Baby formula execs face Congress as 2nd shipment arrives from overseas

A plane carrying some 1 million bottles' worth of specialized infant formula from Europe arrived at an airport outside of Washington on Wednesday, the same day top industry executives and federal regulators faced angry lawmakers on Capitol Hill.

In testimony before a House panel, Dr. Bob Califf, head of the Food and Drug Administration, acknowledged his agency acted "too slow" to ward off the shortage.

"Let me say you're right to be concerned and the public should be concerned," Califf told lawmakers. "As I've said already, it was too slow and there were decisions that were suboptimal along the way."

The second shipment from overseas -- greeted by first lady Jill Biden and part of President Joe Biden's "Operation Fly Formula" -- included 100,000 pounds of formula specialized for infants allergic to cow's milk.

It will head mostly to hospitals 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.

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. Abbott 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.

"It shouldn't take the direct intervention of FDA and the president to keep infant formula on the shelves. The manufacturers have to take responsibility," said Rep. Frank Pallone of New Jersey, Democratic chairman of the House Energy and Commerce Committee.

The FDA has 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 in prepared testimony.

The agency also noted that 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, deeply sorry and are committed to making sure that a shortage like this never happens again," Calamari said.

"I have to tell you Mr. Calamari, I'm actually livid at what happened at Abbott's Sturgis plants," Rep. Jan Schakowsky, D-Illinois, said. "Quite frankly, it's pretty disgusting what we heard, about the water on the floor, water leaking from the ceiling and conditions that could lead to contamination. So, I'm not surprised that it's gonna take you a while to get your act together and clean the place, clean the place up.

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.

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

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.