A look at the findings and recommendations in the Reagan-Udall report on the FDA Human Foods Program
The Reagan-Udall Foundation has released its highly anticipated report, Operational Evaluation of the FDA Human Foods Program, with findings and recommendations resulting from an independent Expert Panel’s evaluation of FDA’s Human Foods Program.
This 49-page document, issued on December 6, was based on input from a wide variety of stakeholders, including industry, consumer groups, academia, scientific organizations, the public health community, and regulatory partners at the state and federal levels. With 28 years of experience at the agency with the FDA Human Foods Program, I was privileged to be asked to provide input to the Expert Panel.
The report is the result of a request from Commissioner Robert M. Califf in the wake of a series of food safety challenges – among them the infant formula crisis – which exposed weaknesses in FDA’s current food safety program. The Expert Panel examined FDA’s public health role, authorities, and functions, as well as the state of the food industry, and made numerous findings and recommendations in four primary areas: culture, structure and leadership, resources, and authorities.
While there is no doubt that FDA staff are committed to protecting the public health in the areas of food safety and nutrition, it is clear that improvements need to be made. The food industry is evolving at a rapid rate with new technologies, ingredients, and business models that require oversight, input, and leadership from FDA. FDA must be able to keep up with these changes and provide clear direction and decision making to foster innovation and public confidence.
Yet this report found many shortcomings at the agency that hinder its ability to do its job. The report cites, among other things, an absence of a unified vision for the Human Foods Program, a lack of clear leadership, uncertain roles and responsibilities, deficient emphasis on nutrition, critical under-funding, outdated information technology (IT), and inadequate and underutilized authorities.
The Expert Panel makes numerous recommendations in response to these findings. Highlights include creating a culture that enhances collaboration and decision making; establishing an organizational model with clear leadership and clear roles and responsibilities; elevating the importance of the both the safety and nutritional aspects of the Human Foods Program; providing crucial resources to the agency through appropriations and/or user fees; improving FDA’s ability to recruit, hire, and retain needed scientific expertise; modernizing the agency’s IT; and outlining new, stronger new authorities and ways to improve the use of existing authorities.
Dr. Califf has stated that he will be forming a group of agency leaders to advise him on how best to implement and operationalize the findings and recommendations in the report. He indicated that there will be opportunities for input from internal and external stakeholders with regard to the future of the Human Foods Program. FDA intends to provide updates to the public at the end of January and February 2023 on the path forward to strengthening the Human Foods Program with regard to food safety and nutrition.
Whatever the path taken, it will be years before the FDA is able to fully implement all of the needed changes to its Human Food Program.
What follows is a summary of some of the key findings and recommendations of the report. For a complete list, please refer to the full Reagan-Udall report on Operational Evaluation of the FDA Human Foods Program
Findings: While the report found that FDA staff are dedicated to protecting public health, the agency faces a number of obstacles that inhibit its ability to accomplish this goal. The report finds significant problems with the current culture at FDA, including a lack of clear, unifying vision and mission to guide staff in conducting their work, obstacles to collaboration and information sharing across organizational lines, inadequate external engagement with stakeholders, and an aversion to risk that hinders its ability to meet its public health mandate in a global and constantly changing food system. The report also notes that FDA’s approach of relying on consensus within the Human Foods Program hinders decisions about regulatory action and generates inertia to progress.
Recommendations: The report recommends that agency leadership create and promote a clear and compelling vision, mission, and value statement for the Human Foods Program. It urges the development of a culture where regulatory decision-making is rooted in scientific evidence and FDA’s legal framework, as well as a commitment to transparency, timeliness, and predictability in decision making, with a preference toward action. It also recommends a commitment to an on-going process of culture change, with incentives and feedback built into the change management strategy. Importantly, the Expert Panel emphasizes the need to nurture current staff and recruit top quality staff, including managers.
Structure and leadership
Findings: The report took aim at the fact that there is no clear leader or decision maker (outside the Commissioner) for the Human Food Program, a flaw which is augmented by the lack of roles and responsibilities among CFSAN, OFPR, and ORA. Moreover, the report highlights that the current structure undermines CFSAN’s ability to meet its responsibilities for food safety AND nutrition, each of which are critical to public health.
Recommendations: While the Expert Panel strongly supports some sort of structural change, it declined to make a singular recommendation about structure. Instead, it outlined several considerations for a structural change, including highlighting the need to increase the visibility and prominence of the Human Foods Program within the agency, clear lines of authority, elevation of the importance of nutrition, and integration of the food aspects of ORA and CVM. The Expert panel also recommended establishing a new Foods Advisory Committee at the commissioner level to strengthen external input to Human Foods Program Activities.
