FDA Reorganizes Departments and Roles as New Unified Human Foods Program Roles Out This Fall

A new Unified Human Foods Program created within the United States Food and Drug Administration (FDA) is a pointed organization aimed to clean up the failures seen within the agency over the past few years. This move comes after an internal review of the FDA’s infant formula response along with feedback from both external and internal stakeholders.

This new Program was approved in March 2024. An effective date of May 13, 2024 was recorded in the Federal Register with an implementation date set for October 1, 2024. Many roles are being shuffled and focus honed in on the safety of human foods and an emphasis on a broader sampling program.

Current Role of the FDA

According to USA Gov:

“The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and product that emit radiation. The FDA also provides accurate, science-based health information to the public.”

While helping to keep the nation’s food supply safe is not the agency’s only responsibility, it is a big part of the scope of the organization. This role is the responsibility of the Human Foods Program. A program both stakeholders and the public have found lacking.

To be more in line with the Food Safety Modernization Act, this Unified Human Foods Program was proposed as an alternative to existing FDA Human Foods Program activities.

Failures During Infant Formula Response Prompted New Unified Human Foods Program

In addition to the Reagan-Udall Foundation evaluation, the Office of Inspector General from the Department of Health and Human Services performed an audit on the agency in response to the agency’s public failures during the Infant Formula recalls in 2022.

In addition to the Infant Formula Recall response, the Office of Inspector General identified issues with the FDA’s inspection of domestic food facilities.

According to the report, “FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond through its complaint, inspection, and recall processes.”

The report cited the FDA’s inadequacies in developing an organizational structure with assigned responsibilities to handle whistleblower complaints.

In fact, an investigation uncovered whistleblower complaints relating to the Abbott facility 15 months prior to FDA action.

Another whistleblower complaint sat for four months before getting the information to senior leadership.

Meanwhile, families were putting infants at risk, unaware of the potential dangers they were mixing into bottles for the baby’s sole source of nutrition.

Additionally, despite the recall authority granted to the agency, the FDA did not have sufficient policies and procedures to initiate an infant formula recall.

The need for change was obvious. In response, Commission of Food and Drugs of the FDA, Robert Califf issued a statement explaining the proposed Unified Human Foods Program in January 2023.

Unified Human Foods Program Vision

This Unified Human Foods Program announced on January 31, 2024, was to be placed under a single leader that reports directly to the Commissioner.

The vision is meant to remove redundancies, creating a more efficient and effective process.

This new Program combines and restructures certain existing organizations such as the Center for Food Safety and Applied Nutrition and Office of Food Policy and Response among others.

Creation of Office of Integrated Food Safety Systems Partnerships

Additionally, a new Office of Integrated Food Safety System Partnerships, as envisioned in the FDA’s Food Safety Modernization Act of 2011 will come to fruition. It’s purpose is to work closely with state and local regulatory partners through food safety and response efforts. The Program aims to use these previously untapped resources, previously held at arms-length due to lapses in coordination efforts.

“We know that we cannot be everywhere, at all times,” says Califf. “Our relationships with our state and local regulatory partners will be more important than ever going forward.

Creation of Center for Excellence in Nutrition to Include Office of Critical Foods

Part of this revamp includes creation of a Center for Excellence in Nutrition. The role of this new Office is aimed at the agency’s ongoing efforts to help American consumers make more informed good choices.

The new Office of Critical Foods will be a part of this Center. Foods like infant formula and medical foods are included in this scope.

Emphasis on Testing Activities

Sampling activities are a key step in preventing foodborne illness. Identifying a problem before it reaches the public is a key prevention strategy. While the FDA cannot sample every product going onto the market, increasing sampling activities at either the national level or within partnerships of state and local partners is necessary.

Federal Register Statement

According to the Federal Register Statement,

“The approved changes in the Human Foods Program (HFP) would allow us to fully realize the preventative vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen local, state, and international partnerships, position the FDA to regulate innovative food and agricultural products more effectively, and uphold safety of the nation’s food supply.”

Infant Formula Cronobacter Contaminations in 2021 Caused Illnesses, Death

While this move was necessary, the infant formula Cronobacter contaminations in 2021 that resulted in illnesses and death in 2022 was the catalyst for this endeavor.

A huge recall from Abbott, Sturgis infant formula manufacturing facilities resulted in at least four illnesses and at least two infant deaths.

The necessary recall created a snowball effect that lead to an infant formula shortage that year. A problem that resulted in mass panic, insufficient infant formula recipes, and use of unapproved imported infant formulas flooding the market.

Other infant formula contaminations were discovered following this large-scale discovery, further compounding the issue.

It was a tragic chaos. One to hopefully be avoided in the future under this new Unified Human Foods Program scope.

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By: Heather Van Tassell (contributing writer, non-lawyer)