Baby Formula Shortage Reveals Gaps in Regulation and Reporting

May 24, 2022

The government has ordered more safeguards at an Abbott Nutrition plant. But the lack of reporting requirements and limited testing make it hard to monitor the deadly bacterium that led to a recall.

Kru San Miguel has had five brain operations, according to medical records, as a result of an infection that his doctors believe probably came from his infant formula – Matthew Busch for The New York Times

Riley San Miguel said her son, Kru, was barely a month old when he started crying all the time, not wanting to eat. When he developed a fever, he was quickly admitted to an intensive care unit. His spinal fluid was infected with bacteria, and it was spreading to his brain. The doctors believed it had probably come from his infant formula.

“Initially, doctors were worried Kru wasn’t going to make it,” said Ms. San Miguel, 23, who lives in Sonora, Texas. The baby underwent the first of several operations on his brain to control escalating seizures and swelling, and when he could no longer breathe on his own, they put him on a ventilator for 21 days. Eventually, most of the right side of his brain had to be removed.

Her son, she learned, had been exposed to Cronobacter sakazakii, a deadly bacterium that is often linked to babies who consume powdered formula and can cause serious brain damage, developmental disabilities and death. Health officials analyzed two open cans of formula from Ms. San Miguel’s home; one tested negative and the other did not have enough product left to test.

Kru fell ill in August 2019, more than two years before similar infections in four babies — two of them fatal — triggered a voluntary recall at an Abbott Nutrition plant in Sturgis, Mich., that manufactured formula consumed by the latest sickened babies.

The recall helped lead the way to a nationwide shortage of infant formula that has left parents struggling to feed their children; the Biden administration has responded by working with Abbott to restart production and flying in additional supplies from Europe.

As with Kru’s illness, no link was established between infections in the four recent sick babies and production at any Abbott Nutrition plant. But while most of the attention has been focused on fixing the dire supply shortfall, regulators are confronting deeper issues of safety that persist in the manufacturing of powdered infant formula.

There is no comprehensive mechanism for detecting or investigating Cronobacter infections, and only one state, Minnesota, requires doctors and laboratories to report cases to the authorities. Manufacturers are left to conduct tests themselves on a relatively small sample of their production, with less than 1 percent of the Abbott plant’s total output required to be tested. The combination of blind spots makes it difficult to trace infections to their source and could leave families at risk of future shutdowns and infant fatalities.

Read the full article here at the New York Times