The report identified five structural options that could meet these recommendations:
- Create a separate Federal Food Administration as an operating division within HHS, separating it from the medical products and tobacco centers.
- Separate food from medical products within FDA, creating two Deputy Commissioners with line authorities over the corresponding centers.
- Establish CFSAN as the overall lead for the FDA Human Foods Program, adding a political appointee as Deputy Chief of Staff for food to advocate within the Commissioner’s office and work with other federal agencies. While CVM and ORA would remain separate operation divisions, this model includes some incorporation of the food aspects of CVM and ORA into this overall structure.
- Commissioner leads Human Foods Program activities while maintaining separating operating divisions for food safety, nutrition, CVM, and ORA. This model would also include establishing Deputy Chief of Staff and/or Chief Foods Officer in the Office of the Commissioner.
- Create a Deputy Commissioner for foods with line authority over all aspects of the Human Foods Program at the Centers and ORA. This model also proposes separating out food safety and nutrition into separate centers.
Findings: The Expert Panel found that the Human Foods Program is critically underfunded in a way that hinders its ability to carry out its mission efficiently and effectively. Modest additions to the budget over the years have not kept up with inflation, agency costs, and the increased responsibilities and mandates from Congress. The report raises particular concerns about the agency’s ability to recruit, hire, and retain scientists in order to meet its public health mission and keep up with changes in the food industry. It also discusses the resource advantages of the other FDA product areas that have user fees with legislative “triggers” that ensure baseline appropriations.
Recommendations: The Expert Panel made many recommendations to address resource problems in three areas, including:
- Personnel and workforce resources: The Expert Panel advocated for securing the agile hiring authorities and salary flexibility of the 21st Century Cures Act, as well as working with OPM to facilitate hiring. The report also recommended that FDA enhance its cooperative relationships with state and regulatory partners for field operations, as well as develop and adequately resource an internal and external research strategy.
- Financial resources: The report recommended that the agency pursue a two-prong strategy that includes increased congressional appropriations and user fees. The report advocated that the agency to formulate a well-defined appropriations strategy to enhance its efforts in a number of areas, including nutrition, chemical safety, FSMA, and cooperative arrangements with state and local partners. In addition, the report encourages the agency to work with the stakeholder community to pursue user fees as a funding source, discussing a registration fee as one possibility.
- Information technology: The report advises the agency to invest and adequately resource its Enterprise Modernization initiative, particularly the Human Foods Program components. This includes additional funding to modernize its IT abilities to access and exchange data in real time. The report stresses the important of involving the users of their systems in the planning process, both internally and externally, such as domestic and foreign regulatory partners, industry, and consumers.
Findings: The report also found that the agency’s mission is hindered by the need for additional authorities, as well as bolder use of existing authorities.
Recommendations: The Expert Panel suggested a number of ways to enhance the agency’s authorities to regulate human food, including:
- Securing legislation to enhance its ability to recruit, hire, and retain personnel with the needed expertise and skills, similar to the agile hiring authorities and salary flexibility of the 21st Century Cures Act.
- Amending the FD&C Act to allow for the disclosure of non-public information to state and local partners by preempting state, local, and territorial disclosure laws. In particular the report emphasized the need to request records from food manufacturers in advance, or in lieu, of an inspection and be notified when designated food categories (eg, infant formula, medical foods) are likely to experience shortages or when supply chain disruptions are anticipated.
- Seeking a substantial amount of “no-year” funding to address longer-term challenges and engage with state and local partners for inspectional activity.
- Pursuing industry fees to fund the Human Foods Program.
The report also made several recommendations to the agency relating to using its existing authorities, including:
- Collecting existing user fees.
- Improving its approach to the GRAS designation, including exploring a routine assessment of what qualifies as GRAS.
- Using its mandatory recall authority more frequently and making accommodations for life-sustaining products (eg, infant formula) that are the sole source of nutrition.
- Identify opportunities to monitor both industry and consumer behavior to better understand the impact of FDA’s nutrition initiatives.
Finally, the Expert Panel put forth additional areas for considering legislative change, including changes around civil monetary penalties, updates to the Delaney Clause, prior approval of labels, expanded criteria for suspension of registration and strengthened authorities for administrative destruction and detention, and clarification of FDA’s jurisdiction to how to regulate pharmacologically active substances (eg, cannabis-derived ingredients) in the food supply.
To learn more about the implications of the Expert Panels’ report, please contact the author or any member of our FDA, USDA, TTB, CPSC and FTC practice.