FDA obstructed review of food program before it started


After facing months of criticism over his slow response to the infant formula crisis and general problems facing the Food and Drug Administration’s food program, 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’s food program is underway, hopefully the process can lead to meaningful reform that addresses the agency’s fragmented structure and lack of transparency that have undermined its effectiveness.

However, in what appears to be an attempt to maintain the status quo, the FDA is preventing a true top-down review of the food program by insisting that the Center for Veterinary Medicine (CVM) be left out of the process. .

By all accounts, there is no reason to doubt that the review process implemented by the Reagan-Udall Foundation will be inclusive and transparent. They have assembled a distinguished panel of experts who will provide relevant knowledge and insights to this effort.

Unfortunately, due to the exclusion of the CVM, this expertise will not be fully exploited due to the FDA’s reluctance to resolve difficult internal issues involving structure and accountability. The FDA explained that this is because of the large portfolio of CVMs regulating both animal medical products and animal foods and that the agency wants the review to remain 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 all elements of the GVC program are related in some way to the food system and food safety, including the animal drug approval program, which applies primarily to food animals. human food and also guarantees 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 feed, including pet food, is regulated almost identically to the regulation of animal feed. food, and many human food by-products are used in the manufacture of animal feed. food.

The FDA’s reasoning also contradicts the agency’s support for the “One Health” approach, which seeks to address health issues by recognizing the interconnectedness of people, animals, plants and the environment. Food safety is one of the main intersections between human and animal health. The FDA is one of many federal agencies that support the “One Health” approach and encourage its use, except apparently when applied to critical reviews of the agency’s fragmented structure.

It is this fragmented structure and dynamic that has led to unprecedented collaboration among consumer groups, industry trade associations, and state and local regulators in calling on the FDA to unify the food program under the leadership of a deputy food commissioner. This position would have direct supervisory authority over the Center for Food Safety and Applied Nutrition (CFSAN), CVM, and 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 the FDA food program and establish a foundation for the culture change that is desperately needed.

We can no longer afford or tolerate the status quo in how the FDA regulates food. The exclusion of CVM from Reagan-Udall Foundation review perpetuates the current fragmented structure and silo culture of the various components of the FDA food program. This increases the risk of future crises, similar to what we have seen happen with the infant formula situation, and virtually guarantees that the food program will continue to have second-class status at the 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 Assistant Secretary for Food Safety at the United States Department of Agriculture (USDA) and prior to that worked in the office of Representative Rosa DeLauro of Connecticut.

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Ryan H. Bowman