FDA announces further updates on Human Foods Program

The FDA has given a further update on its proposed changes to its Human Food Program, including giving the future Deputy Commissioner for Human Foods complete oversight of the HFP’s budget and resource allocation.

“With a human food landscape that is rapidly evolving as consumer preferences, products, and manufacturing processes grow increasingly complex and public health needs increase, the FDA must build a stronger Human Foods Program and Office of Regulatory Affairs. Earlier this year the FDA announced steps to modernize and streamline our food program, including field operations, to address these mounting challenges,” said FDA Commissioner Robert M. Califf, M.D.

“Listening closely to feedback provided by employees and stakeholders, our thinking has significantly broadened. We know that in front of us is a once-in-a-generation opportunity to unify our field work with the priorities of program offices and Centers.

“This is why I’m proposing a number of additional changes to ORA, including moving several of the office’s laboratories and merging its current compliance functions into those of the new HFP and other agency product Centers. These proposed changes are designed to help ensure the most strategic use of resources to meet the demands of our increasingly complex public health mission.”

Based on recommendations from the working group and from an external evaluation conducted by an expert panel of the Reagan-Udall Foundation, the FDA has announced that:

• The new Deputy Commissioner for Human Foods will have oversight of all budget and resource allocations for the entire HFP, including ORA resources.
• Merging compliance functions currently managed within ORA into the HFP and the product Centers’ existing compliance functions to streamline operations and expedite decision-making.
• Realigning the eight Human and Animal Food laboratories that are currently managed by ORA into the HFP. These eight labs will team up with the four labs in the FDA’s current Center for Food Safety and Applied Nutrition to form a unified food laboratory enterprise under the HFP. The labs will report to a member of the executive leadership team under the Deputy Commissioner for Human Foods, who will work closely with the Chief Scientist and Center for Veterinary Medicine (CVM) director to coordinate on research priorities. These labs will remain open and in the same geographic location under the proposal.

“I believe these proposed changes will result in a new structure that is more nimble, better equipped to prevent and respond to emergencies, like recalls, and enhance the agency’s ability to align inspection resources with our Center and program priorities while also supporting our employees and the public we serve,” added Commissioner Califf.

“We will continue to evaluate and make adjustments as we work closely with experts throughout the agency to revamp and enhance our field operations.”

The reaction from the industry has been largely positive to this news. Sarah Gallo, Vice President of Product Policy, said: “Consumer Brands supports a Human Foods Program overhaul that will allow the FDA to move at the speed of the consumer.

“We are pleased the FDA is taking bolder action to make meaningful and lasting change by answering informed industry and stakeholder calls to unite and elevate the Human Foods Program and fully authorise the deputy commissioner with control over its strategic direction. This includes complete authority over the budget, as well as the responsibility to execute a common mission throughout all components, including the animal foods program. We are also encouraged that the FDA plans to address areas of duplication and refocus the Office of Regulatory Affairs (ORA) on its core business, inspections and investigations. Consumer Brands will remain engaged as this important process proceeds and the search for a new Foods Program leader continues. We thank Commissioner Califf for taking another significant and necessary step toward transforming the agency into one that is properly equipped to ensure consumer safety and meet rapidly evolving consumer demand.”

Despite this announcement, the FDA is yet to appoint a new Deputy Commissioner after Frank Yiannas stepped down back in January.