Coalition urges review panel to consider food leader for top echelon of FDA

Editor’s note: This is a letter sent by a broad coalition of consumer and industry groups to Jane Henney, chair of the Reagan-Udall Foundation’s FDA Human Foods Program Independent Panel of Experts investigating Food and Drug Administration operations.

Dear Dr. Henney:

The undersigned coalition appreciates the opportunity to submit comments to the Reagan-Udall Foundation as part of its review of the food program at the Food and Drug Administration (FDA). It has become apparent in recent years that the food program needs a significant culture shift that would focus on disease prevention with improved governance, accountability and transparency.

The review panel is likely aware of the April 25 letter signed by many of the groups represented in these comments that highlighted structural, governance, and performance issues with the FDA food program and its effect on the implementation of ongoing implementation of the Food Safety Modernization Act (FSMA) and execution of the New Era of Smarter Food Safety master plan.

The success of these, and all, initiatives depends on all major food program units – the Center for Food Safety and Applied Nutrition (CFSAN), the Center for Veterinary Medicine (CVM) and the Office of Regulatory Affairs (ORA). ) – working together seamlessly. with their state partners and with a common strategic orientation, clear priorities, good management of resources and internal responsibility. Success also requires transparency and strong engagement with industry, consumer groups, state associations and other stakeholders.

As part of our letter, we urged FDA Commissioner Robert Califf to create an empowered deputy food commissioner who would lead a unified food program. This position would have direct line authority over all major program components including CFSAN, CVM and relevant ORA components.

The need for reform within the FDA food program is vast and will not be solved by the appointment of an empowered deputy commissioner alone. However, it would provide focused leadership and accountability, as well as a unified structure that would clearly establish internal roles and responsibilities and strengthen the program’s ability to engage effectively with its many internal and external stakeholders. The empowered deputy commissioner and unified structure would also enable streamlined decision-making and rapid responses that would benefit all stakeholders, both in urgent cases and in day-to-day operations.

Finally, this structural reform would improve transparency across the program, including: clearly documenting where resources are invested in the food program through a transparent and consistent methodology; engage in open sharing of non-proprietary information, both internally and with external stakeholders; and publish the analyzes that support regulatory decisions.

While we recognize that CVM is excluded from your review, we are concerned that this exclusion demonstrates the FDA’s unwillingness to resolve difficult internal issues involving structure and liability, and may be an attempt to influence this panel’s recommendations. It also demonstrates a lack of understanding of how the food system works. Virtually all elements of the CVM program are related in some way to the food system, including the animal drug approval program, which applies primarily to food animals, and animal feed regulations, which affect both human and animal health. The exclusion of CVM from this review increases the possibility that the final report and recommendations of this group will be incomplete.

We appreciate your consideration for these comments and the panel’s overall work on this critical review of the FDA food program.


Consumer/public health groups Industry groups
Antibiotic Resistance Action Center (GWU) American Association of Bakers
Center for Biological Diversity American Institute of Frozen Foods
Center for Food Security Consumer Brands Association
Consumers Federation of America Corn Refiners Association
consumer reports IMF – The Food Industry Association
Environmental Defense Fund Global Cold Chain Alliance
Environmental Working Group International Fresh Produce Association
Friends of the Earth National Association of Confectioners
Healthy babies A bright future National Institute of Fisheries
Johns Hopkins Center for a Livable Future National Grocers Association
National Consumers League National Pasta Association
Natural Resources Defense Council National Restaurant Association
STOP foodborne illnesses National Association of Seasoning Manufacturers.
North American Millers Association
State and local government Association of Peanut and Tree Nut Processors
Association of Food and Drug Officials Chilled Food Association
SNAC International
Western producers

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