FDA Announces Revised Plans for Human Foods Program

Shook, Hardy & Bacon L.L.P.

The U.S. Food and Drug Administration (FDA) has announced additional proposed changes to the Office of Regulatory Affairs (ORA) as part of its proposal to create a unified Human Foods Program (HFP), building on a proposal announced earlier this year.

On June 27, FDA Commissioner Robert Califf said in a statement that since the agency released its proposal, a cross section of agency professionals have been working to identify additional opportunities to boost operations within the new HFP and ORA. Listening to that feedback, he said the agency's thinking has “significantly broadened.”

“We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers," he said. "This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.”

Following recommendations from a working group and an external evaluation conducted by a panel of experts of the Reagan-Udall Foundation, FDA is proposing:

  • Establishing ORA’s core mission as conducting investigations, inspections and imports for all FDA-regulated products, with assignments planned in partnership with the HFP and other product programs or Centers. Under this proposal, the new Deputy Commissioner of Human Foods will oversee all budget and resource allocations for the entire Human Foods Program.  
  • Merging compliance functions currently managed within ORA into the HFP and the product Centers' existing compliance functions to streamline operations and expedite decision-making. 
  • Realigning ORA-managed Human and Animal Food laboratories into the HFP. 
  • Transitioning certain functions under the Office of Security and Emergency Management to ORA. 
  • Unifying state and local food safety partnership functions and certain aspects of the international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP. 
  • Reviewing support functions ORA-wide and proposing realignment of resources and personnel to support these changes. 
  • Prioritizing recruitment, retention and training opportunities for the agency's field-based employees. 

As part of the announcement, FDA has released high-level organization charts to reflect the proposed changes. The agency also said it is considering a renaming effort for ORA to ensure the office's title is aligned with the structure and functional duties of the agency's field operations.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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