Background

FDA’s Human Foods Program (the Program) has been the subject of intense scrutiny throughout 2022. Criticism began in the wake of a large-scale recall of infant formula that affected supplies nationwide and grew louder following a widely read article published by Politico in April that alleged infighting and resource shortfalls at the Center for Food Safety and Applied Nutrition (CFSAN).¹ The article also criticized the Program for delay and inaction on a number of issues beyond the infant formula situation, including regulation of heavy metals in infant and toddler foods, PFAS in food packaging, pathogen control standards for agricultural produce water, and sodium reduction. 

In July, FDA Commissioner Robert Califf asked the RUF to undertake an operational evaluation of the Program.² An Independent Expert Panel (Panel) comprised of six outside experts in epidemiology, public health, food science and safety, microbiology, nutrition, and regulatory operations, appointed by RUF, was convened to evaluate four areas of the Program: 1) structure and leadership, 2) authorities, 3) resources, and 4) culture.  The Panel gathered information through stakeholder meetings, online public portal comments, and a series of stakeholder interviews.  The resulting report is a lengthy assessment of opportunities for improving the Program, from enhancing culture to overhauling the organizational structure and the Program’s position within the Department of Health and Human Services (HHS) more broadly.³ On the whole, the Panel found that while “passage . . . of the FDA Food Safety Modernization Act (FSMA) . . . was meant to move food safety towards prevention rather than reaction” this envisioned shift “has yet to be realized.”  The Panel attributes this delay to a combination of inadequate resources and leadership issues exacerbated by an inefficient agency structure.  

Below we summarize some of the key takeaways for each of the four areas evaluated. 

Summary of Findings and Recommendations

Structure and Leadership

The Panel found the Program’s current structure reinforces “duplicative or competing roles and responsibilities, siloed work, and inadequate internal and external engagement.” The Report notes that CFSAN is charged with two critical and equally important tasks – food safety and food nutrition. However, according to the Panel, the nutrition-related responsibilities of the organization are not “recognized at the level implied by the national reliance on the FDA for essential public health nutrition policy.” 

A broad overhaul of the Program’s structure is suggested. The Panel offers five alternative structural/organizational designs (summarized below).  The Panel presents each option along with its advantages and disadvantages, and does not recommend any structure in particular.  For all five options, the Panel focused on implementing certain themes including increasing the visibility and prominence of the Human Foods Program, elevating the importance of nutrition, and integrating the food-specific activities of the Office of Regulatory Affairs into the Program.

The five structural options offered by the Panel are as follows:

• Option A – Create separate Food and Drug Administrations within HHS.  This option would separate the FDA into two administrations: the Federal Drug Administration and the Federal Food Administration, each with a Commissioner reporting directly to the HHS Secretary.  The Panel notes that the structural changes presented in this option would likely require Congressional action. 

• Option B – Separate medical products and foods programs within FDA.  This option would create two new Deputy Commissioner roles within FDA; one for Foods and one for Medical products and Tobacco.  It would also establish a Chief Foods Officer within the Office of the Commissioner similar to the existing role of Chief Medical Officer.  According to the Panel, the presence of two deputies would, “indicate the equal importance of the foods and medical products mandates” and increase the visibility of the Human Foods Program. 

• Option C – Establish CFSAN as overall lead for the FDA Human Foods Program.  This option would consolidate the Program under the Director of CFSAN with the Center for Veterinary Medicine (CVM) Director as the deputy for the program.⁴ However, the CVM Director would still report on non-food-related activities directly to the FDA Commissioner.  It would also establish a Chief Foods Officer in the Office of the Commissioner who would, “coordinate response to outbreaks and cross-Agency food issues, medical foods, biotech, etc. and serve as the lead for cross-Government food-related activities.”

• Option D – FDA Commissioner to lead the Human Foods Program; Separate CFSAN and ORA.  Under this option, the FDA Commissioner would lead the Human Foods Program.  Separate Centers for Nutrition, for Food Safety, and the food-specific activities of ORA would report directly to the Commissioner along with the CVM Director.  It would also establish a Chief Foods Officer in the Office of the Commissioner.  This option would not require explicit Congressional approval, but may require Congressional notification.

• Option E – Create a Deputy Commissioner for Foods role.  This option is similar to Option D but would keep the FDA Commissioner role unchanged and instead create a Deputy Commissioner for Foods to serve as the head of the Human Foods Program.  Like Option D, it would  establish separate Centers for Food Safety and Nutrition, as well as the food-specific activities of ORA.  This option may only require Congressional notification, as opposed to Congressional approval.   

