The Food and Drug Administration blocked the review of the food program before it began

– Opinion –

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 Reagan. Udall Foundation. Now that a review of the FDA’s food program has begun, there should be hope that the process will lead to a meaningful reform that addresses the fragmented structure and lack of transparency in the agency that has undermined its effectiveness.

However, in what appears to be an effort to maintain the status quo, the FDA is preventing a comprehensive review of the food program 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 implemented by the Reagan Udall Foundation will be thorough and transparent. They have assembled an outstanding team of experts who will provide the right knowledge and insight for this effort.

Unfortunately, due to the exclusion of the continuous assessment model, this expertise will not be fully utilized due to the FDA’s unwillingness to address the difficult internal issues that involve structure and accountability. The FDA has made it clear that because of CVM’s broad portfolio that regulates both animal medicinal products and animal foods and that the agency wants to keep the review focused on its work in human food safety.

What is troubling about this interpretation is that it demonstrates a lack of understanding of the food program and how the diet works. Almost every component of the CVM program is related in some way to diet and food safety, including the Animal Drug Approval Program, which applies primarily to human food animals and also ensures the safety of drug residues in human food. CVM also regulates animal feed, which affects human and animal health.

In addition, under the common framework mandated by the Food Safety Modernization Act (FSMA), the safety of animal foods, including pet foods, is regulated almost identically to human food regulation, and many byproducts of human foods are used in the manufacture of animal food.

The FDA’s rationale also contradicts the agency’s support for the “One Health” approach, which aims to solve health problems by recognizing the interdependence between people, animals, plants, and the environment. Food safety is one of the main points of intersection between human and animal health. The Food and Drug Administration is one of several federal agencies that support the One Health approach and encourage its use, except when apparently applicable to critical reviews of the agency’s fragmented structure.

It is this fragmented and dynamic structure that has led to unprecedented collaboration between consumer groups, industry trade associations, and state and local regulators in calling for the Food and Drug Administration to standardize the food program under the direction of the Deputy Commissioner for Food. This position will have direct oversight authority over the Center for Food Safety and Applied Nutrition (CFSAN), CVM, and food-related operations for the Office of Regulatory Affairs (ORA). A unified structure and a full-time expert leader bring focused leadership and accountability to the FDA’s food program and lay the foundation for much-needed culture change.

We can no longer afford or tolerate the status quo in how the Food and Drug Administration regulates food. The exclusion of CVM from the Reagan-Udall Foundation review perpetuates the current fragmented structure and culture of isolating the various components of the FDA’s food program. It raises the risk of future crises, similar to what we’ve seen with the infant formula status, and effectively ensures that the food program continues to earn Tier 2 status in the Food and Drug Administration.

About the author: Brian Runholm is director of food policy at Consumer Reports. He leads advocacy efforts in the organization to advance a safe and healthy diet. Previously, he served as Deputy Under Secretary for Food Safety at the United States Department of Agriculture (USDA) and prior to that, worked in the office of Rep. Rosa DeLoro of Connecticut.

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