FDA Proposes New Structure For Human Foods Program

Acknowledging issues within its existing system, the U.S Food and Drug Administration (FDA) is seeking to reimagine its food program through an agency-wide restructuring, per a letter published by Commissioner Robert Califf earlier today.

The revisions were developed with insight from internal agency reviews in addition to the in-depth, six-month-long, independent review conducted by the Reagan Udall Foundation which concluded that the FDA’s existing food program structure is highly inefficient.

According to the announcement, the proposed realignment will allow the agency to modernize data systems, better deploy existing resources, improve emergency response plans and build a “more robust regulatory program.” Califf’s proposed structure will be overseen by a new authority figure within the agency, Deputy Commissioner for Human Foods, for which a national recruitment search is already underway.

“Creating a Human Foods Program under a single leader who reports directly to the Commissioner unifies and elevates the program while removing redundancies, enabling the agency to oversee human food in a more effective and efficient way,” the announcement states.

Additionally, the proposed Human Food Program aims to take a more active role in nutrition standards with the creation of a new division, the Center for Excellence in Nutrition. The new office will work with the private sector food industry to develop, deploy and educate Americans on nutritious food products.

The Office of Integrated Food Safety System Partnerships will be another new department, tasked with helping realize the priorities of the 2011 Food Safety Modernization Act by integrating the federal agency’s activities with state and local regulatory partners. A Human Foods Advisory Committee composed of external experts will also be established to guide the agency’s continued evolution and progress on emerging issues in food safety, nutrition and innovative food technologies.

Califf’s vision for a new Human Food Program will also unify the agency’s field-based operations division, the Office of Regulatory Affairs (ORA), as well as The Center for Food Safety and Applied Nutrition (CFSAN) and The Office of Food Policy and Response (OFPR) under the oversight of the new commissioner. ORA specifically will be restructured so it has the ability to support all of the agency’s food departments with its core functions: inspections, laboratory testing, imports and investigative operations.

The FDA’s Center for Veterinary Medicine (CVM) will continue to operate as a standalone entity; however, related food safety actions will be coordinated between the CVM Director and new Deputy Commissioner for Human Foods.

But for now, all departments within the FDA will continue to operate as usual. The recently formed Implementation and Change Management Group is developing a detailed plan to execute this vision, Califf said, noting that he will provide an update at the end of February on the group’s progress.

The news comes less than a week after the resignation of Frank Yiannas, Deputy Commissioner for Food Policy and Response. Upon his departure, Yiannas said in a letter to Califf that the agency’s decentralized structure “significantly impaired” the OFPR’s ability to function. He recommended the OFPR, a department he oversaw, be unified under a new program that reports to a dedicated human food deputy commissioner.

The Reagan Udall report highlighted similar issues with the agency’s internal culture and structure that led to communication issues, gaps in authority and a resistance toward taking action. Some of those challenges will be addressed with the adoption of new technology, Califf explained in today’s announcement. The agency will specifically focus on realizing the promises made in the New Era of Smarter Food Safety plan, which was spearheaded by Yiannas, said Califf.