Top FDA official resigns over infant formula crisis and unrest at agency

“FDA remains committed to providing an update on steps to strengthen the human food program in late January and additional updates on the organizational structure, including how Mr. Yiannas’ job responsibilities will be managed going forward, by the end of February,” the spokesperson said.

Yiannas was among senior FDA officials implicated in the Biden administration’s hampered response to the infant formula crisis. FDA officials had been warned months before about food safety issues at a key plant in Sturgis, Michigan, operated by Abbott Nutrition. The factory issued a recall of some formula products, after reports that babies died after drinking formula from the facility and FDA inspectors found strains of bacteria that could be deadly to infants. Abbott maintained that there was no connection between the deaths and the formula at the plant.

Yiannas, FDA Commissioner Robert Califf, and Susan Mayne, director of the FDA’s Center for Food Safety and Applied Nutrition, acknowledged to lawmakers last May a series of failures that contributed to the crisis – including a breakdown of internal FDA communication that officials say kept them unaware of the safety issues until just weeks before the recall. Yiannas and Califf also said a whistleblower report alleging food safety issues at the plant, which was mailed in October 2021, did not reach the highest levels of the FDA until mid -February 2022, although it was sent directly to senior FDA officials.

As POLITICO reported, Mayne and Yiannas have personal differences, which have created tension at higher levels of an agency that is already struggling to make decisions. Key industry executives, despite internal FDA breakdowns, generally respected Yiannas and believed his role was minimized within the agency.

“It is disappointing that the structure and culture of the FDA food program has failed to take full advantage of its vast expertise in food safety,” said Brian Ronholm, former deputy assistant secretary for food safety. at the Ministry of Agriculture.

Yiannas, a former vice president in charge of food safety at Walmart, later met with formula makers and retail distributors as the Biden administration rushed to address shortages triggered by Abbott’s recall as empty shelves were turning into a political crisis for President Joe Biden.

Yiannas’ resignation comes as the FDA is set to announce a series of actions it is taking to address the findings of a recent external review following the infant formula crisis and other outages at the FDA.


Politico

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