FDA Commissioner, vested groups respond to report on inner workings of FDA food program

Reactions to yesterday’s report on the inner workings of the food side of the Food And Drug Administration were cautiously optimistic. The commissioner of the agency was less than specific in his response to the report.

Commissioner Robert Califf commissioned the report from the Reagan-Udall Foundation for the FDA in July. The foundation, which was created by Congress, is a 501(c)(3) entity that receives funding from the FDA and other sources, private.

Califf wanted to know the status of the FDA’s food program and how to make it better. In his written response to the foundation’s Tuesday report, he said: “The agency is committed to providing a public update on the new vision at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures. … I am forming a group of agency leaders to advise me on how best to implement and operationalize these findings.”

He also said “America’s food supply is as safe as it’s ever been” and that over the past several years it has been “stressed by the increasing diversity and complexity of the nation’s food systems and supply chain, the ongoing impacts associated with climate change and rapid advances in the science underlying many of the foods we eat today.” 

Califf failed to mention that several years ago the organizational chart at FDA was changed so that various sub-administrators began reporting directly to him instead of going through a deputy commissioner of foods. That means the commissioner was deluged with reports and requests from multiple leaders on the food side of the FDA in addition to those from the drug side of the agency. The drug side makes up vastly more of the FDA’s business than the food side.

Consumer groups and industry advocates have been keenly anticipating the Reagan-Udall report. Here are some of their reactions.

Consumer reports 
“Today’s report is a very encouraging first step that will hopefully translate into meaningful reform within the FDA foods program,” said Brian Ronholm, director of food policy for Consumer Reports. “We cannot afford to tolerate the status quo and let this moment go by without adopting fundamental changes to improve the FDA’s ability to protect the public and ensure our food is safe.

“We need strengthened leadership and accountability at the FDA to implement a culture of prevention, respond more quickly to problems as they arise, and take timely action on proposed food safety rules and initiatives. The FDA needs an empowered leader to ensure that all of the agency’s food program staff work together seamlessly with a common strategic direction, clear priorities, sound resource management, and internal accountability.” 

“In April, Consumer Reports joined an unprecedented coalition of 30 organizations representing consumers, industry leaders, and local regulators, which called for more focused leadership and accountability at the FDA. The coalition supports unifying the food program under a deputy commissioner for foods with accountability to the FDA commissioner and direct line authority over the Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the food-related components of the Office of Regulatory Affairs (ORA).”

Environmental Working Group
Scott Faber, Environmental Working Group senior vice president for government affairs:

“This report confirms that cultural and organizational flaws and resource needs are contributing to failures that are making our food less safe. We applaud the Reagan-Udall Foundation panel and urge Commissioner Califf to move quickly to make the structural changes needed to break down silos and improve communication within the FDA. And we urge Congress to ensure the FDA has the resources it needs to address the risks posed by foodborne illness.”

AFDO – Association of Food and Drug Officials
According to AFDO’s Executive Director Steven Mandernach, the report’s recommendations clearly reflect the significant information and testimony that was provided and address most of the concerns shared by the AFDO membership.    

“While AFDO engages many stakeholder groups, state, local, tribal, and territorial regulatory personnel are our focus as we navigate the road to an integrated food safety system. These specific stakeholders perform a significant number of field inspections, and these recommendations are the beginning of the recognition and stepped-up support for those on the front lines of protecting public health across the country. We strongly agree with the panel’s recommendations on improving information sharing with state and local partners, which improves cooperative relationships with these partners, including funding methods. 

“We do believe that creating a separate agency within HHS for the foods program deserves longer-term evaluation and consideration. We also are strongly supportive of the option to create a new center within FDA focused on nutrition, especially with the renewed focus on nutrition in the White House’s National Strategy on Hunger, Nutrition, and Health.” Mandernach concludes.  

The state and local agencies AFDO represents collaborate with FDA in conducting food processing and produce inspections, and they conduct retail inspections. They also perform key roles in identifying potential illnesses, investigating illnesses, and effectuating product removals through recalls. Further, FDA often requests the use of state authority to expedite product recalls and removals, closures, embargoes, etc.

Consumer Brands Association 
From the vice president of regulatory and technical affairs, Roberta Wagner:

“We appreciate the Reagan-Udall Foundation’s work to address the structural, governance, and leadership issues plaguing FDA’s food program. Many actions in the report support critical changes Consumer Brands advocated for including multiple options to appoint a deputy commissioner of foods with direct line authority over all major program components, which was also backed by numerous, diverse stakeholder groups. Integrating FDA’s inspection and enforcement arm with policymakers under a single leader will position the agency to effectively deliver the food program’s mission on behalf of consumers.

“The report mirrored Consumer Brands’ call for a culture shift and a new inspection paradigm to make FDA’s food program more effective and aligned with the prevention-oriented focus of the bipartisan Food Safety Modernization Act. We understand certain recommendations will require additional funding from Congress to implement, and we’re pleased the report aligned with our support for a full understanding of FDA’s current budget use to help secure future funds.”

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