FDA Officials Reveal Series of Failures That Led to Baby Formula Shortage

FDA Officials Reveal Series of Failures That Led to Baby Formula Shortage
Grocery stores are implementing new restrictions on baby formula purchases due to a shortage of supply. (Photo: Michael Conroy, AP)

Government officials are set to testify at a hearing regarding the ongoing shortage in baby formula, which was made worse through a failure to act sooner on part of the U.S. Food and Drug Administration (FDA). The FDA issued a background memo ahead of Wednesday’s hearing that detailed the events leading up to the shortage, including “mailroom issues” that led to the delay in delivering a whistleblower report to the administration’s top officials.

Parents across the U.S. are struggling to find baby formula due to a supply shortage that first began earlier this year. The shortage was made worse after Abbott Nutrition recalled some of its products due to health safety concerns over bacterial contamination that led to four infants being hospitalized. The FDA had received a whistleblower report in October 2021, but did not issue a public warning against the risk of contamination until February 2022, according to the memo.

Congresswoman Rosa DeLauro issued a statement that claimed the FDA did not interview the former Abbott employee who submitted the 34-page report until December, and did not hold an in-person inspection until January 31, 2022. The FDA then conducted 24 visits to the Abbott plant, and found Cronobacter bacteria in five environmental samples. By the time the FDA issued its warning, the plant had already shut down voluntarily and recalled its products from the market.

“I want to remind everyone we are talking about infant formula. Parents trust that formula will be safe and healthy for their newborn babies – it should be the most regulated of any product,” DeLauro wrote in the statement. “Why did the FDA not spring into action? Why did it take four months to pull this formula off store shelves?”

In the testimony prepared ahead of the hearing, FDA commissioner Robert Califf cited an issue with the administration’s mailroom that led to the delay in the report reaching the higher officials. They eventually received the report via email on February 14, three days before the products were recalled.

Editor’s Note: Release dates within this article are based in the U.S., but will be updated with local Australian dates as soon as we know more.