Senators Maintain Biden Administration, FDA should have Anticipated Crisis, Citing Declining Supplies Starting in mid-2021

WASHINGTON, D.C. – U.S. Senator Cindy Hyde-Smith (R-Miss.) and 21 colleagues today demanded the Food and Drug Administration (FDA) explain why the Biden administration didn’t act sooner to ensure the availability of infant formula, supplies of which began to decline in mid-2021.

In a letter to FDA Administrator Robert Califf, M.D., the 22 Senators requested specific information regarding the agency’s inadequate investigation into Abbott Nutrition’s Michigan manufacturing facility and failure to mitigate the nationwide baby formula shortage.

“Families, who are trying desperately to find safe infant formula for their children, have every right to be upset with this situation,” said Hyde-Smith, who serves on the Senate Agriculture, Rural Development, FDA and Related Agencies Appropriations Subcommittee.

“The Biden administration should have seen the baby formula shortage coming as soon as Abbott was shut down.  Instead, it looks like they chose to do nothing about it.  Now we’re faced with a crisis complicated by supply chain challenges, product recalls, and record inflation,” she said.

In their letter, the Senators say the current crisis raised questions about the ability of the FDA Center for Food Safety and Applied Nutrition to ensure the safety of and access to infant formula.  The Senators also seek a detailed explanation of the agency’s prolonged Abbott investigation, and why infant formula imports from FDA-permitted facilities in the Netherlands, Spain, and France weren’t considered sooner.

“It’s concerning that FDA and key officials in the Administration did not anticipate this crisis or take action within days following Abbott Nutrition’s voluntary recall considering the company holds 48.1 percent of the U.S. market in infant formula,” the Senators wrote. 

“The shortage, felt by all families in need, is disproportionately impacting vulnerable populations. As you know, Medicaid is a major source of coverage for low-income vulnerable populations including pregnant women, infants, and children,” the letter continues.  “The FDA must do everything within its statutory authority to ensure it facilitates access to safe, quality foods.”

Medicaid covered 42 percent of births in the United States in 2020.  In addition, 49 percent of infants born in the United States participate in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Also on Thursday, Hyde-Smith supported Senate passage of the bicameral Access to Baby Formula Act (HR.7791/S.4257) to give the U.S. Department of Agriculture permanent authority to respond in the event of a product recall or supply chain disruptions and to provide broader flexibility for WIC recipients to access infant formula.  The measure has already passed the House of Representatives, making it available to be signed into law.