May 25 (UPI) -- Federal regulators and executives from the baby formula industry appeared before a congressional hearing on Wednesday to explain what's behind the present shortage of infant formula in the United States and shed light on some possible answers.
The House energy and commerce subcommittee on oversight and investigations convened the hearing titled "Formula Safety and Supply: Protecting the Health of America's Babies" on Wednesday morning.
Lawmakers heard more about the shortage that began when Abbott Nutrition, the largest U.S. infant formula manufacturer, announced a recall of several lines of powdered formula in February after they were linked to infections that caused at least two deaths.
Appearing at the hearing Wednesday were Christopher Calamari, Abbott's North American president of nutrition; Scott Fitz, vice president of technical and production at Gerber; and Robert Cleveland, a senior vice president of nutrition at Reckitt. FDA Commissioner Robert Califf, Deputy Commissioner Frank Yiannas and Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, also appeared to testify.
Rep. Diana DeGette, D-Colo., chair of the subcommittee, said the baby formula shortage is unacceptable and heaped some of the blame on Abbott. She also said the FDA needs additional resources to make sure food is safe.
Califf told the panel that the FDA didn't act fast enough in responding when it became clear there was a contamination problem at Abbott's Sturgis, Mich., formula plant.
"It was too slow and there were decisions that were sub-optimal along the way," he said. "Our oversight is critical, but a return to normal will only occur when Abbott takes the steps to resume production in a safe manner."
Califf expressed the FDA's "deepest empathy" for parents and said the agency found "egregiously unsanitary" conditions at the Abbott plant.
The Abbot North American President of Nutrition told the committee that Abbott plans to re-start formula production at the Michigan plant in the first week of June, but said getting formula fully back on store shelves will take several weeks.
"By the end of June we will deliver more product in June than we did in January before the recall. And from there we're going to continue to sustain those efforts," Calamari said. He told the committee Abbott is deeply sorry the formula shortage happened and is committed to seeing that it never happens again.
Abbott, Calamari said, is airlifting millions of cans of infant formula powder into the U.S. from an FDA-registered plant in Ireland. He said the company is bringing up to 50 flights a week into 12 major U.S. airports in efforts to alleviate the formula shortage.
Calamari said Abbott is also establishing a $5 million fund to help affected families with medical and living expenses.
"We will continue to look for new ways to improve, because operating a clean and safe plant is a job that requires constant vigiliance," Calamari said.
In prepared testimony released ahead of the hearing, the FDA said its investigators found serious cracks in spray dryers at the Abbott plant as well as water leaks and condensation, which are key risk factors for Cronobacter infections.
Investigators also found that employees there lacked adequate handwashing techniques, and that Abbott did not ensure that all surfaces that came into contact with formula were maintained to prevent infection.
In his opening remarks, Calamari said that Abbott maintains that there's "no conclusive evidence to link our formulas to these infant illnesses" after conducting an analysis with the FDA and the Centers for Disease Control and Prevention.
Calamari added that Abbott has taken steps to improve safety conditions at the Sturgis facility, including installing non-porous, easily cleanable sanitary floors, increasing finished product testing and enhancing monitoring of areas of the facility that do not come into contact with products.
Last week, Abbott and the FDA reached a consent decree deal that's intended to speed up resumption of infant formula production.
Calamari added that the company plans to resume production at the Sturgis facility in the first week of June, adding that it will take six to eight weeks before new products are available on shelves.
"On behalf of all of us at the company, I want to express our extraordinary disappointment that this situation has occurred and our dedication to ensuring that it is addressed as soon as possible," the Abbott executive said in his opening statement. "As a parent, I know firsthand how important a reliable supply of infant formula can be for a family, and all of us at Abbott regret the stress that this shortage has caused for parents.
"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."
President Joe Biden's administration has taken several steps to mitigate the formula shortage, including invoking the Defense Production Act last week to direct the federal government to prioritize key ingredients for formula production and compel suppliers to provide resources to formula manufacturers before any other customers that have ordered those supplies.
On Sunday, a shipment of 78,000 pounds of specialty infant formula arrived in Indiana to be distributed to hospitals, doctors, home healthcare facilities and pharmacies. None of that shipment ended up in store shelves.
First lady Jill Biden and U.S. Surgeon General Dr. Vivek Murthy were at Dulles International Airport near Washington, D.C., to meet a shipment of baby formula.