FDA Policy/General

Califf Proposes ‘Transformation’ of Foods Program, ORA

FDA commissioner Robert Califf announced 1/31 a new “transformative vision” for the agency’s human foods program and the Office of Regulatory Affairs that addresses recommendations and findings from a 12/2022 external evaluation by the Reagan-Udall Foundation that the agency requested. Califf says the new proposed structures for both groups will have “clear priorities that are focused on protecting and promoting a safe, nutritious U.S. food supply that more quickly adapts to an ever-changing and evolving environment.” The proposed changes come on the heels of last week’s resignation of the agency’s top food official, deputy commissioner Frank Yiannas (see resignation letter).

Califf’s new vision includes a national search for a new deputy commissioner for human foods, who will oversee the re-engineered foods 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,” according to an agency release. “The deputy commissioner will have decision-making authority over policy, strategy, and regulatory program activities within the Human Foods Program, as well as resource allocation and risk-prioritization.”

Other key components of the food program include:

Creating a Center for Excellence in Nutrition that prioritizes the agency’s ongoing efforts to help consumers make better food choices. FDA proposes to establish an Office of Critical Foods, as mandated by the 2023 Consolidated Appropriations Act, within this center.
Establishing an Office of Integrated Food Safety System Partnerships that will focus on elevating, coordinating and integrating food safety and response activities with state and local regulatory partners.
Creating a Human Foods Advisory Committee to obtain advice on various issues. The Human Foods Advisory Committee will consist of external experts to advise on challenging and emerging issues in food safety, nutrition and innovative food technologies.
Strengthening information technology and analytical capabilities to guide the priorities of the food program and the work in the field.

As for ORA’s new vision, Califf proposes transforming its operating structure into an “enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs (e.g., agency Centers) by focusing on its critical activities. This realignment will allow ORA to be singularly focused on excellence in its core mission – inspections, laboratory testing, import, and investigative operations. This will optimize ORA’s operations in line with the FDA’s public health and prevention-oriented goals. Certain other functions of ORA will be aligned in other parts of the FDA to create an overall stronger agency.”

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