The Subcommittee on Oversight and Investigations of the powerful House Committee on Energy and Commerce today holds its much-anticipated hearing on “Formula Safety and Supply: Protecting the Health of America’s Babies.”
It will be live-streamed from the Rayburn House Office Building via Cisco WebEx online video conferencing, beginning at 11 a.m. EDT. The Oversight and Investigations hearing will examine the nation’s infant formula crisis including the recall, shortage, and attempts to increase supply.
Sworn testimony will be taken from top U.S. Food and Drug officials including FDA Commissioner Robert M Califf, Deputy Commissioner Frank Yiannas, and Center for Food Safety and Applied Nutrition Director Susan Mayne.
Corporate officials from the three top formula producers will also be on the hot seat, including Abbott Senior Vice President Christopher J. Calamari, Gerber VP Scott Fitz, and Reckitt Senior VP Robert Cleveland.
The background paper, prepared for the Oversight and Investigations Subcommittee by committee staff, says reports of a supply shortage of infant formula first surfaced in January 2022. The report says the shortage was then exacerbated by the Abbott recall of certain brands of powdered infant formula in February 2022.
The Abbot recall followed reports of possible Cronobacter sakazakii contamination in the Abbott production facility located in Sturgis, Michigan.
As many as 75 percent of America’s infants depend upon a formula, at least partially during their first six months of age for nutritional needs. Formulas also help manage metabolic, gastrointestinal, and allergic disorders.
About 95 percent of the U.S. infant formula market is dominated by just three producers; Abbott (Similac); Reckitt (Enfamil) and Gerber (Good Start). Nine production facilities in the U.S. and an Abbott factory in Ireland that is registered with FDA usually fill domestic formula demand.
FDA and the federal Centers for Disease Control and Prevention (CDC) began investigating rare Cronobacter infections beginning on September 20, 2021, where the four reports of infant illnesses involved consuming products from Abbott’s Sturgis facility.
Unlike most foodborne illnesses, there is no requirement outside of Minnesota for the medical community to report Cronobacter to a central authority– such as the state health department. Without normal reports, FDA and CDC have had to rely on consumer complaints.
FDA began additional inspections on January 31, 2022, through March 18, 2022, when it completed a series of 24 visits to the Sturgis plant, and concluded that Abbott failed to establish processes to prevent formula contamination or to maintain surfaces that could lead to product contamination.
FDA found Cronobacker in five environmental samples inside the plant, but not in product to patient samples.
Between Abbott’s February recall and May 8, 2022, a major data source found that 43 percent of the nation’s formula inventory was gone. Panic buying was also adding to the shortages being experienced around the country.
Congress on May 18, 2022, passed a $28 million emergency spending bill to help increase the U.S. supply of infant formula and military airlift capacity is being used to move foreign formula, mostly from Europe, to Indianapolis, Indiana for domestic distribution. Further, the government entered into a consent decree to restart Abbott’s Sturgis facility with outside expertise.
Today’s hearing is not the first time the FDA Commissioner has appeared before Congress on the formula crisis. He’s acknowledged the FDA response was slow Yiannas and Mayne were the FDA officials responsible for how fast or slow the formula crisis moved. Their appearances today will be firsts.
Janet Woodcock, the former acting FDA Commissioner, has not been called to testify. Califf has put Woodcock in charge of FDA food policy, When she was acting Commissioner, a whistleblower in October gave FDA a 34-page complaint about Abbott’s Sturgis plant.
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