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The FDA announces a revision of the food program to protect consumers and the food supply

The head of the Food and Drug Administration on Tuesday announced an overhaul of the agency’s Food Safety and Nutrition Division, promising a new structure will better protect consumers and the U.S. food supply.

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

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

The move brings together two existing FDA programs and some regulatory agencies. The addition of a single leader “unifies and enhances the program while eliminating redundancies, allowing the agency to monitor human nutrition more effectively and efficiently,” Califf said.

The announcement follows a month-long FDA investigation into contamination at a Michigan factory that led to a nationwide infant formula shortage. And there follows a scathing report that found that the FDA’s food division was plagued by decentralized leadership, indecisiveness and a culture of “constant turmoil” that hampered action to protect public health. For years, the agency has been criticized for being slow to respond to outbreaks on products, heavy metals in baby formula and the need to reduce sodium in the US diet, among other things.

Califf’s measures drew mixed criticism from food safety advocates. Some said it was a good start, while others said it hadn’t gone far enough to heal deep-rooted structural issues.

“I think it does a good job of identifying the key issues and addressing them head-on,” said Dr. Peter Lurie, director of the Center for Science in the Public Interest, which focuses on consumer nutrition, food safety and health.

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Mike Taylor, who previously served as FDA 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 facilities, laboratory testing, imports and investigations.

“If that is the case, the human nutrition program at the FDA will remain fragmented and the Deputy Commissioner will not have the authority to make the necessary changes,” Taylor said. He also questioned whether the new deputy commissioner would control funding for the programme.

The changes aim to straighten out a muddled leadership structure. The FDA oversees human and veterinary drugs and medical devices, as well as much of the US food supply. The Department of Agriculture also monitors some food products.

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

The revised food program includes a separate center focused on nutrition, including foods such as infant formula, and an office to coordinate government efforts to detect and prevent outbreaks of foodborne illness. The plan also envisages the creation of a new advisory committee of experts to deal with issues of food safety, nutrition and new food technologies.

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Under the new structure, the Deputy Commissioner will not oversee the FDA’s Veterinary Center. Califf said that’s because much of the center’s work involves veterinary medicines and equipment, not food. In addition, the animal feed industry fears it will become a “subsidiary of human nutrition,” Califf said.

This disappointed Mitzi Baum, President of the non-profit organization STOP Foodborne Illness. Human food, animal food and outbreaks are often closely related and should be part of the same program, she said.

“Any change is messy. It’s going to be disruptive,” Baum said. “Why not make all the necessary changes to create the most efficient and effective agency?”


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