FDA revamping foods program to move past ‘constant turmoil’

The head of the Food and Drug Administration on Tuesday announced an overhaul of the agency’s food safety and nutrition division, vowing that the new structure will better protect consumers and the US food supply.

FDA Commissioner Dr. Robert Califf said he would create a new human food program led by a deputy commissioner with authority over policy, strategy and regulatory activities for the part of the agency that oversees 80% of the food Americans eat.

“This is one of the most significant changes in FDA history,” Califf said in an interview.

The move combines two existing FDA programs and several regulatory authorities. Tapping a leader “consolidates and improves the program while eliminating redundancies, allowing the agency to oversee human food in a more effective and efficient way,” Califf said.

The announcement follows a months-long FDA investigation into contamination at a Michigan plant that caused a nationwide shortage of infant formula. And it follows scathing reports which found the FDA’s food division plagued by decentralized leadership, uncertainty and a culture of “constant turmoil” that impeded action to protect public health. Over the years, the agency has been criticized for reacting too slowly to outbreaks in produce, heavy metals in baby food and the need to reduce sodium in the US diet, among other issues.

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Califf’s action drew mixed reviews from food safety advocates. Some say it’s a good start, while others say he doesn’t go far enough to unravel deep-rooted structural problems.

“I think it does a good job of identifying important problems and addressing them directly,” said Dr. Peter Lurie, who heads the Center for Science in the Public Interest, which focuses on consumer nutrition, food safety and health.

Mike Taylor, who previously served as the FDA’s deputy commissioner for food and veterinary medicine, said the new deputy does not appear to have full authority over the office responsible for inspecting company factories, laboratory tests, imports and investigations.

“If that happens, the human food program at FDA will remain fragmented and the deputy commissioner will not be empowered to make the necessary changes,” Taylor said.

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Califf said that the deputy commissioner will have authority over the budget and human food priorities. He said it would be a mistake to create a “monolithic organization” to overcome resistance to change.

“Just because there was resistance in the past, it doesn’t mean it can’t work,” Califf added.

The change aims to straighten out the convoluted leadership structure. The FDA oversees human and veterinary drugs and medical devices, along with most of the US food supply. The Department of Agriculture also oversees some food products.

Frank Yiannas, the FDA’s current deputy commissioner for food policy and response, will leave his post next month. Susan Mayne, the current director of the Center for Food Safety and Applied Nutrition, said in a statement that Califf asked her to stay on through the transition. The new deputy, who will report directly to the commissioner, will be named by spring, Califf said.

The revamped food program will include a separate center focused on nutrition, including foods such as infant formula, as well as an office to coordinate government efforts to identify and prevent foodborne disease outbreaks. The plan also calls for a new expert advisory committee to consider food safety, nutrition and new food technology.

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Under the new structure, the deputy commissioner will not oversee the FDA’s veterinary medicine center. Califf said that’s because most of the center’s work involves drugs and animal devices, not food. In addition, the pet food industry worries that it will become “subsidiary to human food,” Califf said.

That frustrates Mitzi Baum, president of the nonprofit STOP Foodborne Illness. Human food, animal food and epidemics are often closely related and they should be part of the same program, he said.

“Any change is messy. It will be disruptive,” Baum said. “Why not make all the changes that need to be made to create the most efficient and effective agency possible?”


The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Science and Education Media Group. AP is solely responsible for all content


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