U.S. baby instructions supply is vulnerable; retired FDA official tells lawmakers

March 29, 2023: A retired Food and Drug Administration official told U.S. lawmakers that the U.S. supply of infant formula industry is vulnerable to safety issues and supply disruptions over a year after a nationwide shortage that is leaving parents scrambling to feed their children.

“It is my point of view that the state of the infant formula industry is not much later than it was then,” Frank Yiannas, the agency’s retired deputy commissioner for food policy, stated in the testimony before a subcommittee of the House Oversight Committee. Yiannas is helping lead the FDA’s response to the shortage before resigning this year.

“In other words, the nation has stated one outbreak, tornado, flood, or cyber-attack away from finding itself in the same place as February 17, 2022,” he stated.

The FDA announced an over recall that day of Abbott Nutrition’s popular Similac, Alimentum and EleCare baby formulas that sparked the national shortage. The infant formula is recalling after several infants sickened with bacterial infections, and two died.

He said the agency needed to act faster when those contamination concerns arose at Abbott’s formula manufacturing plant in Sturgis, Mich. The plant was shuttered for months, sharply decreasing formula supply across the U.S. Before the recall, Abbott controlled 40% of the nation’s baby formula market.

Yiannas underscored dysfunction within the FDA that he thinks exacerbated the shortage. He points to structural and cultural issues within the agency, a failure to monitor the supply chain and inadequate public health maintenance of the fatal bacteria, Cronobacrer sakazakii, that contaminated Abbott’s formula.

But he then highlighted ongoing threats to infant formula supply that need to be addressed to similar crises in the future, like manufacturing plants needing refurbishment and huge consolidation in the industry.