Whistleblower report on baby formula factory safety issues was slow to reach FDA food safety chief

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said he never heard about complaint until four months later, by which time one baby had died and two had been hospitalized after consuming formula from the factory.
Cans of Enfamil in an Illinois Walmart, Jan. 2022

A whistleblower sent a 34-page report to the Food and Drug Administration in October alleging a number of safety violations at the Abbott infant formula factory that the top government official in charge of food safety did not see, according to a report in the Washington Post.

FDA Deputy Commissioner for Food Policy and Response Frank Yiannas said he didn't even hear about the complaint until four months later. By then, one baby had already died and two had been admitted to the hospital after consuming formula from the factory.

When another infant death appeared to be linked to the Abbott factory formula, the plant shut down and the company issued a recall, prompting a national shortage of baby formula. 

"It wasn't sent to me, and it wasn't shared with me internally," Yiannas, who formerly headed up the food safety program for Walmart, told the Post. "How does this happen? There were early signals, and in any safety profession you want to take those seriously to stop the domino effect. That didn't happen."

Experts say the FDA has long prioritized the handling of drugs and medications over food safety. 

Despite his title, neither of the FDA's food policy divisions are required to report to Yiannas, nor are the agency's food safety inspectors. Instead, they report to FDA Commissioner Dr. Robert Califf, who was appointed on the same day in February that Abbott recalled a number of its powdered formula products.

This week, two House panels will hold separate hearings to investigate the actions taken by the FDA on this matter, as well as ask questions about potential deeper structural issues at the agency.

The agency is due for a self-reckoning, Yiannas told the Post. "Why didn't we act more quickly on the complaints and the whistleblower report?" he asked. "Who knew what when? Those are going to be some of the tough questions that will have to be answered."

According to FDA testimony released ahead of Wednesday's hearings, the agency was scheduled to inspect the Abbott facility in early December, but mail room failures and a COVID-19 outbreak delayed the inspection and receipt of the report. By the time inspectors showed up on Jan. 31 to collect samples that confirmed the presence of the cronobacter bacteria at the plant, one infant had already died and two sickened after drinking formula from the plant.

Abbott says that after a "review of all available data," there is no "conclusive evidence" linking the infant medical issues with its formula.