FDA Looks at Reorganizing Its Human Foods Program After Botched Similac Infant Formula Recall

Critics say the proposed reorganization of the Human Foods Program does not go far enough to adequately protect public health.

The U.S. Food and Drug Administration (FDA) is considering a massive overhaul of the national food safety program, after the agency received scalding criticism about how it handled a recent Similac baby formula recall and other food-related health emergencies. However, critics indicate the plans still don’t go far enough to protect Americans.

On January 31, FDA Commissioner Robert Califf issued a press release to announce plans to redesign the Human Foods Program, including a new focus on nutrition, and major structural changes to how foods are regulated.

The announcement comes two months after an independent review of the FDA’s food safety programs found the agency lacked direction, feared confronting industry and called for the FDA to make more use of its enforcement powers, such as more frequently forcing food recalls.

The report came after the agency received widespread criticism for its handling of widespread problems with contaminated infant formula recalled almost a year ago, after it was discovered that the agency allowed Abbott laboratories to continue distributing Similac, Alimentum and EleCare formula to families, even after there were reports of babies becoming sick and dying due to Cronobacter sakazakii and Salmonella Newport bacteria that was discovered months earlier.

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Baby Formula Lawsuits

Premature infants fed Similac or Enfamil cow's milk formula faced increased risk of necrotizing enterocolitis (NEC) or wrongful death.


“Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a newly envisioned organization called the Human Foods Program,” Califf wrote. “The FDA will conduct a competitive national search for a Deputy Commissioner for Human Foods, who will oversee the Program. The person in this position will report directly to me and will be charged with leading a unified Human Foods Program that keeps the foods we regulate safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition.”

The proposed plan also includes the creation of a Center for Excellence in Nutrition, which would make it a priority to better inform Americans about healthy food choices, and would push industry toward making healthier, more nutritious food offerings to the public. Califf also proposes the establishment of an Office of Integrated Food Safety System Partnerships, which would enable the agency to coordinate better with state and local food safety and health regulators.

The FDA would also establish a Human Foods Advisory Committee, which would provide the agency with independent expert advice on food regulatory issues.

Critics Say Human Foods Plan Falls Short

On the same day as Califf’s announcement, Consumer Reports issued a statement saying the proposed plan, while an improvement, would fail to protect the public.

“We’re disappointed that the FDA’s plan falls short of what’s needed to strengthen the agency’s ability to protect the public and keep our food safe,” Brian Ronholm, director of food policy at Consumer Reports, said in the press release. “The FDA’s plan fails to ensure that all of the agency’s food program staff will work together seamlessly with a common strategic direction, clear priorities, sound resource management, and internal accountability. We’ll continue to urge Commissioner Califf to strengthen leadership and accountability at the FDA to modernize its food program, emphasize prevention and enable it to better protect the public when problems arise.”

Consumer Reports is part of a coalition of 30 consumer protection organizations calling for the FDA to improve its focus on leadership and accountability in its food safety programs.

Similac Recall Enforcement Problems

In the independent review of the FDA’s activities, reviewers repeatedly pointed to the FDA’s handling of the recent Similac infant formula recall as an example of the agency’s failings, and specifically called for the FDA to require infant formula manufacturers to retain microbiological testing records available for agency review.

In September, the FDA issued a 10-page report which indicated the agency failed to properly respond to the massive infant formula recall.

Abbott Laboratories first announced the infant formula recall involving Similac, Alimentum and EleCare products in February 2022, after FDA inspections confirmed the presence of bacteria throughout the Michigan facility, and identified widespread manufacturing problems. By the time the problems were disclosed to families, contaminated formula had already caused hundreds infant illnesses and hospitalizations nationwide, including several deaths.

Shortly after the recall, it became apparent that Abbott and the FDA knew about the Similac contamination problems since at least September 2021, when the Minnesota Department of Health began investigating a case involving an infected infant. However, the formula continued to be distributed, remained on store shelves and families nationwide continued to feed the contaminated products to infants for another several months.

Abbott was forced to temporarily close the Sturgis, Michigan plant where the formula was contaminated for several months last year, due to widespread safety problems, which shut down production at one of the major sources of infant formula in the United States. This contributed to a nationwide shortage of infant formula earlier this year.

Abbott now faces a growing number of Similac recall lawsuits brought by families of infants nationwide who were diagnosed with Salmonella, Cronobacter or other infections linked to bacteria at the manufacturing facility, and serious questions are being raised about why the problems were not addressed much earlier.


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