When makers of toddler system be taught that infants have change into significantly sick or died after utilizing their merchandise, federal rules require them to inform the FDA. However in a significant investigative discovering printed July 2, 2026, KFF Well being Information revealed that the FDA has no file of a single such notification from any system producer going again greater than 26 years.
That hole within the federal security file shouldn’t be as a result of untimely infants have not died. In line with a KFF Well being Information evaluation of federal information, roughly 2,300 newborns died from necrotizing enterocolitis (NEC) in the US between 2017 and 2023 — roughly one per day. A wave of greater than 1,700 lawsuits has alleged that system made by Abbott (Similac) and Mead Johnson (Enfamil) precipitated or contributed to those deaths by triggering NEC in untimely infants, and that producers knew in regards to the elevated danger with out adequately warning mother and father or physicians.
Why This Issues
Federal rules give toddler system producers substantial discretion in deciding whether or not and when to inform the FDA {that a} product might have contributed to a severe antagonistic occasion. In line with KFF Well being Information’s investigation, that discretion has translated to zero notifications — at the same time as tons of of lawsuits proceeded by way of the courts and testimony from firm executives confirmed that inside information of antagonistic occasions existed and have been investigated internally.
The sensible consequence is important: mother and father harmed by system have been preventing Abbott and Mead Johnson in court docket, with no authorities notification system creating an unbiased security file. Households who lose a untimely toddler to NEC should not knowledgeable that different households have reported the identical consequence to the producer. And the FDA — which doesn’t pre-approve toddler system earlier than it reaches the market — has had no formal mechanism to detect a sample of hurt tied to particular merchandise.
What We Know So Far
From KFF Well being Information’s FOIA investigation printed July 2, 2026, and court docket information cited within the report:
Beneath the Freedom of Data Act, KFF Well being Information requested the FDA for all notifications from system producers since January 1, 2020. The company’s Human Meals Program responded: “didn’t obtain any.”
KFF Well being Information prolonged the request to January 1, 2000. The FDA responded: “After a diligent search of our recordsdata, we didn’t find any responsive information.”
John Wallingford, a paid knowledgeable witness for Abbott, testified in Missouri court docket in October 2024 that “Abbott had by no means reported a single demise below any regulation for preterm toddler system.”
Courtney Colombo, who recognized herself in a March 2024 deposition as Abbott’s director of postmarketing medical security and surveillance, testified she knew of no occasion wherein Abbott had reported to any regulatory authority anyplace on this planet that one among its preterm toddler formulation was presumably associated to a NEC demise.
An Abbott inside doc from 2010, displayed in deposition video clips obtained by KFF Well being Information, acknowledged that NEC “is probably the most extreme GI complication of prematurity and the usage of bovine milk-based fortifiers and formulation are believed to be the first danger issue.”
A Mead Johnson advertising slide deck from 2020 — later utilized in trial — outlined a plan for “Branding NICU Infants,” a method to seize preterm toddler feeding contracts by way of hospital relationships.
As of late January 2026, roughly 1,760 NEC lawsuits have been pending towards Abbott alone.
About 2,300 newborns died of NEC within the U.S. from 2017 by way of 2023, the equal of almost one per day. The database doesn’t attribute causation.
The place the System Fails Households
The regulatory framework governing toddler system reporting offers producers the authority to find out whether or not antagonistic occasions — together with deaths — meet the brink requiring FDA notification. Not like pharmaceutical medicine, that are topic to rigorous post-market surveillance and necessary severe antagonistic occasion reporting with particular timelines, toddler system operates below a framework wherein reporting is essentially on the producer’s discretion.
The FDA doesn’t approve toddler system merchandise earlier than they attain market. It doesn’t license system labeling for security claims. And, in keeping with the KFF Well being Information investigation, its Human Meals Program obtained zero demise notifications from system makers throughout a 26-year window — at the same time as inside firm paperwork confirmed the businesses have been monitoring NEC-related complaints internally.
This creates a structural hole: a producer can examine an antagonistic occasion internally, shut the file internally, and the FDA might by no means obtain a notification that enables it to establish a sample of hurt.
What the Firms and Businesses Say
Abbott spokesperson Scott Stoffel acknowledged in November that “Abbott complies with all relevant FDA rules on antagonistic occasion reporting, together with by protecting detailed information of each single grievance/antagonistic occasion report Abbott receives and investigating NEC complaints.”
The FDA acknowledged in a 2024 joint assertion with the CDC and NIH that there’s “no conclusive proof that preterm toddler system causes NEC.” Abbott’s chief government has publicly stated that claims linking preterm system to NEC are “with out benefit or scientific help.”
Nevertheless, courts have repeatedly present in favor of households suing Abbott and Mead Johnson. A Chicago jury awarded $53 million to 4 households in April 2026, and a separate Chicago verdict in the identical month awarded an extra $70 million. A Missouri appeals court docket upheld a $495 million verdict towards Abbott. As of June 2026, roughly 798 federal NEC instances stay pending in multidistrict litigation within the Northern District of Illinois, with tons of extra in state courts.
