Deputy commissioner Frank Yiannas resigned as the top food safety official at the FDA, effective Feb. 24, in a three-page letter that defended his record and criticized the agency for a decentralized structure that hobbled its protection of the food supply. With a reorganization of the FDA looming, Yiannas called on Wednesday for the appointment of “a fully empowered and experienced deputy commissioner for foods with direct oversight” of all offices dealing with human and animal food.
FDA commissioner Robert Califf has said he will outline “a new vision” for the agency’s food program by the end of this month, based on an outside review, and announce a new leadership structure for the FDA by the end of February. Califf requested the review last summer as a result of the FDA’s bumbling response to contaminated infant formula and the nationwide shortage that followed.
“I am fully committed to building a world-class Human Foods Program that works best for the public, our stakeholders, and our employees — and that will allow us to effectively deliver on our mission,” he said on the day the review was released.
The February updates will include “how responsibilities of Mr. Yiannas’ position will be handled moving forward,” said the FDA. Yiannas was deputy commissioner for the Office of Food Policy and Response. An FDA statement said he helped “create a safer and more digital, traceable food system for our country.”
The FDA has jurisdiction over 78 percent of the U.S. food supply, including fruits, vegetables, and most prepared foods. Yet its work in food safety and nutrition is often overshadowed by the agency’s role overseeing drugs and medical devices, leading to grim jokes that the “F” in FDA is silent. “Food is not a high priority at the Food and Drug Administration,” concluded a Politico investigation last April.
Operating under the aegis of the Reagan-Udall Foundation, a panel of experts recommended last Dec. 6 that the Biden administration restructure the FDA to give more prominence to food safety. The outside review listed five options ranging from the appointment of a deputy commissioner for food to a dramatic splitting of the agency into two entities, one dealing with drugs and the other with food.
“The current organizational structure lacks a clear leader and decision-maker,” said the panel report. “It is imperative that the Human Foods Program become more prominent. When compared to the medical products program within FDA, the Human Foods Program continuously struggles for visibility and prominence.”
In resigning, Yiannas said he had considered leaving the FDA a year ago because of “the decentralized structure of the foods program,” which “significantly impaired FDA’s ability to operate as an integrated food team and protect the public.” Instead, he stayed to handle the infant formula crisis. With a problem factory reopened and formula more widely available, “I believe the time is right for me to leave,” he said.
As deputy commissioner, Yiannas “was at the center of the agency’s flawed response to the baby food crisis,” said the Washington Post. At least two children died from allegedly tainted formula. Yiannas said it was months before he learned of a whistleblower report pointing to a formula plant in Sturgis, Michigan. The owner of the plant has said there were no shortcomings in its product.
To read Yiannas’ resignation letter, click here.
The Reagan-Udall Foundation report is available here.