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FDA Human Foods Food Safety Regulation

What will FDA’s Approved Reorganization Really Mean for the Industry?

A year and a half after “reimagining” a newly unified FDA, the agency’s Human Foods Program has been approved by the Department of Health and Human Services (HHS), targeted for Fall 2024 implementation. How will it change the regulation of the food industry?

To provide some background:

  • In February 2023, FDA created a vision for a “reimagined” Human Foods Program to address its internal structural and communication issues that came to light with the infant cronobacter outbreaks and formula crisis of 2021 and 2022 and were highlighted in both the Reagan-Udall Evaluation and FDA’s internal review. As a part of that plan, the new Deputy Commissioner for Human Foods position was developed and realignment plans were set.
    TAG’s Take: At that time, TAG expressed the hope that it would not be simply a “slow-moving government notion that will be outdated before it is implemented,” but that the infant formula crisis would ensure it retained momentum.
  • In January 2024, FDA published its Proposal for a Unified Human Foods Program and New Model for the Office of Regulatory Affairs, for which the overarching goal was “transforming the FDA to be more efficient, nimble and ready for the future.”
    TAG’s Take: At that time, TAG noted that we saw the proposed changes as both overdue and welcome, but expressed some concern about ensuring the leadership commitment to lead the culture change that will be required.
  • On May 30, 2024, FDA announced the approval of its reorganization that involved the creation of a unified Human Foods Program, with the reorganization implementation targeted for Oct. 1, 2024.
    TAG’s Take: While a year and half is not exactly lightning speed, it’s not bad for government. But conducting a reorganization and making it make a difference are two entirely different things.

So, with the new Human Foods Program having moved from imagination to approval, what is in the plan and what does it mean?

With a goal of making the agency “more efficient, nimble, and ready for the future,” FDA states that the approved Human Foods Program “would allow us to fully realize the preventive vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen local, state, and international partnerships, position the FDA to regulate innovative food and agricultural products more effectively, and uphold safety of the nation’s food supply.”

As such, key offices in the Human Foods would be:

  • Center for Food Safety and Applied Nutrition (CFSAN), with the Office of Cosmetics and Colors and functions from the Office of Regulatory Science moved out of CFSAN
  • Office of Food Policy and Response
  • Key functions from the Office of Regulatory Affairs (ORA) – retitled as Office of Inspections and Investigations (OII) – to include human foods compliance, human and animal food laboratories, and state partnerships. The new OII would also include the establishment of new offices to focus on inspections, investigations, and imports as its core mission.
  • Office of Critical Foods (OCF), as mandated by the Food and Drug Omnibus Reform Act of 2022, which will help to support oversight and regulation of infant formula and other critical foods and establish a critical foods cadre. 

We did, however, find it interesting that the plan included a lot that has nothing to do with food. Stating that the organizational changes will also impact medical products and cosmetics as collaboration will be enhanced across the FDA, it seems that the FDA has leveraged the food issue for other agency changes; that it has taken this opportunity to undertake lots of changes which will likely cause lots of disruption. This is particularly evident in the 33 of the 38 pages of the report which simply list who reports to whom.

Given all this, it is obvious that a lot of time and effort was put into the reorganization with the intent to make the agency more efficient, collaborative, and responsive to food-related emergencies. But with little definition of what will actually be changed with the realigned reporting structure, the work now begins for FDA to not only implement the realignment, but to ensure it makes a difference and enables the agency to make good use of its resources and become more efficient. 

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