Top FDA Safety Official Frank Yiannas Resigns

A top Food and Drug Administration (FDA) safety official resigned this week because of concerns about the agency’s oversight structure and the infant formula shortage.

Frank Yiannas, deputy commissioner for food policy and response since 2018, told FDA Commissioner Dr. Robert Califf that he’s leaving the agency in February.

“Today, I informed Commissioner Califf that I will be resigning my position as Deputy Commissioner for the Office of Food Policy and Response effective February 24,” Yiannas wrote on Twitter. “I am honored to have served the American public, alongside each and every one of you, over these past four years.”

Yiannas’s notice comes less than a week before Califf is expected to release a response to a scathing report calling for an overhaul of the way the agency regulates human and animal foods. Currently, no single official has full oversight of the FDA’s sprawling food operations.

The FDA issued a statement on Jan. 25 that praised Yiannas for his service on the panel. His work has helped “create a safer and more digital, traceable food system for our country.”

“The FDA remains committed to providing an update on steps to strengthen the Human Foods Program at the end of January and additional updates on the organizational structure, including how responsibilities of Mr. Yiannas’ position will be handled moving forward, by the end of February,” the FDA statement reads.

In a letter obtained (pdf) by several media outlets, Yiannas cited the “decentralized structure of the foods program that you and I both inherited” as a reason for departing. He wrote that the way the division is being operated has “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”

But Yiannas said he postponed leaving in 2022 after learning of problems at the Abbott Laboratories infant formula plant in Michigan, which was shuttered for months because of contamination. The plant has since reopened, and Abbott is facing a Justice Department criminal investigation.

Yiannas said infant formula supplies have increased and necessary monitoring is in place, making it the right time to leave the FDA.

“It was also in February of 2022 that I first learned of the infant formula incidents [that] had been reported to various parts of the FDA several months before, so I postponed this decision and dedicated myself and my staff to doing all we could to help tackle this crisis,” he wrote. “With the Abbott facility now reopened, infant formula availability more prevalent, and—very importantly—the necessary monitoring, data systems, and insights now in place through the 21 Forward platform to help address the current and any future infant formula supply chain challenges, I believe the time is right for me to leave and vacate this position.”

In the letter, he noted that his hope is that consumers won’t have to deal with any future baby formula shortages.

Last week, the Justice Department opened an investigation into the Abbott Laboratories plant in Sturgis, Michigan, after it shut down for more than four months after inspectors found the presence of Cronobacter sakazakii, which can cause potentially deadly infections in newborns and immunocompromised infants. This, in turn, along with other supply chain disruptions, led to widespread formula shortages across the United States.

Officials with Abbott have said that the bacteria didn’t come from the Michigan factory, a key U.S. production site for baby formula.

Yiannas told The Washington Post that a whistleblower sent a report to the FDA in October 2022 that alleged problems at the Abbott factory. But he didn’t see it for many months.

“It wasn’t sent to me, and it wasn’t shared with me internally. How does this happen?” Yiannas told the paper. “There were early signals, and in any safety profession you want to take those seriously to stop the domino effect. That didn’t happen.”