SILVER SPRING, MD. — The Food and Drug Administration (FDA) has gained approval from the Department of Health and Human Services to proceed with a more than year-old reorganization plan that will create a unified Human Foods Program (HFP) to oversee the nation’s food supply chain and food safety.

With the move, announced May 30, the functions of the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR) — plus certain functions of the Office of Regulatory Affairs (ORA), the FDA’s field operations — will be brought under one program.

The FDA also will change the ORA’s name to the Office of Inspections and Investigations (OII), which the agency said will underscore that office’s role as “the frontline of the FDA.” The ORA’s restructuring is expected to enable the field operations unit to sharpen its focus on inspections, investigations and imports. In addition, the FDA will create a Center for Excellence in Nutrition and an Office of Integrated Food Safety System Partnerships.

Plans call for the reorganization to be implemented by Oct. 1. The FDA noted that offices and centers impacted by the reorganization are developing new processes and procedures for a smooth transition to the new structure.

“This is a distinctive moment for the FDA,” said Robert Califf, commissioner of the FDA. “I’m very pleased to see that after a year and a half of arduous work and effort put into this transformative vision for the FDA Human Foods Program and the architecture of the agency, we are a step closer to seeing the largest reorganization of the agency in recent history come to life this fall. This reorganization has been a major undertaking for the FDA, and I am proud of what we will be able to accomplish more efficiently and collaboratively to better meet our public health mandate.” 

The FDA said the reorganization will bolster its ability to oversee the human food supply and other products.

“The reorganization will enable the FDA to be more efficient, nimble and prepared for the ever-changing and complex industries we regulate, new food and medical product technologies, as well as the impacts of globalization, climate change and other factors that require the agency to quickly adapt,” the FDA said. 

A unified HFP, the FDA added, also will further its vision under the Food Safety Modernization Act; buttress local, state and international partnerships; and help the agency regulate innovative food and agricultural products more effectively. The FDA said the reorganization will boost its ability to respond to food-related emergencies, such as the 2022 infant formula shortages.

Last August, the FDA named Environmental Protection Agency (EPA) veteran James Jones as the HFP’s first deputy commissioner, and Jones started in his new post at the FDA on Sept. 24, 2023. At the EPA, his work focused on reducing the impact of chemicals and pollution on the US food supply.

The FDA’s reorganization plan came after Califf said in December 2022 that the agency would evaluate an expert panel’s recommendations to strengthen the food regulatory apparatus, which included proposals to separate the food and drug oversight functions. He made that announcement with the release of the Reagan-Udall Foundation’s Operational Evaluation of the FDA’s Human Foods Program report, commissioned by Califf in July 2022 and following a study by an independent expert group beginning in September 2022. The panel assessed the FDA’s culture, structure/leadership, resources and authorities and made suggestions to hone the agency’s regulatory function, tighten state and local government ties, and better secure the nation’s food supply. In 2022, the FDA also completed a separate internal review of its infant formula supply chain response.

The Consumer Brands Association applauded the upcoming implementation of the FDA’s plan for a unified HFP.

“The Consumer Brands Association commends the FDA for the approval of the Human Foods Program reorganization and other modernization actions,” said Sarah Gallo, vice president of product policy at the Arlington, Va.-based CBA. “The makers of America’s trusted household brands depend on the FDA to perform its regulatory role effectively, efficiently and transparently. Consumer Brands believes the FDA can, and must, move at the speed of the consumer using a modernized regulatory system to better provide for consumer safety and keep pace with rapidly evolving consumer preferences and growing opportunities to introduce innovative products to the marketplace. This will ultimately benefit the most important people whom the consumer packaged goods industry and FDA serve, American consumers. We look forward to continue working with the FDA under this new structure to bring safe food, beverage, household and personal care products to the marketplace.”