FDA Proposes Overhaul Of Food Regulation In The Wake Of Baby Formula Shortage

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James Lynch Reporter
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The Food and Drug Administration (FDA) has proposed an overhaul of its food regulation division in the wake of the baby formula shortage of 2022.

FDA Commissioner Robert Califf announced Tuesday a plan to create a Deputy Commissioner for Human Foods to oversee its newly reorganized food divisions and certain parts of its Office of Regulatory Affairs (ORA).

Under the new plan, the responsibilities of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the ORA will be consolidated into a new organization, the Human Foods Program. The new commissioner will report directly to Califf and make decisions about the policy, strategy and regulatory activities within the Human Foods Program.

His plan comes shortly after an independent review found that the agency’s decision-making is “unacceptably slow” and “can be left appearing sluggish and nonresponsive to public health concerns.” (RELATED: Abbott Labs Facing Criminal Probe Over Baby Formula Shortage)

“The lack of a single clearly identified person to lead the Human Foods Program has adversely impacted the organizational culture and led to overlapping roles and competing priorities that result in what is perceived as constant turmoil,” the review found.

A panel of experts with the Reagan-Udall Foundation for the Food and Drug Administration conducted the review at Califf’s request and submitted their recommendations in Dec. 2022. Califf commissioned the review in July 2022 after the FDA received intense scrutiny during the baby formula shortage, which led to over 40 percent of U.S. baby formula supplies being out of stock, CNBC reported.

The agency was criticized for its lack of oversight regarding Abbott Labs, the largest formula producer in the U.S., when Abbott recalled formula products and temporarily closed its Michigan plant in Feb. 2022 because of bacteria found at the site. Abbott’s contaminated formula allegedly caused the deaths of two infants and the hospitalization of two others.

A subsequent FDA investigation into the Michigan plant discovered faulty equipment and a previous citation for inadequate hand washing. Califf said during a May 2022 hearing with the House Oversight Committee that the plant had been “egregiously unsanitary.” The recall was a major contributor to the baby formula shortage.

Califf also announced the creation of a Center for Excellence in Nutrition to inform American consumers about healthy food choices and work with the food industry to make healthier products. The FDA proposed an Office of Critical Foods within the nutrition center, as directed by the $1.5 trillion omnibus bill passed in Dec. 2022.