FDA Focus on Drugs at Expense of Food Safety Caused Infant Formula Shortage, Former FDA Official Tells Lawmakers

A former FDA official on Tuesday told members of the House Subcommittee on Health Care and Financial Services that the U.S. Food and Drug Administration’s decentralized and siloed culture and its focus on drugs and medicines at the expense of food safety were responsible for the infant formula contamination incident that killed two infants and the formula shortage that followed.

A lack of strong regulations, a decentralized structure that’s slow to respond to reports of problems in the food supply, lax inspections and aging production facilities — these were among the issues raised Tuesday during a hearing on the infant formula shortage and the U.S. Food and Drug Administration’s (FDA) response.

The hearing, held by the U.S. House of Representatives Subcommittee on Health Care and Financial Services, focused on bacterial contamination at a Sturgis, Michigan, plant operated by Abbott Laboratories, one of the nation’s largest producers of infant formula, in 2021 and 2022.

Two infants died after the contamination made its way into the formula produced at the facility.

The formula was contaminated with Salmonella Newport and Cronobacter sakazakii — a germ that causes rare-but-serious infections in babies.

The FDA took more than four months from when the first case was reported before the agency sent inspectors to investigate the Abbott plant.

In February 2022, Frank Yiannas, M.P.H., who served as deputy commissioner for food policy and response since 2018, announced his resignation, citing concerns over the “decentralized structure of the foods program” at the FDA, that has “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”