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Food and Drug Administration Commissioner Robert Califf gave a scathing review of “egregiously unsanitary” conditions at Abbott’s baby formula plant in Michigan during sworn testimony before a House subcommittee about the baby formula shortage on Wednesday.
Califf described bacteria growing from multiple sites in the facility, cracks in key equipment, leaks from the roof, standing water and a previous citation for inadequate handwashing.
“Frankly, the inspection results were shocking,” Califf told House lawmakers on the Oversight and Investigations subcommittee. “This is so far removed from my previous experience with the company that I am concerned.”
Abbott closed its Sturgis, Mich., plant and recalled multiple baby formula products in February, after the FDA found five different strains of Cronobacter at the facility. Cronobacter is a bacteria that can cause dangerous blood infections. Four infants who consumed powdered formula from the Abbott plant fell ill and were hospitalized with Cronobacter infections, two of whom died.
Califf said the FDA and the Centers for Disease Control and Prevention’s investigation couldn’t conclude that the insanitary conditions at the plant caused the illness. However, he said the health agencies cannot rule it out either, calling the confluence of events “highly unusual.” None of the Cronobacter strains at the Sturgis plant matched two clinical samples from the ill infants, according to the FDA.
Four manufacturers – Abbott, Mead Johnson Nutrition, Nestle USA and Perrigo – control 90% of the domestic infant formula market in the U.S. Infant formula supply chains were already strained due to the Covid pandemic, but the closure of Abbott’s plant and the recall tipped the shortages into a crisis. Califf said reports of shortages began to spread about a month ago as parents started stocking up on formula to ensure they had adequate supply at home.
The Abbott manufacturing facility in Sturgis, Michigan, on May 13, 2022.
Jeff Kowalsky | AFP | Getty Images
Califf said Abbott CEO Robert Ford assured him on Tuesday that the Michigan plant would be ready to resume production in early June. Califf said the plant is not ready now because conditions at the facility were so bad that Abbott is required to complete hundreds of steps to come into compliance with food safety laws under a consent degree subject to enforcement by the Justice Department and a federal court.
“Abbott’s enormous market share left it with a responsibility for producing safe infant formula that wasn’t met,” Califf said. “We will do everything in our power to work with Abbot to make this happen as quickly and safely as possible but this timing is in Abbott’s control.”
Califf said actions taken by the FDA and the Biden administration should result in an infant formula surplus in the U.S. in the next few weeks, though he did not provide more specific timing. The FDA has eased import restrictions to bring in formula from abroad, and the U.S. is using military aircraft to fly the product in.
“This is a war mentality. It is a crisis. We are fully aware of it. Families should not be searching for formula but they have to do it now until we fill in,” Califf said.
Califf faced a grilling from lawmakers about why it took months for the FDA to inspect the Abbott plant. The FDA first learned in September of an infant with Cronobacter infection who consumed powered formula from the Abbott plant, and the agency received a whistleblower complaint about food safety violations at the plant in October. However, the FDA did not initiate inspections at the plant until January.
Califf acknowledged that it took too long for the FDA to conduct inspections, but said he has found no evidence of intentional delay or malfeasance at the agency. The FDA reported the September case to Abbott and tested formula associated with the case but did not find Cronobacter contamination, according to Califf’s testimony. The agency learned of another infant infected with Cronobacter who consumed formula in December, but again didn’t find Cronobacter in the product.
The FDA’s deputy commissioner for food policy, Frank Yiannis, told the committee that he did not receive the whistleblower report until February.
“I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” Yiannis.
Califf said the FDA has repeatedly requested the authority to implement an early warning system for when there’s shortages of critical products like baby formula, but that would require congressional authorization and industry has opposed it.
“There’s no reason we don’t put together a national system to enable us to do stress testing on the supply chain for critical products like this just like we have with banks,” Califf said.
Later Wednesday, House lawmakers will also question Abbott executive Christopher Calamari, Gerber Vice President Scott Fritz, and Reckitt Senior Vice President Robert Cleveland. Nestle owns Gerber and Mead Johnson merged with Reckitt in 2017.
This is a developing story. Please check for updates.
