FDA Food Division Too Afraid of Confronting Industry to Protect Public Health, Review Finds

The report found the FDA Food division would often avoid enforcement actions to protect public health out of fear of legal action by industry.

According to an independent review of how federal regulators handle human food safety claims, the FDA lacks clear direction, has a fear of confronting the industry and faces other challenges, which leaves the agency unable to adequately protect public health.

On December 6, the Reagan-Udall Foundation released an external evaluation (PDF) of the U.S. Food and Drug Administration (FDA) Human Foods Program, calling for changes in how the program is run, to make it more effective at keeping the food supply safe.

The report came after the agency received widespread criticism for its handling of the Similac infant formula food poisoning recall earlier this year, which allowed contaminated formula to be distributed to families nationwide, sickening hundreds of newborns and potentially causing several deaths.

The findings calls for the FDA unit to make more bold use of its enforcement power, such as more frequently requiring mandatory food recalls, and called for changes in the Human Foods Programs culture, to make its regulatory decisions more rooted in scientific evidence. It also called for broad changes in the program’s structure and leadership.

The unit’s aversion to taking risks was cited by the report as a significant liability.

“The FDA Human Foods Program’s aversion to risk compromises the Agency’s willingness to act in enforcement or policy development, to collaborate within the Agency and across government, and to discuss novel and innovative approaches to policy and science as part of meaningful stakeholder dialogue,” the report states. “For example, FDA’s Human Foods Program has at times appeared to be reluctant to take enforcement action unless they feel that, with certainty, the action could withstand legal challenges.”

The report estimates that about 46 million Americans suffer a food poisoning illness every year, resulting in 128,000 hospitalizations and 3,000 deaths. The report estimates the medical costs and lost productivity cost the country about $90 billion annually.

Contaminated Similac, Alimentum and EleCare Recall

Throughout the report, the 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.

In February 2022, Abbott Laboratories announced an infant formula recall involving Similac, Alimentum and EleCare products, 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.

In February 2022, Abbott was forced to close the Sturgis, Michigan plant where the formula was contaminated, 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 contaminated Similac 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.

FDA’s Vows Response and Plans for a New Vision Next Year

On the same day the report was released, FDA Commissioner Robert M. Califf, who ordered the review in July, issued a press release indicating the agency is still reviewing the report’s findings.

“The work of these independent evaluators will help to inform a new vision for the FDA Human Foods Program,” Califf wrote. The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures.”

Califf said he will make final decisions regarding the Human Foods Program after he reviews the report and consults with stakeholders. The Commissioner also announced he is forming a group of agency leaders who will advise him on how to best implement the report’s findings.