A new coalition that includes consumer advocates and major industry groups plans to work with the Food and Drug Administration, as well as policymakers and media, to ensure the agency's new Human Foods Program has the vision and execution required to make needed cultural and organizational changes.
The FDA Foods Coalition, which also includes public health groups and state and local regulators, bills itself as an "advocate for a modernized, effective foods program" as the agency works to prevent foodborne illness outbreaks and reduce diet-related chronic diseases.
Many of the founding members of the coalition have been supportive of actions taken this year by FDA Commissioner Robert Califf, including the overseeing the reorganization efforts and the naming of Jim Jones to serve as the deputy commissioner of foods at the new human foods division. Food industry stakeholders are optimistic regarding the level of engagement with Jones since he started a month ago.
Several of the organizations in the diverse coalition began working together following FDA’s delayed response to the infant formula crisis. The new coalition is even broader than the informal coalition that member groups commonly refer to as the "Breakfast Club." It was formed over a year ago and continues to meet regularly to discuss the agency's actions, 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.
Wagner, who spent 33 years in public service serving at FDA and USDA's Food Safety Inspection Service, has been outspoken in pushing FDA to empower a leader over the human foods division to take decisive action when needed.
She said the initial push of the informal coalition was about the structure, leadership and governance, but the FDA Foods Coalition plans to shift focus to performance issues.
"We want to support the redesign efforts, but we also want to hold the agency accountable for doing a lot of the things they said they will do," she said. "One thing we've been talking about during the whole entire process, and we'll continue to talk about, is the agency's lack of transparency and stakeholder engagement. So, we're going to continue to really push on that."
Brian Ronholm, director of food policy at Consumer Reports and co-chair of the FDA Foods Coalition, said in a statement the coalition supports the changes in Califf's proposed agency redesign and "believes the implementation of them is critically important to all of the FDA’s food system stakeholders.”
The coalition hopes to work with FDA to "facilitate greater transparency, accountability and meaningful stakeholder engagement."
Wagner and Ronholm plan to meet with Jones next week to discuss more extensively the goals of the coalition, and the agency has been supportive of the idea of the coalition, Wagner told Agri-Pulse.
Wagner said FDA is "extremely risk-adverse, extremely slow with decision making" which makes it very difficult for industry to navigate innovate and grow.
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"Industry values FDA’s oversight role in assuring companies produce safe food every day for American consumers," she said.
Specifically, the coalition said it will work to ensure the new Human Foods Program does the following:
- "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 culture that is well-equipped 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 where 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 effective risk management principles, maximum transparency and data sharing.
- Establishes a stronger, more cooperative relationship with state, local and tribal governments, including 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 and clarity and transparency on how program funding would be allocated.
- 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."
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 said it will continue its outreach to other stakeholders that align with this mission.
In an interview with Agri-Pulse earlier this week, Ronholm said FDA's authorized budget from Congress is "chronically underfunded, particularly as it relates to food issues." He and others in the coalition believe that as FDA increases its transparency in how funds are used, and improves the agency's structure and governance, coalition members will be willing to advocate for additional funding. Wagner also expressed optimism about actions taken by FDA in recent months to be more transparent regarding its budget spent on food safety.
Steven Grossman, executive director of the Alliance for a Stronger FDA, said in a statement, the coalition is "uniquely positioned" and a "natural complement" to the Alliance's efforts to help advocate for increased FDA funding.
“FDA needs substantial 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 that confront food safety,” said Grossman.
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