Grand Canyon Times

Arizona Sen. Mark Kelly was among many lawmakers who questioned the response by Food and Drug Administration (FDA) Chairman Dr. Robert Califf to the nation's ongoing baby formula shortage, despite Kelly being one of 50 Senate Democrats who voted to approve Califf’s appointment.

According to a story by CNBC, members of Congress called the FDA’s slow response to the shortage a “dereliction of duty.” During a May 19 House Appropriations subcommittee hearing, Connecticut Democrat Rosa DeLauro said the shortage was caused by “the lack of action by the FDA and by corporate greed and consolidation.” 

The closure of the Abbott Nutrition plant in Sturgis, Michigan, reportedly was the biggest factor lawmakers identified that contributed to the shortage. They also criticized the FDA for failing to promptly investigate a complaint in October that “accused the company of numerous safety violations at the facility, including falsifying records and failing to properly test baby formula before releasing it," the article said.

Kelly was among 30 lawmakers who wrote on May 13 to Mardi Mountford, president of the Infant Nutrition Council of America, urging formula manufacturers to increase production amid a shortage where Arizona was among the hardest-hit states.

“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,” they wrote in the letter, which was posted on Kelly’s official website. “Formula is a critical source of nutrition for newborns and infants, and this supply shortage has put their health and development at risk. We are calling on you and your member companies to take immediate action and ensure that infant formula manufacturers are making every effort to mitigate this dangerous shortage and get children the nourishment they need.”

Abbott Nutrition voluntarily recalled its Sturgis-manufactured products on Feb. 17 and shut down the plant after four infants reportedly became ill from bacterial infections and two died after taking formula produced in the Michigan plant, according to Fortune. The whistleblower complaint, submitted to the FDA in October, said there were other health and safety compliance problems at the facility, which helped lead to a formal inspection by the FDA in early 2022.

The FDA has complained of staffing shortages, and Califf has asked for budget increases to compensate. Still, congressional leaders said the formula shortage was due less to budget concerns than internal problems within the FDA. 

“You have serious structural leadership issues,” DeLauro said in the subcommittee hearing 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.”

Kelly, who is up for re-election this year, was among 50 Democrats who voted to approve Califf’s nomination to lead the FDA in February 2022.

The Biden Administration was forced to ship specialized formula to the U.S. from Europe, but according to ABC News, the formula was to be sent "mostly to hospitals and offered to families through prescription only." 

Califf expects formula supply to return to normal within two months. CNBC also reported that Abbott would restart production June 4. Once production resumes, Abbott officials said it could take six to eight weeks for products to arrive in stores.