FDA Updates Plan for Human Foods Program

In late June, FDA announced an update to its January 31 proposal to create a unified Human Foods Program (HFP), which includes a new model for the Office of Regulatory Affairs (ORA). The update aims to enhance coordination, prevention, and response activities across the agency.

Since the original announcement, a group of agency officials with expertise in different functional and operational areas has been working to identify additional opportunities to bolster operations within the new Human Foods Program and the ORA. The plan was informed by both the external evaluation conducted by an expert panel facilitated by the Reagan-Udall Foundation and the internal review of the agency’s infant formula supply chain response completed last year.

“This shift would allow us to fully realize the preventive vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen state partnerships, and embrace innovative food and agricultural technologies that will allow us to supply the nation—and the globe—with ample safe and nutritious food in the decades ahead,” an FDA spokesperson tells Food Quality & Safety.

Among the new recommendations are granting the new deputy commissioner for human foods oversight of all budget and resource allocations for the entire HFP, including ORA resources; merging compliance functions currently managed within ORA into the HFP to streamline operations and expedite decision making; realigning the eight human and animal food laboratories that are currently managed by ORA into the HFP; transitioning certain functions under the Office of Security and Emergency Management, currently in the Office of Operations, to ORA; and unifying state and local food safety partnership functions and certain aspects of international food safety partnerships into an Office of Integrated Food Safety System Partnerships in the HFP.

Matt Regusci, director of growth for ASI Food Safety, a St. Ann, Missouri-based food safety consulting and certification firm, notes that these updates are part of what food safety and consumer advocates have been asking for. “Many people will say that this move is great but doesn’t go all the way, as most want a full split and separate commissioner of human food—truly separating the food and drug administration,” he says. “Still, it is a huge step in the right direction. The consultation of departments under the addition of a new deputy commissioner of human foods would go a long way to increase the efficiency of dealing with outbreaks and saving human lives.”