Authorities

The Report discusses opportunities for FDA’s Human Foods Program to make “bolder use of existing authorities,” and also proposes that several new authorities be granted to the agency.

• Bolder Use of Existing Authorities – The Report urges FDA to be bolder in exercising existing authorities related to mandatory recalls, GRAS designations, nutrition labeling, user fees, and data sharing.  According to the Report:
  • Mandatory Recall: FDA should use its mandatory recall authority more frequently and collect user fees in mandatory recall situations.⁵
  • Data Sharing: FDA should apply existing authority regarding infant formula microbiological testing to require “real time disclosure of final product testing results from infant formula manufacturers.”
  • Nutrition Labeling: FDA should identify opportunities to monitor industry and consumer behaviors in response to FDA nutrition initiatives like sodium reduction and the definition of “healthy.”  The Report identifies CFSAN’s finalization of its voluntary sodium guidance as a positive step but says “sufficient monitoring needs to take place to ensure the industry is indeed lowering sodium in the food supply.”
  • GRAS: FDA should work with stakeholders to “better structure the approach to GRAS designation,” including instituting a routine assessment of what qualifies as GRAS. It should also undertake a review of its own practices related to GRAS “in light of current U.S. Dietary Guidelines and the evolution of modern manufacturing practices.”
  • User Fees: FDA should use existing authority under FSMA to collect user fees in domestic and foreign facility reinspections and mandatory recall situations, as these could provide an important supplemental source of funding.
• Proposed New Authorities – The Panel also identifies five new authorities that FDA should seek on an urgent basis or over the longer term:
  • Data Reporting & Data Sharing Authority (Urgent):  Among other things, FDA should seek authority to request records from food manufacturers in advance of or in lieu of an inspection and to be notified when designated food categories (e.g., medical foods and infant formula) are likely to experience shortages or anticipate supply chain disruptions. 
  • Personnel & Workforce Related (Urgent): FDA should secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act for the Human Foods Program to improve its ability to recruit, hire, and retain qualified staff.
  • Funding (Urgent): FDA should seek a substantial amount of ‘no-year’ funding from Congress for the Human Foods Program, particularly to address longer term challenges such as IT and inspectional activity engagement with State, Local, Tribal, and Territorial agencies. 
  • Preventive Controls (Important, but longer term): FDA should seek authority to align the consequences for violations of the  Preventive Controls rule with those for violations of its mandatory HACCP rules.  According to the Panel, “[j]ust as the lack of a HACCP plan or an inadequate plan renders the food from that processor adulterated under FDA’s seafood and juice HACCP regulations, it should also render food adulterated under the Preventive Controls regulation.” 
  • Industry Fees (Important, but longer term):  FDA should engage with stakeholders to explore industry financial support such as user or registration fees to increase financial resources for the Human Foods Program.

Resources

The Report describes the Human Foods Program as “significantly under-resourced,” identifying “relatively modest increases in federal budget authority, flat staffing levels, and lack of sustained and sufficient commitment to upgrading” IT as substantial impediments to the Program’s ability to execute its mission.  The Panel noted that from a budgetary perspective the Human Foods Program is one of the slowest growing components of the FDA, with funding growing 46% from 2011-2022, compared with the 121% funding increase seen in the Human Drugs Program over the same period.  According to the Report, this resource disparity between food and drug is due in part to the fact that Congressional appropriations have not kept pace with the needs of the Program, and is also due to an “imbalance of user fee programs” at FDA.⁶ Regarding personnel, the Report points out that CFSAN staffing levels have remained relatively flat since 1978, while its responsibilities have grown immensely.

The Report offers a number of resource-related recommendations, some of which overlap with the recommendations related to authorities discussed above.  Key resource recommendations include:

• FDA should secure the agile hiring authorities and salary flexibility of the 21st Century Cures Act.

• FDA should move to a stronger, more cooperative relationship with states and other local authorities with the goal of expanding utilization of state capabilities.

• FDA should more fully implement the industry fee authorities provided by FSMA.

