FDA reorganization gets green light

On Thursday, the FDA issued a press release to announce that it is officially undergoing a significant reorganization to modernize the agency and better fulfill its public health mission. According to the release, the reorganization will include:

• Creation of a unified Human Foods Program (HFP) that will consolidate functions from various offices to more effectively realize the preventive vision laid out in the FDA Food Safety Modernization Act, elevate the importance of nutrition, strengthen partnerships and regulate food and agricultural products more effectively.
• Restructuring of the Office of Regulatory Affairs (ORA) to be renamed the Office of Inspections and Investigations (OII), with a focus on inspections, investigations and imports as its core mission.
• The reorganization is aimed at making the FDA more efficient, nimble and prepared to adapt to the ever-changing and complex industries it regulates, new technologies and factors like globalization and climate change.
• The overall goal is to enhance the agency's ability to oversee and protect the human food supply and other products it regulates.

“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,” said FDA Commissioner Robert M. Califf, MD. “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.” 

According to the statement, the reorganization is slated to be implemented by October 1, 2024.

Commenting on the FDA’s publication of the new Food Center reorganization, United Natural Products Alliance (UNPA) senior political advisor Patricia Knight said, “While UNPA commends FDA Commissioner Califf and Center Director Jones for consulting with the dietary supplement industry on the necessary Food Center modernization, that consultation took place after the agency commissioned the foundational Reagan-Udall Foundation report upon which the reorganization was based. The RUF study explicitly did not embrace supplements…and it shows. 

“A major concern was, and is, the title of the new center, which refers to ‘chemical ingredients’ rather than ‘food ingredients’—a key shift in perspective which may well underlie FDA’s current perception of nutritional supplements, which are, by law, foods. UNPA joined other trades in asking that title be revised, and our request was rejected. Now, we must wait to see how the plan is implemented and if Congress provides adequate funding to make sure ODS does not become buried at the expense of other priorities. A key priority is assuring the consumer safety of key ingredients, many of which come from China,” Knight said. 

The Consumer Healthcare Products Association (CHPA) said that it congratulates FDA and thanks Deputy Commissioner Jones for taking the time to engage with CHPA throughout the reorganization process. 

“CHPA will continue to reiterate the importance of ensuring the dietary supplements category receives appropriate attention, authority and resources within the FDA and hopes this reorganization will increase the Agency’s operational agility so that it can more quickly respond to the evolving industries it regulates. We look forward to staying involved with FDA through the official implementation of the reorganization and beyond.” 

The Natural Products Association was less enthusiastic about the reorg, with NPA President and CEO Daniel Fabricant, PhD, saying he thinks the office is being put down a peg.

"It's not the office of DS anymore, it’s like the office of ‘stuff’," he said. "I think that's our concern. Six or seven years ago, Dr. Calliff said the program needed to be elevated, and now they've done a complete about face within seven years. Why?”

The Council for Responsible Nutrition is also not convinced the reorganization will benefit the dietary supplement industry: "While the FDA claims the reorganization aims to enhance efficiency, concern remains that the creation of new regulatory layers could complicate oversight without offering significant benefits," said Steve Mister, President & CEO of CRN. 

"As we have said previously, the proposed reorganization feels like a step backward. Since the establishment of the office in 2016, the industry has consistently lobbied Congress for increased funding, successfully more than doubling the budget for the Office of Dietary Supplement Programs to ensure more resources. And, while it remains underfunded, we were making progress by securing more attention, resources, and staffing for ODSP. It remains to be seen whether what is being proposed here will jeopardize or further that progress, but we remain committed to working with the agency under this new structure."

The FDA declined to comment on how the reorganization will impact ODSP.