FDA Proposes Restructuring of Its Regulatory Oversight of Human Food

U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These include the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and Office of Regulatory Affairs (ORA), which implement and enforce food safety regulations.

This proposed restructuring comes in response to an operational evaluation of the FDA Human Foods Program issued in December 2022 by the Reagan-Udall Foundation. This evaluation was requested by Califf in July 2022 in the wake of nationwide infant formula shortages resulting from a high-profile food safety incident.

Under the proposed restructuring, CFSAN, OFPR and ORA functions (related to food safety inspections) would be consolidated under a Human Foods Program, reporting to a Deputy Commissioner for Human Foods. Though this proposed restructuring is welcomed by some food industry and safety advocates, it has also received criticism from food safety advocates as not sufficiently consolidating all the agency's food safety authority.

Holland & Knight clients in the food and agriculture space should closely monitor this proposed restructuring, since it poses both opportunities and challenges, including:

• FDA will likely host public meetings and listening sessions, as well as issue proposed measures for public comment. Food and agriculture stakeholders should take advantage of these FDA requests for input to guide the agency's work. Holland & Knight can ensure client priorities and concerns are voiced in these fora, either directly or through larger stakeholder groups with similar views.
• FDA's search for its first Deputy Commissioner for Human Foods presents a unique opportunity for food/agriculture stakeholders to provide input to the selection of an individual who will directly impact their ability to operate. The new Deputy Commissioner will likely require Senate confirmation, which allows food/agriculture stakeholders to weigh in via their elected officials to ensure the candidate understands food manufacturer/producer/processor/distributor/retailer capabilities and limitations. Holland & Knight can gather, refine and convey client viewpoints to key executive and legislative branch officials, thus increasing the likelihood that the first person to occupy this important FDA post has a keen understanding of client priorities.

Holland & Knight will continue to monitor the FDA's reorganization plans and the regulatory environment as developments unfold. Please reach out to the authors with any questions.

Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.