FDA pitches revamp of Human Foods Program

The U.S. Food and Drug Administration has proposed a reorganization of the Human Foods Program to oversee the nation’s food supply chain and food safety.

Announced Tuesday by FDA Commissioner Robert Califf, the new program would unify functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain functions of the Office of Regulatory Affairs (ORA), the FDA’s field-based operations. The reconstituted program also would create a Center for Excellence in Nutrition and an Office of Integrated Food Safety System Partnerships.

The restructuring plan comes after Califf said in early December that the FDA would evaluate an expert panel’s recommendations to buttress the agency’s food regulatory apparatus, which included proposals to separate the food and drug oversight functions.

He made that announcement with the release of the Reagan-Udall Foundation’s Operational Evaluation of FDA’s Human Foods Program report, commissioned by Califf in July and following a study by an independent expert group beginning in September. The panel assessed the FDA’s culture, structure/leadership, resources and authorities and made suggestions to sharpen the agency’s regulatory function, tighten state and local government ties, and better secure the nation’s food supply. Last year, the FDA also completed a separate internal review of the agency's infant formula supply chain response. (*Editor's Note: All graphics below from the FDA.)

Related:FDA to examine proposal to split food and drug oversight

“I am announcing a new, transformative vision for the FDA Human Foods Program. I am also announcing a transformative vision for the Office of Regulatory Affairs to support the FDA organization as a whole,” Califf said in a statement on Tuesday. “The 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. I believe this proposed approach addresses the recommendations outlined in both reports, and takes into consideration feedback from stakeholders, as well as the voices of employees working in the Human Foods Program.”

Under the new structure, a deputy commissioner for Human Foods would oversee the program. The FDA said it plans to conduct a national search to fill the post.

“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,” Califf commented.

“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,” he explained. “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.”

The proposed Center for Excellence in Nutrition would focus on the FDA’s efforts to help U.S. consumers make smarter food choices and work with industry to offer healthier, more nutritious food products. Within this center, the FDA also would form an Office of Critical Foods, as directed by the 2023 Consolidated Appropriations Act.

Meanwhile, the planned Office of Integrated Food Safety System Partnerships would drive collaboration and support of food safety and response activities with state and local regulatory partners. The FDA said this new office would enable it better meet the the “Integrated Food Safety System” envisioned in the FDA Food Safety Modernization Act of 2011.

FMI-The Food Industry Association said the proposed FDA reorganization would help streamline the federal government’s food oversight function.

“FMI welcomes the announcement by Commissioner Califf to enact reforms within the FDA to strengthen the administration of the Human Foods Program, specifically through the creation of a deputy commissioner for human foods with clear authority and a clear reporting line to the commissioner,” stated Jennifer Hatcher, chief public policy officer for FMI, which represents grocery retailers, distributors, suppliers and other industry stakeholders.

“We agree with FDA’s determination that this individual should have the authority and resources needed to lead the program and fulfill the public health mission of the agency through science-based policies to prevent the contamination of foods and advance the protection of the food supply,” Hatcher noted. “We further expect this position to reduce unnecessary regulation and paperwork, foster more efficient and effective decision-making and communication, eliminate silos within the agency, and help create a culture that is proactive and open to change and continuous improvement.”

In addition, the FDA proposed the creation of a Human Foods Advisory Committee to collect independent expert advice on various issues in food safety, nutrition and food technology. The agency said it also will bolster its enterprise information technology and analytical capabilities to foster improved workflow, simpler communication, more efficient operations and enhanced empirical risk algorithms in the area of food safety.

The operating structure of ORA, too, will be transformed into an enterprisewide organization supporting the Human Foods Program and all other FDA regulatory programs—including agency centers—through a realignment focusing on in its core mission of inspections, laboratory testing, import and investigative operations, the FDA reported. Also, the Center for Veterinary Medicine (CVM) will continue to operate as a stand-alone center but with closer coordination between the CVM center director and deputy commissioner for Human Foods.

“We commend the commissioner for moving the needle on unified calls to appoint a deputy commissioner for foods to elevate the program’s function and importance and initiate critical culture change and modernization,” Roberta Wagner, vice president regulatory and technical affairs at the Consumer Brands Association (CBA), said in a statement Tuesday.

“While today’s announcement is a positive first step, it fails to provide the deputy commissioner with direct line authority over all major foods program components or fully integrate the agency’s policymakers with its inspection force,” Wagner said. “We are concerned that anything short of this and a fully empowered deputy commissioner will make it difficult to truly unify the program and deploy the prevention mindset envisioned under the Food Safety Modernization Act.”

The CBA noted it was part of a coalition that on Monday released a statement recommending “meaningful” reforms for the FDA’s foods program. Other coalition members included the American Frozen Food Institute, the International Fresh Produce Association, Western Growers, the Association of Food and Drug Officials, STOP Foodborne Illness, Consumer Reports and the Environmental Working Group.

The FDA’s proposed Human Foods Program reorg marks “significant steps in the right direction,” according to Jennifer McEntire, chief food safety and regulatory officer at the International Fresh Produce Association.

“The vision laid out by the commissioner is likely to streamline decision-making within the agency,” McEntire stated on Tuesday. “The parts of FDA that produce industry members interact most closely with—inspectors, regulatory labs and import operations—will still be managed separately within the Office of Regulatory Affairs, necessitating strong, collaborative leadership between the new deputy commissioner and ORA.”