In January 2023, the Food and Drug Administration announced plans to develop a reorganization proposal to create a “unified Human Foods Program and restructure its field operations,” it said.
The reorganization — which was approved in May 2024 and implemented today — aims to elevate the importance of nutrition, reduce diet-related diseases, strengthen state partnerships and embrace innovative food and agriculture technologies to more effectively regulate the nation’s food supply. The FDA had come under fire over its response to an infant formula shortage in 2022, sparking the program.
“This is really trying to address the silos that have existed at the FDA around food,” said David Lennarz, the president of business development and operations at Registrar Corp, a company that helps businesses meet FDA regulations, in an interview with Food Dive.
“We work with about 26,000 food companies around the world, so that means we are the point of contact between the FDA and these foreign food facilities, companies that are producing the food and exporting it. And so we’re privy to see some of the dysfunctions around inspections, for example,” he said.
Under the reorganization plan, the Human Foods program will take over the roles of the Center for Food Safety and Applied Nutrition and the Office of Food and Policy Response, along with the responsibilities of the Office of Regulatory Affairs, which is renamed the Office of Inspections and Investigations.
“I think time will tell if this really changes anything as far as how the industry is regulated. But the intention is good,” said Lennarz.
Regarding how exactly the FDA has been siloed, Lennarz said issues have mainly come up in transferring results from inspections into accurate data for the rest of the organization to see and understand.
Food executives should expect a greater enforcement of the Food Safety Modernization Act, which enables the FDA to design measures that prevent foodborne outbreaks from occurring, and be proactive in regulating the food industry.
Large CPGs and food retailers should also be prepared for more thorough inspection, according to Lennarz.
“We will start to see the FDA sending an email to companies, asking them about a specific entry of products that they imported into the U.S on a very specific shipment on a specific date, and asking them for evidence of their foreign supplier, and most companies are failing on that.”