On January 31, 2023, the Commissioner of the Food and Drug Administration, Dr. Robert Califf, announced a proposal to overhaul the human foods program to protect food safety.

The statement, published on the FDA’s site here, follows an external evaluation conducted by the Reagan-Udall Foundation at the request of the FDA. This evaluation identified several issues surrounding culture, structure, resources, and authorities. It also indicated a need for modernized data systems, improved emergency response systems, and a more robust regulatory program.

In response to the evaluation, the FDA’s commissioner promised a “transformative vision” that would fulfill the mandate of the FDA to ensure the safety of food products consumed by hundreds of millions of Americans every day.

This transformative vision includes:

1. A consolidation of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain functions of the Office of Regulatory Affairs (ORA), under a new organization, called the Humans Food Program (HFP)
2. Hiring a single leader, a “Deputy Commissioner” for the HFP, who reports directly to the FDA Commissioner, will remove redundancies and has authority over policy, strategy, and regulatory program activities within the HFP.

In addition, two new entities will exist within the HFP:

1. A Center for Excellence in Nutrition
   The CEN will prioritize the agency’s efforts to help American consumers make better-informed food choices, through collaboration with the industry to offer healthier, more nutritious food products.
2. An Office of Integrated Food Safety System Partnerships
   The OIFSSP will focus on food safety response activities with State and Local regulatory partners to “more effectively meet the vision of an Integrated Foods Safety System” as envisioned by the Food Safety Modernization Act of 2011.

The FDA will also create a food advisory committee to assist with “scientifically grounded decision-making”.

In order to meet the need for “modernized data systems”, the organization will focus on “strengthening our information technology and analytical abilities” to “fulfill the promise described in the New Era of Smarter Food Safety”.

Finally, the transformative vision proposes transforming the ORA into an enterprise-wide organization that will have regulatory authority over the HFP and all other FDA regulatory programs.

What does this mean for the food industry?

To be determined. At the moment, this statement remains a proposal, so nothing has changed. Also, the food regulations remain the same, and this proposal only recommends pooling resources and a reorganization of the departments responsible for Food Safety within the FDA. However, it could mean better regulatory oversight and resource management by the FDA.

This article provides a supplemental review of the FDA statement, “FDA Proposes Redesign of Human Foods Program to Enhance Coordinated Prevention and Response Activities“, and is not a substitute for reading the full statement.

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