FDA: Updates Restructured Human Foods Program, Withdrawing Aged Food Standards Rule

On Tuesday, the Food and Drug Administration (FDA) announced its progress on restructuring the Human Foods Program under the new Office of Integrated Food Safety Systems Partnerships which will consolidate some of the FDA’s other offices under one leadership role and streamline food safety operations internally and in the field.

The update officially announced the beginning of the hiring process for the newly created position, Deputy Commissioner for Human Foods, who will oversee the Office of Integrated Food Safety Systems Partnerships. This new arm of the FDA will incorporate the functions of the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and certain aspects of the Office of Regulatory Affairs (ORA) to more efficiently monitor and respond to food safety issues.

“We’ve heard loud and clear that the current resource distribution and operational model between the FDA’s regulatory programs and field operations are siloed and there’s too much duplication,” said FDA commissioner Robert M. Califf in a press release. “Both subject matter experts in the programs and the expertise of our investigators in the field will see more interaction as part of multidisciplinary teams that have clarity on who is in charge of making decisions.”

The FDA did not include a timeline or further details on the hiring of the Deputy Commissioner for Human Foods but Califf reported that the search is underway both internally and externally and the agency will be “making a selection for this important position as soon as possible.”

This has left some industry leaders “scratching our heads” about the direction of the FDA’s plan, said Consumer Brands Association VP of regulatory and technical affairs Roberta Wagner in a statement.

“At this point, he (Commissioner Califf) owes an explanation for his decision to outright refuse widespread calls from industry leaders, food policy experts, members of Congress and the expert panel review conducted at his request to elevate, integrate and unite the Foods Program under a fully empowered deputy commissioner for foods.”

Wagner went on to say that the “redesign plan favors business as usual instead of bold change” and leaves the food safety program “fragmented.”

The FDA’s Tuesday update came one month after the agency announced its plans to restructure the Human Foods Program stemming from two reports that criticized the its ability to target food safety issues and adequately address and remedy the problems.

In September, the FDA released a report evaluating its response to the infant formula shortage in 2022. The review was followed in December by a similar evaluation by private, nonprofit organization The Reagan-Udall Foundation which had been auditing the Human Foods Program for six months. That report highlighted the need for more funding and a centralized leadership structure to make the program more effective.

Also included in the update were the FDA’s plans to innovate the Human Foods Program through better FDA investigator training programs and overhauling the inspections and compliance oversight through the ORA. The update also addressed how the agency could improve its ability to conduct risk prioritization and risk management as well as modernizing the agency’s IT tracking by creating an “enterprise-wide platform for managing inspections and compliance activities.”

The FDA expects to finalize its plan by the Fall. The newly designed structure, budget and staffing requirements will have to go through a 30-day notification period in Congress to address questions from lawmakers before it is ready to be instituted fully.

FDA Tables Ineffective Food Standards Rule

In addition to the Human Foods Program update, the FDA also announced Tuesday that it was withdrawing the 2005 proposed rule, “Food Standards; General Principles and Food Standards Modernization.”

The rule was initially proposed jointly by the U.S. Department of Agriculture Food Safety and Inspection Service and the FDA to establish a set of general principles for food standards. These principles would help protect the public and inform consumers through honest identification of a food product’s content, production and standards of identification.

The nearly 20-year old rule was addressed during public meetings in July 2018 and September 2019 by stakeholders who told the FDA that “changes in manufacturing, food technology, market trends and nutrition science since 2005” make the food standards outdated.

The FDA went on to reopen the comment period in February 2020 and announced Tuesday that it will now “reconsider how best to approach general principles and food standards modernization to ensure any future revised general principles are consistent with the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Federal Food, Drug, and Cosmetic Act.”