The FDA Foods Coalition was announced Thursday in Washington, D.C., promising to put more pressure on the federal government for improved food safety.

Since February 2022, when Dr. Robert M. Califf began his second tour as FDA Commissioner,  all sorts of pressures have been applied for change. Early in his tenure, the FDA was blistered for its handling of an infant formula outbreak and the resulting shortages. This was followed by reports of ongoing missteps up and down FDA’s food regulation. Two top food regulators were depicted as conflicting with one another and have since departed.

However, this is the first time an outside organization has come together to make change happen.

The organizers say the FDA Foods Coalition  will “advocate for a modernized, effective foods program at the U.S. Food and Drug Administration focused on preventing food-borne illness outbreaks and other food safety risks, and decreasing diet-related chronic diseases.”

about 80 percent of the food consumed in America falls under FDA regulation, but drugs and medical devices have long been dominant at the agency. This has led to a movement to “get the F out of the FDA.”

The new coalition is made up of consumer advocates, food industry representatives, public health groups, and state and local regulators

It will educate policymakers, media, and the public about improving the governance of the FDA Human Foods Program.

The Coalition supports the FDA’s proposed redesign of the Human Foods Program. It plans to work with Commissioner Califf and new Deputy Commissioner for Human Foods Jim Jones to implement changes and facilitate greater transparency, accountability, and meaningful stakeholder engagement.

Many organizations in the diverse coalition began working together following the FDA’s delayed response to the infant formula crisis. They called on Commissioner Califf to appoint a leader empowered to address the fundamental problems plaguing the agency’s food program. 

In response, Commissioner Califf ordered an external review of the program by the Reagan Udall Foundation, which concluded that the FDA’s culture, organizational structure, and governance model undermine its effectiveness. Earlier this year, Commissioner Califf announced plans to adopt many of those recommendations and recently appointed Jim Jones as deputy commissioner of the agency’s Human Foods Program.

“Consumers depend on the FDA to be effectively organized and governed to prevent food safety risks and ensure our food is safe,” said Brian Ronholm, director of food policy at Consumer Reports and co-chair of the FDA Foods Coalition. “Commissioner Califf has proposed a redesign to allow the Human Foods Program to carry out its critical mission and make the agency more accountable and transparent. Our coalition supports these changes and believes implementing them is critically important to all of the FDA’s food system stakeholders.”

“Industry needs a strong, unified, and modernized FDA to facilitate innovation, growth, and the production of safe, nutritious foods that are accessible and affordable for all consumers,” said Roberta Wagner, senior vice president of regulatory and scientific affairs at the International Dairy Foods Association and co-chair of the FDA Foods Coalition. “The coalition will continue to advocate that the FDA shift away from its traditional reactionary model to a modernized, prevention-oriented oversight model that aligns with industry’s immense efforts to ensure continual improvement and prevent problems from occurring, as exemplified by the industry’s ongoing implementation of the Food Safety Modernization Act (FSMA). Industry values FDA’s oversight role in assuring companies produce safe food every day for American consumers, and we look forward to supporting the agency’s Human Foods Program through this coalition.”

“FDA needs additional resources to strengthen and improve its human food safety and nutrition programs.  Maximizing the value of such an investment will require stakeholders and the FDA to address the organizational, cultural, and policy challenges confronting food safety,” said Steven Grossman, Executive Director of the Alliance for a Stronger FDA. “The FDA Foods Coalition is uniquely positioned to achieve this and is a natural complement to the Alliance’s efforts to increase funding.”

In addition to Consumer Reports and the International Dairy Foods Association, the Coalition includes the American Frozen Food Institute, Association of Food and Drug Officials, Center for Science in the Public Interest, Consumer Brands Association, Consumer Federation of America, Environmental Defense Fund, Environmental Working Group, International Fresh Produce Association, Peanut and Tree Nut Processors Association, STOP Foodborne Illness, and Western Growers. The Coalition will continue its outreach to other stakeholders that align with its mission.

The FDA Foods Coalition will work with the agency to ensure that FDA’s Human Foods Program: 

• Communicates, embraces, and promotes a clear and compelling vision, mission, and value statement. 
• Institutes an organizational structure with a single leader with a clear articulation of roles, responsibilities, and accountability and a well-equipped culture to sustain leadership transitions. 
• Establishes — through the new deputy commissioner position — a management system that fully integrates the Human Foods Program on policy, resource management, and field operations and leads a program-wide transformation that prioritizes the shift to a public health prevention culture in both headquarters and field operations.
• Develops and nurtures a culture wher regulatory decision-making is focused on consumer safety and public health, rooted in scientific evidence and FDA’s legal framework, and occurs in a timely and predictable way.
• Prioritizes meaningful stakeholder engagement and collaboration in regulatory priority setting and decision-making based on science-driven and practical risk management principles, maximum transparency, and data sharing.
• Establishes a stronger, more cooperative relationship with state, local, and tribal governments, fulfilling the FSMA vision of a National Integrated Food Safety System. 
• Formulates an appropriations strategy that considers stakeholder input and includes a well-defined, prioritized agenda, clarity, and transparency on allocating program funding.
• Has authority and resources to ensure that the agency’s Enterprise Modernization initiative meets the operational and data management needs of the Human Foods Program.