When makers of infant formula learn that babies have become seriously ill or died after using their products, federal regulations require them to notify the FDA. But in a major investigative finding published July 2, 2026, KFF Health News revealed that the FDA has no record of a single such notification from any formula manufacturer going back more than 26 years.
That gap in the federal safety record is not because premature infants haven’t died. According to a KFF Health News analysis of federal data, approximately 2,300 newborns died from necrotizing enterocolitis (NEC) in the United States between 2017 and 2023 — roughly one per day. A wave of more than 1,700 lawsuits has alleged that formula made by Abbott (Similac) and Mead Johnson (Enfamil) caused or contributed to these deaths by triggering NEC in premature infants, and that manufacturers knew about the elevated risk without adequately warning parents or physicians.
Why This Matters
Federal regulations give infant formula manufacturers substantial discretion in deciding whether and when to notify the FDA that a product may have contributed to a serious adverse event. According to KFF Health News’s investigation, that discretion has translated to zero notifications — even as hundreds of lawsuits proceeded through the courts and testimony from company executives confirmed that internal records of adverse events existed and were investigated internally.
The practical consequence is significant: parents harmed by formula have been fighting Abbott and Mead Johnson in court, with no government notification system creating an independent safety record. Families who lose a premature infant to NEC are not informed that other families have reported the same outcome to the manufacturer. And the FDA — which does not pre-approve infant formula before it reaches the market — has had no formal mechanism to detect a pattern of harm tied to specific products.
What We Know So Far
From KFF Health News’s FOIA investigation published July 2, 2026, and court records cited in the report:
- Under the Freedom of Information Act, KFF Health News asked the FDA for all notifications from formula manufacturers since January 1, 2020. The agency’s Human Foods Program responded: “did not receive any.”
- KFF Health News extended the request to January 1, 2000. The FDA responded: “After a diligent search of our files, we did not locate any responsive records.”
- John Wallingford, a paid expert witness for Abbott, testified in Missouri court in October 2024 that “Abbott had never reported a single death under any regulation for preterm infant formula.”
- Courtney Colombo, who identified herself in a March 2024 deposition as Abbott’s director of postmarketing medical safety and surveillance, testified she knew of no instance in which Abbott had reported to any regulatory authority anywhere in the world that one of its preterm infant formulas was possibly related to a NEC death.
- An Abbott internal document from 2010, displayed in deposition video clips obtained by KFF Health News, stated that NEC “is the most severe GI complication of prematurity and the use of bovine milk-based fortifiers and formulas are believed to be the primary risk factor.”
- A Mead Johnson marketing slide deck from 2020 — later used in trial — outlined a plan for “Branding NICU Babies,” a strategy to capture preterm infant feeding contracts through hospital relationships.
- As of late January 2026, approximately 1,760 NEC lawsuits were pending against Abbott alone.
- About 2,300 newborns died of NEC in the U.S. from 2017 through 2023, the equivalent of nearly one per day. The database does not attribute causation.
Where the System Fails Families
The regulatory framework governing infant formula reporting gives manufacturers the authority to determine whether adverse events — including deaths — meet the threshold requiring FDA notification. Unlike pharmaceutical drugs, which are subject to rigorous post-market surveillance and mandatory serious adverse event reporting with specific timelines, infant formula operates under a framework in which reporting is largely at the manufacturer’s discretion.
The FDA does not approve infant formula products before they reach market. It does not license formula labeling for safety claims. And, according to the KFF Health News investigation, its Human Foods Program received zero death notifications from formula makers across a 26-year window — even as internal company documents confirmed the companies were tracking NEC-related complaints internally.
This creates a structural gap: a manufacturer can investigate an adverse event internally, close the file internally, and the FDA may never receive a notification that allows it to identify a pattern of harm.
What the Companies and Agencies Say
Abbott spokesperson Scott Stoffel stated in November that “Abbott complies with all applicable FDA regulations on adverse event reporting, including by keeping detailed records of every single complaint/adverse event report Abbott receives and investigating NEC complaints.”
The FDA stated in a 2024 joint statement with the CDC and NIH that there is “no conclusive evidence that preterm infant formula causes NEC.” Abbott’s chief executive has publicly said that claims linking preterm formula to NEC are “without merit or scientific support.”
However, courts have repeatedly found in favor of families suing Abbott and Mead Johnson. A Chicago jury awarded $53 million to four families in April 2026, and a separate Chicago verdict in the same month awarded an additional $70 million. A Missouri appeals court upheld a $495 million verdict against Abbott. As of June 2026, approximately 798 federal NEC cases remain pending in multidistrict litigation in the Northern District of Illinois, with hundreds more in state courts.