What the Proof Reveals — and What It Does Not
The scientific debate over whether or not bovine (cow’s milk-based) system causes NEC in untimely infants versus the absence of human milk rising NEC danger is ongoing and genuinely contested. The FDA, CDC, and NIH have acknowledged there isn’t a conclusive causal proof. The American Academy of Pediatrics recommends human milk — together with pasteurized donor milk — for untimely infants when the mom’s personal milk shouldn’t be accessible.
What shouldn’t be contested is the reporting file: the FDA obtained no demise notifications from system producers going again to 2000, and Abbott’s personal knowledgeable witness confirmed the corporate made no such studies.
MedicalDaily Proof Verify
Investigation kind: FOIA requests + court docket file evaluation (KFF Well being Information, printed July 2, 2026)
What it discovered: Zero FDA demise notifications from system producers from January 2000 by way of the current; Abbott’s knowledgeable witness confirmed Abbott by no means made a single demise report below any regulation for preterm system
What it didn’t show: That the system straight precipitated the deaths — this stays contested between firms and plaintiffs
Regulatory context: FDA doesn’t pre-approve toddler system; antagonistic occasion reporting for system is essentially at producers’ discretion
What readers ought to know: The regulatory hole in system demise reporting is confirmed by FOIA information; households of untimely infants have been preventing producers in court docket and not using a authorities notification system creating an unbiased security file
Who Is Most Affected?
This challenge impacts:
Dad and mom of untimely infants at the moment in NICUs who’re receiving cow’s milk-based system or fortifiers
Households who’ve skilled a untimely toddler demise from NEC and will not know there’s a reporting hole on the regulatory stage
NICU clinicians and hospitals whose knowledgeable consent discussions about system feeding might not have mirrored the producer’s inside consciousness of NEC-related antagonistic occasions
Policymakers and advocates engaged on toddler system regulation reform
Signs of NEC in Untimely Infants
Necrotizing enterocolitis sometimes develops in untimely infants two to 4 weeks after delivery, typically across the time feedings start. Warning indicators that require quick analysis by the neonatal crew embrace:
Sudden belly swelling or rigidity
Feeding intolerance after beforehand tolerating feeds
Bloody stool
Temperature instability
Lethargy or decreased responsiveness
Pores and skin discoloration over the stomach
In case your untimely toddler is within the NICU, ask the neonatal crew particularly about NEC danger and what the protocol is for early detection.
What You Can Do Now
In case your untimely toddler is at the moment in a NICU, ask the neonatologist whether or not your child is receiving human donor milk or cow’s milk-based system, and what the ability’s protocol is for NEC monitoring.
Ask about your child’s NEC danger primarily based on gestational age and delivery weight — infants born earlier than 32 weeks and people below 1,500 grams face the best danger.
Inquire about human milk availability on the facility. The American Academy of Pediatrics recommends human milk — together with pasteurized donor milk — as the popular diet for very untimely infants.
In case your untimely toddler beforehand suffered NEC whereas receiving cow’s milk-based system, you could want to seek the advice of a authorized skilled about your choices. As of June 2026, lively multidistrict litigation is continuing within the Northern District of Illinois.
Report antagonistic occasions by way of the FDA’s MedWatch program when you imagine a system product contributed to a severe antagonistic occasion in your toddler.
Value and Entry: What Sufferers Ought to Know
Human donor milk is dearer than cow’s milk-based system, and insurance coverage protection varies. NICU households ought to ask the billing division and the neonatology crew about donor milk entry and protection. Many NICUs take in donor milk prices for the highest-risk infants.
For households who imagine their toddler was harmed by system, authorized consultations are sometimes supplied at no upfront value by companies dealing with NEC system litigation. The Pancreatic Most cancers Motion Community NICHD web page on NEC and toddler feeding supplies a current scientific overview of the proof.
What Occurs Subsequent
The KFF Well being Information investigation is predicted to immediate renewed regulatory scrutiny of toddler system antagonistic occasion reporting necessities. The continued multidistrict litigation will produce extra bellwether trials in 2026 that will enhance strain on Abbott and Mead Johnson to contemplate broader settlements.
Congress has proven some curiosity in strengthening system security oversight following the 2022 Abbott toddler system scarcity and contamination recall. Whether or not the KFF Well being Information reporting prompts legislative motion on antagonistic occasion reporting necessities stays to be seen.
The Backside Line
The FDA obtained zero demise notifications from toddler system producers going again to the yr 2000, in keeping with FOIA information obtained by KFF Well being Information — confirmed by Abbott’s personal knowledgeable witness, who testified the corporate by no means made a single such report for preterm system. Roughly 2,300 untimely infants died of NEC within the U.S. between 2017 and 2023. The mix of these two information shouldn’t be proof of causation — however it’s a documented regulatory hole that left households preventing for accountability in court docket with no unbiased authorities security file to attract on.
