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NewsContamination ControlRegulatoryChemicalFDAInspectionInternational Standards/Harmonization

FDA Budget Constraints Lead to International Information-Sharing for Chemical Safety Reviews

By Bailee Henderson
close-up of benjamin franklin face on US 100 dollar bill with FDA logo overlay

Image credit: ededchechine via Freepik

October 31, 2024

In an October 31, 2024 webinar hosted by the Alliance for a Stronger FDA, Jim Jones, Deputy Commissioner for Human Foods at the U.S. Food and Drug Administration (FDA), provided insight into the work and budget of the new Human Foods Program (HFP).

Mr. Jones overviewed the HFP Priority Program Deliverables for Fiscal Year (FY) 2025, which was published the day prior to the webinar and outlines the priority work objectives that FDA’s HFP intends to deliver upon within the next year. Read a detailed summary of the HFP FY 2025 Priority Program Deliverables here.

In a question-and-answer session, Mr. Jones provided new insights into the budgetary challenges of FDA’s HFP, and how these constraints affect HFP’s work.

Historically, surplus funds have been given to state public health agencies to conduct frontline inspections and other food safety work, but as of FY 2025, those surplus provisions will no longer be offered—resulting in what is effectively a 30 percent reduction in funds from FDA given to its state partners for food safety functions. When questioned about this budgetary challenge and how it will affect national food safety, Mr. Jones shared that FDA and state public health agencies are currently in discussions about how their limited funds could best be spent to ensure priority work is carried out. However, he also recognized that the challenge is regrettable, and shared that, although FDA is talking to appropriators and looking inside the agency for resources, he is “not optimistic” about the outcomes of either of those two strategies.

Aside from the reduction in available funding for state public health partners, which Mr. Jones called “budgetary shortfall number one,” he also mentioned other financial challenges affecting HFP’s three priority work areas, which include microbiological food safety, chemical safety, and nutrition. A major concern is the lack of money available to support FDA’s post-market chemical review efforts, an area which Mr. Jones says is “very under-resourced compared to what people hope [FDA] is able to do.”

However, he also expressed his confidence that assessments for several priority chemicals will be completed in FY 2025, and he shared that within the next couple of months, FDA’s list of chemicals under post-market review will include projected completion dates for the assessment of each substance.

Additionally, because FDA is so under-resourced, Mr. Jones said that the agency is collaborating with international and domestic regulatory and scientific counterparts like the European Food Safety Authority (EFSA), the California Environmental Protection Agency, Health Canada, Codex committees, and other authorities, to leverage chemical safety assessment work that has already been done. Such collaboration would not guarantee regulatory harmonization, said Mr. Jones, but it would help FDA to avoid starting from scratch on the assessments for many chemicals, and the agency would consider the data and findings of its regulatory counterparts.

A common criticism of FDA is that the agency permits chemicals in the U.S. food supply that are prohibited by EFSA and other regulatory agencies around the globe (for example, this point was made by lawmakers to support the recently passed California Food Safety Act, which bans some federally allowed food additives from foods sold or manufactured in the state of California). Although international collaboration is being pursued out of financial necessity, this criticism could be partially addressed in that the scientific research informing the regulatory decisions of other competent authorities will be considered in FDA’s chemical safety reviews.

KEYWORDS: budgets Human Foods Program

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Baileehendersonmay23

Bailee Henderson is the Digital Editor of Food Safety Magazine. She can be reached at hendersonb@bnpmedia.com.

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