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    February 1, 2023

    Major Changes at the FDA and What it Signals to Food Businesses

    2023 is poised to be an impactful year for the FDA, and FDA Commissioner Dr. Robert Califf ended the month of January with a major announcement. Read on to learn how this may impact food businesses and future food safety legislation.

    frank-yiannas-fdaIn a press release from the FDA, FDA Commissioner Dr. Robert Califf proposed significant changes to the Office of Regulatory Affairs, including a new director position, committees, and structure.

    These changes come just a few days after the announced departure of the FDA Deputy Commissioner for Food Policy and Response, Frank Yiannas, who will be vacating his position on February 24. Additionally, the administration has faced increased scrutiny due to the infant formula shortage and other food safety issues.

    As the FDA continues to hone in on whole-chain traceability, improving nutritional standards, and prioritizing consumer food safety, these changes could have significant impacts on future legislation or recall efforts. Let’s explore the memo.

    What Changed: New Direction, Committees, and Roles

    The largest proposed changes will be focused on the Office of Regulatory Affairs (ORA), which is the FDA’s field-based operation, and the new Human Foods Program. In summary, the press release addressed a few key changes:

    • Various functions across the FDA – the Center for Food Safety and Applied Nutrition (CFSAN), Office of Food Policy and Response (OFPR) and some functions under the ORA – will now be unified under the new organization of the Human Foods Program.
    • The Human Foods Program will be focused on keeping foods “safe and nutritious, while ensuring the agency remains on the cutting edge of the latest advancements in science, technology, and nutrition.”
    • The Human Foods Program will be led by a single director who reports to the head of the FDA. They are currently searching for a candidate to fulfill the role of Deputy Commissioner for Human Foods. Update: The FDA named James "Jim" Jones as the first Deputy Commissioner on August 23, 2023.
    • The Human Foods Program will have a new structure, including a Center for Excellence in Nutrition, an Office of Critical Foods, and an Office of Integrated Food Safety System Partnership, which will work closely and coordinate with state and local authorities across the country.
    • The FDA will create a new Human Foods Advisory Committee made up of external experts on food safety, nutrition, and technology to inform the direction and priorities of the Human Foods Program.

    Further details on these changes are still in development and more announcements may come at the end of February 2023.

    What Prompted These Changes?

    There are a few factors influencing this move from the FDA. In a press conference on the changes, Dr. Califf shared, “As I look at the 10-year horizon, I see threats from climate change, supply chain disruption and international strife. All these factors threaten our ability to provide Americans with safe, plentiful, and nutritious food.” However, outside influences were also at play.

    During the 2022-2023 infant formula shortages, the FDA faced serious scrutiny for its slow response to consumer concerns. As a result, both an internal and external investigate was launched looking into the processes, departments, and culture at the FDA that hindered their response. While the internal review found no individual was at fault but that it was a “systems problem,” the external review was more critical of the organization.

    As CNN shared: “The external review [from the Reagan-Udall Foundation] acknowledged that the food system in the US is generally recognized as safe but was highly critical of the FDA’s operations, noting a ‘lack of a single, clearly identified person’ to lead the food program and ‘constant turmoil’ that led to ‘indecisiveness and inaction.’”

    Dr. Califf mentioned the external review in the press release, stating, “The findings and recommendations from these reviews identified issues surrounding culture, structure, resources, and authorities. They also noted several areas of need, including modernizing data systems, providing more resources and authorities, improving emergency response systems, and building a more robust regulatory program.”

    Leaders’ Thoughts on FDA Changes and The New Era of Food Safety

    As mentioned, Frank Yiannas announced he would be stepping down from his role as Deputy Commissioner for Food Policy and Response at the FDA just five days before this press announcement.

    According to his departure letter, Yiannas also developed a critical lens on the current state of the FDA when the infant formula shortage first hit. He noted the decentralized structure of the FDA “significantly impaired the FDA’s ability to operate as an integrated food team and protect the public.” He saw completing the investigation on that shortage as his last successful project. He wrote:

    “I firmly believe the agency would operate more effectively and be better able to protect the American public from foodborne illness, with the creation of a more integrated operating structure and a fully empowered and experienced Deputy Commissioner for Foods, with direct oversight of those centers and offices responsible for human and animal foods. In this manner, she or he can more easily make the necessary changes that are needed to transform FDA’s Food Program for the 21st Century.” 

    While the changes at the FDA have positive intentions, time will tell how future recall efforts and food safety concerns are addressed. Brian Ronholm with Consumer Reports told CNN “the FDA’s plan fails to ensure all of the agencies food program staff will work together seamlessly with a common strategic direction, clear priorities, sound resource management, and internal accountability.”

    The FDA will no doubt continue to focus their efforts on food traceability and adopting their plan of a New Era of Food Safety into legislation. The finalization of FSMA 204 will help push the needle as more businesses adopt traceability recordkeeping requirements. Additionally, we may see future changes spurred on by the creation of The Human Foods Program, as they aim to improve food safety efforts and invest in technology.

    Hear from Industry Leaders at the Next FoodLogiQ Webinar

    Is your business preparing for FSMA 204’s recordkeeping requirements? Companies will need to adopt enhanced traceability recordkeeping by January 20, 2026, which isn’t something that can be done overnight.

    Luckily, leaders in the industry are already making changes and can offer tips and best practices to help other businesses make the transition. Join FoodLogiQ for our next webinar, with guests from Chick-fil-A and Beaver Street Fisheries, as they share their approach to traceability, how they work with supply chain partners, and how they capture, store, and share FSMA compliant data. 

    Webinar: FSMA 204: Lessons Learned from Leaders in Traceability
    Wednesday, February 22nd, 2023
    1:00 PM (ET) | 10:00 AM (PT)
    Watch On-Demand

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