An Independent Expert Panel Releases a Report on FDA’s Human Foods Program

An Independent Expert Panel Releases a Report on FDA’s Human Foods Program

December 7, 2022, Covington Alert

On December 6, 2022, an Independent Expert Panel facilitated by the Reagan-Udall Foundation for the FDA released a report detailing the Panel’s evaluation of FDA’s Human Foods Program.[1] The Panel was led by Dr. Jane Henney, former FDA Commissioner, and included researchers, former regulators, and process improvement specialists with disciplinary expertise and experience in epidemiology, food science and safety, microbiology, nutrition, and regulatory operations. The Panel’s evaluation was informed in part by a September public meeting, which we summarized in a recent client alert.

At a high level, the Panel recommends that FDA consider strengthening its operations through a focus on culture, structure and leadership, resources, and authorities. We summarize the Panel’s key findings and recommendations below.

1. Culture: The current culture of the FDA Human Foods Program inhibits FDA’s ability to effectively protect public health. Several factors contributing to this culture include: lack of a clear vision and mission; a disparate structure and a consensus governance model; competing priorities; and the lack of a strong, supportive leader and an ultimate decision-maker, who is responsible for the Human Foods Program. The report finds that these factors create an environment where decision-making is unacceptably slow.
   • Recommendations include: Establish an organizational structure with: (1) a clear leader, (2) clear articulation of roles and responsibilities within the Human Foods Program, and (3) a culture equipped to survive leadership transitions; commit to timeliness in decision-making, with a preference towards action; and create a culture of feedback where honest and constructive feedback is given and received.
2. Structure and Leadership: The report cited the “lack of a single clearly identified person to lead the Human Foods program” as adversely impacting organizational culture and leading “to overlapping roles and competing priorities.” The report also notes that the implementation of policies and field work done by ORA is largely independent of CFSAN, which creates a disconnect between two crucial arms of the Human Foods Program.
   • Recommendations include: Increase the visibility and prominence of the Human Foods Program; create a new Center of Nutrition to elevate the importance of nutrition; integrate the ORA food inspectional and compliance programs with CFSAN; and proposals for several additional FDA structural changes, including the creation of a Federal Food Administration within HHS, the creation of a Deputy Commissioner of Foods, and the establishment of CFSAN as the overall lead for the FDA Human Foods Program.
3. Resources: The report states that “FDA’s Human Foods Program is significantly under-resourced and additional resources, in conjunction with other changes, are critical to future success.” For example, the panel found modest increases in appropriations, flat staffing levels, and the lack of updated information technology have constricted the ability for the Human Foods Program to carry out its mission efficiently and effectively.
   • Recommendations include: Use the hiring authorities of the 21st Century Cures Act to recruit, hire, and retain personnel; develop an appropriations strategy to enhance the nutrition program, chemical safety work (e.g., food additives and GRAS), implementation of FSMA, and resources for state and local partners; and explore additional mechanisms such as industry fees to support of the Human Foods Program.
4. Authorities: FDA’s Human Foods Program relies on physical presence to inspect facilities and confirm establishments are adhering to food safety requirements. The Human Foods Program also relies on intermittent communications with industry to learn about potential supply chain challenges.
   • Recommendations include: Seek authority to request records from food manufacturers in advance of or in lieu of an inspection; request authority to allow for the disclosure of non-public information to state and local agencies; seek authority to render a food adulterated for violations of the Preventive Controls rules; and use mandatory recall authority more frequently.

In a press release announcing the report, Commissioner Califf stated that “the work of [the] independent evaluators will help to inform a new vision for the FDA Human Foods Program.” Commissioner Califf will work with an internal FDA task force to assess the Panel’s recommendations. FDA plans to provide a public update on next steps at the end of January 2023 and additional public updates by the end of February 2023, including the planned leadership structure and any changes to key internal processes and procedures.

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If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Beverage, and Dietary Supplements practice.