May 24, 2022
Millions of Imported Infant Formula Cans Headed to US, FDA Says
(Bloomberg) -- Millions more cans of baby formula will be available in the US in the coming months, the nation’s Food and Drug Administration said, detailing steps it’s taken to alleviate a shortage that has alarmed families and caregivers.
About 2 million cans of infant formula made by UK-based company Kendal Nutricare are expected to arrive on US store shelves starting next month after receiving special clearance from the FDA. The company has 40,000 cans in stock ready for immediate dispatch, and the government is evaluating ways to get them on US soil as quickly as possible.
The announcement late Tuesday comes ahead of a hearing on Wednesday where the FDA commissioner and a top Abbott Laboratories executive will be grilled by lawmakers seeking to get to the bottom of the nationwide infant formula shortage.
The agency also announced that it would be releasing roughly 300,000 cans of Abbott’s specialty infant formula EleCare on a case-by-case basis. This would only be for individuals needing urgent, life-sustaining supplies of this specialty formula.
Abbott, the largest manufacturer of infant formula in the US, has been under scrutiny ever since its main facility in Michigan was closed after four babies who consumed formula made there were infected with cronobacter, and two of them died. The FDA stressed that although some EleCare product was included in a recall of products from the facility, the cans that will be released were from different lots. As a precaution, they will undergo enhanced microbiological testing before they are shipped out.
“We anticipate additional infant formula products may be safely and quickly imported into the US in the near term based on ongoing discussions with manufacturers and suppliers worldwide,” FDA Commissioner Robert Califf said in the statement.
Christopher Calamari, Abbott’s senior vice president of US and Canada nutrition, will testify at a hearing of the House Committee on Energy and Commerce’s oversight subcommittee on Wednesday. Executives from other top formula manufacturers are also scheduled to testify, including Scott Fitz, a vice president at Nestle SA’s Gerber, and Robert Cleveland, senior vice president at Reckitt Benckiser Group Plc, which makes Enfamil.
Lawmakers are likely to seek specific details on a whistle-blower’s report that warned of serious safety issues at the plant and alleged that the company retaliated against any employee who raised concerns about practices at the plant. It took several months before the FDA took action on details from the report, and the agency has come under fire for its slow response to the complaints.
Read more about a leading Democrat who’s questioning Abbott’s deal with the government
Califf is also likely to be asked to discuss the root cause of the infant formula shortage.
In prepared testimony published ahead of the hearing, Califf detailed the agency’s inspection of the plant. “The totality of evidence obtained during our inspection caused FDA to conclude that infant formulas produced at this plant were produced under insanitary conditions and may be contaminated with cronobacter,” he said.
This will be Califf’s second time testifying on the topic. Last week, at a House Appropriations hearing, Califf skirted questions from lawmakers on the report, saying he wasn’t prepared to say who at the FDA received it when it was first given to officials there in October. However, he said he would go into more detail at this coming meeting. “I am committed to get back to you with specifics on what happened,” Califf said.
Another House appropriations subcommittee meeting, called “The Infant Formula Crisis,” is also scheduled on Wednesday afternoon, with witnesses from St. Jude Children’s Research Hospital and Consumer Reports.
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