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External Evaluation of FDA’s Human Foods Program Published

  • As mentioned in July, FDA Commissioner Robert Califf commissioned an external evaluation of the FDA’s Human Foods Program (HFP), including the Office of Food Policy and Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), as well as relevant parts of the Office of Regulatory Affairs (ORA). The external evaluation was conducted by an expert panel facilitated by the Reagan-Udall Foundation, who was asked to assess the processes and procedures, resourcing, and organizational structure for the HFP.

  • On December 6, the expert panel released its findings and recommendations in the “Operational Evaluation of FDA’s Human Foods Program.” The report gives an overview of the HFP’s primary functions and provides recommendations regarding the Program’s culture, structure, resources, and authorities:

    • Culture – The Panel found that while the staff are dedicated to protecting public health, the current culture, structure, and governance model detract from the HFP’s effectiveness. Among other suggestions, the Panel recommended the establishment of an organizational structure with a clear leader that can identify, communicate, embrace, and promote a clear and compelling vision, mission, and value statement. The Program must also commit to transparency, timeliness, and predictability in decision-making, with a preference towards action.

    • Structure – Related to their recommendations regarding the culture, the Panel found the HFP lacked a clear leader or decision-maker, outside of the Commissioner. While the missions of CFSAN and OFPR are different on paper, according to the report, staff are often left wondering which program is responsible for decision-making. Similarly, neither CFSAN nor ORA have a direct stake in ensuring that their work and perspectives align. Thus, the Panel strongly recommended some sort of structural change to address these challenges. For instance, the Panel stated that FDA should increase the visibility and prominence of the Program, establish clear lines of authority, and the importance of nutrition should be elevated.

    • Resources – The Panel found that the HFP is significantly under-resourced and additional resources, in conjunction to other changes, are critical to future success. Congressional appropriations, the primary source of funding for the Program, have not kept pace with its needs, which is exacerbated by the imbalanced availability of user fee programs across the Agency. The Panel recommended the FDA secure the hiring authorities and salary flexibility of the 21st Century Cures Act to improve ability to recruit, hire, and retain personnel. FDA should move to a stronger, more cooperative relationship with states and other local authorities. However, FDA should give the highest priority to the formulation of an appropriations strategy that creates a clear case for why increased funding is necessary. FDA should also more fully implement the industry fee authorities provided by FSMA, as well as do more to support the HFP budget internally.

    • Authorities – The HFP is challenged in keeping up with the innovations in food and regulatory science. According to the Panel, the FDA should seek to amend the FDCA to allow for disclosure of non-public information to state, local, and US territorial government agencies with counterpart functions related to FDA-regulated products by preempting related state, local, or territorial disclosure laws. FDA should also seek authority to request records from food manufacturers in advance of or in lieu of an inspection, and also be notified when designated food categories are likely to experience shortages or when supply chain disruptions are anticipated. The FDA should also seek a substantial amount of “no-year” funding.

  • In a press release about the report, Commissioner Califf stated that he will be “making final decisions regarding the future of the FDA Human Foods Program after reviewing the report and consulting with stakeholders both externally and internally.” The Commissioner intends to form a group of agency leaders to determine how best to implement and operationalize the Panel’s findings.

Lauren Haas, Nicholas Prust, Frederick Stearns, and Emily Thomas also contributed to this article.

© 2023 Keller and Heckman LLPNational Law Review, Volume XII, Number 341
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About this Author

Lisa P. Alsobrook Attorney Keller Heckman DC Office
Associate

Lisa Alsobrook practices in the area of food and drug law. She advises domestic and foreign clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world. Her main focus is regulatory and compliance matters of the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture relating to human food, food packaging material, animal feed, food additives and ingredients, and dietary supplements.

Prior to attending law school, Lisa earned a master’s degree in Food Science. She worked as a...

202-434-4237
Melvin S. Drozen, FDA, regulatory lawyer, Keller Heckman, law firm
Partner

Melvin S. Drozen joined Keller and Heckman in 1987.

Mr. Drozen advises clients on a broad spectrum of FDA, FTC, USDA and EPA (pesticides) regulatory matters, ranging from premarket approval requirements for food additives, dietary supplement ingredients, drugs, and medical devices to advertising and labeling provisions applicable to all of these products. Prior to joining Keller and Heckman, he was an Assistant District Attorney in Brooklyn, N.Y., and then an attorney in the General Counsel's Office of the Food and Drug Administration for seven...

202-434-4222
Jill M Mahoney Associate Attorney Keller Heckman
Associate

Jill Mahoney advises clients on regulatory requirements for food, animal feed, food additives, dietary supplements, and cosmetics. She counsels clients on labeling and advertising compliance and claims substantiation issues, including nutrition labeling, ingredient declarations, nutrient content claims, structure function claims, and Country of Origin labeling. She assists food, animal feed, and dietary supplement manufacturers in preparing self-determined GRAS positions, GRAS Notifications for Food and Drug Administration (FDA) submissions, New Dietary Ingredient Notification submissions...

202-434-4184
Richard Mann Partner Keller Heckman DC
Partner

Richard (Rick) Mann represents his clients in business and trade association disputes relating to food advertising, promotional and labeling claims, food safety and compliance issues, and general business and corporate law matters.

Rick works extensively with clients in the development of compliant advertising, promotional, and labeling claims and campaigns, and the development of appropriate support for such claims. His regulatory experience allows him to represent his clients in proceedings at the Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the National...

202-434-4229
Paula S. Pastuskovas San Francisco Food and Drug Attorney Keller and Heckman
Associate

Paula Pastuskovas counsels domestic and international clients on regulatory and compliance matters in food and drug law. She assists clients in obtaining regulatory clearances for food additives and food-contact materials from the U.S. Food and Drug Administration (FDA), Health Canada, and other comparable international agencies. She advises clients on food labeling, ingredient, and substantiation issues. 

As a resident of the firm’s San Francisco office, Paula also advises companies on compliance with California’s state and local laws. This...

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