Yesterday and today in Washington, D.C., the Reagan-Udall Foundation is facilitating a public meeting of its Independent Expert Panel on food. 

The independent expert panel has been charged with evaluating the structure, leadership, authorities, resources and culture of the FDA’s human foods program.

FDA Commissioner Robert Califf announced the review in May while a congressional committee was questioning him about an outbreak of cronobacter infections linked to infant formula from Abbott Nutrition. The agency was under fire for their slow response and disorganization. Some people have called for a reorganization of top positions at the FDA. 

In the public meeting’s food safety session, six food safety experts from various fields provided feedback and suggestions for the FDA.

The Speakers:

  • Bill Marler, JD, Marler Clark LLP, PS
  • Mitzi Baum, MS, STOP Foodborne Illness
  • Scott Faber, Environmental Working Group
  • Jennifer McEntire, Ph.D., International Fresh Produce Association
  • Caroline Smith DeWaal, EatSafe
  • David Goldman, MD, MPH, formerly of FDA’s Office of Food Policy and Response

Bill Marler, JD, Marler Clark LLP, PS

Bill Marler, JD, Marler Clark LLP, PS

Seattle food safety attorney Bill Marler explained that he’s spent nearly 30 years coming to D.C. from Washington state for discussions on how to make food safety perfect. But he implored the panel to “not make perfect the enemy of the good.”

Marler said that it is past time to address the fragmented and illogical division of federal oversight of food safety. “For decades multiple experts have cited the need to revamp the food safety and quality of the U.S. food supply,” Marler said. “I believe that FSMA’s (Food Safety Modernization Act) failures are not due to the legislation itself, but due to the lack of sustained consistent effective and accountable leadership at the FDA, due to the culture of fragmentation the essential food safety functions between the four main center.”

 In closing, Marler’s advice to the panel was to create separate commissioners in the FDA — one for food and one for drugs.

Mitzi Baum, MS, STOP Foodborne Illness

Mitzi Baum, MS, Stop Foodborne Illness

“I’m here on behalf of individuals and families that continue to be impacted by foodborne disease,” said Mitzi Baum, the chief executive officer at the Chicago-based organization STOP Foodborne Illness. With more than two decades of experience at Feeding America, including time as the non-profit’s director of food safety, Baum said that consumers are still waiting for a food safety culture shift from reactionary to preventive. She said this is evidenced in the powdered infant formula recall from Abbott Nutrition. “The culture remains reactive, the process lacks clarity and the system is not structured for swift urgent action to protect consumers.”

“Consumers want to trust that foods that they feed their families are safe.” Baum lists the slow implementation of FSMA, the same foods regularly being recalled and the ongoing powdered infant formula crisis as things impacting consumers’ trust and reasons why the FDA can’t be resistant to change. “The process that you (the foundation) have undertaken will have a meaningful impact on their (consumer) safety,” she told the panel. “Consumers can’t wait 88 years and continue to suffer the consequences of resistance to change.”

Scott Faber, Environmental Working Group

Scott Faber, Vice President for government affairs at the Environmental Working Group, made five key points. “One, it’s clear that FDA food program nutrition and food safety needs more resources and that user fees are essential to the program’s success.”

“Two, it’s equally clear that the fragmented leadership at the top of the FDA hampers FDA’s ability to make risk-based decisions about how to best deploy these resources.”

“Three, that the prevention mandate enshrined in FSMA has not been fully embraced by FDA especially by FDA inspectorate and FSMA’s command to protect consumers from pathogens and produce has simply been ignored.”

“Four, FDA has systematically failed to address the risks posed by food chemicals.”

“Five, Americans trust and respect FDA, but FDA must be much more transparent if the agency hopes to retain that trusted respect.”

Jennifer McEntire, Ph.D., International Fresh Produce Association

Jennifer McEntire, Ph.D., International Fresh Produce Association

Jennifer McEntire, Chief Food Safety and Regulatory Officer at the International Fresh Produce Association, started by saying that having an empowered deputy commissioner for foods who truly understands the food system and has the authority to lead and coordinate the foods programs at the FDA will go a long way and would address many of the issues. 

McEntire added that the “FDA would benefit from a leader who can set direction, get people on board, look for partnerships and collaborations that can stretch and leverage those resources and occasionally make tough decisions.”

Caroline Smith DeWaal, EatSafe

Caroline Smith DeWaal, EatSafe

Caroline Smith DeWaal, Deputy Director at EatSafe at Global Alliance for Improved Nutrition, wanted to make it clear that her comments reflect her own views not those of any organization where she currently works or previously worked. 

“I saw more clearly how the agency challenge really lies both in its leadership, but much more in its culture,” DeWaal explained. “The agency is set up with systems that devolve leadership and decision making to an absurd extent.” She said that this devolving of decision-making could be because of fear. “It’s fear of making a decision that could be criticized by the industry by the media, by other agencies in the federal government or even by FDA colleagues.”

Finally, she said, “To address the crisis at FDA, there is an urgent need to segregate and streamline the agency’s food safety functions, provide dedicated inspection and regulatory resources to the food program and provide a clear path for decision making, with a dedicated food safety professional at the top.”

David Goldman, MD, MPH, formerly of FDA’s Office of Food Policy and Response

David Goldman, MD, MPH, formerly of FDA’s Office of Food Policy and Response

The last of the six experts, Dr. David Goldman has 20-plus years of working in food safety with the USDA Food Safety and Inspection Service and recently with the FDA. “I think that my work at the two federal food regulatory agencies has provided me a rare perspective,” Goldman said. “I want to respectfully offer an insider’s perspective.”

Goldman suggested that the major challenge he observed in his time at the FDA was the fragmentation of roles and responsibilities that followed the reorganization in 2019. “At that time and several times after that, I made the observation that dotted lines on an org chart are very different than solid lines.”

He said he would favor a single food safety agency or a separate operating division that reports up to the secretary of the Department of Health and Human Services.

“I wanted to offer something that may be a little more practical, but yet is still bold. I think I propose that all the functions related to say, science, both research and regulatory lab operations, policy compliance, communications, response, consumer education and most importantly inspection, be placed under one roof in a new Center for Food Safety within the FDA.”

Goldman finished his recommendations by saying that his purposed structure would replicate the one that he worked under at FSIS, where everyone in their respective roles are focused solely on food safety.

About the foundation

According to its website, the Reagan-Udall Foundation for the Food and Drug Administration is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

The Foundation embodies the FDA’s vision of collaborative innovation to address regulatory science challenges of the 21st century and assist in the creation of new, applied scientific knowledge, tools, standards, and approaches the FDA needs to evaluate products more effectively, predictably, and efficiently, and thereby enhance the FDA’s ability to protect and promote the health of the American public. The Foundation serves as a crucial conduit between FDA and the public, providing a means for FDA to interact directly with stakeholders, including industry and consumers. The Foundation does not participate in regulatory decision-making or offer advice to FDA on policy matters.

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