Baby Formula Shortage Reveals Gaps in Regulation and Reporting


Still, F.D.A. inspectors who returned at the end of the month found more standing water. This time they swabbed around the production area and found Cronobacter, agency records show. They discovered that the company’s own testing from Feb. 6 through 20 found the bacterium 20 times in the plant, including in critical areas, according to the inspection report.

By Feb. 17, the company issued a major voluntary recall and halted production. The F.D.A. is now seeking authority to require formula makers to do more testing and to ensure that details about the Cronobacter they find are entered into a national database.

Determining exactly how much should be tested is a difficult equation that requires regulators to make decisions about what an acceptable amount of risk is and at what cost, said Barbara Kowalcyk, the director of the Center for Foodborne Illness Research and Prevention at Ohio State University.

Meat and poultry are inspected far more regularly than infant formula, she said. “Do I think they need to re-look at the regulation? Absolutely.”

Ms. San Miguel’s son eventually spent about 80 days in a hospital. He has since had five brain operations, according to medical records, and though he is nearly 3, he speaks only a few words and has poor coordination on the left side of his body.

When Ms. San Miguel saw the news about other babies who had become ill with Cronobacter infections and the possible link to powdered formula, it reopened all her old anxiety.

No one ever told her, she said, that powdered formula, unlike its liquid equivalent, could not be considered sterile. The C.D.C. advises parents of newborns to use sterile liquid formula or to prepare powdered formula with very hot water, though no such explicit warning is required to be posted on formula labels.

“I was very angry for a very long time,” Ms. San Miguel said. “If someone told me about the risk I was taking, I never would’ve taken that risk.”

Julie Creswell and Madeleine Ngo contributed reporting.

Audio produced by Adrienne Hurst.



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