US legislators blast regulators over baby formula crisis

Abbott executive apologises after bacteria outbreak led to factory shutdown and recall

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A top official from infant formula maker Abbott apologised on Wednesday to US families affected by supply shortages, while legislators lambasted the federal food safety agency for its response to the crisis.

“We are deeply sorry and are committed to making sure that a shortage like this never happens again,” said Christopher Calamari, the senior vice president of nutrition, in prepared remarks to a congressional committee hearing.

“It will take time” to regain families' trust, he said, noting that the company is doing everything it can to resolve the crisis.

The US has been struggling with a severe shortage of infant formula for months.

Mr Calamari's comments came at a hearing on the issue in the House of Representatives, where the head of the Food and Drug Administration (FDA) faced bipartisan fury.

FDA Commissioner Robert Califf speaks via videolink during a hearing on the baby formula shortage. AFP

FDA Commissioner Robert Califf laid out a series of setbacks that slowed his agency’s response, including a Covid-19 outbreak at the plant and a whistleblower complaint that did not reach FDA leadership because it was apparently lost in the mail.

The shortage has snowballed into a major political controversy and forced the US to begin flying in products from Europe.

The FDA’s response was “too slow and there were decisions that were suboptimal along the way” Mr Califf said.,

Initially caused by supply chain blockages and a lack of production workers due to the pandemic, the shortage was exacerbated in February when, after the death of two infants, Abbott announced a “voluntary recall” for formula made at its factory in Michigan and shut down that location.

The agency and President Joe Biden's administration are facing mounting political pressure to explain why they did not intervene earlier to try to head off the supply crisis.

“Why did it take an onslaught of national media attention for the Biden administration to act with a sense of urgency required to address an infant formula shortage?” asked Morgan Griffith, a Republican congressman.

The shortage mostly stems from Abbott’s Michigan plant, which the FDA shut down in February due to contamination issues.

Mr Calamari said the samples that tested positive for the bacteria were taken from areas that “do not come into direct contact” with the formula.

“We continue to believe that there is no conclusive evidence to link our formula” to the infant illnesses and deaths blamed on the bacteria Cronobacter sakazakii, which was found in certain areas of the Michigan factory, Mr Calamari said.

FDA staff began honing in on Abbott’s plant last fall while tracking several bacterial infections in infants who had consumed formula produced at the facility. The four cases occurred between September and January, leading to hospital admissions and two deaths.

The FDA planned to begin inspecting the Sturgis, Michigan, plant on December 30, Mr Califf said, but Abbott warned that about a dozen of its employees had tested positive for Covid-19 and requested a delay. As a result, the FDA did not begin its inspection until January 31.

After detecting a rare but dangerous bacterium present in several areas of the plant, the FDA closed the facility and Abbott announced a recall of its formula on February 17.

Abbott and the FDA have reached an agreement to reopen the plant next week, under which the company must regularly undergo outside safety audits.

Agencies contributed to this report

Updated: May 25, 2022, 7:32 PM