Baby formula execs face Congress as second shipment arrives from overseas

(WASHINGTON) — A plane carrying some 1 million bottles’ worth of specialized infant formula from Europe was set to arrive at an airport in Virginia on Wednesday, the same day top industry executives and federal regulators faced angry lawmakers on Capitol Hill.

The second shipment from overseas — part of President Joe Biden’s “Operation Fly Formula” — will be headed to hospitals for infants allergic to cow’s milk and offered to families through prescription only. Another 2 million cans of formula made with whole milk from the British manufacturer Kendal Nutricare should arrive on store shelves in the beginning of June, administration officials announced late Tuesday.

The urgently needed shipment comes amid a nationwide shortage that’s sent at least a half a dozen children to the hospital so far and has put enormous pressure on Biden to explain why his administration didn’t act sooner to prevent the crisis.

“There’s no excuse for what’s happening all across this country right now,” said Rep. Diana DeGette, a Colorado Democrat, leading the hearing of the House Energy and Commerce Subcommittee on Oversight and Investigations.

The nation’s supply crunch became urgent this year following the closure of a manufacturing facility by Abbott Nutrition in Sturgis, Michigan. Four infants had fallen ill after drinking powdered formula from the plant, and two died. Federal inspectors found a deadly bacteria inside the plant, and Abbott agreed to shutter the facility and recall the formula, even as it insisted there was no conclusive evidence that its formula caused the illnesses.

The closure of the plant was a substantial blow to the market. Abbot is the largest formula producer in the U.S. and a top contributor to a federal program that supplies formula to low-income families. The Sturgis plant was particularly crucial too because it produced a highly specialized formula made for infants with metabolic disorders.

The crisis also raised questions about why inspectors from the Food and Drug Administration didn’t act sooner to address concerns, including those raised by a whistleblower complaint submitted to the agency last October.

In prepared testimony, the FDA said Abbott didn’t have a contingency plan when the plant closed. It also pushed back on the company’s account of events, insisting there was ample evidence of the deadly bacteria inside the plant and “insanitary conditions” that may have contributed to the babies’ illnesses.

“We lost confidence that Abbott Nutrition had the appropriate safety and quality culture and commitment to fix these problems quickly,” the FDA wrote.

The agency also insisted it acted as quickly as it could to respond to issues, noting FDA leaders didn’t immediately receive a whistleblower complaint last fall “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues.”

Chris Calamari, Abbott’s senior vice president for U.S. Nutrition, told lawmakers that the company plans to reopen the facility during the first week of June and will have more formula available at the end of June than it did before the recall. He reiterated the company’s stance that “there is no conclusive evidence to link our formulas to these infant illnesses,” even as the FDA insisted it can be difficult to detect low contamination levels.

“To all of the families who depend on us for a reliable supply of formula — we let you down. We are deeply sorry and are committed to making sure that a shortage like this never happens again,” Calamari said in prepared testimony.

To address the crisis, Biden has ordered the FDA to open up the U.S. market to global suppliers and arranged for two shipments of Nestlé hypoallergenic formula to arrive from overseas. He also has invoked the Defense Production Act to ensure domestic manufacturers are first in line to access raw materials and other supplies.

The first shipment of imported formula arrived in Indiana on Sunday aboard an Air Force transport plane, and included a half a million bottles of Alfamino Infant and Alfamino Junior — enough hypoallergenic formula for 9,000 infants and 18,000 toddlers for one week.

The second shipment, scheduled to arrive Wednesday at Dulles International Airport outside of Washington, D.C., is expected to include 114 pallets of Gerber Good Start Extensive Hypoallergenic infant formula.

In total, the two shipments would stock provide 1.5 million 8-ounce bottles of the specialty formula.

First lady Jill Biden and Surgeon General Vivek Murthy were scheduled to greet the arrival of the FedEx plane.

As of late Tuesday, five out of the six infants admitted to hospitals in South Carolina and Tennessee in connection to the formula shortage had been released.

One infant who remained hospitalized in South Carolina has not been able to tolerate alternative formulas. This child also has other health complications, a hospital spokesperson tells ABC News.

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