Top FDA Safety Official Frank Yiannas Resigns

The 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 Follow us 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.

On Jan. 25, the FDA released a statement praising Yiannas’ service to the panel. His contributions have made a difference. “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 is as follows:

In a letter (pdf) by several media outlets, Yiannas cited the “decentralized structure of the foods program that you and I both inherited” As a reason to leave. He said that the division’s operation was unacceptable. “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.”

Yiannas claimed that he delayed leaving for 2022 when he discovered problems at the Abbott Laboratories infant-food plant in Michigan. This facility was shut down for months due to contamination. Abbott is now under investigation by the Justice Department.

Yiannas indicated that infant formula supplies are increasing and necessary monitoring is in effect, making it the right moment to leave 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 led to widespread shortages of formula across the United States, as well as other disruptions in supply chains.

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 In October 2022, a whistleblower submitted a report to FDA describing 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 spoke for 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.”

This report was contributed by The Associated Press.