The US Food and Drug Administration (FDA) is the federal agency responsible for the safety of the food products supplied to Americans. This includes goods from both local and international suppliers. The FDA recently announced the proposed redesign of its Human Foods Program. Sweeping changes will unify various FDA authorities, such as the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and other specific aspects of the Office of Regulatory Affairs (ORA), to create the newly envisioned program.
Why Redesign the Human Foods Program?
The proposed redesigning of the Human Foods Program comes after months of scrutiny of the FDA’s handling of the US baby formula shortage. It was criticized for taking too much time to address other concerns related to nutrition and safety.
For example, FDA’s Deputy Commissioner Frank Yiannas, who resigned in February, acknowledged the agency’s decentralized structure was to blame. He said it significantly limited FDA’s ability to operate a single, integrated unit and protect food safety.
Additionally, Director of Food Policy at Consumer Reports Brian Ronholm pointed out that the FDA’s initial program failed to capture what’s required. That’s why the current structure is so dysfunctional to the point that it can’t effectively address the infant formula crisis.
How Will the New Proposed Approach Benefit the Program?
The increased scrutiny of its food protection and safety strategies prompted the FDA to commission a panel of expert researchers from the Reagan-Udall Foundation. Their task was to conduct an external and internal review of its handling of infant formula regulations. Following a careful review of the recommendations and findings, the FDA discovered several issues concerning culture, structure, authorities, and resources. The researchers also identified other areas of concern that needed restructuring, including:
- Modernizing data and IT systems.
- Providing additional resources and authorities.
- Enhancing emergency response programs.
- Establishing more robust regulatory policies and programs.
The proposed new structure of the Human Foods Program was announced on January 31, 2023. The FDA Commissioner Dr. Robert Califf highlighted a transformative change for the Human Foods Program. However, he also said the program’s restructuring includes a transformative vision for ORA, FDA’s oversight office responsible for conducting field inspections, lab testing, and other investigative operations. The proposed redesign will empower the agency to better protect and promote a safe and nutritious food supply chain. The new structure will allow the agency to adapt quickly to the ever-changing and evolving environment.
Additionally, the FDA will begin a search for a new deputy commissioner. This role will oversee the Human Foods Safety Program, and the regulatory policies. It will report directly to the head of the agency. By creating a unified program under a single leader, the FDA aims to improve the program and eliminate redundancies. The changes will enable the agency to undertake its oversight role more effectively and efficiently.
Key Elements of the Newly Proposed Human Foods Program
Besides unifying the authoritative facets of the Human Foods Program, the proposed restructuring also focuses on other key elements that include:
- Creating a Center for Excellence in Nutrition. It will support the agency’s programs that help Americans make informed dietary choices. This includes collaborating with the industry’s stakeholders to ensure the US population consumes healthier and more nutritious food products. The center will also have an Office of Critical Foods, as outlined under the 2023 Consolidated Appropriations Act.
- Establishing an Office of Integrated Food Safety System Partnerships. The goal is to improve, coordinate, and integrate FDA’s food safety and emergency response strategies into State and local regulatory systems. It will help effectively achieve the objectives of the Integrated Food Safety System as proposed under the 2011 Food Safety Modernization Act. The primary purpose of this new design is to foster collaboration and support food inspection activities at the state level.
- Creating a Human Foods Advisory Committee. This group will support the agency’s scientifically grounded decision-making processes. This committee will comprise external experts to offer independent professional advice on the challenging and trending issues related to food safety, nutrition, and advanced food technology.
- Strengthening the agency’s IT infrastructure and analytical capabilities. This element will help the organization achieve the objectives of the New Era Smarter Food Safety system. It will provide the needed resources to streamline workflows and operations critical to making the changes achievable. That will help the Human Foods Program operate more efficiently by creating clear communication channels, more efficient operations, and improved empirical risk algorithms to inform the program’s priorities and operations in the field.
Other Expected Changes Under the Redesigned Foods Program
As part of the proposed new structure, other agencies and offices – such as ORA and the Center for Veterinary Medicine (CVM) – are expected to also undergo several changes.
For example, ORA’s operating structure will be transformed into an organization-wide entity that supports the Human Foods Program and other FDA agencies and regulatory programs. That will allow ORA to singularly concentrate on its primary mission of conducting food inspections, testing, import, and inquisitive operations.
Although CVM will continue operating as an independent organization, its food safety activities will be closely coordinated by the CVM Center Director in partnership with the Deputy Commissioner for Human Foods. That will ensure the CVM supports the Human Foods Program in circumstances where its activities impact human food safety.
The Newly Proposed Foods Program Under Scrutiny
Despite its proposed approach to the foods program, the FDA has come under more criticism. It is coming from the industry’s stakeholders, including consumer organizations, industry leaders, and state and local authorities, who expressed their disappointment in the latest restructuring plan.
From their perspective, the latest updates will only make it more challenging for FDA’s chief commissioner to find a deputy commissioner competent enough to accelerate structural and cultural transformation. The authorities currently serving under FDA continue to be divided amongst the various programs. They feel this is counterintuitive to the new proposal of unifying the agency’s authorities. According to critics, that fuels “matrix management.” That will restrict the new deputy commissioner from undertaking their duties and responsibilities effective and efficient decisions.
To them, nothing has changed in the FDA, because the new design only demonstrates “business as usual.” They want to see transformative measures that will ensure the Foods Program moves from a state of inaction and indecision to one that focuses on proactivity and action.
Meanwhile, the FDA encourages Americans to be confident that the agency’s dedicated workforce is doing everything in its power to ensure they consume safe and nutritious foods. In its announcement, the agency’s next step is to collaborate with internal and external stakeholders to implement the latest update to develop a concrete reorganized agency while meeting its labor obligations. As noted in the announcement, the FDA plans to come up with a proposal this fall to clearly outline the new structure, budget, and workforce management. It will then undergo thorough expert reviews before it’s tabled in Congress.
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