US Baby Formula Shortage: FDA Struggles To Explain Slow Response During Session in Congress

On Wednesday, lawmakers questioned FDA officials about what they regarded as a lack of urgency in the agency's reaction to allegations about probable infant formula contamination at a now-closed Abbott Laboratories factory, which resulted in significant statewide shortages.

After Abbott recalled several goods and halted its manufacturing unit in Sturgis, Michigan, FDA officials testified before a congressional subcommittee to address concerns about the problem.

FDA Acknowledges Slow Response That Led to Baby Formula Shortage

The Democrat noted a four-month delay in returning to investigate the Sturgis plant, as well as a delay in contacting a former Abbott employee whistleblower. According to FDA officials, senior authorities such as then-acting Commissioner Janet Woodcock and Deputy Commissioner for Food Policy and Response Frank Yiannas first learned of the complaint in February due to pandemic-related mail routing concerns.

In late October, the FDA examined the factory in response to allegations of bacterial illnesses in newborns possibly connected to Abbott's formula, as well as a whistleblower complaint. The inspection was postponed until January 31 due to a COVID-19 outbreak at the factory. A second baby's death, perhaps related to the facility, was recorded shortly after the factory was closed in February, Reuters via MSN reported.

Copies of the complaint addressed by mail to Judith McMeekin, the associate commissioner for regulatory affairs, and Janet Woodcock, the acting FDA commissioner at the time, have yet to be discovered.

During a House subcommittee hearing, the current FDA commissioner, Robert Califf, described the blunder as a technical issue in the mailroom that is now being resolved. When asked if it was a lack of coordination or a breakdown in leadership at the FDA, Califf acknowledged that it was coordination. The sequence of events leading up to the Abbott Nutrition plant's closure in February is crucial to understanding the Biden administration's response to the problem.

Parents looking for infant formula to feed their children have discovered rows of empty shop shelves, prompting bipartisan political indignation over why the Biden administration failed to anticipate issues. Last week, the Biden administration used the Defense Production Act to get US infant formula manufacturers to access to the materials they require, and it started "Operation Fly Formula" to import formula from Europe.

Abbott Says Baby Formula Won't Hit Shelves Until Mid-July

The first cargo came on Sunday, while the second arrived on Wednesday in Washington, DC. When the infant formula cargo came, First Lady Jill Biden and US Surgeon General Vivek Murthy greeted it. Abbott's North American president of nutrition, Christopher Calamari, said Wednesday that the Michigan factory will open in the first week of June, but that formula would not be available for many weeks, as per the New York Post.

The corporation issued recalls of various goods manufactured at the factory around the time it was shut down, and it admits that such measures contributed significantly to the infant formula shortage. Abbott is the country's leading maker of baby formula, accounting for 40% of the market. Before its closure, the Sturgis factory generated 40% of Abbott's total formula.

During the shutdown, Abbott agreed to make many improvements to the plant in compliance with the FDA's recommendations but has maintained that the available data indicates no proof that its formula is connected to the childhood illnesses. Abbott claims that since the Michigan factory's shutdown, it has increased production at other locations and sent millions of cans of formula from its FDA-approved plant in Foothill, Ireland.

Calamari told legislators that he expects the firm to supply more goods in June than we did in January before the recall by the end of next month. Meanwhile, the out-of-stock rate on formula continues to rise, reaching 45 percent countrywide for the week ending May 15, according to Fox Business.