What does research say about baby formula and NEC?
In 2024, FDA, CDC and NIH said there is no clear proof that formula for preterm babies causes NEC. They also said there is strong proof that human milk helps protect babies from it.
The agencies said evidence so far suggests that being born too early is the main risk. They called preterm formula a critically important option for these babies.
An NIH working group said the evidence supports the idea that the lack of human milk, not formula itself, is linked to a higher risk. It also said the link between feeding and NEC is unclear, and that babies fed only human milk can still get NEC.
In May 2025, the judge who handles the federal formula cases let the families’ experts testify that cow’s milk formula can raise the risk of NEC. The judge called the ruling provisional and did not decide whether formula causes NEC. In the federal court papers we read, no judge has ruled that formula causes NEC.
On July 24, 2026, a federal appeals court upheld Abbott’s win in one family’s case. The court said the family had not shown that the different warning they wanted would have prevented their baby’s death. It said it did not need to decide whether the formula was a cause of the baby’s NEC.