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Ranking Member Cassidy, Colleagues Demand More Information on FDA’s Foods Reorganization

WASHINGTON – Today, U.S. Senators Bill Cassidy, M.D. (R-LA), ranking member of the Senate Health, Education, Labor, and Pensions (HELP) committee, Roger Marshall, M.D. (R-KS), Mike Braun (R-IN), and Ted Budd (R-NC) urged the Food and Drug Administration (FDA) to provide more information on its reorganization of the newly-unified Human Foods Program. This comes as FDA largely failed to provide substantive answers to the senators’ previous inquiry into the reorganization, instead punting to the reorganization plan scheduled to be released later this fall. 

The new Human Foods Program will combine the Center for Food Safety and Applied Nutrition, the Office of Food Policy and Response, and certain functions of the Office of Regulatory Affairs into one organization run by a Deputy Commissioner for Human Foods. Recently, significant shortcomings with FDA’s foods activities were exposed, including its handling of the infant formula crisis, the reported failures to address food safety issues, and the reported dysfunction and mismanagement in its foods program.  FDA has indicated it intends to release a full plan on the foods program reorganization later this fall. 

“In light of the recent infant formula crisis, Congress needs more information to be able to assess FDA’s planned reorganization,” wrote the senators. “While we appreciate FDA’s recognition that a reorganization of its human foods program is necessary, we are concerned that FDA has not provided specific details about how it will foster an improved culture within the [Human Foods Program].” 

Specifically, the senators pressed FDA to address several important aspects in the forthcoming reorganization, including:  

  • A clear vision and strategic goals for the program.  
  • Concrete metrics to measure whether the program is achieving its goals.  
  • Greater detail on how the Office of Critical Foods, which Congress created last year in response to the infant formula crisis, will operate and ensure the safety of critical foods like infant formula and medical foods. 
  • More information on efforts to improve interagency coordination on food safety activities.  

Read the full letter here or below.   

Dear Commissioner Califf:

Thank you for your March 10, 2023 response to our joint letter outlining additional details on how the Food and Drug Administration (FDA) intends to reorganize the Human Foods Program (HFP).[1] Ensuring that the reorganized HFP has a clear vision to protect public health is a priority for all stakeholders. However, you have yet to provide sufficient detail on how the HFP will accomplish this mission, instead pointing to the forthcoming reorganization plan that FDA plans to publish later this Fall.[2]  FDA should not use the forthcoming plan to dodge congressional oversight over FDA’s progress in improving food safety, and we will continue to press for answers to questions about how FDA will better protect American families from food safety events.

In light of the recent infant formula crisis, Congress needs more information to be able to assess FDA’s planned reorganization. Nearly all of FDA’s answers to our February letter provided little detail, punting to forthcoming announcements. Accordingly, when you release the reorganization plan this fall, we ask that you provide updated answers to the questions from our February letter on a question-by-question basis and that the reorganization announcement provide clear and comprehensive answers addressing these questions.[3] We would also request a staff briefing with the new deputy commissioner to better understand the changes made in the reorganization and the deputy commissioner’s vision for implementing such changes. We expect that this plan will address the following points to ensure that American families have access to safe, nutritious food:

An Empowered Deputy Commissioner for Foods is Essential to Improve Food Oversight

One of the greatest challenges FDA’s human foods program faces is the lack of a single voice to oversee the many functions FDA plays in ensuring food safety. Creating a new deputy commissioner for foods is a positive step, but the lack of clarity thus far leaves many unanswered questions about how this role will be able to successfully manage the HFP.

FDA had a similar deputy commissioner position from 2010-2019, but this role lacked the power needed to effectively manage food oversight.[4] While FDA has stated that this new role will oversee some of the responsibilities previously within the Office of Regulatory Affairs (ORA), the reorganization will still maintain ORA as a separate office.[5] Numerous stakeholders have raised concerns that failing to fully integrate ORA’s food oversight within the HFP will deprive the new deputy commissioner of the ability to serve as an effective leader.[6] An empowered deputy commissioner is essential to properly manage the HFP. Consequently, FDA must provide greater detail about the authorities and responsibilities of the deputy commissioner and how regulatory duties will be divided between the HFP and ORA. This should include a specific accounting of the steps taken to ensure seamless coordination between HFP and ORA on food-related oversight activities. We look forward to hearing from the recently announced deputy commissioner on how he intends to fulfill this new role and effectively implement the planned reorganization.[7]

Clear Performance Metrics Are Needed to Measure the Success of FDA’s Reorganization

Congress, FDA, and other stakeholders cannot evaluate whether the HFP reorganization is improving food safety without a framework to define goals and assess progress. Unfortunately, FDA has yet to provide such a framework or any details on how it will assess the HFP. FDA commonly releases strategic plans for other programs that measure progress across different metrics and issues quantitative status updates via FDA-TRACK. FDA must establish a similar framework to measure the reorganization and evaluate what more may need to be done to effectively regulate foods.

