FDA will streamline food safety and regulation under a single leader

Dive Brief:

• FDA will restructure its Human Foods program, consolidating all functions and employees under a new deputy commissioner. This will bring the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response and some functions of the Office of Regulatory Affairs under a single leader.
• In the new structure, FDA will add a Center of Excellence in Nutrition to prioritize the agency’s efforts to improve consumers’ food choices, and an Office of Integrated Food Safety System Partnerships to better integrate food safety and response activities with state and local regulators. It will also add an external advisory committee to talk to FDA about present and upcoming issues in food safety, nutrition and technologies.
• This change was among recommendations made in an independent investigation of the program done by the Reagan-Udall Foundation. Commissioner Robert Califf requested the investigation in July, after structural problems at the department were exposed by a massive baby formula recall and shortage.

Dive Insight:

This change, Califf said on a call with members of the media, will “fundamentally transform the way the FDA oversees the U.S. food supply.”

Under the proposal, the deputy commissioner for Human Foods would work on food safety and the food policy Currently, there are two equivalent branches of the food program: the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response. The Reagan-Udall report found these different departments run by different leaders led to an unclear overall mission.

On the media call, FDA Principal Deputy Commissioner Janet Woodcock said the new deputy commissioner for Human Foods would have “a clear line of authority” over everything dealing with human foods in FDA’s purview: from food recalls and outbreaks, to food science, to labeling and nutrition. A nationwide search is currently underway for a person to fill that role, Califf said.

While FDA investigators would still be under the Office of Regulatory Affairs, Woodcock said that part of the FDA is being restructured through policy and technology to better interface with individual regulatory programs. The rest of the food program is also upgrading its internal systems to better focus on analytical capabilities. Woodcock said this would strengthen the department’s risk assessment capabilities, allowing for more data-driven prioritization for inspections.

Califf said the findings of the Reagan-Udall report, as well as an internal report that focused more on the infant formula shortage last year, and comments and reactions from outside stakeholders all informed the ultimate decision.

The change would allow FDA “to fully realize the preventive vision laid out in the Food Safety Modernization Act” as well as elevate nutrition’s importance, strengthen partnerships, and better embrace partnerships with food and agricultural innovators, Califf said on the call.

For the most part, consumer groups cautiously welcomed the proposal — though they stressed that success lay in finding the right leader and implementation strategy. 

Center for Science in the Public Interest President Peter Lurie, who served as an associate commissioner at FDA from 2014 to 2017, especially applauded the plans for the nutrition center of excellence.

“Poor diet is one of the top risk factors for preventable morbidity and mortality in this country,” he said in a written statement. “This new structure recognizes this reality and properly foregrounds the often-sidelined food functions at FDA.”

The Institute of Food Technologists said in an email that the plan will help position FDA for the future.

“While the U.S. has one of the world’s safest food supplies, the food supply is rapidly evolving,” the group said. “As such, the FDA must evolve its structure too.”

Stop Foodborne Illness CEO Mitzi Baum said in an emailed statement that while there are many details left unannounced, the group anticipates the restructuring “will facilitate accelerating decision-making, create seamless communication within a still fragmented agency, and forge consequential cultural changes.”

Consumer Brands Association Vice President for Regulatory and Technical Affairs Roberta Wagner said in a statement that the restructuring was a good first step, but not enough. The proposal doesn’t give the deputy commissioner direct line authority over all the major program components or integrate the inspection force with policymakers, 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.”