presented as if they are safe or even essential, blurring the line between medical necessity and commercial product (HKGCLaw, 2025).
When challenged, companies argue that NEC is caused by prematurity itself or by other medical complications, not formula. They claim formula is incidental, not causal. But for families watching their infant fight for life after being fed cow’s milk–based formula, these defenses feel like denial. The lawsuits unfolding today are, at their heart, a struggle between the science and the spin (Reuters, 2024).
What We Can Do
The risks are undeniable—and so is our responsibility. For preterm infants, human milk must be the first line of defense. Whether maternal or donor, it provides protections that no artificial milk can replicate. Formula should not be the default when safer alternatives exist.
Families also deserve transparency. That means honest conversations about NEC and Cronobacter in NICUs, not muted disclosures. True informed consent requires that parents understand both the benefits of human milk and the dangers of formula.
We must also push for systemic changes. Stronger environmental monitoring, stricter hygiene protocols, and faster recall systems are essential to prevent another Michigan-style outbreak. And labels must tell the truth: if cow’s milk–based formula raises NEC risk, parents should see that warning in bold print. Regulatory agencies should mandate it, not wait for the courts to force their hand.
Conclusion
Formula saves lives when no alternative exists. But it is not risk-free, and pretending otherwise has cost families dearly. From bacterial contamination to NEC, the dangers are real, well documented, and too often hidden behind marketing and weak oversight.
As lactation professionals, we must insist on honesty. We must advocate for stronger protections, clearer warnings, and policies that place human milk at the center of preterm care. Because for the most vulnerable infants, the difference between formula and milk is not just nutritional—it can be the difference between life and death.
References
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Food and Drug Administration. (2023). FDA’s strategy to help prevent Cronobacter sakazakii illnesses associated with powdered infant formula. U.S. Food and Drug Administration. https://www.fda.gov/food/new-era-smarter-food-safety/summary-fdas-strategy-help-prevent-cronobacter-sakazakii-illnesses-associated-consumption-powdered
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