Food and Drug Administration Proposes Human Foods Program Redesign

Commissioner of the United States Food and Drug Administration Dr. Robert Califf speaks during the COVID Federal Response Hearing on Capitol Hill on June 16, 2022, in Washington. Joe Raedle/Getty Images

Food and Drug Administration (FDA) Commissioner Robert Califf said on Jan. 31 that major reforms will be coming to his agency in the wake of the recent infant formula shortages.

The FDA chief said in a press release that he was “announcing a new, transformative vision for the FDA Human Foods Program.”

The decision came on the heels of a review of findings and recommendations by experts after much of the nation experienced a severe shortage of infant formula.

Califf said the internal and external reviews of the FDA’s practices pointed to several problems, including a need to modernize the administration’s data systems, improve emergency responses, and create a “more robust regulatory program.”

A major component of Califf’s vision for the new program includes major changes for the Office of Regulatory Affairs (ORA), which is the field-based operational hub for the administration.

“Under this plan, the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR), as well as certain functions of ORA will be unified into a newly envisioned organization called the Human Foods Program,” Califf said in the press release.

“The FDA will conduct a competitive national search for a deputy commissioner for human foods, who will oversee the program.”

Included in the upcoming changes is the creation of a Center for Excellence in Nutrition to focus on the agency’s efforts to help Americans make “more informed food choices” as well as “working with [the] industry to offer healthier, more nutritious food products.”

The FDA is also working on a plan to form an office of partnerships, which will help to blend the FDA’s responses with local partners to “more effectively meet the vision of an Integrated Food Safety System as envisioned in the FDA Food Safety Modernization Act of 2011.”

According to the FDA’s statement, ORA’s operating structure will be modified as part of this proposed new vision into an enterprise-wide organization that supports the Human Foods Program and all other FDA regulatory programs by focusing on its important activities.

Califf wrapped up his explanation of the changes by saying, “Finally, there will be an emphasis on strengthening our enterprise information technology and analytical capabilities to fulfill the promise described in the New Era of Smarter Food Safety and support the improvement in workflow that will accompany these changes.”