Infant Formula Bill Would Expand FDA Oversight of Inspections

The FDA would need to inspect infant formula manufacturing facilities at least every six months under a bill that aims to hold the agency accountable for its actions leading up to the nationwide shortage.

The measure, obtained by Bloomberg Law, would give the Food and Drug Administration expanded authority to conduct unannounced inspections on formula plants and require manufacturers to alert the FDA once they become aware of situations that could lead to shortages.

House Appropriations Chairwoman Rosa DeLauro (D-Conn.) introduced the legislation Friday to prevent future safety issues. Lawmakers and watchdogs are examining the FDA’s response to reports of potentially contaminated infant formula from Abbott‘s Sturgis, Mich., facility that has fueled shortages across the country.

“In the wealthiest nation on Earth, there is no excuse for a child going hungry,” DeLauro said in a statement. She said her bill will “better product safety, maintain infant formula supply, and keep workers safe.”

DeLauro is also asking the Health and Human Services Department’s inspector general to investigate the FDA’s recent policy to use enforcement discretion on certain importation requirements for infant formula. The FDA announced in May that it would let certain infant formula products enter the country so long as they meet the agency’s safety and nutrition standards, even if they don’t comply with all statutory and regulatory requirements.

The FDA is moving too quickly with approval decisions with only nine full-time staff members working on application reviews, the congresswoman said in a letter to the HHS watchdog Friday.

She also argued there is “no standardized application that the FDA is making their decisions from,” adding, “if manufacturers are able to pick and choose what they submit from the guidance list, then there is no uniform application being submitted.”

The HHS inspector general announced Thursday that it would probe the FDA’s actions leading up to the infant formula recall at the Abbott facility in February, specifically looking at whether the FDA followed procedures for conducting inspections at the Abbott facility. DeLauro sent a request to the office in March to examine the FDA’s response.

Despite the Biden administration’s ongoing efforts to boost national baby formula supply, out-of-stock rates rose to 74% nationally for the week ending May 28, according to data on 130,000 stores followed by Datasembly.

FDA’s Authority

DeLauro’s bill, which has dozens of co-sponsors, contains several other provisions that the FDA itself has argued are needed to improve oversight on infant formula manufacturers.

The legislation calls for a multi-agency effort to examine methods for short- and long-term storage of infant formula, including a potential national stockpile, and distribution models to adopt during shortages. FDA Commissioner Robert Califf said in a recent Senate health hearing that it would be useful for officials to consider whether a national stockpile of infant formula should be created “as a backup” to prevent dire nationwide shortages in the future.

DeLauro’s legislation also seeks to amend the Defense Production Act so that it may be invoked for any food-related shortage, including infant formula and its ingredients. President Joe Biden recently invoked the act to boost supplies of infant formula, allowing domestic manufacturers to obtain needed ingredients and speed shipments of foreign stocks. The president also announced “Operation Fly Formula” to ship in supplies from other countries.

The Department of Labor would also be required under the bill to issue fact sheets and technical assistance to baby formula manufacturing plants to ensure worker safety is maintained with any increase of production.

DeLauro’s office said it hopes to pass the bill on its own but added the congresswoman is also open to having it attached to broader legislative packages. Congress is working to develop comprehensive legislation reauthorizing the user fees from the drug and medical device industries that help fund the FDA.

Brian Ronholm, director of food policy for Consumer Reports, said in a statement that the legislation “would ensure the plentiful supply of safe infant formula and hold manufacturers accountable.”

“Parents and caregivers should never have to desperately scramble to find infant formula only to find empty shelves at the grocery store,” he said.