When the panel convened by the Reagan-Udall Foundation released its report evaluating FDA’s foods program, it emphasized that cultural change is needed to improve food safety oversight.[8] Specifically, the report highlighted FDA’s inability to make policy decisions, inhibiting successful regulatory actions.[9] While we appreciate FDA’s recognition that a reorganization of its human foods program is necessary, we are concerned that FDA has not provided specific details about how it will foster an improved culture within the HFP.

FDA is responsible for protecting the public health and keeping the American food supply safe. As such, we look forward to FDA providing a clear vision for the HFP and outlining the program’s strategic goals. Beyond the need for radical cultural change within this program, FDA must provide concrete, granular details in the upcoming reorganization plan specifying which metrics the agency will use to measure the HFP’s performance over time. Each discrete part of the reorganized HFP should have its own metrics, tailored to the mission and functions of that organizational unit. These should include metrics both on activities and outcomes, such as:

  • Activities
    • Number of State and FDA inspectors trained or re-trained on food safety and the consideration of company and facility food safety culture in prevention-oriented inspections;
    • Number of preventive control inspections and allocation of inspection time to prevention-oriented activities, including review of company food safety principles, food safety plans and programs, review of environmental monitoring records and actions taken in response to adulteration of product and/or contamination of environment, and assessments of what companies did to address process or product failures in the system;
    • Number of inspections, including number per type of product facility, and allocation of inspection time to educational activities, such as providing guidance documents and other activities to foster regulatory compliance and prevent food safety risks;
    • Number of prevention action plans developed and implemented to address the highest-priority risks, such as risks related to produce and non-produce foods, as well as chemical contaminants;
    • Number of follow-up inspections conducted within FDA’s goal timeframe;
    • Number of guidance documents published and how those guidance documents relate to the overall strategic goals and priorities of the HFP;
    • Number of submissions reviewed (e.g., infant formula notifications, food additive petitions, food contact substance notifications, consultations on food from new plant varieties, etc.), and associated timelines.
  • Outcomes
    • Number of food safety incidents (e.g., foodborne illness outbreaks); 
    • Number of product recalls;
    • Number of product recall notices released within one day of initiation;
    • Number of remedial actions, by type, to bring facilities into compliance successfully completed, and the timelines for implementing such actions.

The Office of Critical Foods Must Address Food Safety Issues

Congress established the Office of Critical Foods (OCF) in 2022 in response to the infant formula crisis to ensure accountability and oversight over the safety of infant formula and medical foods. FDA, however, intends to place OCF within its new Center of Excellence in Nutrition. Your response expanded on this decision, emphasizing that FDA considers critical foods to be a subset of nutrition work, pointing to these foods as “a sole source of nutrition for vulnerable populations.”[10]

We remain concerned that placing the OCF within the new nutrition-focused Center of Excellence will detract from its intended mission to oversee the safety and supply of critical foods. It is essential that FDA provide greater detail in the upcoming reorganization plan on how it intends to structure the OCF within the Center of Excellence and prioritize its mandate to oversee the safety and availability of critical foods.

FDA Must Work with Other Agencies to Improve Food Oversight

As FDA implements the HFP reorganization, it should also consider how to improve its partnerships with other federal agencies involved with food safety. Both the Centers for Disease Control and Prevention (CDC) and the Department of Agriculture (USDA) play a role in monitoring foodborne illnesses and supporting the development of innovative foods.

It is unclear how well the food safety agencies are working together to carry out their respective responsibilities. For example, CDC has failed to regularly update its data on foodborne illness incidence, last publishing a report on foodborne disease surveillance reflecting events in 2017.[11] Additionally, CDC continues to use outdated information to estimate foodborne illness incidence, relying on data from 2006.[12] FDA, however, collects extensive and up-to-date information related to recall events and preventive controls to ensure food safety.[13] FDA should be working with CDC and USDA to maximize interagency activities to protect public health, including sharing updated data between agencies to inform cross-agency priorities. We ask that FDA provide additional detail in the upcoming reorganization plan on how it intends to improve its engagement with other federal stakeholders and leverage updated information to inform HFP’s activities.

*          *          *          *          *

We look forward to reviewing the final reorganization plan this fall and working with you and other stakeholders to ensure FDA’s foods program is best equipped to protect food safety.

 
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