Peach Tree Times

U.S. legislators recently challenged U.S. Food and Drug Administration (FDA) Commissioner Dr. Robert Califf and the agency as a whole on the baby formula shortage, which continues to be a key concern across the nation, according to a CNBC report.

On May 19, legislators questioned Califf over the national infant formula shortage, calling the agency's reaction a "dereliction of duty." 

Among those now questioning Califf is Georgia Senator Raphael Warnock, among 50 Senate Democrats who cast their votes for Dr. Califf in February. 

“The shortage was caused in large part by the lack of action by the FDA and by corporate greed and consolidation,” Rep. Rosa DeLauro, (D-CT) said during a House Appropriations subcommittee hearing. 

According to CNBC, lawmakers also condemned the FDA for failing to immediately examine a whistleblower report that accused Abbott Nutrition facility in Sturgis, Michigan, of several safety violations at the plant, including fabricating documents and failing to conduct adequate infant formula testing prior to distribution. They highlighted the shutdown of the Sturgis facility, which has been tied to the baby formula shortage.

The formula shortage is the result of a Feb. 17 incident during which Abbott Nutrition recalled its Sturgis-manufactured products and shut down the plant, Fortune reports.

This shutdown was prompted by news that four newborns suffered bacterial illnesses and two infants died after drinking formula manufactured in Michigan.

A whistleblower complaint filed with the FDA in October 2021 indicated more health and safety compliance concerns at the plant, prompting the agency to conduct a formal inspection in early 2022.

Califf and the FDA have requested a budget increase to assist with personnel and to boost recruiting and salary authorities, CNBC reports.

However, politicians argue the infant formula shortfall is caused by internal FDA issues.

“You have serious structural leadership issues,” Rep. DeLauro said according to CNBC. “Someone in this agency needs to have serious and relevant food credentials who understand it because otherwise, food safety will continue to be a second-class citizen at the FDA.”

Califf told legislators that he expects formula distribution to stabilize within two months.

Abbott aims to begin operations at its Sturgis factory on June 4, CNBC reports. The company has said that once manufacturing begins, its formula will be available in shops in six to eight weeks.

Meanwhile, Warnock and 30 other Democratic senators have sent a letter to the president of the Infant Nutrition Council of America, requesting an increased supply of infant formula and faster delivery.

“We write to express our concern about the infant formula supply shortage which is making it harder for parents and caregivers nationwide to get their children the nourishment they need," Sen. Warnock and his colleagues wrote, "Formula is a critical source of nutrition for newborns and infants, and this supply shortage has put their health and development at risk."

In order to overcome the shortage, the Biden Administration has moved to import specialist baby formula from other countries.

According to ABC News, the formula imports from Europe will be supplied primarily to hospitals and given to families only by prescription.