Food Safety News, September 16, 2022
After facing months of criticism about its slow response to the infant formula crisis, and the overall troubles facing the food program at the Food and Drug Administration, Commissioner Robert Califf announced earlier this summer that he was ordering a review of the food program by the Reagan Udall Foundation. Now that the review of the FDA food program is underway, there should be hope that the process could lead to meaningful reform that addresses the fragmented structure and the lack of transparency at the agency that has undermined its effectiveness.
However, in what appears to be an attempt to maintain the status quo, the FDA is preventing a true top-to-bottom review of the food program from being conducted by insisting that the Center for Veterinary Medicine (CVM) be excluded from the process.
By all accounts, there is no reason to doubt that the review process being implemented by the Reagan-Udall Foundation will be inclusive and transparent. They have gathered a distinguished panel of experts that will provide the knowledge and insight that is appropriate for this effort.
Unfortunately, because of the CVM exclusion, this expertise will not be fully leveraged because of FDA’s unwillingness to address difficult internal issues involving structure and accountability. FDA has explained that it’s because of CVM’s broad portfolio regulating both animal medical products and animal foods and that the agency wants to keep the review focused on its human food safety work.
What is troubling about this explanation is that it demonstrates a lack of understanding of the food program and how the food system works. Virtually every element of CVM’s program relates in some way to the food system and food safety, including the animal drug approval program, which mainly applies to human food animals and also ensures the safety of drug residues in human food. CVM also regulates animal feed, which affects both human and animal health.
Additionally, under the common framework mandated by the Food Safety Modernization Act (FSMA), the safety of animal food, including pet food, is regulated nearly identically to the regulation of human food, and many human food byproducts are used in the manufacture of animal food.
The FDA’s reasoning also contradicts the agency’s support of the “One Health” approach, which aims to solve health problems by recognizing the interconnection of people, animals, plants and the environment. Food safety is one of the main intersections between human and animal health. FDA is one of several federal agencies that support the “One Health” approach and encourages its use, except apparently when it applies to critical reviews of the agency’s fragmented structure.
It is this fragmented structure and dynamic that led an unprecedented collaboration between consumer groups, industry trade associations, and state and local regulators in calling on FDA to unify the food program under a deputy commissioner for foods. This position would have direct oversight authority over the Center for Food Safety and Applied Nutrition (CFSAN), CVM, and the food-related operations of the Office of Regulatory Affairs (ORA). A unified structure and a full-time expert leader would bring focused leadership and accountability to FDA’s food program and establish a foundation toward the culture change that is desperately needed.
We can no longer afford or tolerate the status quo in how the FDA regulates food. Excluding CVM from the Reagan-Udall Foundation review perpetuates the current fragmented structure and the culture of siloing the different components of FDA’s food program. It increases the risk of future crises, similar to what we have seen transpire with the infant formula situation, and virtually ensures that the food program will continue to have second-class status at FDA.
About the author: Brian Ronholm is the director of food policy for Consumer Reports. He leads the organization’s advocacy efforts to advance a safe and healthy food system. He previously served as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA) and, prior to that, served in the office of Rep. Rosa DeLauro of Connecticut.