What the Evidence Shows — and What It Does Not
The scientific debate over whether bovine (cow’s milk-based) formula causes NEC in premature infants versus the absence of human milk increasing NEC risk is ongoing and genuinely contested. The FDA, CDC, and NIH have stated there is no conclusive causal evidence. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — for premature infants when the mother’s own milk is not available.
What is not contested is the reporting record: the FDA received no death notifications from formula manufacturers going back to 2000, and Abbott’s own expert witness confirmed the company made no such reports.
MedicalDaily Evidence Check
- Investigation type: FOIA requests + court record analysis (KFF Health News, published July 2, 2026)
- What it found: Zero FDA death notifications from formula manufacturers from January 2000 through the present; Abbott’s expert witness confirmed Abbott never made a single death report under any regulation for preterm formula
- What it did not prove: That the formula directly caused the deaths — this remains contested between companies and plaintiffs
- Regulatory context: FDA does not pre-approve infant formula; adverse event reporting for formula is largely at manufacturers’ discretion
- What readers should know: The regulatory gap in formula death reporting is confirmed by FOIA records; families of premature infants have been fighting manufacturers in court without a government notification system creating an independent safety record
Who Is Most Affected?
This issue affects:
- Parents of premature infants currently in NICUs who are receiving cow’s milk-based formula or fortifiers
- Families who have experienced a premature infant death from NEC and may not know there is a reporting gap at the regulatory level
- NICU clinicians and hospitals whose informed consent discussions about formula feeding may not have reflected the manufacturer’s internal awareness of NEC-related adverse events
- Policymakers and advocates working on infant formula regulation reform
Symptoms of NEC in Premature Infants
Necrotizing enterocolitis typically develops in premature infants two to four weeks after birth, often around the time feedings begin. Warning signs that require immediate evaluation by the neonatal team include:
- Sudden abdominal swelling or rigidity
- Feeding intolerance after previously tolerating feeds
- Bloody stool
- Temperature instability
- Lethargy or decreased responsiveness
- Skin discoloration over the abdomen
If your premature infant is in the NICU, ask the neonatal team specifically about NEC risk and what the protocol is for early detection.
What You Can Do Now
- If your premature infant is currently in a NICU, ask the neonatologist whether your baby is receiving human donor milk or cow’s milk-based formula, and what the facility’s protocol is for NEC monitoring.
- Ask about your baby’s NEC risk based on gestational age and birth weight — infants born before 32 weeks and those under 1,500 grams face the highest risk.
- Inquire about human milk availability at the facility. The American Academy of Pediatrics recommends human milk — including pasteurized donor milk — as the preferred nutrition for very premature infants.
- If your premature infant previously suffered NEC while receiving cow’s milk-based formula, you may wish to consult a legal professional about your options. As of June 2026, active multidistrict litigation is proceeding in the Northern District of Illinois.
- Report adverse events through the FDA’s MedWatch program if you believe a formula product contributed to a serious adverse event in your infant.
Cost and Access: What Patients Should Know
Human donor milk is more expensive than cow’s milk-based formula, and insurance coverage varies. NICU families should ask the billing department and the neonatology team about donor milk access and coverage. Many NICUs absorb donor milk costs for the highest-risk infants.
For families who believe their infant was harmed by formula, legal consultations are typically offered at no upfront cost by firms handling NEC formula litigation. The Pancreatic Cancer Action Network NICHD page on NEC and infant feeding provides a recent scientific overview of the evidence.
What Happens Next
The KFF Health News investigation is expected to prompt renewed regulatory scrutiny of infant formula adverse event reporting requirements. The ongoing multidistrict litigation will produce additional bellwether trials in 2026 that may increase pressure on Abbott and Mead Johnson to consider broader settlements.
Congress has shown some interest in strengthening formula safety oversight following the 2022 Abbott infant formula shortage and contamination recall. Whether the KFF Health News reporting prompts legislative action on adverse event reporting requirements remains to be seen.
The Bottom Line
The FDA received zero death notifications from infant formula manufacturers going back to the year 2000, according to FOIA records obtained by KFF Health News — confirmed by Abbott’s own expert witness, who testified the company never made a single such report for preterm formula. Approximately 2,300 premature infants died of NEC in the U.S. between 2017 and 2023. The combination of those two facts is not proof of causation — but it is a documented regulatory gap that left families fighting for accountability in court with no independent government safety record to draw on.
