U.S. food safety regulator announces shakeup after infant formula crisis

[February 01, 2023]  By Leah Douglas

(Reuters) - The U.S. Food and Drug Administration (FDA) said on Tuesday it will restructure its food program that was slammed last year for responding too slowly to an outbreak of illness among infants who consumed formula from an Abbott Laboratories production plant.

In response to recommendations made by an outside group following the crisis, the FDA will establish a Human Foods Program led by a deputy commissioner, uniting its Center for Food Safety and Applied Nutrition, food policy office, and certain functions of its regulatory affairs office, agency head Robert M. Califf announced.

The new structure "unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way," Califf said in a statement.

The changes were aligned with several recommendations made last year by the Reagan-Udall Foundation, an organization in part funded by FDA, that assessed how the agency could shore up its food operations.

The report, released in December, found FDA lacked a clear vision for its food program. It recommended consolidating food-related functions under one leader.

Califf requested the report after critics slammed the agency for its response to the infant formula crisis. Ultimately, five infants were sickened and two died after consuming formula from the plant, according to FDA.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

The plant's temporary closure led to widespread formula shortages that lasted months. Abbott is facing a criminal investigation by the Justice Department.

Consumer groups cheered Tuesday's announcement.

The new structure "is likely to improve efficiency and benefit the American people," said Peter G. Lurie, president of the Center for Science in the Public Interest and former associate commissioner of FDA from 2014 to 2017.

FDA oversees the vast majority of the U.S. food supply including produce, dairy, infant formula, and food additives. The Department of Agriculture regulates meat, poultry, and egg products.

(Reporting by Leah Douglas; Editing by David Gregorio)

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