FDA food safety chief Frank Yiannas resigns

Dive Brief:

• FDA Deputy Commissioner for Food Policy and Response Frank Yiannas has resigned from the position, effective Feb. 24. The resignation letter, of which Food Dive recieved a copy, is dated Wednesday.
• In his resignation letter, Yiannas recommended that Califf realign the department’s food program to be under one deputy commissioner for foods. Right now, FDA has two top food program directors who both report directly to the commissioner: the position Yiannas is leaving and the director of the Center for Food Safety and Applied Nutrition.
• Yiannas’s resignation comes just days before FDA is expected to issue an agency response to an independent report recommending the agency be restructured.

Dive Insight:

When Yiannas was appointed as FDA’s first deputy commissioner for food policy and response in 2018, one of the reasons behind his selection was his experience in using new technology to bolster food safety. Before FDA, Yiannas was vice president for food safety and health at Walmart, and had previously been the director of safety and health at Walt Disney World. 

In his resignation letter, Yiannas told Califf he considered leaving the agency last February, largely because of his “concern that the decentralized structure of the food program that you and I both inherited, significantly impaired the FDA’s ability to operate as an integrated food team and protect the public.”

Yiannas said he deferred his decision to leave after learning of reports of contamination in a large infant formula factory. Under current FDA structure, Yiannas is responsible for food safety. 

The agency’s food division has been under fire for its response to an Abbott Laboratories infant-formula manufacturing site in Michigan that was linked to contamination. Contaminated formula produced at the factory led to a massive recall and more than four-month shutdown of the Abbott Laboratories plant in Sturgis, Michigan, which led to a nationwide shortage. At least four babies became ill and two died after drinking contaminated formula, according to the Centers for Disease Control and Prevention. Yiannas has told media outlets that he did not know about reported issues at the factory until four months after they were first reported.

The report from the Reagan-Udall Foundation — which Califf requested last summer after the baby formula crisis and news reporting exposed internal issues in the agency — recommends big changes at FDA. The current structure does not provide a clear chain of command, and it creates an ineffective way to regulate food to protect public health, the report says. The lack of a clear leader for the foods program, the report says, “has contributed to a culture of indecisiveness and inaction and created disincentives for collaboration.”

In a statement after the report was published in December, Califf said he was committed to putting some of its recommendations into action. He said the FDA would provide an update on its new vision for the Human Foods Program by the end of January, and will announce proposed changes to its leadership structure by the end of February.

Yiannas’s departure at the end of February might make it easier for FDA to transition into having a single deputy commissioner for foods to run the program. Nobody would need to be removed from a high-ranking position in the agency. Also, whoever is chosen as Yiannas’s replacement could have a brand new position and set of responsibilities, much like Yiannas himself got when he first joined FDA more than four years ago.