• FDA should invest and adequately resource its Enterprise Modernization initiative, particularly the Human Foods Program components.  The Enterprise Modernization Action Plan is a framework to integrate all of FDA’s operations into a cross-agency system that would enhance operational efficiency and use of data through a common operational approach

Culture

According to the Report, while the Program’s staff are strongly committed to the cause of protecting public health, the current culture suffers more broadly from a lack of a clear unifying mission, a “consensus governance model,” competing priorities, and the lack of an ultimate decision-maker, all of which contribute to a culture of indecisiveness that inhibits FDA’s ability to effectively accomplish its goals.  The Panel offers nine recommendations to foster an effective and dynamic culture.  Senior leaders are urged to participate in the process by personally communicating more regularly about the importance of building a culture and their expectation that all members of the Human Foods Program participate actively.  The Report’s key recommendations on culture include:

• Vision, Mission & Values: FDA should “identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement for the Human Foods Program.” According to the Report, insufficient communication within the Program has created inter- and intra-Agency confusion.  In turn, this has reinforced a perception of conflict among Foods Program Centers as certain decisions may or may not be consistent between the Foods Program centers.  The Report warns that this lack of communication, “erodes confidence, generates frustration, and may result in loss of staff.”

• Clear Leadership & Structure: FDA should “establish an organizational structure with a clear leader and ensure that there is a clear articulation of roles and responsibilities within the Human Foods Program and a culture that is well-equipped to survive (inevitable) leadership transitions.”  The Panel’s key findings related to culture focus on indistinct lines of authority, insufficient internal communication, and overreliance on “consensus decision-making.”  The Panel found that the Human Foods Program is in “what is perceived as constant turmoil” due to overlapping roles and competing priorities attributable to a lack of a single program lead.  According to the Panel, establishing clear lines of authority is vital for fostering an effective organizational culture.

• Improved Decision-making: FDA should “commit to transparency, timeliness, and predictability in decision-making, with a preference towards action.”  The Panel also raised concerns related  to reliance on “consensus decision-making” by the Human Foods Program Governance Board, a process which assigns higher priority to unanimous agreement rather than “finding the best solution”.  According to the Panel, this type of decision making has the effect “more often to stop an initiative than to advance it,” which tends to  encourage “inaction, minimizing risk, and maintaining the status quo.”  This inertia in decision-making can make the program appear non-responsive to public health concerns.

Next Steps

The RUF Report reflects the seriousness of the recent criticism directed at the Program and the possibility for significant near-term changes in response.  Commissioner Califf is expected to provide a public update on his new vision for the Program by the end of January 2023 and provide further information on implementation by the end of February 2023.   According to the Commissioner’s statement, these updates will include “the planned leadership structure and any changes to key internal processes and procedures.”  Additionally, Commissioner Califf announced that a group of agency leaders will be formed to assist in operationalizing and implementing the findings. 

We will continue to monitor and report on these and other updates related to structural and cultural changes at FDA’s Human Foods Program.  Please do not hesitate to reach out to us if you have any questions. 
 

Authored by Maile Gradison, Andrea Bruce, Mary Lancaster Grywatch, and Molly Mulligan.

References

1 See Bottemiller, Helena, “The FDA’s Food Failure,” Politico (April 8, 2022), available at https://www.politico.com/interactives/2022/fda-fails-regulate-food-health-safety-hazards/. 

2 The scope of the requested review excluded the Center for Veterinary Medicine, as well as CFSAN’s oversight of cosmetics and dietary supplements. 

3 Reagan-Udall Foundation for the Food and Drug Administration, Operational Evaluation of the FDA Human Foods Program, (December 2022), available at https://reaganudall.org/sites/default/files/2022-12/Human%20Foods%20Program%20Independent%20Expert%20Panel%20Final%20Report%20120622.pdf.

4  The Panel also recommended the establishment of the Human Food Program Inspectional Council, with representation from CFSAN, CVM, Office of Regulatory Affairs (ORA), State, Local, Tribal, and Territorial (SLTT) agencies and international regulators to strengthen partnerships.

5  FDA’s mandatory recall authority has only been used on three occasions since the authority was established with the passage of FSMA in 2011.

6  “The Foods Program receives about 1% of its budget in user fees, in contrast to other FDA programs such as tobacco (at 100%) and human drugs (66% of budget is user fee funded).”

7  FDA, “FDA Provides Update on External Evaluation to Strengthen Agency’s Human Foods Program” (December 6, 2022), available at https://www.fda.gov/news-events/press-announcements/fda-provides-update-external-evaluation-strengthen-agencys-human-foods-program.