FDA Provides Update on Proposed Human Foods Program and Office of Regulatory Affairs Restructuring
On February 28th, the U.S. Food and Drug Administration announced that it has begun a national search for a new Deputy Commissioner for Human Foods and is providing an update on last month’s proposed restructuring of the agency’s Human Foods Program and Office of Regulatory Affairs (ORA) to enhance coordination, prevention and response activities. The announcement includes additional details about the proposed structure, status of activities and timeline for next steps.
According to the FDA for the proposed Human Foods Program, one key to success will be an empowered Deputy Commissioner for Human Foods who will report directly to the FDA Commissioner. The agency says it is focused on identifying a candidate that has the expertise to provide leadership over the FDA’s nutrition and food safety programs (including programs aimed at preventing and responding to chemical, microbial, and other hazards). The FDA says an ideal candidate will have executive-level and real-world experience sufficient to lead the newly envisioned Human Foods Program and its vast remit. This individual will also have clear line of authority over the proposed Human Foods Program, which would include the existing components of the Center for Food Safety and Applied Nutrition (CFSAN), the Office of Food Policy and Response (OFPR), and certain human foods-related components of ORA.
To ensure the new Human Foods Program and all other regulatory programs at the FDA are successful, work on an agency-wide transformation effort of how the programs and field functions are organized and operate is underway. The FDA’s proposal will create a new model that better integrates ORA’s enterprise-wide expertise in field-based operations with product subject matter experts who sit in all the agency’s programs. The Deputy Commissioner for Human Foods and other program leads will be charged with setting strategic direction for food inspections and have authority over program resource allocation.
The FDA stated that it is seeking to finalize its proposal this Fall. This process includes the development of a reorganization package that contains the newly designed structure, an established budget, and a detailed mapping and crosswalk of staff from the current to new organization. The package then undergoes a thorough review before advancing to Congress for a 30-day notification period where members may raise any concerns that the FDA may need to address. Afterwards, the FDA will issue a Federal Register Notice, provide notification to and engage, as needed, in negotiations with the Unions for impacted staff, prior to initiation of the new proposal. The FDA will continue to engage with stakeholders throughout this process.
March 6, 2023
Government & Regulatory Affairs
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