A senior Food and Drug Administration official resigns after the infant formula crisis and agency upheaval

“The FDA remains committed to providing an update on steps to strengthen the Human Food Program at the end of January and additional updates on the organizational structure, including how the responsibilities of Mr. Yanas’ position will be handled in the future, by the end of February,” the spokesperson said.

Yanas was among the top FDA officials involved in the Biden administration’s faltering response to the infant formula crisis. Food and Drug Administration officials were warned months ago of food safety concerns at a major plant in Sturgis, Michigan, operated by Abbott Nutrition. The manufacturer issued a recall of some formula products, after reports of babies dying after consuming formula from the facility, and FDA inspectors finding strains of bacteria that could be fatal to babies. Abbott confirmed that there was no link between the deaths and the formula in the plant.

Yanas, FDA Commissioner Robert Calif and Susan Main, 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 in internal FDA communications that officials said prevented them from that. Learn about safety issues up to a few weeks before recall. Yiannas and Califf also said that a whistleblower report alleging food safety problems at the plant, which was mailed in October 2021, did not reach the FDA’s highest levels until mid-February 2022, despite being sent directly to senior administration officials. Food and medicine.

As Politico reported, Maine and Yanas have personal differences, which has created tension at higher levels at an agency already struggling to make decisions. Key industry leaders, despite the FDA’s internal malfunctions, generally respected Yiannas and believed his role was being reduced at the agency.

“It is disappointing that the structure and culture of the FDA’s food program has consistently failed to take full advantage of its extensive experience in food safety,” said Brian Ronholm, former Deputy Undersecretary for Food Safety at the Department of Agriculture.

Yanas, the former vice president in charge of food safety at Walmart, later met with formula manufacturers and retailers as the Biden administration scrambled to address shortages caused by the Abbott recall as empty shelves turned into a political crisis for President Joe Biden.

Yanas’ resignation comes as the Food and Drug Administration prepares to announce a series of steps it is taking to address the findings of a recent external review in the wake of the infant formula crisis and other failures at the FDA.